Fabhalta (Iptacopan) is an oral complement factor B inhibitor indicated for the treatment of specific complement-mediated disorders. It targets the alternative complement pathway and is used in patients with conditions such as paroxysmal nocturnal hemoglobinuria (PNH).
Iptacopan
Fabhalta (Iptacopan) is a drug used to treat proteinuria and paroxysmal nocturnal hemoglobinuria. It is consumed orally .It received approval for medical use in the European Union in May 2024 and the United States in December 2023. It is regarded as a first-in-class drug by the US Food and Drug Administration.
Iptacopan controls the cleavage of C3, the production of downstream effectors, and the amplification of the terminal route via binding to Factor B of the alternative complement pathway. The downstream membrane assault complex mediates intravascular hemolysis in paroxysmal nocturnal hemoglobinuria, whereas C3b opsonization facilitates extravascular hemolysis. Fabhalta (Iptacopan) regulates both terminal complement-mediated intravascular hemolysis and C3b-mediated extravascular hemolysis by acting proximally in the complement cascade’s alternative pathway.
Strength:
Capsules: 200 mg
Dosage:
The recommended dosage of Iptacopan is 200 mg orally twice daily without regard to food.
If a dose or doses are missed, advise the patient to take one dose of Iptacopan as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule.
Adverse reactions:
- Most common adverse reactions in adults with PNH (incidence ≥ 10%) were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea and rash.
- Most common adverse reactions in adults with IgAN (incidence ≥ 5%) were upper respiratory tract infection, lipid disorder, and abdominal pain.
- Most common adverse reactions in adults with C3G (incidence ≥ 10%) were nasopharyngitis and viral infections.
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)
- Monitoring of PNH Manifestations After Iptacopan Discontinuation: Monitor for signs of hemolysis after discontinuation. Inform patients with PNH of the importance of taking Iptacopan as prescribed in order to minimize the risk of hemolysis.
- Hyperlipidemia: Monitor serum lipid parameters periodically during treatment and initiate cholesterol-lowering medication, if indicated.
- Serious Infections Caused by Encapsulated Bacteria: Advise patients of the risk of serious infection. Inform patients of the need to complete or update their vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of Iptacopan or to receive antibacterial drug prophylaxis if Iptacopan treatment must be initiated immediately and they have not been previously vaccinated. Inform patients of the requirement to be revaccinated according to current ACIP recommendations for encapsulated bacteria while on Iptacopan therapy
FAQ
How does Iptacopan work?
Fabhalta (Iptacopan) selectively inhibits complement factor B, a key component of the alternative complement pathway. By blocking this pathway, Iptacopan helps reduce complement-mediated damage associated with diseases such as PNH and certain kidney disorders.
What is Iptacopan used for?
Iptacopan is used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). It is also being evaluated for other complement-mediated diseases, including IgA nephropathy (IgAN) and C3 glomerulopathy (C3G).
What are the common side effects of Iptacopan?
Common side effects of Iptacopan may include headache, diarrhea, nausea, abdominal pain, and upper respiratory tract infections. Patients should consult their healthcare provider regarding any adverse events experienced during treatment.
Is Iptacopan available in India?
Iptacopan may be available in India through authorized pharmaceutical suppliers and import channels, subject to regulatory requirements and product availability. Patients and healthcare professionals may contact 24/7QualityMeds at +91 9967979080 for current availability information.
Who should not take Fabhalta (Iptacopan)?
Iptacopan should not be used in patients with known hypersensitivity to Iptacopan or any of its components. It should also not be initiated in patients with active serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b. Patients should consult their healthcare provider before starting treatment.
What is the cost of Fabhalta (Iptacopan) Capsules in India?
Fabhalta (Iptacopan) is an oral complement factor B inhibitor indicated for the treatment of specific complement-mediated disorders. It targets the alternative complement pathway and is used in patients with conditions such as paroxysmal nocturnal hemoglobinuria (PNH).
How to Buy Fabhalta (Iptacopan) Capsules Online in India?
To Buy Fabhalta (Iptacopan) Capsules Online in India , a valid prescription from a licensed healthcare practitioner is generally required. Authorized suppliers such as 24/7QualityMeds can assist with product availability, procurement, and import support. For assistance, call +91 9967979080.




