Molecule
Iptacopan is a complement factor B inhibitor indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), among other approved uses. It is available as capsules for oral use. MedsAcross supplies Iptacopan for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.
Source: US FDA prescribing information
Iptacopan binds to Factor B of the alternative complement pathway and regulates the cleavage of C3, generation of downstream effectors, and the amplification of the terminal pathway. In PNH, intravascular hemolysis (IVH) is mediated by the downstream membrane attack complex (MAC), while extravascular hemolysis (EVH) is facilitated by C3b opsonization. Iptacopan acts proximally in the alternative pathway of the complement cascade to control both C3b-mediated EVH and terminal complement-mediated IVH. In IgAN, the deposition of galactose deficient IgA1 (Gd-IgA1) containing immune complexes in the kidney locally activates the alternative complement pathway which is thought to contribute to the pathogenesis of IgAN. By binding to Factor B, iptacopan inhibits the alternative pathway.
Source: US FDA prescribing information
200 mg orally twice daily with or without food. Recommended Vaccination and Prophylaxis for Encapsulated Bacterial Infections Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations at least 2 weeks prior to initiation of FABHALTA. If urgent FABHALTA therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Healthcare providers who prescribe FABHALTA must enroll in the FABHALTA REMS.
Source: US FDA prescribing information
FABHALTA is contraindicated: in patients with serious hypersensitivity to iptacopan or any of the excipients. for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b. Serious hypersensitivity to iptacopan or any of the excipients. Initiation in patients with unresolved serious infection caused by encapsulated bacteria.
Source: US FDA prescribing information
Boxed warning (serious infections caused by encapsulated bacteria fabhalta): a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. Monitoring of PNH Manifestations After FABHALTA Discontinuation: Monitor for signs of hemolysis after discontinuation. Hyperlipidemia: Monitor serum lipid parameters periodically during treatment and initiate cholesterol-lowering medication, if indicated.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections Caused by Encapsulated Bacteria. Hyperlipidemia. 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 abdominal pain and dizziness. Most common adverse reactions in adults with C3G (incidence ≥ 10%) were nasopharyngitis and viral infections.
Source: US FDA prescribing information
CYP2C8 inducers (e.g., rifampin): May decrease iptacopan exposure. Monitor for loss of efficacy. Strong CYP2C8 inhibitors (e.g., gemfibrozil): May increase iptacopan exposure. Coadministration not recommended.
Source: US FDA prescribing information
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).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Iptacopan, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fabhalta 200 mg capsuleOral | Novartis Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Iptacopan and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Iptacopan, including Fabhalta.
Yes. The US FDA first approved Iptacopan on 5 December 2023, according to Drugs@FDA.
Yes. Iptacopan has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Iptacopan is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Iptacopan is classified under ATC code L04A (Immunosuppressive drug).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.