Important Safety Information

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.

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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.

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You must complete or update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of FABHALTA.

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If you have not completed your vaccinations and FABHALTA therapy must be started right away, you should receive the required vaccinations as soon as possible.

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If you have not been vaccinated and FABHALTA must be started right away, you should also receive antibiotics to take for as long as your health care provider tells you.

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If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your health care provider will decide if you need additional vaccinations.

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Vaccines do not prevent all infections caused by encapsulated bacteria.
Call your health care provider or get emergency medical care right away if you have any of these signs and symptoms of a serious infection:

▪	Fever with or without shivers or chills
▪	Fever with chest pain and cough
▪	Fever with high heart rate
▪	Headache and fever
▪	Confusion
▪	Clammy skin
▪	Fever and a rash
▪	Fever with breathlessness or fast breathing
▪	Headache with nausea or vomiting
▪	Headache with stiff neck or stiff back
▪	Body aches with flu-like symptoms
▪	Eyes sensitive to light

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:

•	Enroll in the FABHALTA REMS program.
•	Counsel you about the risk of serious infections caused by certain bacteria.
•	Give you information about the symptoms of serious infections.
•	Make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start FABHALTA right away and you are not up to date on your vaccinations.
•	Give you a Patient Safety Card about your risk of serious infections.

Who should NOT take FABHALTA?

Do not take FABHALTA if you:

•	Are allergic to FABHALTA or any of the ingredients in FABHALTA.
•	Have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b when you are starting FABHALTA.

Before you take FABHALTA, tell your health care provider about all your medical conditions, including if you:

•	Have an infection or fever.
•	Have liver problems.
•	Are pregnant or plan to become pregnant. It is not known if FABHALTA will harm your unborn baby.
•	Are breastfeeding or plan to breastfeed. It is not known if FABHALTA passes into your breast milk. You should not breastfeed during treatment and for 5 days after your final dose of FABHALTA.

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:

•	Decreased hemoglobin level in your blood
•	Blood in your urine
•	Shortness of breath
•	Trouble swallowing
•	Tiredness
•	Pain in the stomach (abdomen)
•	Blood clots, stroke, and heart attack
•	Erectile dysfunction (ED)

It is important 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 possible side effects of FABHALTA?

FABHALTA may cause serious side effects, including:

•	See “What is the most important information I should know about FABHALTA?”
•	Increased cholesterol and triglyceride (lipid) levels in your blood. Your health care provider will do blood tests to check your cholesterol and triglycerides during treatment with FABHALTA. Your health care provider may start you on a medicine to lower your cholesterol if needed.

The most common side effects of FABHALTA in adults include:

•	Headache
•	Nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis)
•	Diarrhea
•	Pain in the stomach (abdomen)
•	Infections (bacterial and viral)
•	Nausea
•	Rash

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.

Approved Use

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.

One study compared FABHALTA with SOLIRIS^® and ULTOMIRIS^®

•	A study of 97 adults with PNH over a period of 24 weeks compared the effect of switching to FABHALTA (200-mg oral capsule twice daily) from SOLIRIS^® or ULTOMIRIS^® versus continuing on these infusions
•	Everyone had been on SOLIRIS^® or ULTOMIRIS^® for at least 6 months before the study and had Hb levels of <10 g/dL
•	The study was primarily set up to understand the percentage of people whose Hb levels increased by 2 g/dL or more and whose Hb levels reached 12 g/dL or higher without the need for red blood cell transfusions

Hb, hemoglobin.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080