Binimetinib

Array BioPharma has developed Binimetinib, a MEK signaling pathway inhibitor. The drug specification produced by Lucius is 15mg * 180pills.

After clinical trials, Binimetinib has shown significant efficacy in treating metastatic melanoma with BRAF V600E or V600K mutations.

Binimetinib is an inhibitor of the MEK signaling pathway. Inhibiting the activity of MEK can block downstream pathways, thereby inhibiting abnormal activation caused by upstream gene mutations and exerting anti-tumor effects.

1.Main components

Binimetinib

2.Adapt to the population

Binimetinib can be used for the treatment of melanoma and non-small cell lung cancer.

3.Medication for special populations

3.1Pregnancy

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.

3.2Lactation

There are no data on the presence of binimetinib or its active metabolite in human milk, or the effects of  binimetinib on the breastfed child, or the effects on milk production. Because of the potential for serious  adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Binimetinib and  for 3 days after the last dose.

3.3Females and Males of Reproductive Potential

Females

Advise females of reproductive potential to use effective contraception during treatment with Binimetinib  and for 30 days after the last dose.

3.4Pediatric Use

The safety and effectiveness of Binimetinib have not been established in pediatric patients.

3.5Geriatric Use

No overall differences in the safety or effectiveness of Binimetinib plus encorafenib were observed in older  patients as compared to younger patients.

3.6Hepatic Impairment

Binimetinib concentrations may increase in patients with moderate or severe hepatic impairment. Dose  adjustment for Binimetinib is not recommended in patients with mild hepatic impairment (total bilirubin >1 and ≤1.5 × ULN and any AST or total bilirubin ≤ ULN and AST > ULN). Reduce the dose of Binimetinib for patients with moderate (total bilirubin >1.5 and ≤3 × ULN and any AST) or severe (total bilirubin levels >3 × ULN and any AST) hepatic impairment.

4.Drug overdose

Since binimetinib is 97% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment  of overdose with Binimetinib.

5.Drug storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

6.Pharmacokinetics

After oral administration, at least 50% of the binimetinib dose was absorbed with a median time to  maximum concentration (T_max) of 1.6 hours.

from FDA，2024.09