Abbreviated Prescribing Information
Koselugo

Presentation: Koselugo 10 mg and 25 mg hard capsules (as hydrogen sulfate). Indications: Treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above. Dosage: 25 mg/m2 of body surface area (BSA), taken orally twice daily. Swallowed whole with water and taken on empty stomach. Continue treatment as long as clinical benefit is observed, or until PN progression or unacceptable toxicity. Interruption and/or dose reduction or permanent discontinuation may be required based on individual safety and tolerability. Contraindications: Hypersensitivity to the active substance or excipients; severe hepatic impairment. Precautions: Evaluate with echocardiogram for left ventricular ejection fraction (LVEF) before initiation of treatment and at approximately 3-month intervals, or more frequently as clinically indicated. Ophthalmological evaluation prior to treatment initiation and at any time patient reports new visual disturbances. Monitor liver laboratory values, for abnormalities, specifically AST and ALT elevations, before initiation and at least monthly during 6 first months. Skin rash, paronychia and hair changes have been reported. Advise not to take any supplemental vitamin E. Not to administer to patients who are unable or unwilling to swallow the capsule whole due to risk of choking. Not recommended in women of child bearing potential without contraception. Pregnancy. Breast-feeding. Drive and use machines. Interactions: Strong and moderate inhibitors of CYP3A4 and CYP2C19, strong and moderate CYP3A4 inducers, OAT3 substrates, supplemental vitamin E. Undesirable effects: Vision blurred; Dyspnoea; Vomiting; Diarrhoea; Nausea; Stomatitis; Dry mouth; Rash; Dry skin; Rash acneiform; Paronychia; Hair changes; Asthenic events; Pyrexia; Peripheral oedema; Facial oedema; Blood CPK increased; Hypoalbuminaemia; AST increased; Haemoglobin decreased; ALT increased; Blood creatinine increased; Ejection fraction decreased; Increased blood pressure. Full local prescribing information is available upon request. API.HK.KOS.0721

HK-10000 19/02/2024