iptacopan hydrochloride monohydrate: clinical use

Prescribing considerations

• Confirm meningococcal and pneumococcal vaccination status; consider Hib vaccination where available.
• Provide and discuss the approved educational materials and patient safety card.
• Evidence is limited in recurrent C3G after kidney transplantation and absent for native-kidney C3G with low baseline proteinuria.
• Safety and efficacy have not been established in people under 18 years.

Contraindications and cautions

• Hypersensitivity to iptacopan or an excipient.
• Lack of current meningococcal and pneumococcal vaccination, unless delaying treatment presents the greater risk.
• Unresolved infection with encapsulated bacteria at treatment initiation.
• Use is not recommended in severe hepatic impairment; severe renal impairment and dialysis have not been studied.

Monitoring

• Assess promptly for serious infection even in vaccinated patients.
• In PNH, monitor clinical and laboratory evidence of haemolysis, including lactate dehydrogenase.
• Closely monitor for haemolysis following interruption or discontinuation in PNH.
• Consider platelet count, blood pressure and lipid changes in the clinical context.

Clinical pharmacology

A proximal, selective Factor B inhibitor of the alternative complement pathway. Metabolism is mainly oxidative, predominantly through CYP2C8, with minor CYP2D6 and glucuronidation pathways; metabolites are not considered pharmacologically active.

Formulation and product differences

• The selected product is a pale-yellow, opaque hard gelatin capsule supplied in blister packs.
• The capsule contains iron oxides and titanium dioxide; the printing ink includes shellac and propylene glycol.

Capsule

Route: Oral

Strengths: 200 mg