onasemnogene abeparvovec-xioi 2 x 10exp13 vg/mL IV suspension,kit

Generic name:
Onasemnogene abeparvovec - injection

Pronunciation
(ON-a-SEM-noe-jeen A-be-PAR-voe-vek)

Brand name(s)
Itvisma , Zolgensma

Onasemnogene abeparvovec may rarely cause very serious (possibly fatal) liver disease. Before treatment with this product, tell your doctor if you have liver disease. Your doctor should do lab tests to monitor your liver function before and after you receive treatment. To decrease the risk of liver problems, your doctor may also direct you to take another medication by mouth (a corticosteroid such as prednisolone) before and after you receive onasemnogene abeparvovec. Get medical help right away if you develop symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, or dark urine.

This product is used to treat a certain nervous system disorder that can lead to muscle weakness and muscle loss (spinal muscular atrophy). Onasemnogene abeparvovec is made from a certain virus that has been specially prepared. The virus is used to carry a certain human gene into cells. This type of treatment is known as gene therapy. Treatment may improve motor function.

This product is given as directed by your doctor, usually as a single dose. Depending on your brand, this product is given by slow injection into a vein or into the area around the spinal cord (intrathecal) by a health care professional. The dosage may be based on your body weight if this product is given into a vein.

Infusion reactions may happen during the infusion of this product into a vein. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, swelling of the face/tongue/throat, rash, vomiting, or shortness of breath. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

If this product is given into a vein, small amounts of virus may shed from your stool for up to 1 month after the injection. Ask your doctor how to handle and dispose of waste materials (such as diapers) for up to 1 month after the injection.

See also Warning and How to Use sections.

Vomiting may occur when this product is given into a vein. Headache or dizziness may occur when this product is given into the area around the spinal cord. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this product has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.

When this product is given into the area around the spinal cord, numbness/tingling/pain in the arms/legs may occur. Tell your doctor right away if you have these serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• signs of kidney problems (such as change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before this product is given, tell your doctor or pharmacist if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• liver problems (including cirrhosis, fatty liver disease, hepatitis B or C)
• current/recent infection

This product may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Onasemnogene abeparvovec may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell the health care professional that you have received this product before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using onasemnogene abeparvovec. Onasemnogene abeparvovec may harm an unborn baby. Your doctor should order a pregnancy test before you start this product. Women should ask about the use of reliable forms of birth control for 6 months after treatment. Men should ask about the use of reliable forms of birth control for 3 months after treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this product.

It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as liver/kidney function, complete blood count) must be done before you start receiving this product and after you receive it. Keep all medical and lab appointments.

After receiving this treatment, ask your doctor if you can donate blood, organs, tissues, or cells.

Not applicable.

Not applicable. This type of product is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.