Lucius LuciBinim Binimetinib 15mg

Product Information

• Product name: LuciBinim Binimetinib 15mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Binimetinib
• Current strength: 15mg
• SKU: LU-ITEM-30
• Site category: BRAF V600E/V600K target, other cancer

Product Summary

LuciBinim Binimetinib 15mg is an AISTIKA-listed product supplied by Laos Lucius 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

Binimetinib is the active ingredient used for this product page. Public prescribing information for Binimetinib 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

Binimetinib is a reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Binimetinib also inhibited in vivo ERK phosphorylation and tumor growth in BRAF-mutant murine xenograft models. Binimetinib and encorafenib target two different kinases in the RAS/RAF/MEK/ERK pathway.

Reference Indications

Binimetinib is a kinase inhibitor indicated: in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma Binimetinib is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test .

Reference Dosage and Administration

Recommended dose is 45 mg orally twice daily in combination with encorafenib. Take Binimetinib with or without food.

With this 15mg product, that corresponds to 3 x 15mg tablets 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

New Primary Malignancies, Cutaneous and Non-cutaneous: Can occur when Binimetinib is used in combination with encorafenib. Monitor patients for new malignancies prior to initiation of treatment, during treatment, and after discontinuation of treatment. Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) before initiating treatment, after one month of treatment, then every 2 to 3 months thereafter. The safety of Binimetinib has not been established in patients with LVEF below 50%. Venous Thromboembolism: Deep vein thrombosis and pulmonary embolism can occur. Ocular Toxicities: Serous retinopathy, retinal vein occlusion (RVO) and uveitis have occurred. Perform an ophthalmologic evaluation at regular intervals and for any visual disturbances.

Common Adverse Reactions and Monitoring

The data described in reflect exposure of 192 patients with BRAF V600 mutation-positive unresectable or metastatic melanoma to Binimetinib 45 mg twice daily in combination with encorafenib 450 mg once daily in a randomized open-label, active-controlled trial (COLUMBUS) or, for rare events, exposure of 690 patients with BRAF V600 mutation-positive melanoma to Binimetinib 45 mg twice daily in combination with encorafenib once daily across multiple clinical trials (NCT03915951, NCT01909453).

Drug Interactions and Special Populations

Lactation: Advise not to breastfeed. There are no available clinical data on the use of Binimetinib during pregnancy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In reproductive toxicity studies, administration of binimetinib to rats during the period of organogenesis resulted in maternal toxicity, decreased fetal weights and increased variations in ossification at doses ≥30 mg/kg/day (approximately 37 times the human exposure based on AUC at the recommended clinical dose of 45 mg twice daily).

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: MEKTOVI 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.