Nexavar

Generic Name: sorafenib (sor a FEN ib)

What is Nexavar?

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

Nexavar is used to treat a type of kidney cancer called advanced renal cell carcinoma. It is also used to treat liver cancer.

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

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

Nexavar can cause high blood pressure (hypertension). Before using Nexavar, 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 Nexavar.

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

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

Do not use Nexavar if you are allergic to sorafenib.

Before using Nexavar, 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 need a dose adjustment or special tests to safely take Nexavar.

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 Nexavar 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 Nexavar passes into breast milk or if it could harm a nursing baby. Do not use Nexavar without telling your doctor if you are breast-feeding a baby.

How should I take Nexavar?

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 Nexavar 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 Nexavar 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 Nexavar. You may need to stop using the medicine for a short time. Store Nexavar 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.

Overdose symptoms may include severe diarrhea, and skin rash, redness, swelling, or blistering.

What should I avoid while taking Nexavar?

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

Nexavar side effects

Stop using Nexavar 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 Nexavar side effects may include:

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.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nexavar?

Before taking Nexavar, 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 docetaxel (Taxotere), doxorubicin (Adriamycin, Rubex) or irinotecan (Camptosar).

This list is not complete and there may be other drugs that can interact with Nexavar. 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.