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Overview: Itvisma is a one-time treatment for certain people with spinal muscular atrophy. Itvisma provides the instructions for your body to make a protein that is needed for muscles to work normally. Your health care provider will give this medicine by an injection into or near the spinal cord. Common side effects include infection in the nose or throat, sore throat, or common cold symptoms, vomiting, fever, and headache. You will need regular blood tests after receiving this medicine.

Uses

What is Itvisma used for?

Itvisma (onasemnogene abeparvovec-brve) is commonly used to treat certain people with spinal muscular atrophy (SMA).

Itvisma for Spinal Muscular Atrophy: What Should I Know?

Itvisma may also be used for other conditions as determined by your health care provider.

How does Itvisma work (mechanism of action)?

Itvisma is a medicine known as a gene replacement therapy. This medicine provides the instructions for the body to make a protein that is needed for muscles to work normally. People without enough of this protein may have muscle weakness that can cause problems in breathing or walking.

How is Itvisma supplied (dosage forms)?

Itvisma is available in an injectable form that is given by a health care provider.

How should I store Itvisma?

Itvisma is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Itvisma?

The most common side effects of Itvisma are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Vomiting
  • Fever
  • Headache

There may be other side effects of Itvisma that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at https://www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Itvisma?

While less common, the most serious side effects of Itvisma are described below, along with what to do if they happen.

Severe Allergic Reactions. Itvisma may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severely Low Platelet Levels. Itvisma can cause a severely low number of platelets in the blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Tell your health care provider if you or your child have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds

Liver Damage. Liver damage, also called hepatotoxicity, can happen after receiving Itvisma. Liver damage can be life-threatening. Keep all appointments for blood work, which will likely be needed for several months. Call your health care provider right away if you or your child have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness, unusual tiredness, or decreased alertness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Nerve Problems. Nerves are the fibers that carry sensations from your body to the brain. Damage to these nerves, called peripheral neuropathy, can happen in people who have used Itvisma. Call your health care provider right away if you or your child have pain, burning, tingling, numbness, or weakness in the arms, hands, legs, or feet.

Small Blood Vessel Clots. Itvisma may cause a life-threatening condition called thrombotic microangiopathy (TMA). Small blood clots form in the blood vessels and can damage the kidneys. Keep all appointments for blood work. Tell your health care provider right away if you or your child has any of the following symptoms.

  • Not peeing as much or fewer wet diapers 
  • Unusual bruising or bleeding
  • High blood pressure
  • Seizures

Warnings & Precautions

Who should not use Itvisma?

Allergies to Ingredients. People who are allergic to any of the following should not use Itvisma.

  • Itvisma
  • Onasemnogene abeparvovec-brve
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Itvisma.

What should I know about Itvisma before using it?

Itvisma will be injected into or near the spinal cord (intrathecal injection) by a health care provider in a hospital or clinic.

Keep all appointments for blood tests.

You or your child will likely get a medicine called a corticosteroid before getting Itvisma and afterward for a period of time. Tell your health care provider right away if you miss a corticosteroid dose or if you throw up after taking a corticosteroid.

Stay away from people who are sick. Wash your hands often, and stay away from crowded spaces. Ask anyone you live with to also try to stay well. If you get sick around the time Itvisma is given, you may have a more serious illness. Tell your health care provider right away if you are sick or you think that you may be sick before or after getting this medicine. Symptoms you may have if you are sick include cough, wheezing, runny nose, sneezing, sore throat, or fever.

If you can get your partner pregnant, use effective birth control, like condoms, for 6 months after your Itvisma dose. See the Pregnancy section for more information.

Refrain from egg donation for 6 months and sperm donation for 3 months after an Itvisma dose.

What should I tell my health care provider before using Itvisma?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Itvisma is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Current infection
  • Liver problems

Vaccines. Talk to your health care provider about any vaccines that you may need. You should get all needed vaccines before starting Itvisma, such as flu and respiratory syncytial virus (RSV). You may not be able to receive certain vaccines right before or while using Itvisma because you likely will also be using another medicine called a corticosteroid. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. It is not known if or how Itvisma could affect pregnancy or harm an unborn baby. If you can become pregnant, you will need a pregnancy test before starting Itvisma. You will also need to use effective birth control for 6 months after your Itvisma dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Itvisma passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Itvisma while breastfeeding.

How can I get more information about Itvisma?

For more information about Itvisma, you can visit the drugmaker’s website at www.itvisma.com or call them at 855-441-4363.

Interactions

Does Itvisma interact with foods or drinks?

There are no known interactions between Itvisma and foods or drinks.

It is unknown if drinking alcohol will affect Itvisma.

Does Itvisma interact with other medicines (drug interactions)?

There are no known interactions between Itvisma and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Itvisma?

If you or someone else has used too much Itvisma, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Itvisma?

Itvisma is usually given as a one-time dose by a health care provider in a hospital or clinic. If you miss your appointment to get Itvisma, call to make another appointment as soon as possible.