Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant (Twinrix) is a bivalent vaccine containing the antigenic components of hepatitis A and hepatitis B vaccines. It is considered an inactive vaccine. The combination is used to confer immunity in adults at risk of hepatitis A virus (HAV) and hepatitis B virus (HBV). The antibody responses to the bivalent vaccine have been statistically equivalent to the individual vaccines. One month after the third dose of the bivalent vaccine, the seroconversion rate against hepatitis A was 99.9%, and the seroprotection rate against hepatitis B was 98.5%. A pediatric formulation of Twinrix, containing half the antigenic components of the adult formulation is available in other countries but is not approved in the US.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
NOTE: Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients.
NOTE: According to U.S. federal laws, the health care provider must record the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine in the patient's permanent record.
Route-Specific Administration
Injectable Administration
-Administer intramuscularly; do not inject intravenously or intradermally.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration. After thorough agitation, the injection should appear as a slightly turbid, white suspension. Discard if it appears otherwise.
Intramuscular Administration
-Upon storage, a fine white deposit with a clear colorless layer above may be present. The vaccine should be re-suspended before withdrawal and use.
-To re-suspend the vaccine, hold the vaccine in a closed hand and shake the syringe by tipping it upside down and back upright again vigorously for at least for at least 15 seconds. If the vaccine appears as a uniform hazy white suspension, it is ready to use. If not, tip upside down and back upright again for at least another 15 seconds and inspect again.
-Attach a sterile needle to the prefilled syringe and administer intramuscularly.
-Follow the ACIP guidelines for intramuscular injection in individuals with clotting disorders.
Intramuscular (IM) injection:
-Inject into a muscle in the deltoid region; do not inject into the gluteal region as this may result in a suboptimal response.
-Use the vaccine as supplied; no dilution or reconstitution is necessary. After removal of the appropriate volume from a single-dose vial, any vaccine remaining in the vial should be discarded.
-When concomitant administration of other vaccines or immunoglobulin is required they should be given with different syringes and at different injection sites.
Adverse events seen after the administration of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant are similar to those that occur after administration of the monovalent components. Most adverse events reported have been mild, self-limiting and did not last for more than 48 hours. An injection site reaction is common after hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant receipt: 35-41% had soreness, 8-11% had erythema, and 4-6% had swelling. Induration at the injection site was noted in 1-10%, < 1% had injection site bruising, and < 1% had injection site pruritus. Postmarketing, immediate injection site pain, stinging, and burning sensation has been noted.
Adverse events noted with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant include fatigue (11-14%), fever (2-4%), headache (13-22%), flushing (< 1%), irritability (< 1%), back pain (< 1%), myalgia (< 1%), and arthralgia (< 1%). Postmarketing, chills, malaise, and vasculitis have been noted. Serum sickness-like syndrome has occurred days to weeks after hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant administration. The syndrome includes arthralgia or arthritis that is usually transient, as well as fever, hives, ecchymosis, erythema multiforme, and erythema nodosum. Stevens-Johnson syndrome has been noted postmarketing with the hepatitis B vaccine, recombinant, and lymphadenopathy (< 1%) has been noted with both hepatitis A vaccine, inactivated and hepatitis B vaccine, recombinant.
Rash (unspecified) and urticaria were each noted in < 1% of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant recipients. Postmarketing angioedema, anaphylactoid reactions, anaphylactic shock, dyspnea, and bronchospasm were noted. Review the patient's immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to help determine the benefits and risks of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant receipt. If the vaccine is administered, have appropriate medical treatment and supervision available to manage possible anaphylactic reactions after vaccine administration.
Alopecia has been noted postmarketing with the hepatits A vaccine, inactivated; hepatitis B vaccine, recombinant. Approximately 60 cases of alopecia occurring after vaccination (primarily with the monovalent vaccine for hepatitis B) have been reported. Although some people lost all of their hair, including eyelashes, in most instances, some or all of the hair grew back. A positive rechallenge was reported in sixteen cases. Alopecia has been estimated to occur in roughly 5 people a year out of about 1 billion vaccinations.
Dizziness, insomnia, paresthesias, vertigo, weakness, and migraine were all noted in less than 1% of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant recipients. Postmarketing, tinnitus, encephalopathy, Guillain-Barre syndrome, hypoesthesia, hypertonia, seizures, myelitis, peripheral neuropathy, encephalitis, Bell's palsy, neuritis, optic neuritis, paralysis, paresis, transverse myelitis, and multiple sclerosis (MS) have been noted with the vaccine or 1 of its components. Photophobia (less than 1%) was noted with the hepatitis A vaccine, inactivated and could occur with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. Several well-designed epidemiologic studies have shown that there is no association of hepatitis B vaccine administration with the development of MS. Hepatitis B vaccination does not appear to increase the risk of relapse in MS. Similarly, one would not expect an increased risk of MS with the combined hepatitis A and B vaccine.
Syncope (< 1%) has been noted with the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Have procedures in place to avoid falling injury and to restore cerebral perfusion after syncope.
Thrombocytopenia and thrombocytopenic purpura have been reported postmarketing with the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. The frequency of occurrence or causal relationship to the vaccine of postmarketing events cannot be reliably determined because events are reported voluntarily from a population of uncertain size.
Adverse reactions to hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant include anorexia (< 1%), abdominal pain (< 1%), diarrhea (4-6%), vomiting (<= 1%), and nausea (2-4%). Adverse events noted with a component of the vaccine (hepatitis A vaccine; inactivated) include constipation and dysgeusia.
Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is (800) 822-7967.
As with any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant.
For known exposures to HAV or HBV, immune globulin for intramuscular administration (IGIM) or hepatitis B immune globulin (HBIG), respectively should be given in combination with the appropriate vaccine in accordance with the ACIP recommendations. Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant may not prevent HAV or HBV in those with an unrecognized illness at the time of vaccination. Additionally, it may not prevent HAV or HBV if adequate antibody titers are not achieved.
Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant (Twinrix) is contraindicated in patients with a previous or known hypersensitivity to any component of the combination or individual vaccines including patients with yeast hypersensitivity or neomycin hypersensitivity. Anaphylaxis and anaphylactoid reactions have been reported after routine use of Twinrix.
Do not give hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant via intravenous administration or intradermal administration. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia) or receiving anticoagulant therapy should be monitored closely when given hepatitis A vaccine, inactivated; hepatitis B vaccine because bleeding can occur at the IM injection site.
Any serious active infection including a fever is reason for delaying use of the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant except when in the opinion of the prescriber, withholding the vaccination entails a greater risk. Caution and appropriate care should be exercised in administering the vaccine to individuals with severe cardiac disease or to others in whom a febrile or systemic reaction could pose a significant risk.
Patients with immunosuppression may respond to hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant with lower antibody titers than non-immunosuppressed patients. This is particularly a concern in patients receiving chemotherapy or in patients with human immunodeficiency virus (HIV) infection. Since a second infection in HIV-positive patients further weakens their immune system, it is still preferable to administer the vaccine. The seroconversion (SC) rate to hepatitis A vaccine is higher than the seroprotection (SP) rate to hepatitis B in these patients. Following vaccination with hepatitis A vaccine, inactivated the SC rates ranged between 77% to 88% for HIV-positive individuals and was 100% for HIV-negative individuals. Following vaccination with hepatitis B vaccine, recombinant the seroprotection rates ranged between 24% to 46% in HIV-positive individuals and was 93% in HIV-negative individuals. The guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV recommend vaccinating patients with a CD4 count less than 200 cells/mm3 if they have ongoing risks for hepatitis A or B. For HIV patients without risk factors, waiting to vaccinate until CD4 count is 200 cells/mm3 or higher is an option. Assess the antibody response (anti-HAV IgG, anti-HBs) to the vaccine 1 to 2 months after completing the series. If a primary immunization course fails to confer immunity, repeat doses may be required.
In the US, the safety and effectiveness of hepatitis A vaccine, inactivated; hepatitis B vaccine (Twinrix), recombinant in neonates, infants, and children < 18 years have not been established.
Adequate numbers of geriatric subjects (> 65 years of age) were not included in clinical trials to determine if geriatric populations will respond differently to hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. The response to hepatitis B immunization is known to decline in vaccinees over age 40.
No adequate and well controlled studies have been conducted with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during pregnancy. A pregnancy exposure registry of 245 women who received hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during pregnancy or within 28 days prior to conception found that the rates of miscarriage and major birth defects were consistent with estimated background rates. Additionally, 45 pregnant women who were inadvertently administrated hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant in pre- and post-licensure clinical studies had no increased rates of miscarriage or major birth defects. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated or recombinant virus vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration to pregnant women only if clearly indicated.
Data are limited regarding use of the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant during breast feeding and its' excretion in human milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however, according to the Advisory Committee on Immunization Practices (ACIP), inactivated and recombinant vaccines pose no risk to breast-feeding mothers or their infant. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
The hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant (Twinrix) is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap that may contain natural rubber latex. The other type has a tip cap and a rubber plunger that contain dry natural latex rubber. The vial stopper does not contain latex. Use of a prefilled syringe in someone with latex hypersensitivity may be unadvisable.
Laboratory test interference may occur between the hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant and hepatitis B surface antigen (HBsAg) in blood samples. HBsAg has been transiently detected in blood samples after vaccination. Serum HBsAg may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine.
General Dosing Information
-Vaccine administration is recommended for several at risk patient groups: patients with chronic liver disease, homosexually active males, users of injectable and non-injectable illicit drugs, homeless persons, patients infected with HIV, pregnant women identified to be at risk for hepatitis A virus (HAV) during pregnancy, handlers of hepatitis A-infected primates, and laboratory workers handling hepatitis A. Additionally, vaccine administration is recommended for unvaccinated persons who provide services to injection or noninjection drug users or group homes and nonresidential day care facilities for developmentally disabled persons.
-Vaccinate patients traveling to, living in, or relocating to an area of high endemic risk. Information regarding specific locales may be found through the CDC or a local public health agency.
-Hepatitis A vaccination is recommended for all previously unvaccinated persons who anticipate close personal contact (e.g., household contact or regular babysitting) with an international adoptee from a country of high or intermediate endemicity during the first 60 days after arrival of the adoptee in the United States. Ideally, administer the first dose at least 2 weeks before the arrival of the adoptee. Patients with an impaired immune system may need additional doses of vaccine in order to obtain an adequate anti-hepatitis A response; consult current CDC guidelines for immunosuppressed patients.
For hepatitis A prophylaxis and hepatitis B prophylaxis:
Intramuscular dosage (Twinrix):
Adults: 1 mL IM for 3 or 4 doses. For the 3 dose standard regimen, give the second dose 1 month after the initial dose and the third dose 6 months after the initial dose. For the 4 dose accelerated regimen, give the second dose 7 days after the initial dose and the third dose 21 to 30 days after the initial dose, followed by a booster dose at month 12.
Children* and Adolescents*: Dosage regimen is not yet established. An initial dose of 0.5 mL IM, repeated at 1 and 6 months after initial dose, has been used. An alternative, 2-injection schedule has been used. Initial dose is 1 mL IM; repeat at 6 months after initial dose.
Maximum Dosage Limits:
-Adults
1 mL/dose IM.
-Geriatric
1 mL/dose IM.
-Adolescents
Safety and efficacy have not been established; 1 mL/dose IM has been used.
-Children
Safety and efficacy have not been established; 1 mL/dose IM has been used.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Active immunization with hepatitis A and B vaccine stimulates the immune system to produce antibodies without exposing the patient to the risks of active infection. Infection with hepatitis D can occur only with concurrent hepatitis B infection, so vaccination with hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant provides protection against hepatitis D as well.
Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant contains inactivated hepatitis A virus (HAV, strain HM175) that is propagated in MRC5 cells and combined with purified hepatitis B surface antigen (HBsAg). The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Natural infection with either HAV or HBV that results in adequate antibody titers provides lifelong immunity. Routine booster doses of hepatitis A and hepatitis B vaccine are not currently recommended by the ACIP, except for the use of hepatitis B vaccine boosters in hemodialysis patients.
Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant is administered by intramuscular injection only.
The distribution, metabolism, and elimination of these vaccines are not well characterized. Anti-HAV antibody titers >= 33 milliunits/mL are considered consistent with seroconversion; anti-HBs antibodies >= 1 milliunits/mL indicate seroconversion and titers >= 10 milliunits/mL are considered protective. Antibodies to both HAV and HBV persisted in adults for at least 4 years after the 3-dose series of hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant. In this study, immunogenicity was positive in > 95% of subjects at month two. Follow-up determined that after 4 years, 100% of evaluated subjects were positive for anti-HAV and 95.3% were protected against hepatitis B. A decline in antibody titers did occur, but titers were similar to those seen with the corresponding monovalent vaccines. The seroprotection rate for hepatitis B at month 13 after 4 doses of Hepatitis A vaccine, inactivated; hepatitis B vaccine, recombinant given on days 0, 7, 21-30, and month 12 was 96.4% (92.7-98.5). In contrast, the seroprotection rate for hepatitis B after separate vaccinations with monovalent hepatitis A vaccine at 0 and 12 months and hepatitis B vaccine at 0, 1, 2, and 12 months was 93.4% (89-96.4). The seroconversion rate for hepatitis A at month 13 was 100% (98.1-100) for both groups.