Valoctocogene roxaparvovec

Generic name: valoctocogene roxaparvovec [ val-OK-toe-KOE-jeen-ROX-a-PAR-voe-vek ]
Brand name: Roctavian
Dosage form: intravenous suspension (rvox 20 trillion vg/mL)
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com on Apr 8, 2024. Written by Cerner Multum.

What is valoctocogene roxaparvovec?

Valoctocogene roxaparvovec is used to treat severe hemophilia A in adults.

Your doctor will make sure you can be treated with valoctocogene roxaparvovec.

valoctocogene roxaparvovec may not work for every person who receives it. Talk to your doctor if you have any questions.

Valoctocogene roxaparvovec may also be used for purposes not listed in this medication guide.

Valoctocogene roxaparvovec 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.

Also tell your doctor right away if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of a blood clot--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, chest pain, shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg.

Common side effects of valoctocogene roxaparvovec may include:

• nausea, vomiting, stomach pain;

• abnormal blood tests;

• a reaction after receiving injection; or

• feeling weak or tired, headache.

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.

Related/similar drugs

Warnings

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

Before taking this medicine

You should not be treated with valoctocogene roxaparvovec if you have:

• any active, or uncontrolled chronic infection;

• an allergy to mannitol; or

• cirrhosis or stage 3 or 4 liver fibrosis.

Tell your doctor if you have or have ever had:

• heart disease, a blood clot or stroke;

• any type of hepatitis, HIV;

• a planned surgery or medical procedure;

• abnormal liver function tests;

• if you drink alcohol; or

• any other allergies.

Using valoctocogene roxaparvovec may increase your risk of developing certain types of cancer including liver cancer. Ask your doctor about your individual risk.

Tell your doctor if you recently received a vaccine or are scheduled to receive a vaccine. Your doctor may need to adjust your vaccination schedule.

Make sure you are current on all vaccines before you start using valoctocogene roxaparvovec.

Your name should be listed on a registry to track the effects of valoctocogene roxaparvovec on you.

This medicine is not intended for use by women.

Men and their female partners should use effective birth control to prevent pregnancy. If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose. Ask your doctor about birth control options. Tell your doctor right away if a pregnancy occurs.

Men using valoctocogene roxaparvovec should not donate semen for at least 6 months after treatment.

How is valoctocogene roxaparvovec given?

Your doctor will perform medical tests before starting treatment with valoctocogene roxaparvovec to make sure is the right treatment for you.

Valoctocogene roxaparvovec is given in one dose as an infusion into a vein. A healthcare provider will give you this injection.

You will be watched during and for at least 3 hours after the infusion to make sure you do not have a reaction.

You will need weekly blood tests to check your liver function for at least 26 weeks after treatment. You may need other medical tests for a longer period of time if you have certain medical conditions or side effects.

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.

Tell your doctor ahead of time if you need surgery or a medical procedure or if any bleeding occurs after receiving valoctocogene roxaparvovec. You may need to start another medicine to treat hemophilia A. Follow your doctor's instructions.

Valoctocogene roxaparvovec dosing information

Usual Adult Dose for Hemophilia A:

6 × 10(13) vg/kg as a single IV infusion at a rate of 1 mL/min

Duration of therapy: Once

Comments:
-Do not administer this drug to patients with a positive test for antibodies to AAV5, factor VIII inhibitor, active acute or uncontrolled chronic infections, known significant hepatic fibrosis or cirrhosis, or mannitol hypersensitivity.
-To determine dose needed in mL, multiply patient body weight in kg by 3.
-To determine number of vials to be thawed, divide the patient dose volume (mL) by 8.
-Infuse the suspension through a suitable peripheral vein using an infusion catheter with an in-line filter and a programmable syringe pump.
-If tolerated, the rate of infusion may be increased every 30 minutes by 1 mL/min up to a maximum rate of 4 mL/min.
-Treatment with this drug should be carried out under the supervision of a physician experienced in hemophilia/bleeding disorder treatment.
-Safety and effectiveness of this drug in patients with prior or active factor VIII inhibitors have not been established.

Use: For the treatment of adults with severe hemophilia A without pre-existing antibodies to adeno-associated virus serotype 5

What happens if I miss a dose?

Valoctocogene roxaparvovec is given in one dose. Call your doctor for instructions if you miss an appointment for your valoctocogene roxaparvovec injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving valoctocogene roxaparvovec?

Ask your doctor before using any other medicine for hemophilia A.

Do not drink alcohol for at least a year after receiving this treatment. Dangerous side effects could occur.

Avoid receiving a "live" vaccine while you are being treated with valoctocogene roxaparvovec.

Do not donate blood, organs, tissues, or cells for transplantation after receiving valoctocogene roxaparvovec.

What other drugs will affect valoctocogene roxaparvovec?

Valoctocogene roxaparvovec can harm your liver, especially if you also use certain health supplements, steroids, or other medicines for infections, birth control, high cholesterol, seizures, pain, or arthritis (including Advil).

Tell your doctor about all your other medicines, especially:

• isotretinoin; or

• efavirenz.

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

Valoctocogene roxaparvovec Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for valoctocogene roxaparvovec.

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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