Fabhalta

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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, kidney disease, 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.

Do not share this medication with others.

Lab and/or medical tests (such as LDH level, 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.

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.

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

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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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

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 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.

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).