Fidanacogene Elaparvovec Side Effects

Applies to fidanacogene elaparvovec: intravenous suspension.

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.

For healthcare professionals

Applies to fidanacogene elaparvovec: intravenous suspension.

General adverse events

The most common adverse reaction was an increase in transaminases.^[Ref]

Hepatic

• Very common (10% or more): Increased transaminases (up to 53.3%)^[Ref]

Increased transaminases included increased ALT, increased AST, increased hepatic enzyme, abnormal hepatic function, abnormal liver function tests, and increased transaminases.^[Ref]

See also:

Further information

Fidanacogene elaparvovec side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer