Etranacogene dezaparvovec

Generic name: etranacogene dezaparvovec
Brand names: Hemgenix (101-105 kg), Hemgenix (106-110 kg), Hemgenix (111-115 kg), Hemgenix (116-120 kg), Hemgenix (121-125 kg), ... show all 39 brands Hemgenix (126-130 kg), Hemgenix (51-55 kg), Hemgenix (56-60 kg), Hemgenix (61-65 kg), Hemgenix (66-70 kg), Hemgenix (71-75 kg), Hemgenix (76-80 kg), Hemgenix (81-85 kg), Hemgenix (86-90 kg), Hemgenix (91-95 kg), Hemgenix (96-100 kg), Hemgenix (46-50 kg), Hemgenix (236-240 kg), Hemgenix (231-235 kg), Hemgenix (226-230 kg), Hemgenix (221-225 kg), Hemgenix (216-220 kg), Hemgenix (211-215 kg), Hemgenix (206-210 kg), Hemgenix (201-205 kg), Hemgenix (196-200 kg), Hemgenix (191-195 kg), Hemgenix (186-190 kg), Hemgenix (181-185 kg), Hemgenix (176-180 kg), Hemgenix (171-175 kg), Hemgenix (166-170 kg), Hemgenix (161-165 kg), Hemgenix (156-160 kg), Hemgenix (151-155 kg), Hemgenix (146-150 kg), Hemgenix (141-145 kg), Hemgenix (136-140 kg), Hemgenix (131-135 kg)
Dosage form: intravenous suspension (drlb)
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Drugs.com on Nov 2, 2023. Written by Cerner Multum.

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.

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 of etranacogene dezaparvovec 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.

Warnings

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

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.

etranacogene dezaparvovec is not intended for use by women.

How is etranacogene dezaparvovec given?

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.

Etranacogene dezaparvovec dosing information

Usual Adult Dose for Hemophilia B:

Usual dose: 2 x 10(13) genome copies per kilogram of body weight (or 2 mL/kg body weight) as a single IV infusion

Comments:
-Refer to manufacturer product information for detailed dose calculation.
-Patients with any of the following criteria are eligible for this treatment:
---Currently on Factor IX prophylaxis therapy
---Have current or historical life-threatening hemorrhage
---Have repeated, serious spontaneous bleeding episodes
-The following tests should be performed for screening patients before treatment:
---Factor IX inhibitor titer testing: A re-test should be performed within 2 weeks in case of initial positive test results. If both tests are positive, this therapy should not be administered.
---Liver health assessments: Enzyme testing (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and total bilirubin), hepatic ultrasound and elastography
-Consult hepatologist in case of radiological liver abnormalities and/or sustained liver enzyme elevations to assess appropriateness of this treatment.

Use: Treatment of adults with Hemophilia B (congenital Factor IX deficiency)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your etranacogene dezaparvovec injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving etranacogene dezaparvovec?

Do not donate blood, organs, tissues, or cells for transplantation after receiving etranacogene dezaparvovec.

What other drugs will affect etranacogene dezaparvovec?

Other drugs may affect etranacogene dezaparvovec, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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