Individualized Dosing Regimen for KOSELUGO

The recommended dosage of KOSELUGO (selumetinib) for pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas is 25 mg/m² administered orally twice daily, approximately every 12 hours. Dosing is adjusted according to body surface area, with specific dose bands provided in the prescribing information. Dose modifications are required for patients with moderate hepatic impairment (Child-Pugh B), reducing the dose to 20 mg/m² twice daily. Further dose adjustments are necessary in the event of adverse reactions or drug interactions, particularly with CYP3A4 inhibitors or inducers. Administration in patients unable to swallow capsules is not recommended.