Nexavar

DRUG DESCRIPTION

NEXAVAR, a kinase inhibitor, is the tosylate salt of sorafenib.

Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2methylpyridine-2-carboxamide 4-methylbenzenesulfonate and its structural formula is:

NEXAVAR (sorafenib)  Structural Formula Illustration

Sorafenib tosylate is a white to yellowish or brownish solid with a molecular formula of C21H16ClF3N4O3 x C7H8O3S and a molecular weight of 637.0 g/mole. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400.

Each red, round NEXAVAR film-coated tablet contains sorafenib tosylate (274 mg) equivalent to 200 mg of sorafenib and the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate, polyethylene glycol, titanium dioxide and ferric oxide red.

What are the possible side effects of sorafenib (Nexavar)?

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;
  • ...

Read All Potential Side Effects and See Pictures of Nexavar

What are the precautions when taking sorafenib (Nexavar)?

Before taking sorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., heart attack, angina), high blood pressure, liver problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters,...

Read All Potential Precautions of Nexavar


Nexavar Consumer (continued)

SIDE EFFECTS: Acne, dry skin, nausea, diarrhea, patchy hair loss/thinning, loss of appetite, dry mouth, hoarseness, or tiredness may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you notice skin problems on the palms of your hands or the soles of your feet (e.g., rash, blisters, redness, swelling, pain). Your doctor might prescribe medication for your skin or change your treatment plan.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/muscle pain, depression, stomach/abdominal pain, dark urine, headache, tongue/mouth sores or pain, easy bruising or bleeding, numbness/tingling of the hands/feet, swollen hands/ankles/feet, shortness of breath.

Seek immediate medical attention if these rare but very serious side effects occur: chest/jaw/left arm pain, severe abdominal/stomach pain, bloody vomit, coughing up blood, bloody stools, difficulty speaking, loss of balance, sudden vision changes, seizures, mental/mood changes (e.g., confusion).

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., heart attack, angina), high blood pressure, liver problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

If you need to have a surgical or dental procedure, tell your doctor or dentist that you are using sorafenib.

Wash your hands well to prevent the spread of infections.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. To avoid pregnancy, both males and females using sorafenib must use reliable form(s) of birth control during treatment and for at least 2 weeks after stopping this drug. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Nexavar Patient Information Including Side Effects

Brand Names: Nexavar

Generic Name: sorafenib (Pronunciation: sor a FEN ib)

  • What is sorafenib (Nexavar)?
  • What are the possible side effects of sorafenib (Nexavar)?
  • What is the most important information I should know about sorafenib (Nexavar)?
  • What should I discuss with my health care provider before taking sorafenib (Nexavar)?
  • How should I take sorafenib (Nexavar)?
  • What happens if I miss a dose (Nexavar)?
  • What happens if I overdose (Nexavar)?
  • What should I avoid while taking sorafenib (Nexavar)?
  • What other drugs will affect sorafenib (Nexavar)?
  • Where can I get more information?

What is sorafenib (Nexavar)?

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. It is also used to treat liver cancer.

Sorafenib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of sorafenib (Nexavar)?

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 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 is the most important information I should know about sorafenib (Nexavar)?

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.

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