Fidanacogene Elaparvovec Side Effects

Applies to fidanacogene elaparvovec: intravenous suspension.

Important Warnings This medicine can cause some serious health issues

This medicine may not work for every person who receives it.

Talk to your doctor if you have any questions.

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

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]

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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer