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PARIGLASGENE BRECAPARVOVEC (PAR i GLAS jeen BREK a PAR voe vek) treats glycogen storage disease type Ia (GSDIa). It works by helping your liver make an enzyme that releases stored sugar (glucose) into your blood. This enzyme helps your body manage blood glucose levels between meals. It can reduce the amount of cornstarch you need to eat. It is a gene therapy.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
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This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.
Talk to your care team about the use of this medication in children. While it may be given to children as young as 8 years for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
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Interactions are not expected.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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Your condition will be monitored carefully while you are receiving this medication. Visit your care team for regular health checks after your infusion.
You may need blood work done before and after your infusion.
This medication can cause serious side effects. To reduce the risk, your care team may give you other medications to take before and after your infusion. Follow the directions from your care team.
Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.
After gene therapy, it is important to avoid contact with the treated person's body fluids for 3 months. Body fluids include urine, stool, and saliva. By avoiding contact, the gene therapy will not affect others by accident. Wash hands with soap and water after coming into contact with body fluids and before eating. Use disposable gloves. Place items that have body fluids on them, such as diapers, in a sealed bag. Get rid of the bag in the regular trash.
Talk to your care team if you may be pregnant. This medication has not been well studied during pregnancy. Contraception is recommended for 12 months after your infusion. Your care team can help find the option that works for you.
If your partner can get pregnant, use a condom during sex for 6 months after your infusion.
Do not donate semen for 6 months after your infusion.
Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.
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This does not apply. This medication is not for regular use.
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Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
-Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
-Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Constipation
-Headache
-Nausea
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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This medication is given in a hospital or clinic. It will not be stored at home.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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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