Iptacopan (ip-ta-KOE-pan)

Treats paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s):

Fabhalta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not open, break, or chew it.
• Tell your doctor if you are changing treatment from eculizumab or ravulizumab to iptacopan.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If a dose is missed, take it as soon as possible even if it is almost time for your next dose. Then, take the next dose at the regularly scheduled time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 iptacopan works. Tell your doctor if you are using gemfibrozil or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, a weak immune system, or any kind of infection.
• Do not breastfeed during treatment and for at least 5 days after the last dose.
• This medicine can increase your risk of serious infections, including pneumonia and meningitis. You will need to be vaccinated against these infections at least 2 weeks before you start treatment with this medicine. You may be given antibiotic medicines to prevent infections if you are to use this medicine right away. You will also be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times. Show the card to any doctor who treats you.
• When you stop receiving this medicine, you may develop hemolysis (breakdown of red blood cells). Your doctor will monitor you for at least 2 weeks.
• This medicine may increase your cholesterol and triglycerides (fats). Talk with your doctor if you have any concerns about this.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

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

• Blurred vision, headache, fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Unusual bleeding, bruising, or weakness

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

• Diarrhea, nausea, stomach pain
• Dizziness
• Joint pain

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