Selumetinib (Koselugo) is a kinase inhibitor primarily used for the treatment of specific types of nervous system tumors. As a targeted therapy drug, its unique pharmacological effects provide an important treatment option for patients with certain hereditary neurofibromatosis diseases.

What is Selumetinib (Koselugo)?

Drug Properties

Selumetinib is a kinase inhibitor, with its main active ingredient being selumetinib sulfate.

The drug is available in two dosage forms: capsules and oral granules, providing flexible medication options for patients of different ages and swallowing abilities.

Indication Scope

Selumetinib is indicated for the treatment of pediatric patients aged 1 year and older, specifically targeting symptomatic, inoperable plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1).

By inhibiting MEK1/2 proteins and regulating the RAS-RAF-MEK-ERK signaling pathway, the drug inhibits tumor growth.

Specifications and Characteristics of Selumetinib (Koselugo)

Capsule Specifications

10mg Capsules: White to off-white opaque hard capsules with a transparent sealing band, imprinted with "SEL10" in black.

25mg Capsules: Blue opaque hard capsules with a transparent sealing band, imprinted with "SEL25" in black.

Oral Granule Specifications

5mg Oral Granules: Off-white to pale yellow free-flowing granules. The capsule has a yellow cap and a white body; the cap is imprinted with "sel5" in black, and the body is imprinted with a capsule-spilling pattern indicating opening.

7.5mg Oral Granules: Off-white to pale yellow free-flowing granules. The capsule has a pink cap and a white body; the cap is imprinted with "sel7.5" in black, and the body is imprinted with a capsule-spilling pattern indicating opening.

Ingredient Composition

Capsules contain d-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS) as an excipient, while oral granules do not contain vitamin E.

Storage Conditions for Selumetinib (Koselugo)

Capsule Storage Specifications

Store at a temperature of 20°C to 25°C (68°F to 77°F).

Short-term storage within the range of 15°C to 30°C (59°F to 86°F) is allowed.

Must be stored in the original bottle to protect from light and moisture.

Keep the bottle cap tightly closed after the first opening.

Do not remove the desiccant.

Oral Granule Storage Specifications

Refrigeration is required during storage and transportation, at a temperature of 2°C to 8°C (36°F to 46°F).

After receipt, patients can store the product at room temperature (20°C to 25°C / 68°F to 77°F).

Storage temperature must not exceed 30°C (86°F).

If exposed to high temperatures, the granules may clump or stick to the inside of the capsule shell, resulting in insufficient dosage.

Handling of Special Cases

When carrying selumetinib oral granules outside, they should be placed in a cool bag with an ice pack to maintain a low temperature.