Big Bear SEMEDX Selumetinib 25mg

Product Information

• Product name: SEMEDX Selumetinib 25mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Selumetinib
• Current strength: 25mg
• SKU: BB-ITEM-64
• Site category: neurofibromatosis, other cancer

Product Summary

SEMEDX Selumetinib 25mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Selumetinib is the active ingredient used for this product page. Public prescribing information for Selumetinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

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.

Reference Indications

Selumetinib 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) . 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).

Reference Dosage and Administration

Recommended dosage is 25 mg/m 2 , swallowed whole, taken orally twice daily with or without food (see Table 1) .

With this 25mg product, that corresponds to 1 x 25mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety 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 Selumetinib based on severity of adverse reaction. ( 2.3 , 5.1 ) Ocular Toxicity : Conduct ophthalmic assessments prior to initiating Selumetinib, at regular intervals during treatment and for new or worsening visual changes. Permanently discontinue Selumetinib for retinal vein occlusion (RVO). Withhold Selumetinib for retinal pigment epithelial detachment (RPED), monitor with optical coherence tomography assessments until resolution, and resume at reduced dose.

Common Adverse Reactions and Monitoring

The NF1 PN pediatric safety pool described in the reflects exposure to Selumetinib at the recommended dosage in 134 pediatric patients in SPRINKLE (N = 36) (NCT05309668), SPRINT Phase I (N = 24) (NCT01362803), SPRINT Phase II Stratum 1 (N = 50) , and Phase I Food Effect Study (N = 24) (NCT05101148). Among pediatric patients, the duration of Selumetinib exposure was 12 months or longer (80%), more than 2 years (44%), or more than 3 years (37%). Among adult patients, the duration of Selumetinib exposure in the randomized period was 6 months or longer (92%), and 11 months or longer (66%).

Drug Interactions and Special Populations

Strong or Moderate CYP3A4 Inhibitors or Fluconazole : Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with Selumetinib. If coadministration cannot be avoided, reduce the dose of Selumetinib. ( 2.5 , 7.1 ) Strong or Moderate CYP3A4 Inducers : Avoid concomitant use of strong and moderate CYP3A4 inducers. If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce Selumetinib dosage . Strong or Moderate CYP3A4 Inducers Management Avoid concomitant use of strong or moderate CYP3A4 inducers with Selumetinib. Clinical Impact Concomitant use of Selumetinib with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations , which may reduce Selumetinib efficacy.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: KOSELUGO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.