Drug reference

iptacopan

Complement factor B inhibitor (oral) · Complement inhibitor (Factor B inhibitor)

START

200 mg PO twice daily (after meningococcal/pneumococcal/Hib vaccination)

TYPICAL MAX

400 mg/day

STOP IF

Serious encapsulated-bacterial infection or hypersensitivity

WATCH

Vaccination status, infection signs, Hb/LDH, lipid profile

CDSCO approvedATC L04AJ08

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1h · absorption
PEAK: 2h · Tmax
t½: 1d · t½
DURATION: 12h · twice-daily

EXCRETION

Faecal and renal — metabolites

route + CYP

INTERACTIONS

2 major

SEVERE in our sources

PREGNANCY

Limited data; use only if benefit outweighs risk.

FDA category + note

Top interactionssee all 5 →

Strong Cyp2c8SevereDatabaseKimi deep-research + Cla
Strong Cyp2c8 InhibitorsSevereDatabaseKimi deep-research + Cla

Mechanism

Selective, oral inhibitor of complement factor B, blocking the alternative-pathway C3 convertase; controls both intravascular and extravascular haemolysis in paroxysmal nocturnal haemoglobinuria.

Indications

Paroxysmal nocturnal haemoglobinuria (PNH)IgA nephropathy / C3 glomerulopathy (emerging/approved indications)

Dosing

Adult: 200 mg PO twice daily.
Pediatric: Not established.
Renal adjustment: No adjustment for mild–moderate; limited data severe.
Hepatic adjustment: Mild–moderate: no adjustment; severe: not recommended (limited data).
Geriatric: No specific adjustment.
Max dose: 400 mg/day (200 mg twice daily)

Pharmacokinetics

Onset

Haemolysis control over days–weeks

Peak effect

~2 h (Tmax)

Duration

~12 h (twice-daily)

Half-life

~25 h

Bioavailability

High oral

Protein binding

~75–93% (saturable, target-binding)

Metabolism

Hepatic CYP2C8 (and others)

Excretion

Faecal and renal (metabolites)

Contraindications

Unresolved serious infection with encapsulated bacteria
Not vaccinated against Neisseria meningitidis/S. pneumoniae/H. influenzae before start
Hypersensitivity