Hemgenix

Generic name: Etranacogene Dezaparvovec-drlb
Dosage form: suspension, for intravenous infusion
Drug class: Miscellaneous uncategorized agents

Usage of Hemgenix

Hemgenix is a one-time gene therapy for the treatment of adults with hemophilia B.

Hemophilia B is an inherited bleeding disorder resulting from missing or insufficient levels of blood clotting Factor IX, a protein needed to produce blood clots to stop bleeding.

Hemgenix consists of a viral vector that carries a gene for Factor IX. The gene is expressed in the liver to produce the Factor IX protein, which increases the blood levels of Factor IX to limit episodes of bleeding.

Hemgenix side effects

Hemgenix may cause serious side effects.

See Important information.

The most common side effects include:

liver enzyme elevations

headache

elevated levels of a certain blood enzyme

flu-like symptoms

infusion-related reactions

fatigue

nausea, and

feeling unwell.

These are not the only side effects possible. Tell your healthcare provider about any side effect you may experience.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Hemgenix

Before you receive Hemgenix:

you will be tested for Factor IX inhibitors. If the test result is positive, a retest will be performed 2 weeks later. You will NOT be able to receive Hemgenix if both tests are positive.

you will also be tested to check the health of your liver.

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How to use Hemgenix

Usual Adult Dose for Hemophilia B:

2 x 1013 genome copies (gc) per kg of body weight

Comment: -administer as an intravenous infusion after dilution with 0.9% normal saline at a constant infusion rate of 500 ml/hour (8 mL/min).

Use: -treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or who ave current or historical life-threatening hemorrhage, or who have repeated, serious spontaneous bleeding episodes.

Warnings

Hemgenix may cause serious side effects, including:

Infusion reactions. Signs and symptoms of infusion reactions may include:

chest tightness

headaches

abdominal pain

lightheadedness

flu-like symptoms

shivering

flushing

rash, and

elevated blood pressure.

You will need to be monitored while you are receiving the infusion, and for at least 3 hours after. If a reaction occurs, the infusion rate may be slowed or interrupted, then re-started at a slower rate.

Elevation of certain liver enzymes. You will need tests to assess the health of your liver before you receive Hemgenix, and then weekly blood tests to monitor your liver enzymes for 3 months after receiving the infusion. If you have preexisting risk factors for liver cancer, you will receive regular liver health testing for 5 years.

Hemgenix is not intended for administration in women.

What other drugs will affect Hemgenix

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Disclaimer

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