Class: Biological Therapy

Generic Name: vemurafenib

Trade Name: Zelboraf™

How is this drug used? Zelboraf is used for the treatment of melanoma that has metastasized or cannot surgically removed and that tests positive for a specific mutation (V600E) in the BRAF gene.

What is the mechanism of action? Approximately half of all late-stage melanomas have a mutation known as V600E in the BRAF gene. Zelboraf inhibits the protein produced by this mutated gene and helps to control cell growth.

How is Zelboraf given (administered)? Zelboraf is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Zelboraf. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients will undergo skin examinations in addition to other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Zelboraf?

• Joint pain
• Rash
• Hair loss
• Fatigue
• Sunburn or sun sensitivity
• Nausea
• Itching
• Warts

What are some of the less common but potentially serious side effects of Zelboraf?

Zelboraf may cause a type of skin cancer known as cutaneous squamous cell carcinoma. This type of skin cancer does not usually spread to other parts of the body, but patients should notify their physician if they notice a new wart, a skin sore or reddish bump that bleeds or does not heal, or a change in the size or appearance of a mole.

Other potentially serious side effects include the following:

• Allergic reaction
• Severe skin reaction
• A change in the electrical activity of the heart called QT prolongation
• Abnormal liver function tests
• Eye problems
• New melanomas

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?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.
• Avoid sunlight during treatment with Zelboraf. When you go outside, wear sun-protective clothing and use broad-spectrum, high-SPF sunscreen and lip balm.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including problems with the heart, kidneys, or liver; low blood levels of potassium, calcium, or magnesium; and planned surgical, dental, or other medical procedures.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter), including blood thinners, anti-fungal medicines, antibiotics, HIV medicines, seizure medicines, antidepressants, and medicines to treat irregular heart beat.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Zelboraf may harm an unborn baby.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: possible signs of a new skin cancer include a new wart, a skin sore or reddish bump that bleeds or does not heal, and a change in the size or color of a mole; symptoms of an allergic reaction include rash or redness all over the body, feeling faint, trouble breathing or swallowing, throat tightness or hoarseness, fast heartbeat, and swelling of the face, lips, or tongue; symptoms of a severe skin reaction include blisters on the skin or in the mouth, peeling of the skin, fever, and redness or swelling of the face, hands, or soles of the feet; symptoms of QT prolongation (a heart problem) include feeling faint or lightheaded, dizziness, and a heartbeat that is irregular or fast; symptoms of liver problems include yellowing of the skin or the whites of the eyes, fatigue, dark urine, nausea or vomiting, lack of appetite, and pain on the right side of the stomach; symptoms of eye problems include blurred vision, other vision changes, and eye pain, swelling, or redness.

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.

Copyright © 2016 CancerConnect Last updated 08/11.

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