Selumetinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). MedsAcross supplies Selumetinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Source: US FDA prescribing information
Selumetinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2). MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Both MEK and ERK are critical components of the RAS-regulated RAF-MEK-ERK pathway, which is often activated in different types of cancers. In genetically modified mouse models of NF1 that generate neurofibromas that recapitulate the genotype and phenotype of human NF1, oral dosing of selumetinib inhibited ERK phosphorylation, and reduced neurofibroma numbers, volume, and proliferation.
Source: US FDA prescribing information
• KOSELUGO capsules: The recommended dosage is 25 mg/m 2, swallowed whole, taken orally twice daily with or without food. • KOSELUGO oral granules: The recommended dosage is equivalent to 25 mg/m 2, sprinkled onto or mixed with soft food and taken orally twice daily. • Moderate hepatic impairment (Child-Pugh B): The recommended dosage is 20 mg/m 2 orally twice daily. • Severe hepatic impairment (Child-Pugh C): The recommended dosage has not been established. • Strong or Moderate CYP3A4 Inhibitors or Fluconazole: If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce the dose of KOSELUGO.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
• Left Ventricular Dysfunction: Assess ejection fraction prior to initiating treatment, every 3 months during the first year, then every 6 months thereafter and as clinically indicated. Withhold, reduce the dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. • Ocular Toxicity: Conduct ophthalmic assessments prior to initiating KOSELUGO, at regular intervals during treatment and for new or worsening visual changes. Permanently discontinue KOSELUGO for retinal vein occlusion (RVO). Withhold KOSELUGO for retinal pigment epithelial detachment (RPED), monitor with optical coherence tomography assessments until resolution, and resume at reduced dose. • Gastrointestinal Toxicity: Advise patients to start an anti-diarrheal agent immediately after the first episode of loose stool and to increase fluid intake.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Left Ventricular Dysfunction • Ocular Toxicity • Gastrointestinal Toxicity • Skin Toxicity • Increased Creatine Phosphokinase Most common adverse reactions in pediatric patients (≥ 40%) are: vomiting, diarrhea, increased creatine phosphokinase, dry skin, paronychia, nausea, dermatitis acneiform, and pyrexia. Most common adverse reactions in adult patients (≥ 40%) are rash (all), dermatitis acneiform, and diarrhea.
Source: US FDA prescribing information
• Strong or Moderate CYP3A4 Inhibitors or Fluconazole: Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO. If coadministration cannot be avoided, reduce the dose of KOSELUGO. • Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of strong and moderate CYP3A4 inducers.
Source: US FDA prescribing information
Storage KOSELUGO Capsules Store KOSELUGO capsules at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). KOSELUGO Oral Granules Store and transport KOSELUGO oral granules refrigerated at 2°C to 8°C (36°F to 46°F). After receipt, patients may store at room temperature 20°C to 25°C (68°F to 77°F). Do NOT exceed 30°C (86°F). Dispense and store in the original bottle to protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Selumetinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Koselugo 10 mg capsuleOral Cold chain | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Koselugo 25 mg capsuleOral Cold chain | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Koselugo 5 mg granulesOral Cold chain | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Koselugo 7.5 mg granulesOral Cold chain | AstraZeneca Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Selumetinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Selumetinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Selumetinib, including Koselugo.
Yes. The US FDA first approved Selumetinib on 10 April 2020, according to Drugs@FDA.
Yes. Selumetinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Selumetinib must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Selumetinib is classified under ATC code L01EE04 (Selumetinib).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.