GAMMAGARD LIQUID

  • GAMMAGARD LIQUID

  • QTY 300 • 10 % • VIAL • Near 77381

IMMUNE GLOBULIN (im MUNE  GLOB yoo lin) helps to prevent or reduce the severity of certain infections in patients who are at risk. This medicine is collected from the pooled blood of many donors. It is used to treat immune system problems, thrombocytopenia, and Kawasaki syndrome.\n \nThis medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

GAMMAGARD LIQUID Pediatric Monographs

  • General Administration Information
    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Injectable Administration
    -Titers against specific antigens vary between manufacturers. Due to this variance, some clinicians feel strongly that IVIG products are not equivalent.
    -Prior to administration, ensure that the patient is adequately hydrated. Assess the patient for any risk factors for thrombosis. For patients at risk of thrombosis receiving IVIG, administer at the minimum concentration available and the slowest rate of infusion practicable. Monitor all patients carefully for signs and symptoms of thrombosis; thrombosis can occur even in the absence of risk factors.
    -Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    Intravenous Administration
    -Administer by a separate infusion line. Do not mix with other medications, fluids, or blood products. Do not mix different IVIG products.
    -Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur; headache, nausea, vomiting, flushing, pulse rate, and blood pressure changes may be related to the rate of infusion. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
    -Begin infusions at a low rate and gradually increase if patients are receiving IVIG for the first time, if there has been a prolonged interval between doses, or a different brand is used. Adverse reactions are more likely to occur in these situations.
    -Ensure patients with pre-existing renal insufficiency are not volume depleted.

    Alyglo
    -Alyglo is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter. Do not use any solution that has been frozen, heated, or shaken.
    -Allow refrigerated product to come to room temperature before use and maintain at room temperature during administration.
    -No reconstitution is necessary.
    -Do not dilute
    -If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags. Discard any unused product; each vial is single-use only. Infuse within 24 hours after pooling.
    -Infuse using a separate infusion line. Do not mix with other IVIG products or other intravenous medications or fluids.
    -For the first infusion, the recommended initial infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If tolerated, double the infusion rate every 30 minutes up to 8 mg/kg/minute (0.08 mL/kg/minute). The initial rate for the second infusion may be started at 2 mg/kg/minute (0.02 mL/kg/minute). If tolerated, double the infusion rate every 15 minutes up to 8 mg/kg/minute (0.08 mL/kg/minute).
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Asceniv

    -Asceniv is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter. Do not use any solution that has been frozen, heated, or shaken.
    -Allow refrigerated product to come to room temperature before use and maintain at room temperature during administration.
    -No reconstitution is necessary.
    -Do not dilute.
    -If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute for 15 minutes; if tolerated, increase gradually every 15 minutes to a maximum rate of 8 mg/kg/minute.
    -For patients at risk of developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Consider discontinuation if renal function deteriorates.
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Bivigam 10%
    -Do not dilute.
    -Bivigam is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid. Do not use any solution that has been frozen, heated, or shaken.
    -Allow product to come to room temperature before use.
    -If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute for 10 minutes; if tolerated, increase by 0.8 mg/kg/minute every 20 minutes to a maximum rate of 6 mg/kg/minute.
    -For patients at risk of developing renal dysfunction or thromboembolic events, use the minimum practicable concentration and infusion rate. Consider discontinuation if renal function deteriorates.
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Carimune NF
    -Reconstitute with Sterile Water for Injection, 5% Dextrose Injection, or 0.9% NaCl Injection according to the manufacturer's directions. To aid in dissolution, vigorously swirl the vial; avoid shaking and foaming. Dissolution may take up to 20 minutes.
    -Use a 3% IVIG solution for the first infusion to previously untreated patients with either agammaglobulinemia or hypogammaglobulinemia; higher concentrations may be used for subsequent infusions if the initial infusion is well tolerated. A 6% solution is recommended for patients with ITP.
    -The solution should be clear. Do not use if the solution has been frozen.
    -Bring to room temperature prior to administration.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute; if tolerated, increase to 1 mg/kg/minute after 30 minutes. Thereafter, gradually increase the infusion in a stepwise manner as tolerated every 30 minutes to a maximum rate of 3 mg/kg/minute.
    -Patients at risk of developing renal dysfunction or thromboembolic events should not exceed a rate of 2 mg/kg/minute. For patients at risk of acute renal failure, use the minimum practicable concentration and infusion rate.
    -Filtering is not necessary, but if used, a pore size of 15 microns or larger will be less likely to slow infusion, especially with higher solution concentrations; 0.2 micron antibacterial filters may be used.
    -Storage: Solutions are stable for 24 hours under refrigeration if reconstituted in a sterile laminar flow hood. Otherwise, use promptly and discard unused portions.

    Flebogamma DIF 5% or 10%
    -Do not dilute.
    -Do not use if the solution is cloudy, turbid, or has been frozen.
    -If large doses of Flebogamma are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags. Discard any unused product; each vial is single-use only.
    -For the 5% product, the recommended initial infusion rate is 0.5 mg/kg/minute for 30 minutes; if tolerated, gradually increase to a maximum rate of 5 mg/kg/minute. Patients at risk of developing renal dysfunction or thromboembolic events should not exceed a rate of 3 mg/kg/minute; use the minimum practicable infusion rate.
    -For the 10% product, the recommended initial infusion rate is 1 mg/kg/minute for 30 minutes; if tolerated, gradually increase to a maximum rate of 8 mg/kg/minute. Patients at risk of developing renal dysfunction or thromboembolic events should not exceed a rate of 4 mg/kg/minute; use the minimum practicable infusion rate. For patients experiencing adverse drug reactions, reduce the infusion rate in subsequent infusions or administer at the 5% concentration. Consider product discontinuation if renal function deteriorates.
    -Storage: Protect from light. Vials are for single use only; use promptly and discard any unused portion immediately.

    Gammagard Liquid 10%
    -Gammagard Liquid is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid. Do not use any solution that has been heated, shaken, or frozen.
    -Allow refrigerated product to come to room temperature before use; this may take up to 1 hour.
    -No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% NaCl Injection.
    -Use of an in-line filter is optional. The infusion line may be flushed with 0.9% NaCl Injection.
    -The recommended initial IV infusion rate is 0.8 mg/kg/minute for 30 minutes; if tolerated, gradually increase rate every 30 minutes to a maximum of 8 mg/kg/minute.
    -For patients at risk of developing renal dysfunction or thromboembolic events, use the minimum practicable concentration and infusion rate; do not exceed 3.3 mg/kg/minute. Consider discontinuation if renal function deteriorates.
    -Storage: Protect from light. Vials are for single use only; use promptly and discard any unused portion immediately.

    Gammagard S/D
    -Allow the lyophilized powder and diluent to come to room temperature before reconstitution. Do not use any product that has been frozen.
    -Of note, Gammagard S/D can be reconstituted to make a 5% or 10% solution. Consult the package insert for specific directions.
    -After addition of the diluent, immediately swirl the solution until the product is completely dissolved. Do not shake. Avoid foaming.
    -The solution should be clear to slightly opalescent and colorless to pale yellow; do not use if there is discoloration.
    -Allow the reconstituted solution to come to room temperature before use. It is recommended that the antecubital vein is used, especially for the 10% solution to reduce discomfort at the infusion site.
    -The recommended initial IV infusion rate for the 5% solution is 0.5 mL/kg/hour; if tolerated, gradually increase the rate to a maximum of 4 mL/kg/hour.
    -Patients who tolerate the 5% solution at 4 mL/kg/hour can be infused with the 10% solution starting at 0.5 mL/kg/hour; if tolerated, gradually increase the rate to a maximum of 8 mL/kg/hour.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate; maximum infusion rate should be less than 2 mL/kg/hour for a 10% solution and less than 4 mL/kg/hour for a 5% solution.
    -Storage: Use within 2 hours of reconstitution if prepared outside a sterile laminar air flow hood. The reconstituted product may be stored at 2 to 8 degrees C for up to 24 hours if prepared in a sterile laminar air flow hood. Otherwise, use promptly and discard unused portions.

    Gammaked 10%
    -Gammaked is a clear, colorless to pale yellow solution; do not use if the solution is cloudy or turbid. Do not use any solution that has been shaken or frozen.
    -Allow refrigerated product to come to room temperature before use; this may take up to 1 hour.
    -Use an 18 gauge needle to penetrate the stopper for the 10 mL vial; use a 16 gauge needle or dispensing pin for vials 25 mL or more. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    -No reconstitution is necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% NaCl Injection.
    -The infusion line may be flushed with 5% Dextrose Injection or 0.9% NaCl Injection.
    -The recommended initial IV infusion rate is 1 mg/kg/minute; if tolerated, gradually increase the rate to a maximum of 8 mg/kg/minute.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Consider discontinuation if renal function deteriorates.
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Gammaplex 5%
    -Gammaplex is a clear to slightly opalescent, colorless solution; do not use if the solution is cloudy or turbid. Do not use any solution that has been shaken or frozen.
    -Allow refrigerated product to come to room temperature before use.
    -Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 2 hours after pooling.
    -Infuse using an infusion set preferably fitted with an in-line 15 to 20 micron filter.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute for 15 minutes; if tolerated, gradually increase rate every 15 minutes to a maximum of 4 mg/kg/minute.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Discontinue the infusion if renal function deteriorates.
    -Storage: Protect from light. Vials are for single use only; use promptly and discard any unused portion immediately.

    Gamunex-C
    -Gamunex-C should be a clear to opalescent and colorless to pale yellow solution; do not use if turbid or discolored. Do not use any solution that has been frozen or shaken.
    -Allow refrigerated product to come to room temperature before use.
    -No reconstitution is necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection.
    -Use an 18 gauge needle to penetrate the stopper for the 10 mL vial; use a 16 gauge needle or dispensing pin for vials 25 mL or more. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    -Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
    -The infusion line may be flushed with 5% Dextrose Injection or 0.9% NaCl Injection.
    -The recommended initial IV infusion rate is 1 mg/kg/minute; if tolerated, gradually increase the rate to a maximum of 8 mg/kg/minute.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Discontinue the infusion if renal function deteriorates.
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Octagam 5%
    -Do not use if the solution is turbid or discolored. Do not use any solution that has been frozen.
    -Allow refrigerated product to come to room temperature before use.
    -No reconstitution necessary; Octagam should not be diluted.
    -Use no larger than a 16 gauge needle. Do not insert the needle more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    -Promptly administer the solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
    -The infusion line may be flushed with 5% Dextrose Injection or 0.9% NaCl Injection.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute for 30 minutes; if tolerated, increase to 1 mg/kg/minute for the second 30 minutes and then 2 mg/kg/minute for the third 30 minutes. Do not exceed 3.33 mg/kg/minute.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Discontinue the infusion if renal function deteriorates.
    -Storage: Vials are for single use only; use promptly and discard any unused portion immediately.

    Panzyga
    -No reconstitution necessary. Do not use if cloudy, turbid, contains particles, or was previously frozen.
    -Bottles may be pooled under aseptic conditions into sterile infusion bags and administered within 8 hours after pooling.
    -Throw away any unused product, as it does not contain preservatives. Each vial is single-use only.
    -If an in-line filter is used, the pore size should be 0.2 to 200 microns.
    -After administration, line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection. Recommended initial IV infusion rate for primary immunodeficiency is 1 mg/kg/minute (0.01 mL/kg/minute). If infusion is well tolerated, gradually increase to 8 mg/kg/minute (0.08 mL/kg/minute) in patients using it for the first time or more than 8 weeks since a prior treatment and 12 to 14 mg/kg/minute (0.12 to 0.14 mL/mg/minute) in experienced patients. Recommended initial IV infusion rate for chronic ITP is 1 mg/kg/minute (0.01 mL/kg/minute). If well tolerated, gradually increase to 8 mg/kg/minute (0.08 mL/kg/minute).
    -Titration to a maximum rate of less than 3.3 mg/kg/minute (0.033 mL/kg/minute) is recommended for patients who are at risk of renal dysfunction or thrombotic complications. Consider discontinuation if renal function deteriorates.

    Privigen
    -Privigen is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid. Do not use any solution that has been frozen or shaken.
    -Allow refrigerated product to come to room temperature before use.
    -No reconstitution is necessary. If dilution is desired, use 5% Dextrose Injection.
    -Promptly administer the solution after piercing the cap. If large doses are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 8 hours after pooling.
    -The infusion line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
    -The recommended initial IV infusion rate is 0.5 mg/kg/minute. For ITP, if well tolerated, gradually increase the infusion to 4 mg/kg/minute. Patients receiving IVIG for primary immunodeficiency may receive rates up to 8 mg/kg/minute as tolerated.
    -For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Discontinue the infusion if renal function deteriorates.
    -Storage: Protect from light. Vials are for single use only; use promptly and discard any unused portion immediately.

    Subcutaneous Administration
    Gammagard Liquid 10%
    -Gammagard Liquid may be given by subcutaneous infusion using a subcutaneous infusion pump.
    -Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    -Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear or slightly opalescent, colorless to pale yellow. Do not shake.
    -If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach ambient room temperature. Do not heat the product; the vials may take up to 1 hour to reach room temperature.
    -Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. If using a vented spike, it is not necessary to inject air into the vial. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    -Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    -Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    -Injection sites include the abdomen, thighs, upper arms, and/or lower back. Avoid bony areas, visible blood vessels, scars, and areas of inflammation, irritation, or infection. Rotate the injection site with each weekly administration. New infusion sites should be at least 2 inches from a previous site.
    -Select the number of infusion sites based on the volume of the total dose.-Patients weighing 40 kg and greater: Do not exceed a volume of 30 mL per site. Determine the number of required infusion site by dividing the total weekly dose (mL) by 30. Do not exceed a total of 8 simultaneous infusion sites.
    -Patients weighing less than 40 kg: Do not exceed a volume of 20 mL per site. Do not exceed a total of 8 simultaneous infusions sites.

    -Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of a multi-needle administration set. Injection sites should be at least 2 inches apart.
    -Firmly pinch at least 1 inch of skin between two fingers and insert the needle at a 90-degree angle subcutaneously using rapid motion. Tape the needle into place. Repeat the steps for each injection site.
    -Before starting infusion, ensure correct needle placement. Attach a sterile syringe to the end of the infusion tubing, and pull the plunger back gently. If you see blood in the tubing, take the needle out of the injection site, and throw away the tubing and needle. Try a different site with new infusion tubing and a new needle.
    -Secure needle(s) placement by placing a sterile, clear bandage over the needle. Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
    -Initial and maintenance infusion rates:-Patients weighing 40 kg and greater: Initial subcutaneous infusion rate is 20 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 30 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 30 mL/hour/site, then 30 mL multiplied by 4 sites would be 120 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 240 mL/hour.
    -Patients weighing less than 40 kg: Initial subcutaneous infusion rate is 15 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 20 mL/hour/site, then 20 mL multiplied by 4 sites would be 80 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 160 mL/hour.

    -To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    -After infusion completion, remove clear bandage and needle(s). If needed, gently press a small piece of gauze over the injection site and cover with a protective dressing.
    -Instruct patients or patient's parent/caregiver to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    -Storage: Protect vials from light by storing in their original boxes. Unopened Gammagard vials may be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 36 months or at a room temperature up to 25 degrees C (77 degrees F) for up to 24 months. Both the vial and carton labels contain the refrigerator and room temperature expiration dates. Once a vial has been stored at room temperature, do not refrigerate again. Do not freeze.

    Gammaked
    -Gammaked may be administered subcutaneously for the treatment of primary immunodeficiency.
    -Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    -Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    -If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 1 hour to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
    -Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. If using a vented spike, it is not necessary to inject air into the vial. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    -Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    -Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    -Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing. Injection sites should be at least two inches apart.
    -Select the number of infusion sites based on the volume of the total dose.
    -Pediatric patients weighing 25 kg and greater: Do not exceed a volume of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    -Pediatric patients weighing less than 25 kg: Do not exceed a volume of 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.

    -Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
    -Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
    -Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
    -If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
    -Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
    -Initial and maintenance infusion rates:
    -Pediatric patients weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    -Pediatric patients weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.

    -To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    -After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
    -Instruct patients or the patient's parent/caregiver to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    -Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.

    Gamunex-C
    -Gamunex-C may be administered by subcutaneous infusion for the treatment of primary immunodeficiency.
    -Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    -Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    -If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 1 hour to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
    -Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. If using a vented spike, it is not necessary to inject air into the vial. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    -Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    -Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    -Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing.
    -Injection sites should be at least two inches apart.
    -Select the number of infusion sites based on the volume of the total dose.-Pediatric patients weighing 25 kg and greater: Do not exceed a volume of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    -Pediatric patients weighing less than 25 kg: Do not exceed a volume of 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.

    -Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
    -Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
    -Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
    -If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
    -Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
    -Initial and maintenance infusion rates:
    -Pediatric patients weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    -Pediatric patients weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.

    -To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    -After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
    -Instruct patients or patient's parent/caregiver to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    -Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.

    Adverse reactions are reported in approximately 2% to 25% of all IVIG infusions. The majority of adverse reactions associated with IVIG are minor, transient, and infusion-related. However, serious systemic reactions affecting renal, cardiovascular, central nervous system, integumentary, and hematological systems have been reported. Potential risk factors affecting the risk and intensity of adverse events include underlying condition and pre-existing cardiovascular or renal disease, as well as IVIG formulation, lot number, dose, concentration, and rate of infusion. Conservative product-specific infusion rates should be initiated and patients should be monitored closely throughout each infusion. Particular care should be taken when patients are IVIG-naive, IVIG products have been substituted, or there has been more than 8 weeks delay in therapy.

    Transfusion-related acute lung injury (TRALI) is a life-threatening and potentially fatal complication of blood product administration; it has rarely been reported after IVIG administration. TRALI is characterized by severe respiratory distress, hypoxemia (hypoxia), fever, normal left ventricular function, and severe non-cardiogenic pulmonary edema. Symptoms typically begin 1 to 2 hours after administration and manifest fully within 1 to 6 hours. The clinical presentation may be subtle or significant. Radiographs show bilateral pulmonary infiltrates without evidence of cardiac compromise or fluid overload. Respiratory support may be necessary. Diuretics are not effective in TRALI as the cause involves microvascular injury, rather than fluid overload. The etiology of TRALI may be attributable to the presence of anti-HLA antibodies and/or anti-granulocyte antibodies in the plasma of multiparous females or donors who have received previous transfusions who serve as donors for the plasma-derived product. Recipients of IVIG should be monitored for pulmonary adverse events. If TRALI is suspected, both the product and the patient need to be tested for the presence of anti-neutrophil and anti-HLA antibodies.

    Immune globulin is derived from human plasma. Based on effective donor screening and product manufacturing processes, IVIG carries an extremely remote risk of transmission of viral infection or disease. A theoretical risk for transmission of Creutzfeldt-Jakob disease also is considered to be extremely remote. Before prescribing IVIG, discuss the risks and benefits of its use with the patient. Infectious events reported during IVIG therapy include bronchitis, upper respiratory tract infection, fungal infection, viral infection, otitis media, urinary tract infection, and vaginal candidiasis.

    Respiratory adverse reactions, including cough/increased cough (5% to 54%), epistaxis (5% to 23%), pharyngitis (2% to 41%), nasopharyngitis (22%), rhinitis (4% to 51%), asthma (15% to 29%), pharyngolaryngeal pain (6%), nasal congestion (6% to 52%), sinusitis (6% to 50%), sore throat, rhinorrhea (7% to 17%), sinus congestion, post-nasal drip, sinus pain, respiratory tract congestion (7%), upper respiratory tract infection (8% to 22%), bronchitis (5% to 20%), influenza (1% or less), oropharyngeal pain, cyanosis, throat irritation (6% to 7%), acute otitis media (8% of pediatric patients), tonsillar disorder (8% of pediatric patients), painful respiration, hypoxemia, apnea, hyperventilation, throat tightness, and acute respiratory distress syndrome (ARDS), have been reported with the use of immune globulin. Wheezing (3% to 14%), dyspnea (8% in pediatric patients), and bronchospasm have also occurred and may be associated with immune globulin infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these reactions.

    Nausea (5% to 67%), vomiting (6% to 42%), and diarrhea (5% to 28%) are commonly reported adverse reactions associated with immune globulin. Necrotizing enterocolitis (NEC) has been associated with high-dose immune globulin used for isoimmune hemolytic disease in preterm and term neonates. Other gastrointestinal adverse reactions reported include abdominal pain or cramps (15% or less), dyspepsia (6% to 9%), stomach discomfort (6%), gastroenteritis (9% to 22%), gastroesophageal reflux (7%), and toothache (dental pain). Of note, vomiting was reported more frequently in pediatric patients vs. adult patients during clinical trials of immune globulin for primary immunodeficiency. Nausea, vomiting, abdominal pain/cramping, and loss of appetite (anorexia) may be associated with immune globulin infusion; slowing or stopping the infusion as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms.

    Renal dysfunction, including oliguria, anuria, acute renal failure (unspecified), osmotic nephrosis (osmotic nephropathy), acute renal tubular necrosis, and proximal tubular nephropathy, and death have been reported in patients receiving IVIG. Increases in BUN (azotemia) and serum creatinine have been observed as soon as 1 to 2 days after infusion of IVIG. Progression to oliguria and anuria requiring dialysis has been observed; although, some patients have spontaneously recovered following cessation of treatment. Renal histopathologic examination suggested an osmotic injury to the proximal renal tubules (acute renal tubular necrosis, proximal tubular nephropathy, vacuolar degeneration, and osmotic nephrosis). Renal dysfunction is more common with the use of IVIG products containing sucrose as a stabilizer. Use IVIG with caution in patients at risk for developing renal dysfunction, including those with any pre-existing degree of renal insufficiency or renal disease, sepsis, paraproteinemia, diabetes mellitus, hypovolemia, dehydration, obesity, or concomitant use of nephrotoxic agents. Especially in such patients, use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate. Ensure patients are not volume depleted prior to IVIG administration. Monitor renal function, including BUN, serum creatinine, and urine output at baseline and appropriate intervals thereafter. If renal function deteriorates, consider IVIG therapy discontinuation. Dysuria, cystitis, or urinary tract infection was reported in 5% of patients who received Gammaplex. There are postmarketing reports of renal pain with IVIG therapy.

    Nervous system or psychiatric adverse events have been reported during the use of immune globulin. Headache (8% to 92%), dizziness (4% to 13%), and anxiety may be associated with the immune globulin infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Other adverse events reported with immune globulin use include insomnia (6% to 9%), agitation, migraine (7%), restlessness, tremor, hypoesthesia, paresthesias, coma, encephalopathy, loss of consciousness, confusion, nervousness, depression (6%), dysarthria (speech disorder), lethargy, and seizures.

    Aseptic meningitis syndrome (AMS) may rarely occur after IVIG therapy. Signs and symptoms appear within several hours to 2 days and include severe head pain, nuchal rigidity, drowsiness, pyrexia, photophobia, painful eye movements, and emesis. AMS may be more frequent after high-dose (more than 1,000 to 2,000 mg/kg/dose) or rapid-infusion IVIG treatment. Patients with a history of migraine may be at higher risk for this complication of IVIG. Patients presenting with signs and symptoms should undergo a thorough neurological evaluation, including cerebrospinal fluid (CSF) studies; the CSF is often positive for pleocytosis and elevated protein levels, with negative culture results. Discontinuation of IVIG treatment may result in remission of AMS within several days without sequelae.

    Thrombotic events, such as thromboembolism, myocardial infarction, cerebrovascular accident (stroke), transient ischemic attack, thrombophlebitis, deep vein thrombosis, vena cava thrombosis, arterial thrombosis, retinal thrombosis, and pulmonary embolism, have been reported with IVIG. Signs and symptoms of thrombosis include numbness or weakness (paresis) on one side of the body, pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, chest pain/discomfort, and unexplained tachycardia. Thrombosis may occur regardless of the route of administration and in the absence of known risk factors; however, patients at highest risk for thrombotic events include those with multiple cardiovascular risk factors, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, diabetes mellitus, obesity, thrombophilic disorders, a history of vascular disease, a history of atherosclerosis, a history of a previous thromboembolic event, use of estrogens, indwelling catheters, and/or known or suspected hyperviscosity. Ensure that patients are not volume depleted prior to the initiation of IVIG. For patients judged to be at risk for developing thrombotic events, use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate. Monitor all patients receiving IVIG during and after each infusion and encourage patients to report any signs and symptoms of thrombosis.

    Ecchymosis (40%), purpura (40%), bleeding/hemorrhage (29%), petechiae (21%), and thrombocytopenia (15%) have been reported during clinical trials of IVIG for the treatment of idiopathic thrombocytopenic purpura (ITP). Other coagulation/lymphatic effects reported with IVIG use include anemia (6% to 11%), decreased hematocrit (5%), decreased hemoglobin, pancytopenia, leukopenia, autoimmune pure red cell aplasia exacerbation, hemoglobinuria, hematuria, chromaturia, and lymphadenopathy (7%).

    Antibodies present in IVIG may act as hemolysins and induce immunoglobulin adherence to red blood cells, causing a positive direct antiglobulin test (DAT, Coombs' test), and rarely, hemolysis. Acute hemolysis consistent with intravascular hemolysis, severe hemolysis-related renal dysfunction/failure, and disseminated intravascular coagulation (DIC) have been reported with IVIG therapy. In addition, delayed hemolytic anemia can develop after IVIG therapy due to enhanced red blood cell sequestration; cases have generally been reversible. Hemolytic events not associated with a positive DAT have also been observed in clinical trials. Risk factors related to the development of hemolysis include high doses (2,000 mg/kg or more) as a single infusion or divided over several days, and non-O blood type. An underlying inflammatory state reflected by elevated C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) may also contribute to the risk of hemolysis, however the role is uncertain. Monitor patients receiving immune globulin for hemolysis and hemolytic anemia. In high risk patients, consider appropriate lab testing, including hemoglobin and hematocrit prior to therapy and 36 to 96 hours after infusion. If signs and symptoms of hemolysis are present after the infusion, perform confirmatory lab testing. If a transfusion is indicated, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.

    Anaphylactoid reactions, including angioedema, facial edema, and anaphylactic shock, have been reported with IVIG use. Patients who are IgA deficient and have known antibodies to IgA may be at greater risk for developing severe hypersensitivity reactions. Epinephrine should be immediately available during IVIG infusions. If a hypersensitivity reaction occurs, immediately discontinue the infusion.

    An injection site reaction (5% to 15%), characterized by erythema, pain, irritation/burning, pruritus, edema, and swelling, has occurred with immune globulin infusion. Phlebitis, including thrombophlebitis, has also been reported. Local reactions tend to be more common after hand vein infusions with higher concentrations of immune globulin solution (i.e., 10% solution vs. 5% solution); incidence may be reduced by administering immune globulin via the antecubital vein. Local reactions may also be common with subcutaneous infusion, particularly during the first week of infusion. Local reactions were reported in nearly 60% of subcutaneous infusions, and 100% of pediatric patients (n = 11) during clinical trials; incidence rates were similar in adolescent and adult trials (60% of infusions, 75% of patients). The incidence of local reactions may decrease with time in patients receiving chronic infusions. If local reactions occur, application of a warm compress to the infusion site may alleviate symptoms.

    Dermatologic adverse reactions, such as urticaria or hives, pruritis, and rash, have been reported in approximately 5% to 12% of patients receiving IVIG infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Stevens-Johnson syndrome, epidermolysis, bullous dermatitis/bullous rash, allergic dermatitis (6%), contact thermal burn or abrasion (7%), eczema or atopic dermatitis, dry skin or xerosis (5% to 9%), maculopapular rash, alopecia, skin exfoliation, and erythema multiforme have also been associated with the use of IVIG.

    Hyperproteinemia, increased serum viscosity, hyponatremia, and fluid overload may occur in patients receiving IVIG therapy. The hyponatremia is likely to be a pseudohyponatremia as demonstrated by a decreased calculated serum osmolality or elevated osmolar gap. Distinguishing between true hyponatremia and pseudohyponatremia is important since treatment aimed a decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, further increased serum viscosity, and a disposition to thromboembolic events.

    Musculoskeletal pain (5% to 25%), arthralgia (9.4% or less), back pain (4% to 17%), neck pain (6%), extremity pain (5%), fibromyalgia, myalgia (5% to 6%), muscle cramps or spasms (7%), muscle strain, and muscular weakness or myasthenia have been reported with immune globulin use. Accidental injury (13%) has also been reported. Musculoskeletal adverse events such as arthralgia, myalgia, back pain/backache, muscle cramps, and flu-like symptoms may be associated with IVIG infusion reaction; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Synovitis/tenosynovitis, joint swelling/effusion (6%), bursitis, chondromalacia patellae, epicondylitis, joint sprain, and trigger finger have been reported during clinical trials of IVIG.

    Otalgia (earache/pain 18%) has been reported in patients receiving IVIG. Ocular adverse events reported with IVIG include conjunctivitis (9% to 13%), ocular discharge (7%), ocular irritation (7%), ocular pain, and visual impairment/disturbance.

    Elevated hepatic enzymes and hepatic dysfunction have been reported with the use of IVIG. Elevations in AST (7% to 13%), ALT (7% to 18%), alkaline phosphatase (3%), and lactate dehydrogenase (5%) have occurred. Elevations in AST and ALT are generally mild (less than 3 times upper limit of normal), transient, and not associated with symptoms of liver disease. Hyperbilirubinemia (5.3%) and increases in unconjugated bilirubin (9% to 11%), conjugated bilirubin (9%), and total bilirubin (7%) were all noted during clinical trials. Jaundice and non-infectious hepatitis have been reported postmarketing.

    Infusion-related reactions are common during IVIG administration. Symptoms typically begin 30 minutes to 1 hour after initiation of the infusion and appear to be related to the infusion rate rather than the dose. Slowing or stopping the infusion usually allows these symptoms to resolve. Pretreatment with oral antihistamines and analgesics may help to alleviate these symptoms. Infusion-related symptoms include flushing (6%), chest tightness, chest pain (unspecified) (5% to 15%), headache (greater than 10%), chills (5% to 19%), rigors (7% to 37%), fever or increased body temperature (9% to 29%), diaphoresis, hyperhidrosis (6%), hot flush/hot flashes, dyspnea, wheezing (14%), bronchospasm, dizziness (5% to 13%), asthenia (5% to 15%), fatigue (18% or less), malaise (5%), gastrointestinal complaints (nausea, vomiting, upper abdominal pain and/or cramping, loss of appetite), hypotension (7% to 25%), diastolic hypotension (21%), hypertension (6% to 8%), muscle symptoms (e.g., cramps, backache, arthralgia, myalgia), general flu-like symptoms, anxiety, palpitations, sinus tachycardia (5% to 25%), dizziness, edema, and transient skin reactions. Other general adverse events with IVIG include accidental injury (13% to 16%), angina pectoris, chest discomfort (7% to 9%), and falls (7%). Cardiac arrest, vascular collapse, bradycardia, and pallor have rarely been reported with the use of IVIG. Hyperhidrosis and hot flush/hot flashes have been noted in postmarketing reports. Compared to adult patients, fever was reported more frequently in pediatric patients during clinical trials of IVIG for idiopathic thrombocytopenic purpura (ITP) and primary immunodeficiency, respectively. Patients who have never received IVIG, have been switched from a certain IVIG product to another, or have had an interruption in IVIG therapy greater than 8 weeks may be at a higher risk for the development of an inflammatory reaction, especially with rapid infusion rates.

    Life-threatening hypoglycemia can occur with the use of Octagam 5% and 10%. Some glucose monitoring systems interpret the maltose in Octagam as glucose. Inaccurate glucose readings can result in inappropriate administration of insulin. Furthermore, falsely elevated glucose readings could mask true cases of hypoglycemia. Monitor glucose in diabetic patients with a glucose-specific method only. Ensure blood glucose testing systems, including test strips, are appropriate to use with maltose-containing products.

    IVIG is contraindicated in patients with a history of anaphylactic or severe systemic reaction to immune globulin. Octagam 5% is contraindicated for use by patients with an acute corn hypersensitivity, as the 5% liquid contains maltose (100 mg/mL). Octagam 10% also contains maltose (90 mg/mL); hypersensitivity reactions may occur in patients with corn allergy. Privigen is contraindicated for use by patients with hyperprolinemia because it contains the stabilizer L-proline. Gammaplex is contraindicated in patients with hereditary fructose intolerance as this product contains 50 mg of sorbitol per mL as an excipient; also, do not use in neonates and infants for whom sucrose or fructose tolerance has not been established. Other products (i.e., Flebogamma) also contain sorbitol and should be should with caution in these patients.

    Consider the patient's current fluid status when considering the IVIG dose and product to be used in neonates, infants, children, and adolescents. Administration of IVIG can significantly contribute to the daily fluid balance; high dose regimens (e.g., >= 1000 mg/kg/day) may put patients at increased risk for volume overload (hypervolemia). Monitor patients for signs and symptoms, such as acute edema (peripheral or pulmonary) and dyspnea during infusions.

    IVIG is contraindicated for use in patients with IgA deficiency who have antibodies against IgA and a history of hypersensitivity to human immunoglobulin treatment. Patients with IgA deficiency and known anti-IgA antibodies have a higher risk of developing potentially severe hypersensitivity and/or anaphylactic reactions (including anaphylaxis and shock) with administration of IVIG.

    Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IVIG treatment. Signs and symptoms usually appear within several hours to 2 days and include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. Aseptic meningitis syndrome may occur more frequently after high-dose (e.g., more than 1,000 to 2,000 mg/kg/dose) and/or rapid-infusion IVIG treatment. In addition, patients with a history of migraine may be more susceptible to the development of aseptic meningitis syndrome due to IVIG. Patients presenting with signs and symptoms should undergo a thorough neurological evaluation, including CSF studies, to rule out other causes of meningitis. The diagnosis of aseptic meningitis is one of exclusion. Discontinuation of IVIG treatment has resulted in remission of aseptic meningitis syndrome within several days without sequelae.

    IVIG is a derivative of human blood. As with other products derived from or purified with human blood components, the remote possibility of contamination with bacterial or viral infection, including hepatitis, or Creutzfeldt-Jakob disease (CJD) exists in patients receiving IVIG. Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of transmission of infectious agents; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents are present in the pooled product. Discuss the risks and benefits of IVIG therapy with the patient prior to administration. Patients and caregivers should be encouraged to notify their health care provider if they develop infectious symptoms. All infections thought to have been transmitted by IVIG should be reported to the manufacturer.

    Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG therapy. Distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events. Thromboembolism may occur after immune globulin use, regardless of route of administration or the presence of risk factors. Patients at risk for thrombotic events include those with multiple cardiovascular risk factors, impaired cardiac output (heart failure), coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, a history of atherosclerosis (coronary artery disease), a history of thrombotic or thromboembolic event, use of estrogens, indwelling central vascular catheters, and/or known or suspected hyperviscosity. Assessment of blood viscosity may be warranted for patients at risk for hyperviscosity such as those with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies. Assure patients are not volume depleted prior to the initiation of IVIG. For patients judged to be a risk of developing thrombotic events, use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate. Monitor all patients receiving IVIG for signs and symptoms of thrombosis during and after each infusion. Encourage patients to report any pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, chest pain/discomfort, unexplained tachycardia, and numbness or weakness on one side of the body.

    Renal impairment, acute renal failure, osmotic nephrosis, and death may occur with the administration of IVIG products in predisposed patients. Renal dysfunction and failure are more common with the use of IVIG products containing sucrose as a stabilizer; Carimune NF contains sucrose. Use IVIG with caution in patients at risk for developing renal dysfunction, including those with any pre-existing degree of renal insufficiency or renal disease, sepsis, paraproteinemia, diabetes mellitus, hypovolemia, dehydration, obesity, or concomitant use of nephrotoxic agents. Use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate in patients at risk for developing renal dysfunction. Ensure patients are not volume depleted prior to IVIG administration. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output at baseline and appropriate intervals thereafter. If renal function deteriorates, consider IVIG therapy discontinuation.

    Certain cautions are to be used with patients receiving IVIG who must undergo vaccination. Inactivated vaccines can be administered any time before, after, or simultaneously with IVIG; if administered simultaneously, different administration sites should be used. In addition, the live vaccines Ty21a typhoid, yellow fever, live-attenuated influenza, zoster, and rotavirus vaccines may be administered at any time during IVIG therapy. Because of the passive transfer of antibodies IVIG, like other antibody-containing blood products, can inhibit the immune response to measles and rubella vaccines for >= 3 months. IVIG products also contain antibodies to mumps and varicella, however their effect on immune response to these viruses is unknown. If simultaneous administration of measles-containing vaccine or varicella vaccine is unavoidable, administer the products at different sites, and revaccinate or test for seroconversion after the recommended interval. The duration of interference of IVIG with the immune response to the measles and possibly varicella vaccine is dose related; patients receiving standard-dose therapy must delay 8 months, while those receiving high-dose therapy must delay 10-11 months. The immunizing physician should be informed of recent IVIG therapy so appropriate measures can be taken. It is important to note that various antibodies acquired through passive transfer may confound the results of serological testing.

    IVIG products may contain blood group antibodies that act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin test (DAT, Coombs' test), and rarely, hemolysis. Delayed hemolytic anemia can develop after immune globulin therapy due to enhanced RBC sequestration. Acute hemolysis (consistent with intravascular hemolysis), severe hemolysis-related renal dysfunction, and disseminated intravascular coagulation (DIC) have occurred. Risk factors related to the development of hemolysis include high doses (2,000 mg/kg or more) as a single infusion or divided over several days and non-O blood type. An underlying inflammatory state reflected by elevated C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) may also contribute to the risk of hemolysis, however the role is uncertain. Monitor patients receiving IVIG for hemolysis and hemolytic anemia. In high risk patients, consider appropriate lab testing, including hemoglobin and hematocrit prior to therapy and 36 to 96 hours after infusion. If signs and symptoms of hemolysis are present after the infusion, perform confirmatory lab testing. If a transfusion is indicated, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.

    Subcutaneous administration of immune globulin should not be used in patients with idiopathic thrombocytopenic purpura (ITP) because of the risk of hematoma.

    Immune globulin administration may result in laboratory test interference. After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the blood may yield false-positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, D) may cause a positive direct or indirect antiglobulin (Coombs') test. Measurement of blood glucose must be done with a glucose-specific method if a patient takes a parenteral product that contains maltose, such as Octagam IVIG. Blood glucose testing systems based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods falsely interpret the maltose contained in Octagam as glucose. Falsely elevated glucose readings during Octagam therapy have led to life-threatening hypoglycemia because of inappropriate administration of insulin. Falsely elevated glucose readings could also mask true cases of hypoglycemia. Read the product information of the blood glucose testing system including the information about the test strips to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system.

    Description: Immune globulin IV (IVIG) is an intravenous solution composed primarily of human immunoglobulin G (IgG), with trace amounts of IgA and IgM. IVIG is derived from the pooled human plasma of thousands of donors, ensuring a diversified collection of antibodies with variable antigen-binding regions. All samples undergo human immunodeficiency virus (HIV), hepatitis B, and hepatitis C testing. Although the amount of each IgG subclass is similar to that of human plasma in all IVIG formulations, titers among specific antigens, preparation methods, viral inactivation steps, stabilizing agents, osmolality, and IgA content differ among products. Thus, IVIG products have comparable efficacy but are not pharmaceutically equivalent. IVIG is used for a variety of conditions; its primary indication is as replacement therapy for patients with antibody deficiencies. In pediatrics, IVIG is perhaps most commonly used to treat idiopathic thrombocytopenic purpura (ITP), hemolytic disease of the newborn, Kawasaki disease, and Guillain-Barre syndrome. The majority of adverse reactions associated with IVIG are infusion-related; however, serious reactions including acute renal failure, hemolytic anemia, aseptic meningitis syndrome, and thrombotic events have been reported. Conservative product-specific infusion rates and careful monitoring is essential with IVIG use. While some IVIG products are not FDA-approved for use in pediatric patients, others carry an indication for use in children as young as infants; IVIG has been used in patients as young as neonates.

    General dosing information:
    -Immune globulin products are not pharmaceutically equivalent but are considered to have comparable efficacy. For patients receiving chronic immune globulin therapy, consider product changes carefully; begin with conservative infusion times and increase monitoring if products are substituted.
    -In general, immune globulin should be dosed based on actual body weight in patients weighing up to 100 kg with a body mass index (BMI) less than 30 kg/m2. Some experts recommend using adjusted body weight for dosing immune globulin if the patient exceeds these parameters or is greater than 20% over their ideal body weight.

    For the treatment of primary immunodeficiency (e.g., agammaglobulinemia or hypogammaglobulinemia):
    Intravenous dosage (Alyglo):
    Adolescents 17 years: 300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response.
    Intravenous dosage (Asceniv):
    Children and Adolescents 12 to 17 years: 300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration. The target trough is at least 600 mg/dL. The dose may be proportionally adjusted starting with the second infusion using the patient's trough concentration and initial dose.
    Intravenous dosage (Bivigam or Gammaplex):
    Children and Adolescents 2 to 17 years: 300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.
    Intravenous dosage (Carimune NF):
    Infants, Children, and Adolescents: 400 to 800 mg/kg/dose IV every 3 to 4 weeks. The first infusion of Carimune NF in previously untreated agammaglobulinemic or hypogammaglobulinemic patients must be given as a 3% solution; if tolerated, subsequent infusions may be administered at a higher concentration.
    Intravenous dosage (Flebogamma 5%, Gammagard Liquid or Gammagard S/D, Gammaked, Gamunex-C, or Panzyga):
    Children and Adolescents 2 to 17 years: 300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.
    Intravenous dosage (Octagam 5%):
    Children and Adolescents 6 to 17 years: 300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.
    Intravenous dosage (Privigen):
    Children and Adolescents 3 to 17 years: 200 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.
    Subcutaneous dosage (Gammagard Liquid 10%):
    Children and Adolescents 2 to 17 years: Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then dividing into weekly doses based on the frequency of current IVIG administration (e.g., if IVIG is administered every 3 weeks, divide by 3). Start the initial subcutaneous dose approximately 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight.
    Subcutaneous dosage (Gammaked or Gamunex-C):
    Children and Adolescents 2 to 17 years: Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then dividing into weekly doses based on the frequency of current IVIG administration (e.g., if IVIG is administered every 3 weeks, divide by 3). To convert the calculated initial Gamunex-C dose in grams to mL, multiply by 10. Start the initial subcutaneous dose 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. An IgG trough concentration may be measured as early as 5 weeks after switching from IV to subcutaneous administration. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight. To determine whether further dosage adjustments are necessary, monitor IgG trough concentration every 2 to 3 months.

    For measles prophylaxis in patients with immunoglobulin deficiency who have been exposed to measles or are at risk of measles exposure:
    Intravenous dosage (Alyglo):
    Adolescents 17 years: 400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).
    Intravenous dosage (Flebogamma 5%, Gammagard Liquid, Gammagard S/D, Gammaplex 5%, Gammaplex 10%, or Panzyga):
    Children and Adolescents 2 to 17 years: 400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).
    Intravenous dosage (Gammaked and Gamunex-C):
    Children and Adolescents 2 to 17 years: 400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 400 mg/kg/dose IV every 3 to 4 weeks, administer at least 400 mg/kg IV as a single dose immediately prior to expected exposure.
    Intravenous dosage (Privigen):
    Children and Adolescents 3 to 17 years: 400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).
    Intravenous dosage (Octagam 5%):
    Children and Adolescents 6 to 17 years: 400 mg/kg IV as a single dose should be administered as soon as possible and within 6 days after exposure in patients with primary immunodeficiency. If a patient receives less than 530 mg/kg/dose IV every 3 to 4 weeks and is at risk for measles exposure (e.g., outbreak, travel to an endemic area), increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 mIU/mL of measles antibodies for at least 22 days after infusion).
    Intravenous dosage (Asceniv, Bivigam, Carimmune NF, or Octagam 10%)*:
    Infants, Children, and Adolescents: 400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks.

    For the treatment of immune thrombocytopenic purpura (ITP):
    Intravenous dosage (general neonatal dosing):
    Neonates: 1 g/kg/dose IV once daily for 2 consecutive days. Alternatively, 400 mg/kg/dose IV once daily for 5 consecutive days may be administered. Monitor closely until there is a sustained rise in the platelet count into the normal range. It is important to note that the platelet count in all neonates falls during the first 4 to 7 days of life.
    Intravenous dosage (Carimune NF or Gammaked):
    Infants, Children, and Adolescents: 800 mg/kg/dose to 1 g/kg/dose IV once daily for 2 consecutive days; if platelet count is adequate (30,000 to 50,000/microliter) 24 hours after the initial dose, therapy may be discontinued. Alternatively, 400 mg/kg/dose IV once daily for 2 to 5 consecutive days may be administered. If the platelet count falls below 30,000/microliter or there is clinically significant bleeding after induction therapy, give 400 mg/kg/dose IV as a single infusion. If adequate response does not result, the dose can be increased to 800 mg/kg/dose to 1 g/kg/dose IV administered as a single infusion. May administer intermittently as needed to maintain adequate platelet count.
    Intravenous dosage (Flebogamma 10%):
    Children and Adolescents 2 to 17 years: 1 g/kg/dose IV once daily for 2 consecutive days. Carefully consider the relative risks and benefits in patients at increased risk of thrombosis, hemolysis, or acute kidney injury.
    Intravenous dosage (Gamunex-C):
    Infants, Children, and Adolescents: 400 mg/kg/dose IV once daily for 5 consecutive days. Alternatively, 1 g/kg/dose IV once daily for 2 consecutive days may be administered; if platelet count is adequate 24 hours after the initial 1 g/kg dose, therapy may be discontinued.
    Intravenous dosage (Privigen):
    Adolescents 15 to 17 years: 1 g/kg/dose IV once daily for 2 consecutive days.

    For the treatment of Kawasaki disease:
    Intravenous dosage (Gammagard S/D):
    Infants, Children, and Adolescents: 1,000 mg/kg/dose IV as a single dose or 400 mg/kg/dose IV once daily for 4 consecutive days beginning within 7 days of fever onset. Administer concurrently with moderate- to high-dose aspirin.
    Intravenous dosage (all products* except Gammagard S/D):
    Infants, Children, and Adolescents: 2,000 mg/kg/dose IV as a single dose within 10 days of illness onset but as soon as possible after diagnosis. Administer concurrently with moderate- to high-dose aspirin. Treat children presenting after day 10 of illness if they have unexplained persistent fever or coronary artery abnormalities with ongoing systemic inflammation (e.g., elevated ESR and CRP). Consider a second dose if persistent or recrudescent fever at least 36 hours after completion of the initial IVIG infusion.

    For the treatment of Guillain-Barre syndrome*:
    Intravenous dosage:
    Children and Adolescents: 1,000 mg/kg/dose IV daily for 2 consecutive days. Alternatively, 400 mg/kg/dose IV daily for 5 consecutive days produced similar recovery rates and a lower incidence of early relapse when compared to the 2-day regimen in a randomized trial of 95 pediatric patients.

    For the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)*:
    Intravenous dosage:
    Children and Adolescents: 2,000 mg/kg IV as a total dose divided over 2 to 5 consecutive days. Some experts suggest the minimum effective dose should be used for maintenance therapy (generally every 3 to 6 weeks) based on clinical effectiveness.

    For the treatment of neonatal hyperbilirubinemia* due to hemolytic disease of the newborn (e.g., isoimmune hemolytic disease, Rh incompatibility):
    Intravenous dosage:
    Premature Neonates 32 weeks and older and Neonates: 0.5 to 1 g/kg/dose IV over 2 hours; may repeat dose in 12 hours if necessary. Therapy is most effective when initiated promptly after diagnosis.

    For the adjuvant treatment of neonatal sepsis*:
    Intravenous dosage:
    Neonates: Efficacy data are limited and variable; dosage regimens vary. 500 to 1,000 mg/kg/dose IV once daily for 1 to 6 days beginning as soon as sepsis is diagnosed is a commonly used dosage range. A meta-analyses of 3 prospective, randomized studies reported septic neonates receiving IVIG (n = 55) had a decreased death rate; analyses concluded IVIG administration in addition to conventional therapy increased the survival of early-onset of neonatal sepsis nearly 6-fold. However, the results from the large International Neonatal Immunotherapy Study (n = 3,493) concluded that IVIG 500 mg/kg/dose IV every 48 hours for 2 doses did not affect the outcomes of suspected or proven neonatal sepsis. Pediatric guidelines recommend against the routine use of IVIG in patients with septic shock; however, select patients (e.g., those with toxic shock syndrome, necrotizing fasciitis, primary humoral immunodeficiencies, or low immunoglobulin concentrations) may benefit from such treatment.

    For bacterial infection prophylaxis in immunocompromised patients:
    -for the prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL):
    Intravenous dosage (Gammagard S/D):
    Children and Adolescents: 400 mg/kg/dose IV given every 3 to 4 weeks.
    -for the prevention of serious bacterial infections in hematopoietic cell transplantation (HCT) recipients with severe hypogammaglobulinemia (immunoglobulin G less than 400 mg/dL)*:
    Intravenous dosage:
    Infants and Children (first 100 days post-HCT): 400 mg/kg/dose IV once monthly. Monitor IgG trough concentration every 2 weeks during IVIG therapy, and adjust dose and frequency to maintain a IgG concentration greater than 400 mg/dL. In general, the half-life of IVIG among HCT patients is much shorter than that of healthy patients; larger doses may be required.
    Infants and Children (beyond 100 days post-HCT): 500 mg/kg/dose IV every 3 to 4 weeks.
    Adolescents (first 100 days post-HCT): 500 mg/kg/dose IV once weekly. Monitor IgG trough concentration every 2 weeks during IVIG therapy; adjust dose and frequency to maintain a IgG concentration greater than 400 mg/dL. In general, the half-life of IVIG among HCT patients is much shorter than that of healthy patients; larger doses may be required.
    Adolescents (beyond 100 days post-HCT): 500 mg/kg/dose IV every 3 to 4 weeks.
    -for the prevention of serious bacterial infections in HIV-infected patients who have hypogammaglobulinemia (immunoglobulin G less than 400 mg/dL)*:
    Intravenous dosage:
    Infants and Children: 400 mg/kg/dose IV every 2 to 4 weeks.

    For the treatment of dermatomyositis* and polymyositis*:
    Intravenous dosage:
    Children and Adolescents: 2 g/kg (Max: 70 g) IV divided in equal doses over 1 to 5 consecutive days every 2 weeks for initial therapy and then every 4 to 6 weeks.

    For the treatment of severe exacerbations of myasthenia gravis*:
    Intravenous dosage:
    Neonates: 2,000 mg/kg IV as a total dose divided over 1 to 5 days. 400 mg/kg/dose IV once daily for 5 days was used successfully in a 35 week preterm neonate with transient neonatal myasthenia gravis already receiving neostigmine. The neonate was weaned from the ventilator after the third dose of IVIG. In comparison to plasmapheresis, IVIG may provide equal efficacy and better tolerability in pediatric patients.
    Infants, Children, and Adolescents: 2,000 mg/kg IV as a total dose divided over 1 to 5 days. Improvement is typically seen within 1 week. Duration of clinical effect is 4 to 6 weeks. If additional therapy is required, adjust dose based on response; use minimum effective dose. In comparison to plasmapheresis, IVIG may provide equal efficacy and better tolerability in pediatric patients.

    For the treatment of acute myocarditis*:
    Intravenous dosage:
    Neonates: 2,000 mg/kg IV as a single dose. Efficacy data is limited and variable. Data from a cohort study of 46 pediatric patients suggested those treated with IVIG (n = 21) had improved left ventricular function recovery and survival at 1 year. Systemic reviews and multi-institutional analyses have failed to prove efficacy or survival benefit.
    Infants, Children, and Adolescents: 2,000 mg/kg IV as a single dose. Efficacy data is limited and variable. Data from a cohort study of 46 pediatric patients suggested those treated with IVIG (n = 21) had improved left ventricular function recovery and survival at 1 year. Systemic reviews and multi-institutional analyses have failed to prove efficacy or survival benefit.

    For postexposure varicella (chickenpox) infection prophylaxis* in at-risk populations:
    NOTE: Use only if varicella-zoster immune globulin is unavailable.
    Intravenous dosage:
    Infants, Children, and Adolescents: 400 mg/kg/dose IV as a single dose administered as soon as possible (preferably within 96 hours), but up to 10 days after exposure in those without evidence of immunity.

    For the treatment of immune-mediated encephalitis*, including acute disseminated encephalomyelitis* (ADEM):
    Intravenous dosage:
    Infant, Children, and Adolescents: 1 g/kg/dose IV once daily for 2 days or 400 mg/kg/dose IV once daily for 5 days.

    For the treatment of Stevens-Johnson syndrome* (SJS) and/or toxic epidermal necrolysis* (TEN):
    Intravenous dosage:
    Infants, Children, and Adolescents: 2 g/kg IV divided over 1 to 4 days. Total doses ranging from 1.5 to 5.8 g/kg have been reported.

    For the treatment of tetanus*:
    Intravenous dosage:
    Infants, Children, and Adolescents: 200 to 400 mg/kg IV once if tetanus immune globulin is not available.

    For the management of multisystem inflammatory syndrome in children (MIS-C) post SARS-CoV-2 exposure*:
    Intravenous dosage:
    Infants, Children, and Adolescents: 2 g/kg (based on ideal body weight; Max: 100 g/dose) IV as a single dose in combination with low-to-moderate methylprednisolone or equivalent glucocorticoid. The dose may be divided in patients with cardiac dysfunction or fluid overload (1 g/kg IV every 24 hours for 2 doses). The National Institutes of Health (NIH) treatment guidelines recommend against the routine use of IVIG monotherapy for the treatment of MIS-C, unless glucocorticoid use is contraindicated.

    For the treatment of recurrent pericarditis*:
    Intravenous dosage:
    Children and Adolescents: 400 to 500 mg/kg/dose IV once daily for 5 days or 1 g/kg/dose IV once daily for 2 days, then repeat dose every 4 weeks for several months.

    For the treatment of respiratory syncytial virus (RSV) infection* in high-risk immunocompromised patients (i.e., hematologic malignancies, HSCT recipients, solid organ transplant patients):
    NOTE: Guidelines recommend treatment with aerosolized or systemic ribavirin and IVIG for patients with RSV upper respiratory tract infection disease (URTID) undergoing allogeneic HSCT or recipients of allogeneic HSCT with lower respiratory tract infection disease (LRTID) or risk factors for progression to RSV LRTID and death. For solid organ transplant patients, the addition of IVIG and corticosteroids to ribavirin can be considered for lung transplant recipients with URTID or LRTID.
    Intravenous dosage:
    Infants, Children, and Adolescents: 400 to 500 mg/kg/dose IV in combination with aerosolized or systemic ribavirin. Dosing frequency has ranged from one-time to every 48 hours for 5 to 7 doses in clinical studies.

    Maximum Dosage Limits:
    The maximum dosage is dependent on indication for therapy and patient response. In general, do not exceed 2,000 mg/kg/dose IV.

    Patients with Hepatic Impairment Dosing
    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing
    To minimize the risk for further acute renal function deterioration or renal failure, use the minimum recommended IVIG dose administered at the minimum concentration available and the minimum practicable intravenous rate. Recommended infusion rates may vary by product. Avoid sucrose-containing IVIG products if possible. If renal deterioration occurs despite adequate volume status, it is recommended to discontinue the IVIG.

    *non-FDA-approved indication

    Monograph content under development

    Mechanism of Action: Immunoglobulins are antibodies synthesized by B lymphocytes. IVIG is derived from the pooled human plasma of thousands of donors. Most preparations consist of intact immunoglobulin (Ig)G molecules with trace amounts of IgA, IgM, soluble CD4, CD8, human leukocyte antigen (HLA), and cytokines. The pooled, heterogenous IgG present in IVIG provides a plethora of antibodies capable of opsonization and neutralization of many toxins and microbes as well as complement activation. Although the amount of each IgG subclass in the parenteral products is similar to that of human plasma, the titers against specific antigens vary from manufacturer to manufacturer. The Fc fragment of the IgG molecule allows the molecule to interact with and signal through Fc- gamma receptors on B cells and other cells of the phagocytic system. The Fc fragment also interacts with the Fc-binding plasma proteins, which is essential for complement activation and microorganism clearance. The passive immunity imparted by IVIG is capable of attenuating or preventing infectious diseases or deleterious reactions from toxins, mycoplasma, parasites, bacteria, and viruses.

    In immunomodulatory and anti-inflammatory disease states, it is believed the Fc fragment of IgG and the Fc-gamma receptors on target cells (e.g., macrophages, B cells, natural killer cells, plasma cells, eosinophils, neutrophils, platelets) interact to up-regulate or down-regulate inflammatory and immune responses. In autoimmune cytopenias and inflammatory neurologic disorders, blockade of Fc-gamma receptors on macrophages blocks the clearance of opsonized target cells and suppresses antibody-dependent cell-mediated cytotoxicity, respectively. Immunoglobulins may also modulate inflammatory response by preventing complement-mediated tissue damage and regulating the induction of anti-inflammatory cytokines and cytokine antagonists (e.g., interleukin 1-beta, interleukin-1 receptor antagonist, tumor necrosis factor alpha). Immunomodulatory response may be facilitated by the immunoregulatory effects of anti-idiotypic antibodies on B cells and autoantibodies, regulation of helper T cell production, and apoptosis of immune system gene expression.

    In ITP treatment, IVIG produces an immediate rise in platelet count, usually lasting only a few weeks, although platelet stabilization for up to 1 year after administration has been reported.

    Pharmacokinetics: Immune globulin is administered intravenously; some products (e.g., Gammagard Liquid, Gamunex-C) can also be given as subcutaneous infusion. Data concerning distribution are scant, but immune globulin appears to distribute equally throughout intravascular and extravascular spaces. Mean volume of distribution at steady state is 0.05 to 0.08 L/kg. The exact fate of IVIG is not well defined, but plasma clearance is slow, ranging from 1.3 to 2.5 mL/kg/day; the serum half-life of immune globulin (IgG) is approximately 18 to 25 days. Great interpatient variability exists for the half-life of IgG. Fever, infection, or high IgG concentrations appear to coincide with a shortened half-life whereas immunodeficiency appears to be associated with a longer half-life of IgG (18 to 40 days).


    -Route-Specific Pharmacokinetics
    Intravenous Route
    Peak serum concentrations occur immediately after IV infusion and are dose-related. After infusion, immune globulin follows a biphasic decay curve. The initial phase is characterized by an immediate peak in serum IgG and is followed by rapid decay due to equilibration between the plasma and extravascular fluid compartments; a rapid initial drop in serum IgG is expected. After approximately 6 days, equilibrium is reached and IgG is distributed equally between the intravascular and extravascular space. The second phase is characterized by a slower and constant rate of decay. In a pharmacokinetic study of 61 adult patients with humoral immunodeficiency receiving intravenous (IV) Gammagard Liquid (median dose: 455 mg/kg/dose every 4 weeks), the mean peak and trough IgG concentration for IV Gammagard Liquid was 2,240 +/- 536 mg/dL and 1,050 +/- 260 mg/dL, respectively. The AUC was 9,958 +/- 2,274 mg x days/dL.

    Subcutaneous Route
    Some immune globulin products (e.g., Gammagard Liquid, Gamunex-C) have been administered as subcutaneous infusions. The subcutaneous dose required to provide an exposure non-inferior to the exposure from intravenous (IV) administration was 137% of the IV dose. Specifically, the mean adjusted subcutaneous dose was 141% (100.5% to 160%) for patients younger than 12 years and 137.3% (125.7 to 150.8%) of the IV dose for patients at least 12 years of age. After subcutaneous administration, the peak IgG concentration occurred 2.9 (1.2 to 3.2) days later, and the mean peak concentration was 1,393 +/- 289 mg/dL. The mean trough concentration was 1,202 +/- 282 mg/dL. As compared with IV administration, the mean peak concentration was lower after subcutaneous administration, and the mean trough concentration was higher. Therefore, subcutaneous infusion doses are adjusted to 1.37 times the IV dosage on average for these products.


    -Special Populations
    Pediatrics
    Neonates
    Volume of distribution in neonates has been reported with variance, ranging from 0.04 to 0.25 L/kg. The IVIG half-life is comparable to normal adult parameters with a reported range of 18 to 29 days. In a study of 15 neonates (gestational age 32 to 41 weeks; birth weight more than 1,500 grams), IVIG infusions of 500 mg/kg resulted in a mean peak IgG concentration of 2171 mg/dL, 15 minutes after infusion; this dosage resulted in a significant increase in IgG concentrations more than 8 days after the infusion. IVIG infusions of 1,000 mg/kg resulted in mean peak IgG concentrations of 2,734 mg/dL and resulted in significant increases in IgG concentrations more than 11 days after the infusion. A biphasic decay curve resulted in an initial rapid decay within 24 hours after infusion followed by a slower decay over the next 6 weeks. Plasma clearance was 3 mL/kg/day. Gestational age, birth weight, dose, and pretreatment serum IgG concentrations had minimal effect on pharmacokinetic parameters.

    Children and Adolescents
    The pharmacokinetics of intravenous and subcutaneous immune globulin are similar in children, adolescents, and adults. Both intravenous and subcutaneous infusions of immune globulin appear to be effective in children and with similar trough IgG concentrations achieved as in adults. No pediatric specific dose requirements are necessary to achieve the desired serum IgG levels. Dosage, as in adults, must be individualized and adjusted over time to achieve the desired trough levels and clinical responses.

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.

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