Fabhalta (iptacopan) is a prescription drug that’s used to treat a rare type of kidney disease and a rare blood disorder. Fabhalta comes as an oral capsule that’s typically taken twice per day.
Fabhalta is used in adults to treat:
- paroxysmal nocturnal hemoglobinuria (PNH) (a rare blood disorder)
- primary IgA nephropathy (IgAN) (a rare type of kidney disease)
To learn more about Fabhalta’s uses, see the “What is Fabhalta used for?” section.
Fabhalta basics
Fabhalta contains the active ingredient iptacopan.
Fabhalta is a brand-name medication. A generic version of the drug isn’t currently available.
Fabhalta has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “What should be considered before taking Fabhalta?” section.
Fabhalta is used to treat certain rare conditions in adults. These include:
Paroxysmal nocturnal hemoglobinuria (PNH): With PNH, your immune system mistakenly attacks healthy red blood cells. This lowers the level of red blood cells and hemoglobin (a protein in red blood cells) in your system.
PNH may cause symptoms such as discolored urine, fatigue, and blood clots.
Primary IgA nephropathy (IgAN): With primary IgAN, a protein called IgA builds up in your kidneys. (“Primary” means the condition isn’t related to another health problem.) This buildup of IgA can cause your immune system to attack your kidneys, leading to high levels of protein in your urine.
Primary IgAN may cause symptoms such as discolored urine, high blood pressure, and swelling in your hands and feet.
Fabhalta works to treat PNH and primary IgAN by targeting a specific part of your immune system. This helps reduce the damage to your red blood cells and kidneys.
If you have questions about Fabhalta’s use for PNH or primary IgAN, talk with your doctor.
Like most drugs, Fabhalta may cause mild to serious side effects. The lists below contain some of the more common side effects Fabhalta may cause, but they don’t include all possible side effects.
Keep in mind that side effects of a drug can depend on:
- your age
- other health conditions you have
- other medications you take
Your doctor or pharmacist can tell you more about the potential side effects of Fabhalta. They can also suggest ways to help reduce side effects.
Mild side effects
Here’s a list of some of the mild side effects that Fabhalta can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Fabhalta’s prescribing information.
Mild side effects of Fabhalta that have been reported include:
- abdominal pain
- diarrhea
- dizziness
- headache
- joint pain
- mild infection, such as urinary tract infection (UTI) and upper respiratory infection
- nausea
- skin rash
Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Fabhalta can occur, but they aren’t common. If you have serious side effects from Fabhalta, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.
Serious side effects of Fabhalta that have been reported include:
- high blood pressure
- high levels of cholesterol or triglycerides
- low level of platelets (blood cells that help your blood form clots)
- boxed warning: risk of serious bacterial infection*
* For more information, see the “What should be considered before taking Fabhalta?” section.
ALLERGIC REACTIONFor some people, Fabhalta can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.
In general, symptoms of an allergic reaction can be mild or serious.
What might help
If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep taking Fabhalta.
If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
If your doctor confirms you’ve had a serious allergic reaction to Fabhalta, they may have you switch to a different treatment.
Your doctor will recommend the dosage of Fabhalta that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.
Form and strength
Fabhalta comes as an oral capsule having a strength of 200 milligrams (mg).
Recommended dosage
Fabhalta is used in adults with paroxysmal nocturnal hemoglobinuria or primary IgA nephropathy. To treat either condition, your doctor will likely prescribe a dosage of one capsule taken twice daily.
How to take
Your doctor will explain how you should take Fabhalta. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.
Questions about taking Fabhalta
Below are some common questions about taking Fabhalta.
- Can Fabhalta be chewed, crushed, or split? No, you should not chew, crush, or split Fabhalta capsules. You should swallow them whole. If you have trouble doing so, you can get tips on how to swallow pills, or ask your doctor or pharmacist for advice.
- Should I take Fabhalta with food? Fabhalta can be taken with or without food.
- Is there a best time of day to take Fabhalta? You’ll take Fabhalta twice daily. It’s best to take it around the same times each day. This keeps a consistent level of the drug in your body, which helps Fabhalta work effectively.
- What if I miss a dose of Fabhalta? If you miss a dose of Fabhalta, take it as soon as you remember. You’ll do this even if it’s almost time to take the following dose. Then take your next dose at its usual time.
- Will I need to use Fabhalta long term? Fabhalta is typically used as a long-term treatment. If you and your doctor determine that it’s safe and effective for your condition, you’ll likely take it long term.
- How long does Fabhalta take to work? Fabhalta begins to work after you take your first dose. But you likely won’t feel the drug working in your body. Your doctor will order tests throughout your treatment to check whether Fabhalta is working to treat your condition.
Overdose
Do not take more Fabhalta than your doctor prescribes, as this can lead to harmful effects.
What to do in case you take too much Fabhalta
Call your doctor if you think you’ve taken too much Fabhalta. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room.
Below is important information you should consider before taking Fabhalta.
Interactions
Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.
Fabhalta can interact with several other medications. But the drug isn’t known to interact with any supplements or foods.
Before taking Fabhalta, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
Drug interactions
Below is a list of medications that can interact with Fabhalta. This list does not contain all drugs that may interact with Fabhalta. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
| Drug group or drug name | Drug examples |
|---|---|
| rifampin (Rifadin, Rimactane) | — |
| gemfibrozil (Lopid) | — |
Fabhalta and alcohol
Alcohol is not known to interact with Fabhalta. It’s likely safe to consume alcohol while taking Fabhalta. If you have questions about this, talk with your doctor.
Pregnancy and breastfeeding
It’s not known whether it’s safe to take Fabhalta during pregnancy or while breastfeeding. If you’re pregnant, breastfeeding, or planning for either, talk with your doctor before starting Fabhalta treatment.
Boxed warning
Fabhalta has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.
Taking Fabhalta may increase your risk of serious bacterial infections, including certain types of meningitis and pneumonia. In some cases, these infections can be life threatening.
To lower your risk of these infections, your doctor may advise you to receive vaccines that protect against them. They’ll recommend that you have these vaccines at least 2 weeks before your first dose of Fabhalta.
Vaccines may help lower your risk of serious bacterial infections. But it’s still important to tell your doctor if you have any symptoms of an infection during Fabhalta treatment. Examples include chills or fever, cough, and confusion.
Due to this risk of infection, the drug is available only through the Fabhalta risk evaluation and mitigation strategy (REMS) program. The FDA requires REMS programs for certain drugs to help ensure that they’re prescribed and used safely.
To learn more about this warning and the REMS program, talk with your doctor.
Other warnings
Fabhalta can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Fabhalta is a good treatment option for you.
Talk with your doctor about your health history before you take Fabhalta. Be sure to tell them if any of the following factors apply to you:
- liver problems
- fever or infection
- previous allergic reaction to Fabhalta
- pregnancy
- breastfeeding
Whether you have health insurance or not, cost may be a factor when you’re considering Fabhalta. What you’ll pay for Fabhalta may depend on several things, such as your treatment plan and the pharmacy you use.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A program called Novartis Patient Support may also be available.
Learn more about saving on your prescriptions.
Other drugs are available that can treat your condition. If you’d like to explore an alternative to Fabhalta, talk with your doctor. They can tell you about other medications that might work well for you.
The following drugs are similar to Fabhalta:
- crovalimab (Piasky)
- danicopan (Voydeya)
- eculizumab (Soliris)
- pegcetacoplan (Empaveli)
- ravulizumab (Ultomris)
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.