Fidanacogene Elaparvovec-dzkt (fye-da-NAK-oh-jeen el-a-PAR-voe-vek - dzkt)

Treats hemophilia B.

Brand Name(s):

Beqvez

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 IV will have to remain in place for at least 60 minutes.
• 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 fidanacogene elaparvovec-dzkt works. Tell your doctor if you are using a steroid medicine.
• Do not drink alcohol during treatment and for at least 1 year after receiving this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease (including hepatitis B or C, non-alcoholic fatty liver disease, chronic alcohol consumption, and non-alcoholic steatohepatitis) or cancer.
• This medicine may cause the following problems:
  • Liver problems, including liver cancer
  • Infusion reactions
• Male patients should not donate sperm and must use an effective form of birth control 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes

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

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

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