Powered By
COMPLEMENT FACTOR B INHIBITOR
Fabhalta (iptacopan) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to reduce protein in the urine in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly and in adults with complement 3 glomerulopathy (C3G). Both are kidney diseases.
Fabhalta is a type of medication called a complement factor B inhibitor. It works by blocking factor B, a protein in part of the immune system called the alternative complement pathway.
In primary immunoglobulin A nephropathy (IgAN) and C3G, the alternative complement pathway is thought to play a role in kidney damage. Fabhalta may help reduce protein in the urine in adults with these conditions.
Doctors prescribe Fabhalta for:
Fabhalta is given as a capsule by mouth two times each day, with or without food. Swallow capsules whole. Do not open, break, or chew capsules.
The recommended dose of Fabhalta for adults with IgAN or C3G is 200 milligrams by mouth two times each day.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of adults taking Fabhalta to reduce protein in the urine (proteinuria) from primary IgAN and C3G, the most common side effects occurred in about 6 percent to 29 percent of people. These include:
Fabhalta can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Novartis Pharmaceuticals, the manufacturer of Fabhalta, offers the Novartis Patient Support Co-Pay Plus program. Eligible people with private insurance may pay as little as $0 for Fabhalta, including refills.
The Novartis Patient Support Co-Pay Plus program also offers help with enrollment, insurance support, vaccination support, and ongoing assistance from a dedicated one-on-one team member throughout treatment. To learn more, visit the Fabhalta savings and support page or call 833-993-2242.
Your doctor may check your kidney function, urine protein levels, cholesterol levels, infection history, vaccination status, and current medicines before and during treatment.
You must be up to date on vaccines against certain bacteria, including Streptococcus pneumoniae and Neisseria meningitidis, at least two weeks before starting Fabhalta. This includes meningococcal vaccines for groups A, C, W, Y, and B.
If Fabhalta needs to be started right away and you are not up to date on these vaccines, your doctor should give you antibiotics and the vaccines as soon as possible.
Tell your doctor if you have any allergies to iptacopan or any ingredients in Fabhalta.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Also tell your doctor if you have a fever, have or have had an infection, or have or have had liver problems.
Do not take Fabhalta if you have had a serious allergic reaction to iptacopan or any of its ingredients. Do not start Fabhalta if you have a serious infection caused by encapsulated bacteria.
Fabhalta is also FDA-approved to treat paroxysmal nocturnal hemoglobinuria (PNH).
If you miss a dose, take one dose as soon as you remember, even if it is almost time for your next dose. Then take your next dose at your regular time.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Fabhalta, talk with your doctor about the risks and benefits. You should not breastfeed during treatment and for five days after your final dose.
These answers are fact-checked by our editorial staff.
How effective is Fabhalta?
In adults with primary immunoglobulin A nephropathy (IgAN), Fabhalta lowered urine protein-to-creatinine ratio (UPCR) by 44 percent from baseline at month 9, compared with 9 percent with placebo (an inactive treatment). This worked out to a 38 percent greater reduction versus placebo. It has not been established whether Fabhalta slows kidney function decline in people with IgAN.
How long does Fabhalta take to work for IgAN and C3G?
For IgAN, the main clinical study measured changes in protein in the urine at month 9. In that study, the average UPCR decreased from 1.9 grams per gram at the start of treatment to 1.0 gram per gram at month 9 with Fabhalta.
For C3G, the main study measured proteinuria reduction at six months. People treated with Fabhalta had a 35 percent reduction in 24-hour UPCR compared with placebo.
The study results do not say when individual people may notice symptom improvement.
Should I take Fabhalta for IgAN or C3G if I have an infection?
Do not start Fabhalta if you have an unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b.
Fabhalta can increase the risk of serious and life-threatening infections, even in people who have been vaccinated. If a serious infection is suspected, it should be checked right away. Your doctor may decide to interrupt treatment depending on your condition.
On MyKidneyDiseaseTeam, people share their experiences with chronic kidney disease, get advice, and find support from others who understand.
More resources from MyKidneyDiseaseTeam that mention Fabhalta
Become a member to get even more
Join
Your Privacy Choices
