Before receiving BEQVEZ, tell your healthcare professional about all your medical conditions, including if you:
BEQVEZ may cause serious side effects, including:
Increased Liver Enzymes. Most patients treated with BEQVEZ developed elevated liver enzyme levels and most did not experience any symptoms.
Your healthcare professional will monitor liver enzymes and factor IX activity levels before administration of BEQVEZ and frequently following the administration to detect and identify possible elevations in liver enzymes and to monitor your response to BEQVEZ. Your doctor may prescribe a corticosteroid for the treatment of elevated liver enzymes.
Limit alcohol consumption during the first year following BEQVEZ infusion, as alcohol may reduce the effect of BEQVEZ and may increase liver enzyme levels.
Infusion reactions, including hypersensitivity and severe allergic reactions (anaphylaxis) may occur. Alert your healthcare professional right away if you get any symptoms of hypersensitivity, which may include but are not limited to low blood pressure, fever, heart palpitation, nausea, vomiting, chills, or headache.
BEQVEZ can insert itself into the DNA of cells in the human body. The effect that insertion may have on those cells is unknown but may contribute to a theoretical risk of cancer. There have been no reported cases of cancer caused by treatment with BEQVEZ.
The most common side effect of BEQVEZ is increased liver enzymes. These are not all the possible side effects of BEQVEZ. For more information, ask your healthcare professional.
Talk to your healthcare professional before receiving any vaccinations if you are taking a corticosteroid.
Talk to your doctor about any medications you plan to take including over the counter medications, herbal supplements, and vitamins as certain substances can affect the liver and may reduce the effectiveness of BEQVEZ.
Your healthcare professional will test your factor IX activity levels and for factor IX inhibitors.
After receiving BEQVEZ, your doctor will discuss whether and when you are able to stop prophylaxis, if you need to resume prophylaxis, and actions you may need to take for surgeries, procedures, injuries, and bleeding events.
Do not donate blood, organs, tissues, or cells for transplantation following administration of BEQVEZ.
BEQVEZ is not intended for administration to women. Males should not donate sperm and should use a male condom or not have sexual intercourse for up to 6 months after receiving BEQVEZ.
Patients and caregivers should ensure proper handling of any materials that have come into contact with the patient’s urine, feces, saliva, mucus, or semen in the first 6 months after BEQVEZ infusion.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
What is BEQVEZ?
BEQVEZ is a one-time gene therapy used for the treatment of adults with moderate to severe hemophilia B who are receiving routine prophylaxis, have a current life-threatening bleed or a history of life-threatening bleeds, or have repeated serious spontaneous bleeds.
Before treatment with BEQVEZ, your healthcare professional will conduct a blood test to check for antibodies to the AAVRh74var virus. The results of this testing will help determine if you may receive BEQVEZ.