iptacopan 200 mg capsule

Generic name:
Iptacopan - oral

Brand name(s)
Fabhalta

Iptacopan can lower your body's ability to fight infections. This increases your chance of getting very serious (possibly fatal) infections (especially meningitis or sepsis).

Your doctor may prescribe certain vaccines for you to get at least 2 weeks before your first dose of this medication. Vaccines may not fully protect everyone who receives them, so you should still watch for signs of infection after you get the vaccine. Get medical help right away if you develop symptoms such as nausea/vomiting that doesn't stop, fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), muscle aches with flu-like symptoms, eye sensitivity to light.

To receive iptacopan in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Iptacopan is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria - PNH). This disorder causes your body's immune system to break down red blood cells, which results in anemia. Iptacopan works by helping to block the body's breakdown of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath) and may reduce the need for blood transfusions.

This medication is also used to treat a certain kidney problem (primary immunoglobulin A nephropathy - IgAN). Iptacopan helps to lower levels of protein in the urine.

Read the Medication Guide provided by your pharmacist before you start taking iptacopan and each time you get a refill. Carry the Patient Safety Card with you at all times during treatment and for 2 weeks after your last dose of iptacopan. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Swallow the capsule whole. Do not open, break, or chew the capsules.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

If you are changing to this medication treatment from another drug, carefully follow your doctor's directions for when to start or stop this and your other medication(s). Do not stop taking this medication without consulting your doctor. If you are taking this medication for PNH, your condition may become worse when the drug is stopped. If you do stop taking this medication, your doctor will monitor you for at least 2 weeks after the last dose to make sure your condition does not get worse. Consult your doctor for more details.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Headache, cold symptoms (stuffy/runny nose, cough), nausea, diarrhea, abdominal pain, joint pain, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking iptacopan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent infection
• liver disease

Iptacopan can make you more likely to get certain infections (such as colds, meningitis). Talk to your doctor for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Tell your health care professional that you are using iptacopan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Breastfeeding is not recommended while using this medication and for 5 days after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of iptacopan from your body, which may affect how iptacopan works. An example of an affected drug is gemfibrozil, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, blood cholesterol/triglyceride level) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss one or more doses, take one dose as soon as you remember. Then take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.