Binimetinib (Mektovi) is a highly potent and selective mitogen-activated protein kinase (MEK) inhibitor that plays a crucial role in the field of cancer treatment. As a molecular targeted therapy drug, it specifically blocks the RAS/RAF/MEK/ERK signaling pathway, effectively inhibiting the proliferation and survival of cancer cells.

What are the Indications of Binimetinib (Mektovi)?

Unresectable or Metastatic Melanoma

Binimetinib in combination with encorafenib is indicated for patients with unresectable or metastatic melanoma that has been confirmed to be positive for BRAF V600E or V600K mutations by an FDA-approved detection method.

BRAF gene mutation is a common driver mutation in melanoma. This combination therapy effectively inhibits tumor growth and spread by dual inhibition of the MAPK signaling pathway.

Metastatic Non-Small Cell Lung Cancer (NSCLC)

This combination therapy is also approved for the treatment of adult patients with metastatic NSCLC positive for BRAF V600E mutation.

The combination therapy has shown high objective response rates and durable efficacy in both treatment-naive and previously treated patients with advanced NSCLC.

Genetic Testing Requirements Before Medication Use

Before using binimetinib, the BRAF mutation status must be confirmed in tumor tissue or plasma samples using an FDA-approved detection method.

The requirements for test samples vary slightly across different cancer types. For example, tumor tissue is usually used for melanoma, while tumor tissue or plasma samples can be used for initial screening in NSCLC.

Dosage Form, Strength and Properties of Binimetinib (Mektovi)

Dosage Form and Strength

Binimetinib is available as oral film-coated tablets, with each tablet containing 15 mg of the active ingredient.

The tablets are yellow/dark yellow, unscored, biconvex and oval-shaped. One side is embossed with a stylized "A" and the other side is marked with "15" for easy identification and verification.

Composition

Each binimetinib tablet contains the active ingredient binimetinib, along with other excipients.

Excipients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, vegetable-derived magnesium stearate and colloidal silicon dioxide.

Coating ingredients include polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, yellow iron oxide and black iron oxide.

Packaging Specifications

Binimetinib is supplied in bottles, with each bottle containing 180 tablets, sufficient to support long-term treatment.

The national drug code is marked on the packaging for easy pharmacy management and patient verification.

Storage Methods for Binimetinib (Mektovi)

Storage Temperature Requirements

Binimetinib should be stored at room temperature between 20°C and 25°C (68°F and 77°F). Short-term storage within the range of 15°C to 30°C (59°F to 86°F) is allowed during short-distance transportation.

Avoid placing the drug in locations with large temperature fluctuations, such as bathrooms and car interiors.

Moisture Protection and Sealed Storage

The drug bottle should always be tightly closed and stored in a dry place to prevent the drug from absorbing moisture.

Moisture absorption by the tablets may affect their stability and efficacy, so it is not recommended to repackage the tablets into other containers.

Keep Away from Children and Pets

All medications should be stored out of the reach of children and pets to prevent accidental ingestion.

Disposal of Expired or Unused Medications

Expired or unused medications should be safely discarded in accordance with local pharmaceutical disposal guidelines. Do not randomly discard them in household waste or flush them down the drain.