Generic Name: cobimetinib
Trade Name: Cotellic™
For which conditions is this drug approved? Cotellic is a kinase inhibitor used for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with Zelboraf (vemurafenib).
What is the mechanism of action? A series of proteins called the MAPK cell signaling pathway help control cell growth and survival. When some BRAF proteins are mutated in advanced melanoma, abnormal growth signals are sent into the cell, causing tumors to grow. Zelboraf is designed to work inside melanoma cells to inhibit some mutated forms of BRAF. Cotellic is an inhibitor of some forms of MEK, a protein in the same cell signaling pathway and also found in melanoma cells. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth compared to Zelboraf alone.
How is Cotellic typically given (administered)? Cotellic is taken orally three times per day. It can be taken with or without food and should not be double-dosed if a dose is missed. If you miss a dose, or if vomiting occurs, take the next dose as scheduled.
What are the most common side effects of treatment with Cotellic?
- Sunburn or sun sensitivity
What are some of the more serious but less common side effects of Cotellic?
- Risk of skin cancers
- Increased risk of bleeding
- Heart problems that can lead to inadequate pumping of the blood
- Eye problems
- Abnormal liver test or liver injury
- Increased enzymes in the blood
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Avoid sunlight while you are taking Cotellic.
Are there any special precautions patients should be aware of before starting treatment?
Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment with Cotellic. Patients should not breastfeed while undergoing treatment with Cotellic. Tell your doctor if:
- You have any heart, eye, liver, or muscle problems.
- You have any skin problems other than melanoma.
- You are taking any other medication of any kind, including supplements.
- You have any medical conditions and/or or on any medications that could increase your risk for bleeding.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
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