Fidanacogene Elaparvovec: Uses, Side Effects & Warnings

Pregnancy & Lactation: Risk data not available

What is Fidanacogene Elaparvovec?

Fidanacogene elaparvovec is used to treat a bleeding disorder called hemophilia B in adult men who are receiving preventive treatment for the condition, have recurrent episodes of serious bleeding or have current or previous life-threatening bleeding events.

Your doctor will make sure you have the correct gene type to be treated with fidanacogene elaparvovec.

Fidanacogene elaparvovec may also be used for purposes not listed in this medication guide.

Warnings

Tell your doctor if you have or have ever had:

  • unusual bleeding, any bleeding that will not stop;
  • allergic to factor IX complex replacement products;
  • hepatitis B or C;
  • enlarged spleen;
  • HIV (human immunodeficiency virus);
  • if you are scheduled to receive a vaccine;
  • if you drink large amounts of alcohol; or
  • cirrhosis or other liver disease.

Make sure you are current on all vaccines before you start treatment with fidanacogene elaparvovec. Your doctor may need to adjust your vaccination schedule.

Using fidanacogene elaparvovec may carry the risk of developing liver cancer. Ask your doctor about your individual risk.

This medicine is not intended for use by women.

Men using fidanacogene elaparvovec should use condoms or practice abstinence, and avoid donating sperm for up to 6 months after receiving treatment.

Your name should be listed on a registry to track the effects of this medicine on you.

How should I use Fidanacogene Elaparvovec

Use Fidanacogene Elaparvovec (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor will perform tests to make sure fidanacogene elaparvovec is the right treatment for you.

Fidanacogene elaparvovec is given in one dose and is injected into a vein by a healthcare provider.

You will be watched during and for at least 3 hours after the infusion to make sure you do not have a reaction.

Doses are based on height and weight. Your dose may change if you gain or lose weight or if you are still growing.

You will need your liver function checked once or twice a week for at least 4 months after treatment.

You may be prescribed other medications to help treat abnormal liver function tests. Keep taking these medicines for as long as your doctor has prescribed.

Tell your doctor ahead of time if you need surgery or a medical procedure or if any bleeding occurs after receiving fidanacogene elaparvovec.

Call your doctor if your symptoms do not improve, or if they get worse.

You may need other medical tests for a longer period of time after treatment if you have certain conditions or if you have certain side effects.

You or your caregiver should practice proper hand hygiene when coming into direct contact with your urine, feces, saliva, mucus, and semen for 6 months after receiving fidanacogene elaparvovec. Place any materials that may have your body waste or fluids in a sealed plastic bag and dispose in regular trash.

What should I do if I missed a dose of Fidanacogene Elaparvovec (Intravenous)?

Fidanacogene elaparvovec is used as a single dose and does not have a dosing schedule.

Fidanacogene Elaparvovec side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during or right after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, unusual bleeding, or swelling in your face.

Common side effects may include:

  • abnormal liver tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fidanacogene Elaparvovec?

Avoid drinking large amounts of alcohol for the first year after treatment. Drinking alcohol may increase your risk of liver damage.

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