Sorafenib

What is the most important information I should know about sorafenib?

Sorafenib can cause high blood pressure (hypertension). Before using this medication, tell your doctor if you have a history of hypertension. Your blood pressure will need to be checked on a regular basis while you are using sorafenib.

Call your doctor at once if you have serious side effects such as rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet; unusual bruising or bleeding; chest pain spreading to the arm or shoulder; feeling short of breath; or sudden numbness or weakness.

Using sorafenib while you are pregnant can cause harm to the unborn baby. Do not use this medication if you are pregnant. Tell your doctor if you become pregnant during treatment. Both men and women taking sorafenib should use an effective form of birth control while taking the medication and for at least 2 weeks after treatment ends.

What is sorafenib?

Sorafenib is a cancer (chemotherapeutic) medication. Sorafenib interferes with the growth of cancer cells and slows their growth and spread in the body.

Sorafenib is used to treat a type of kidney cancer called advanced renal cell carcinoma.

Sorafenib may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before taking sorafenib?

Do not use this medication if you are allergic to sorafenib.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• kidney or liver disease;
• a bleeding or blood clotting disorder such as hemophilia;
• high blood pressure (hypertension);
• heart disease; or
• a history of stroke or heart attack.

If you have any of the conditions listed above, you may not be able to use sorafenib or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use this medication if you are pregnant. Tell your doctor if you become pregnant during treatment. Both men and women taking sorafenib should use an effective form of birth control while taking the medication and for at least 2 weeks after treatment ends.

It is not known whether sorafenib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sorafenib?

Take this medicine exactly as your doctor has prescribed it for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take sorafenib on an empty stomach, at least 1 hour before or 2 hours after eating.

Swallow the tablet whole with a glass of water.

To be sure this medication is not causing harmful side effects, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sorafenib. You may need to stop using the medicine for a short time.

Store sorafenib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a sorafenib overdose may include severe diarrhea, and skin rash, redness, swelling, or blistering.

What should I avoid while taking sorafenib?

Use birth control to prevent pregnancy while you are using sorafenib, whether you are a man or a woman. Continue using birth control for at least 2 weeks after you stop taking sorafenib.

What are the possible side effects of sorafenib?

Stop using sorafenib and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
• easy bruising, unusual bleeding;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• sudden numbness or weakness, especially on one side of the body; or
• confusion, loss of balance or coordination, or seizure (convulsions).

Less serious side effects are more likely to occur, such as:

• numbness, tingling, or swelling of your hands or feet;
• nausea, vomiting, constipation, diarrhea, stomach pain, loss of appetite;
• headache, tired feeling;
• tumor pain;
• pain in your joints, bones, or mouth;
• cough, trouble breathing;
• weight loss;
• hair loss; or
• dry, itchy skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect sorafenib?

Before taking sorafenib, tell your doctor if you are using any of the following drugs:

• the blood thinner warfarin (Coumadin);
• dexamethasone (Decadron, Hexadrol);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• St. John's wort;
• seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton); or
• other cancer medications such as doxorubicin (Adriamycin, Rubex) or irinotecan (Camptosar).

If you are using any of these drugs, you may not be able to take sorafenib, or you may require a dosage adjustment or special monitoring.

There may be other drugs not listed that can affect sorafenib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about sorafenib written for health professionals that you may read.

What does my medication look like?

Sorafenib is available with a prescription under the brand name Nexavar. Other brand or generic forms may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Nexavar 200 mg--red, round film-coated tablet

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 1.04. Revision date: 05/04/2007.