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Koselugo is a prescription kinase inhibitor containing selumetinib. It is indicated for adults and children age 1 and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. It is available as capsules and oral granules.
read more about koselugo ...Selumetinib inhibits MEK1 and MEK2, proteins in the mitogen-activated protein kinase pathway. MEK inhibition reduces downstream signaling involved in growth of susceptible tumor cells.
Koselugo is used in adults and pediatric patients age 1 and older with neurofibromatosis type 1 and symptomatic plexiform neurofibromas that cannot be completely removed without substantial morbidity. The adult indication was added in November 2025.
The recommended dose is 25 mg per square meter of body surface area by mouth twice daily with or without food until disease progression or unacceptable toxicity. Capsules are swallowed whole. Oral granules are sprinkled onto or mixed with soft food according to the product instructions.
Serious concerns include left ventricular dysfunction, ocular toxicity, severe gastrointestinal reactions, skin toxicity, increased creatine phosphokinase with muscle injury, and fetal harm. Eye examinations, cardiac function, and creatine phosphokinase are checked during treatment. Koselugo capsules contain vitamin E, which can increase bleeding risk.
Koselugo treats neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas in patients age 1 and older.
The recommended dose is 25 mg per square meter of body surface area twice daily.
Yes. FDA expanded the indication in November 2025 to include adults with qualifying neurofibromatosis type 1 and plexiform neurofibromas.
Yes. Ocular toxicity and reduced left ventricular ejection fraction are recognized risks that require monitoring.
DailyMed - KOSELUGO (selumetinib) capsule and granule. https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d042c61-f28f-4ab5-ab10-d7558c0d49ff. Date Accessed October 8, 2026.
FDA Approves Selumetinib for Adults With Neurofibromatosis Type 1 With Symptomatic, Inoperable Plexiform Neurofibromas. U.S. Food and Drug Administration. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-selumetinib-adults-neurofibromatosis-type-1-symptomatic-inoperable-plexiform. Date Accessed October 8, 2026.
KOSELUGO (selumetinib) Prescribing Information. AstraZeneca. https://koselugo.com/-/media/awtsites/usa/koselugo/patient/uspi_prescribing_information.pdf. Date Accessed October 8, 2026.
Selumetinib. MedlinePlus. https://www.medlineplus.gov/druginfo/meds/a620030.html. Date Accessed October 8, 2026.
Selumetinib. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/KOSELUGO. Date Accessed October 8, 2026.