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Fabhalta is the brand name for iptacopan and is available as an oral capsule.

Fabhalta is available as a 200 mg oral capsule.

Fabhalta is a complement factor B inhibitor that treats paroxysmal nocturnal hemoglobinuria (PNH), a condition that causes low levels of red blood cells (anemia) and blood clots.

Fabhalta works by slowing down an overactive immune system, which reduces the breakdown of red blood cells.

Fabhalta is typically dosed as 200 mg orally twice daily with or without food.

Fabhalta is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Serious hypersensitivity to iptacopan or any of the excipients
• Initiation in patients with unresolved serious infection caused by encapsulated bacteria

Common side effects of Fabhalta:

• Headache
• Common cold symptoms
• Diarrhea
• Abdominal pain
• Bacterial infection
• Viral infection
• Nausea
• Rash

Serious side effects are rare with Fabhalta. Fabhalta increases your chance of getting serious infections caused by encapsulated bacteria. You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of Fabhalta. If you have not completed your vaccinations and Fabhalta must be started right away, you should receive the required vaccinations as soon as possible.
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 healthcare provider tells you. If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting Fabhalta. Your healthcare provider will decide if you need additional vaccinations. Call your healthcare provider or get emergency medical care right away if you have any signs and symptoms of a serious infection.

The following medications may interact with Fabhalta:

• CYP2C8 inducers (e.g., rifampin): May decrease iptacopan exposure.
• Monitor for loss of efficacy.
• Strong CYP2C8 inhibitors (e.g., gemfibrozil): May increase iptacopan
• exposure. Coadministration not recommended.

Novartis Pharmaceuticals

It is not known if Fabhalta can harm your unborn baby. You and your healthcare provider should decide if you will use Fabhalta.

• Iptacopan