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FABHALTA® (Iptacopan)
FABHALTA® (Iptacopan) is a recently FDA approved treatment for IgA Nephropathy (IgAN).
How does FABHALTA® work?
FABHALTA® targets the alternative complement pathway in order to lower proteinuria. When too many IgA immune complexes are produced and deposited in the kidneys filters, it can activate the complement system which may lead to inflammation and damage to the kidney filters. FABHALTA® binds to Factor B of the alternative complement pathway and helps block the effects of IgA Nephropathy on the kidneys.
What does the research say about FABHALTA®?
FABHALTA® has been studied in clinical trials specifically for IgAN. The clinical trials compared patients prescribed FABHALTA® with blood pressure medications and/or SGLT2 inhibitors to patients taking placebo (non-active medication) with blood pressure medications and/or SGLT2 inhibitors. The patients prescribed FABHALTA® had up to 44% lower levels of protein in their urine after 9 months.
What kind of medication is FABHALTA®?
FABHALTA® is an oral treatment (taken by mouth) two times a day. It is a class of medication called complement inhibitors that targets Factor B of the alternative complement pathway in order to reduce protein in the urine in adults. It is not known if FABHALTA® is safe and effective in children with IgAN.
*Note: The decision to prescribe a medication is the responsibility of your physician/medical team based on their evaluation of your condition. The above is meant for informational purposes only. Discuss this information and all information about drugs/medications with your physician before starting or stopping any medication.
Frequently Asked Questions
The most common side effects of FABHALTA® may include:
• Headache
• Nasal congestion, runny nose, cough, sneezing, and sore throat
• Diarrhea
• Stomach pain
• Nausea
• Infections
• Rash
FABHALTA® may cause serious side effects including:
• Serious infections caused by encapsulated bacteria
• Increased cholesterol and triglyceride (lipid) levels in your blood.
See what I should know before taking FABHALTA® for more information regarding side effect management while taking FABHALTA®.
Some things to consider while taking FABHALTA® include:
• FABHALTA® may be prescribed with other medications, such as blood pressure medication. Be
sure to discuss with your nephrologist the best treatment plan and options for you.
• FABHALTA® is a medicine that affects part of your immune system and may lower your ability to fight infections.
• FABHALTA® is only available through a program called FABHALTA® Risk Evaluation and Mitigation Strategy (REMS) and your doctor must counsel you about the risk of serious infections caused by certain bacteria and make sure you are vaccinated against serious infections caused by encapsulated bacteria, and give you a Patient Safety Card. The FABHALTA® REMS program is designed to keep you safe and mitigate potential harmful side effects.
• FABHALTA® is approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether FABHALTA® slows the decline in kidney function.
Before you take FABHALTA® tell your doctor if you:
• Have an infection or fever
• Have liver problems
• Are pregnant or plan to become pregnant or are breastfeeding as it is not known if FABHALTA® will harm your unborn baby.
