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.
3 Table 2. Recommended Dose Modifications for COTELLIC for Adverse Reactions Severity of Adverse Reactiona Dose Modification for COTELLIC New Primary Malignancies (cutaneous and non-cutaneous)
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