• CNS cancers

Koselugo Generic Name & Formulations

General Description

Selumetinib 10mg, 25mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied


Generic Availability


Koselugo Indications


Treatment of neurofibromatosis type 1 (NF1) in pediatric patients who have symptomatic, inoperable plexiform neurofibromas (PN).

Koselugo Dosage and Administration


Not applicable.


<2yrs: not established. Swallow whole on an empty stomach. Do not consume food 2hrs before or 1hr after each dose. Base dose on body surface area (BSA <0.55m2: not established); see full labeling. ≥2yrs: 25mg/m2 twice daily (approx. every 12hrs) until disease progression or unacceptable toxicity. Hepatic impairment (moderate): 20mg/m2 twice daily; (severe): not established. Dose modifications for adverse reactions, hepatic impairment, drug interactions: see full labeling.

Koselugo Contraindications

Not Applicable

Koselugo Boxed Warnings

Not Applicable

Koselugo Warnings/Precautions


Cardiomyopathy. History of impaired LVEF or if baseline ejection fraction below LLN: not established. Assess ECG prior to initiation, every 3 months during 1st year, then every 6 months thereafter and as clinically indicated. If treatment interrupted for decreased LVEF, obtain ECG or cardiac MRI every 3–6 weeks. Ocular toxicity (eg, blurred vision, photophobia, cataracts). Perform ophthalmic exam prior to initiation, at regular intervals during therapy, and for visual changes. GI toxicity (eg, diarrhea). Monitor for severe skin rashes. Obtain serum CPK prior to initiation, periodically during, and as clinically indicated. Moderate or severe hepatic impairment (See Adults). Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).

Koselugo Pharmacokinetics

See Literature

Koselugo Interactions


Avoid concomitant strong or moderate CYP3A4 inhibitors (eg, fluconazole); if unavoidable, reduce dose (see full labeling). Concomitant supplemental Vitamin E: not recommended if daily limit is exceeded. Avoid concomitant strong or moderate CYP3A4 inducers. Increased risk of bleeding with vitamin-K antagonists or anti-platelet agents; monitor frequently for bleeding, anticoagulant assessments (including INR, PT).

Koselugo Adverse Reactions

Adverse Reactions

Vomiting, rash, abdominal pain, diarrhea, nausea, dry skin, fatigue, musculoskeletal pain, pyrexia, acneiform rash, stomatitis, headache, paronychia, pruritus; retinal vein occlusion, retinal pigment epithelial detachment, serious GI toxicity (eg, perforation, colitis, ileus, intestinal obstruction), severe palmar-plantar erythrodysesthesia syndrome, rhabdomyolysis.

Koselugo Clinical Trials

See Literature

Koselugo Note

Not Applicable

Koselugo Patient Counseling

See Literature