Mektovi Full Prescribing Information - arraybiopharma.com

1 NP-US-BIN-0008 07/18 v1 HIGHLIGHTS OF Prescribing Information These highlights do not include all the Information needed to use Mektovi safely and effectively. See full Prescribing Information for Mektovi . Mektovi (binimetinib) tablets, for oral use Initial Approval: 2018 ---------------------------INDICATIONS AND USAGE------------------------- Mektovi 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, ) ---------------------DOSAGE AND ADMINISTRATION--------------------- Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of Mektovi . ( ) The recommended dose is 45 mg orally twice daily in combination with encorafenib. Take Mektovi with or without food. ( ) For patients with moderate or severe hepatic impairment the recommended dose is 30 mg orally twice daily.

2 NP-US-BIN-0008 07/18 v1 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE MEKTOVI® 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 [see Dosage and Administration (2.1)].

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