Bimetinib is a kinase inhibitor indicated in combination with encofenib for the treatment of patients with unresectable or metastatic melanoma whose tumors harbor BRAF V600E or V600K mutations as detected by an FDA-approved test.

LuciBinim Tablets Simple Instructions

Please use under the guidance of a physician

Product Name: LuciBinim

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Bimetinib tablets

English name: Binimetinib tablets

Drug approval number: 09 L 1194/24

 

【Indications】

LuciBinim is a kinase inhibitor indicated in combination with encorafenib for the treatment of patients with unresectable or metastatic melanoma whose tumors harbor a BRAF V600E or V600K mutation as detected by an FDA-approved test.

 

【Usage and Dosage】

• Confirm the presence of BRAF V600E or V600K mutation in tumor specimens before starting LuciBinim.

• The recommended dose is 45 mg orally twice daily, used in combination with Encofenib. LuciBinim can be taken with or without food.

• For patients with moderate or severe hepatic impairment, the recommended dose is 30 mg orally twice daily.

 

【Specification】

15mg/tablet, 180 tablets/box.

 

【 Contraindications 】

none.

 

【 Warnings and precautions 】

• Cardiomyopathy: Assess left ventricular ejection fraction (LVEF) prior to initiating treatment, after one month of treatment, and every 2 to 3 months thereafter. The safety of LuciBinim in patients with an LVEF less than 50% has not been established.

• Venous thromboembolism: Deep vein thrombosis and pulmonary embolism may occur.

• Ocular toxicity: Serous retinopathy, retinal vein occlusion (RVO), and uveitis have occurred. Perform regular ophthalmologic evaluations and examine for any visual disturbances.

• Interstitial lung disease (ILD): Evaluate new or progressive unexplained pulmonary symptoms to determine if ILD may be present.

• Hepatotoxicity: Monitor liver function tests prior to and during treatment and as clinically indicated.

• Rhabdomyolysis: Monitor creatine phosphokinase and creatinine periodically and as clinically indicated.

• Bleeding: Severe bleeding events may occur.

• Embryo-fetal toxicity: May cause harm to the fetus. Advise females of childbearing potential to be aware of the potential risk to the fetus and to use effective contraceptive measures.

 

【Adverse Reactions】

The most common adverse reactions (≥25%) with LuciBinim in combination with Encorafenib were fatigue, nausea, diarrhea, vomiting, and abdominal pain.

 

【Drug Interactions】

No clinically important drug interactions have been observed with LuciBinim.

【Use by specific groups】

Lactation: Breastfeeding is not recommended.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.