Transcription of Reference ID: 4212951 - Genentech
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Reference ID: 4212951 - Genentech
1 HIGHLIGHTS OF PRESCRIBING information These highlights do not include all the information needed to use COTELLIC safely and effectively. See full prescribing information for COTELLIC. COTELLIC (cobimetinib) tablets, for oral use Initial Approval: 2015 --------------------------- INDICATIONS AND USAGE ---------------------------- COTELLIC is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. (1, 14) ----------------------- DOSAGE AND ADMINISTRATION ----------------------- Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of COTELLIC. ( ) The recommended dose is 60 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Take COTELLIC with or without food. ( ) --------------------- DOSAGE FORMS AND STRENGTHS ---------------------- Tablets: 20 mg (3) ------------------------------ CONTRAINDICATIONS ------------------------------ None.
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use COTELLIC safely and effectively. See full prescribing information …
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