Valoctocogene Roxaparvovec-rvox (val-ok-toe-KOE-jeen rox-a-PAR-voe-vek - rvox)

Treats hemophilia A.

Brand Name(s):

Roctavian

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 2 hours.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how valoctocogene roxaparvovec-rvox works. Tell your doctor if you are using efavirenz, isotretinoin, or medicine that can weaken the immune system (including steroid medicine).
• Do not drink alcohol during treatment and for at least 1 year after receiving this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live virus vaccines together with this medicine.

Warnings While Using This Medicine:

• Women should not use this medicine, especially women who are pregnant or able to become pregnant. This medicine can harm an unborn baby. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Males with female partners who can become pregnant must use an effective form of birth control during treatment and for at least 6 months after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
• Tell your doctor if you have liver disease (including hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, and non-alcoholic steatohepatitis), blood clots, cancer, heart or blood vessel disease, or infection.
• This medicine may cause the following problems:
  • Infusion-related reactions
  • Liver problems
  • Increased risk for blood clots
• Do not donate semen for at least 6 months after treatment.
• Do not donate blood, organs, tissues or cells for transplant after treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf)
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Headache
• Pain, itching, burning, redness, swelling, or a lump under your skin where the needle is placed
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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