Generic drug bimetinib/bemetinib package insert

Binimetinib is a highly selective MEK1/2 kinase inhibitor that targets the MAPK signaling pathway. This pathway is closely related to the growth, proliferation, invasion and drug resistance mechanisms of various cancers. The generic version of bimetinib has been launched in Laos and other countries, and its active ingredients, pharmacological effects and clinical indications are consistent with the original drug. The drug was originally developed to treat unresectable or metastatic melanoma with BRAF V600E or V600K mutations, and has also been extended to some patients with BRAF-mutated non-small cell lung cancer (NSCLC).

The indications for bimetinib mainly include two categories:

First, it is used in combination with canafenib (Encorafenib) for the treatment of adult patients with unresectable or metastatic melanoma whose BRAF V600E or V600K mutation is confirmed by an FDA-approved test;

The second one is combined with canafenib for the treatment of adult patients with BRAF V600E mutation-positive metastatic non-small cell lung cancer.

The recommended dose is 45 mg twice daily, with or without food. It is recommended to regularly monitor the patient's liver function, heart function and retinal health during treatment, as long-term inhibition of the MEK pathway may cause adverse reactions related to the eyes, liver or heart.

The adverse reactions of generic bimetinib are generally controllable, but require close observation by doctors. Common adverse reactions include nausea, vomiting, diarrhea, rash, fatigue and blurred vision. Some patients may experience elevated liver enzymes or mildly elevated creatinine, so liver and kidney function should be tested regularly in the early and mid-term of treatment. For patients with cardiac insufficiency or retinal disease, they should be used with caution after a doctor evaluates the risk. If serious adverse reactions occur, the dose needs to be suspended or adjusted. Studies have found that the drug can significantly delay tumor growth and produce a synergistic effect when used in combination with BRAF inhibitors, which can reduce the occurrence of drug resistance and improve the long-term survival rate of patients.

Reference materials:https://go.drugbank.com/drugs/DB11967