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Onasemnogene Abeparvovec-brve (By injection)

Onasemnogene Abeparvovec-brve (on-a-SEM-noe-jeen a-be-PAR-voe-vek - brve)

Treats spinal muscular atrophy (progressive muscle wasting).

Brand Name(s):

Itvisma

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into your spinal cord.
• Your doctor may give you other medicines (including steroids) before and after you receive this medicine to prevent unwanted effects.
• Your doctor may also give you a vaccine to prevent respiratory syncytial virus. Talk to your doctor if you have concerns.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Talk with your doctor before your child receives any vaccines during treatment with this medicine. The vaccination schedule should be adjusted as needed to fit in with the steroid treatment schedule.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, nerve problems, or any type of infection.
• If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting the treatment. Female patients should not donate eggs and must use an effective birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should not donate sperm and must use an effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
• This medicine may cause the following problems:
  • Serious liver problems
  • Peripheral neuropathy (nerve problem)
  • Thrombotic microangiopathy (damage in the smallest blood vessels)
  • Heart problems
  • Increased risk of tumor
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain, fast or uneven heartbeat, swelling of the feet and lower legs, trouble breathing
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Seizures
• Unusual bleeding, bruising, or weakness
• Weakness in the arms, hands, legs, or feet

If you notice these less serious side effects, talk with your doctor:

• Headache, dizziness
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 2/4/2026