Pregnancy & Lactation: Risk data not available
What is Etranacogene Dezaparvovec?
Etranacogene dezaparvovec is used to treat a bleeding disorder called Hemophilia B in adults who are receiving preventive treatment for the condition, have recurrent episodes of serious bleeding or have current or previous life-threatening bleeding events.
Etranacogene dezaparvovec 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;
- hepatitis B or C;
- if you drink large amounts of alcohol; or
- cirrhosis or other liver disease.
This medicine is not intended for use by women.
How should I use Etranacogene Dezaparvovec
Use Etranacogene Dezaparvovec (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 medical tests before starting treatment with etranacogene dezaparvovec to make sure is the right treatment for you.
Etranacogene dezaparvovec 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 weight. Your dose may change if you gain or lose weight.
You will need weekly blood tests to check your liver function for 3 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.
You may need other medical tests for a longer period of time if you have certain conditions or if you have certain side effects.
Call your doctor for instructions if you miss an appointment for your etranacogene dezaparvovec injection.
Etranacogene Dezaparvovec 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 blood tests;
- headache;
- flu-like symptoms;
- a reaction after receiving injection; or
- feeling weak or tired, body aches.
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 Etranacogene Dezaparvovec?
Do not donate blood, organs, tissues, or cells for transplantation after receiving this medicine.