"KOSELUGO (selumetinib) is a kinase inhibitor.KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell
contains hypromellose, carrageenan, potassium chloride, titanium dioxide, carnauba wax, and purified water. The capsule is imprinted with black ink that contains shellac, iron oxide black, propylene glycol and ammonium hydroxide.
KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains hypromellose, carrageenan, potassium chloride, titanium dioxide, FD&C blue 2, ferric oxide yellow, purified water, carnauba wax, and/or corn starch. The capsule is imprinted with black ink that contains ferric oxide red, ferric oxide yellow, FD&C Blue 2 aluminum lake, carnauba wax, shellac, and glyceryl monooleate.
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KOSELUGO (selumetinib) Capsules: 10 mg and 25 mg.
The recommended dosage is 25 mg/m2 taken orally twice daily on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose. *Reduce the recommended dosage to 20 mg/m2 orally twice daily for patients with moderate hepatic impairment (Child-Pugh B). The recommended dosage for use in patients with severe hepatic impairment (Child-Pugh C) has not been established.
KOSELUGO (selumetinib) is a kinase inhibitor indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
