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Fabhalta is used for certain kidney diseases and for a condition called paroxysmal nocturnal hemoglobinuria. Common side effects include headache, stomach pain, nausea, and vomiting. This medicine can increase your risk of a serious infection. You may need certain vaccines before starting this medicine. Get emergency help if you get a fever, especially one with chills, chest pain, cough, racing heart, rash, fast breathing, stiff neck, confusion, headache, or light sensitivity.

Uses

What is Fabhalta used for?

Fabhalta (iptacopan) is commonly used to lower high protein levels in the urine (pee) in people with primary immunoglobulin A nephropathy (IgAN) who are at risk for their disease getting worse. This medicine is also used to treat complement 3 glomerulopathy (C3G) to lower high protein levels in the urine (pee) and a rare blood condition called paroxysmal nocturnal hemoglobinuria (PNH). 

Learn more about Fabhalta for Paroxysmal Nocturnal Hemoglobinuria and Complement 3 Glomerulopathy (C3G).

Fabhalta may also be used for other conditions as determined by your health care provider.

How does Fabhalta work (mechanism of action)?

Fabhalta is a complement factor B inhibitor, which stops your immune system from attacking your red blood cells and kidneys.

How is Fabhalta supplied (dosage forms)?

Fabhalta is available as a 200 mg oral capsule that is taken by mouth.

How should I store Fabhalta?

Fabhalta should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Fabhalta?

The most common side effects of Fabhalta are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Headache
  • Infections, including infections in the nose or throat, sore throat, or common cold symptoms (see below)
  • Stomach pain
  • Nausea and diarrhea
  • Rash
  • Changes in cholesterol or triglyceride blood levels

There may be other side effects of Fabhalta that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Fabhalta?

While less common, the most serious side effects of Fabhalta are described below, along with what to do if they happen.  

Severe Allergic Reactions. Fabhalta may cause allergic reactions, which can be serious. Stop taking Fabhalta and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infection. Fabhalta can increase the risk of infections, including serious infections from certain bacteria that can cause meningitis, pneumonia, or other conditions. These infections can be life-threatening and lead to death. Call your healthcare provider right away or get emergency help if you have any of the following symptoms.

  • Fever, clammy skin, chills, or muscle aches
  • Chest pain with cough
  • Shortness of breath
  • Fast heart rate
  • Persistent headache
  • Confusion
  • Nausea or vomiting
  • Sensitivity to light
  • Stiff neck or back

Warnings & Precautions

Who should not use Fabhalta?

Allergies to Ingredients. People who are allergic to any of the following should not take Fabhalta.

  • Fabhalta
  • Iptacopan
  • Any ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Fabhalta.

Bacterial Infections. Do not start taking Fabhalta if you have a bacterial infection. Tell your healthcare provider if you have symptoms of infection.

What should I know about Fabhalta before using it?

Do not take Fabhalta unless it has been prescribed to you by a health care provider. Take it as prescribed. 

Do not share Fabhalta with other people, even if they have the same condition as you. It may harm them.

Keep Fabhalta out of the reach of children.

Swallow the whole Fabhalta capsules. Do not open, break, or chew them.

If you take Fabhalta for paroxysmal nocturnal hemoglobinuria, do not stop taking Fabhalta without talking with your health care provider, even if your symptoms have improved. Stopping Fabhalta can cause more breakdown of your red blood cells. If you need to stop taking Fabhalta, your health care provider will give you instructions on how to stop the medicine.

You should be up to date with your vaccines at least two weeks before starting Fabhalta. Even if you are current with your vaccines, you can still get serious infections while taking Fabhalta. If you need to start Fabhalta right away and have not received all of your recommended vaccines yet, you may need to take antibiotics to prevent infection until the vaccines have time to work. Ask your health care provider if you are not sure.

You can only get Fabhalta at certain pharmacies that are enrolled in the Fabhalta Risk Evaluation and Mitigation Strategy (REMS) program. To receive Fabhalta, you must understand that the medicine can increase your risk of serious infections. This risk can last for several weeks after you stop taking Fabhalta. When you start Fabhalta, you will receive a Patient Safety Card about this risk that you should keep with you at all times while using the medicine and for at least two weeks after stopping it. To learn more about how to get Fabhalta, you can visit fabhalta-rems.com or call 833-993-2242.

What should I tell my health care provider before using Fabhalta?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vaccines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Fabhalta is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Have an infection or symptoms of an infection (see Side Effects)
  • Liver problems

Pregnancy. It is not known if or how Fabhalta could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will advise you if you should take Fabhalta while you are pregnant or trying to get pregnant. 

Breastfeeding. It is not known if Fabhalta passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking Fabhalta and for five days after your last dose.

Other Medicines and Supplements. Fabhalta may interact with other medicines and supplements. Before taking Fabhalta, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

How can I get more information about Fabhalta?

For more information about Fabhalta, you can visit the manufacturer’s website at www.fabhalta.com or call them at 888-669-6682.

Interactions

Does Fabhalta interact with foods or drinks?

There are no known interactions with Fabhalta and foods or drinks.

It is unknown if drinking alcohol will affect Fabhalta.

Does Fabhalta interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Fabhalta.

  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Gemfibrozil (Lopid), which is a medicine used for high triglycerides

Many other medicines may alter the blood levels of Fabhalta. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Fabhalta. Always check with your health care provider.

 

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Fabhalta?

If you or someone else has used too much Fabhalta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Fabhalta?

If you miss a dose, take it as soon as you remember, even if it is close to the next dose. Then, take your next dose at the regular time. Do not take double or extra doses. 

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