Precautions of Binimetinib

1 New Primary Malignancies

Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after  discontinuation of treatment.

2 Cardiomyopathy

Assess ejection fraction by echocardiogram or MUGA scan prior to initiating treatment, one month after  initiating treatment, and then every 2 to 3 months during treatment. The safety of Binimetinib in combination  with encorafenib has not been established in patients with a baseline ejection fraction that is either below  50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should  be monitored closely when treated with Binimetinib.  

Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

3 Venous Thromboembolism

Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.  

4 Ocular Toxicities

Assess for visual symptoms at each visit. Perform an ophthalmologic examination at regular intervals, for  new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold,  reduce dose, or permanently discontinue based on severity of adverse reaction.

5 Interstitial Lung Disease

Assess new or progressive unexplained pulmonary symptoms or findings for possible ILD. Withhold, reduce  dose, or permanently discontinue based on severity of adverse reaction.

6 Hepatotoxicity

Monitor liver laboratory tests before initiation of Binimetinib, monthly during treatment, and as clinically  indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

7 Rhabdomyolysis

Monitor CPK and creatinine levels prior to initiating Binimetinib, periodically during treatment, and as  clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse  reaction.

from FDA，2024.09