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What is FABHALTA?
FABHALTA is a prescription medicine used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
It is not known if FABHALTA is safe and effective in children.
What is the most important information I should know about FABHALTA?
FABHALTA is a medicine that affects part of your immune system and may lower your ability to fight infections.
FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or fatal if not recognized and treated early.
Your health care provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 weeks after your last dose of FABHALTA. Your risk of serious infections may continue for a few weeks after your last dose of FABHALTA. It is important to show this card to any health care provider who treats you. This will help them diagnose and treat you quickly.
FABHALTA is only available through a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before you can take FABHALTA, your health care provider must:
FABHALTA may increase your cholesterol and triglycerides and your health care provider will do blood tests to check them periodically during treatment.
Who should NOT take FABHALTA?
Do not take FABHALTA if you:
What should I tell my health care provider before taking FABHALTA?
Before you take FABHALTA, tell your health care provider about all your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FABHALTA with certain other medicines may affect the way FABHALTA works and may cause side effects. Know the medicines you take and the vaccines you receive. Keep a list of them to show your health care provider and pharmacist when you get a new medicine.
If you have PNH and you stop taking FABHALTA, your health care provider will need to monitor you closely for at least 2 weeks after stopping FABHALTA. Stopping treatment with FABHALTA may cause a breakdown of red blood cells due to PNH.
Symptoms or problems that can happen due to breakdown of red blood cells include:
It is important that you take FABHALTA exactly as your health care provider tells you to lower the possibility of breakdown of red blood cells due to PNH.
What are the most common side effects of FABHALTA?
The most common side effects of FABHALTA include:
Tell your health care provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of FABHALTA. Call your doctor for medical advice about side effects.
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.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.