Class: Targeted Therapy

Generic Name: Sorafenib (Sora-FEN-ib)
Trade Name: Nexavar®

How is this drug used? Nexavar® is FDA approved for the treatment of advanced renal cell carcinoma (RCC). It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than for which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Nexavar® belongs to a group of drugs called targeted agents. Nexavar® blocks the growth of cancer cells by inhibiting several biological pathways that are involved in cellular replication and spread.

How is Nexavar® typically given (administered)? Nexavar® is taken orally, typically twice per day. Patients should take Nexavar® on an empty stomach.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Nexavar®. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Physical examinations, scans or other measures may also be utilized to assess side effects and response to therapy.

What are the common side effects (occurring in 30% or more of patients) of treatment with Nexavar®?

• Diarrhea
• Fatigue
• Skin reactions on the palms of hands and soles of feet, including, swelling, blisters, ulcers, and pain

What are the less common side effects (occurring in 10% to 29% of patients) of treatment with Nexavar®?

• Hair loss
• Weight loss
• Nausea and vomiting
• Skin reactions (rash, itching, dry skin)
• Pain including headache, joint pain, abdominal pain
• Loss of appetite
• Constipation
• Headache
• Bleeding
• Cough
• Difficulty breathing
• Low levels of immune cells—increases risk for infection
• Low levels of red blood cells—increases risk for anemia and need for blood transfusions
• Low levels of platelets—increases risk of bleeding
• Mouth sores
• Weakness
• Tingling or numbness of hands or feet

This is not a complete list of side effects. Some patients may experience other side effects that are not listed above. 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 inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids (patients should ask their physician about the amount of liquid to consume during a day).
• If possible, avoid large crowds and people who are sick or not feeling well; this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.

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 a form of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

Patients should notify their physician when they experience any of the following symptoms:

• Chest pain
• Difficulty breathing
• Change in heart rate
• Continued or excessive diarrhea
• Continued or excessive nausea and vomiting
• Extreme pain
• Uncontrollable bleeding, blood in the urine or stool
• Severe pain, blistering, or ulcers of the hands or feet
• Numbness or tingling of the hands or feet
• Excessive weakness or fatigue
• Signs of infection—sore throat, cough, fever, chills, redness, swelling

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 by 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 © 2010 CancerConsultants Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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