View by Tumor Type
Melanoma
Home › All Therapies › Cotellic

Cotellic

cobimetinib
MEK Inhibitor FDA Approved 2015 Genentech / Roche
Route
Oral
Half-Life
43 hrs
FDA Approved
2015
Manufacturer
Genentech / Roche
Navigation -->
1. Indications and Usage

Melanoma: With vemurafenib for BRAF V600E/K melanoma.

2. Dosage and Administration

60 mg daily Days 1-21 of 28-day cycles.

3. Dosage Forms and Strengths

Tablets: 20 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Cardiomyopathy: Assess LVEF before and during treatment.
  • Hemorrhage: Serious events reported.
  • Severe Dermatologic Reactions: SJS/DRESS reported.
  • Serous Retinopathy: Ophthalmological evaluations.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Elevated CPK (79%), Diarrhea (60%), Photosensitivity (46%), Nausea (41%), Pyrexia (28%), Vomiting (24%), Rash (16%), Dermatitis (16%)

Elevated CPK
79%
Diarrhea
60%
Photosensitivity
46%
Nausea
41%
Pyrexia
28%
Vomiting
24%
Rash
16%
Dermatitis
16%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A Inhibitors/Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Reversible MEK1/MEK2 inhibitor blocking ERK pathway. Used with BRAF inhibitors to target complementary MAPK nodes.

Pharmacokinetics

Tmax: 2.4h. Bioavailability: 46%. t½: 44h. Feces 76%, urine 18%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Cotellic Trials on ClinicalTrials.gov ↗ 📚 PubMed: Cotellic Clinical Trials ↗
FDA-Approved Tumor Types

Cotellic has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Melanoma
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Cotellic. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Cotellic (cobimetinib) approved for?

Cotellic (cobimetinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Cotellic (cobimetinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Cotellic (cobimetinib) work?

Reversible MEK1/MEK2 inhibitor blocking ERK pathway. Used with BRAF inhibitors to target complementary MAPK nodes.

What are the most common side effects?

Elevated CPK (79%), Diarrhea (60%), Photosensitivity (46%), Nausea (41%), Pyrexia (28%), Vomiting (24%), Rash (16%), Dermatitis (16%) Elevated CPK 79% Diarrhea 60% Photosensitivity 46% Nausea 41% Pyrexia 28% Vomiting 24% Rash 16% Dermatitis 16%

← All Therapies Full Prescribing Information ↗