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|Sorafenib

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SORAFENIB (Systemic)†

Some commonly used brand names are:

In the U.S.—

Nexavar

† Not commercially available in Canada.

Description

Sorafenib ((sor-a-FE-nib ))is an anticancer medicine used to treat adults with kidney cancer called advanced renal carcinoma.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

Oral
Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sorafenib, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sorafenib. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sorafenib has not been studied in pregnant women. However, studies in animals have shown that sorafenib may cause unwanted effects in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether sorafenib passes into breast milk. However, sorafenib is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sorafenib in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than is does in younger adults. However, elderly patients are more likely to be sensitive and may require a lower dose.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sorafenib, it is especially important that your doctor and pharmacist know if you are taking any of the following:

Doxorubicin (e.g., Adriamycin)—May increase your chance for side effects from doxorubicin

Drugs metabolized by UGT1A1 such as irinotecan (e.g., Camptosar)— May increase your chance for side effects from irinotecan

Proper Use of This Medicine

Read the patient information leaflet before taking sorafenib and each time the prescription is refilled.

Take this medicine exactly as prescribed.

Swallow the tablet whole with water.

Take on an empty stomach (at least 1 hour before or 2 hours after a meal).

Use of effective birth control during sorafenib treatment and for at least 2 weeks after stopping treatment for both male and female patients.

Dosing—The dose of sorafenib will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of sorafenib. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablets):
- Kidney cancer
  - Adults—400 milligrams (2 x 200 milligram tablets) taken twice daily, without food (at least 1 hour before or 2 hours after a meal).
  - Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

Keep out of the reach of children.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Regular visits: If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for high blood pressure that may be caused by this medicine.

Check with your doctor if any redness, pain, swelling or blisters on the palms of your hands or soles of your feet occur.

Check with your doctor if any chest pain.

Report any bleeding.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums; blurred vision; coughing up blood; difficulty in breathing or swallowing; dizziness; headache; increased menstrual flow or vaginal bleeding; nervousness; nosebleeds; paralysis; pounding in the ears; prolonged bleeding from cuts; red or black, tarry stools; red or dark brown urine; shortness of breath; slow or fast heartbeat

Reported during clinical trials

Area rash; black, tarry stools; bleeding gums; bloating; blood in urine or stools; bone pain; chest pain or discomfort; chills; clay-colored stools; coma; confusion; continuing ringing or buzzing or other unexplained noise in ears; constipation; convulsions; cough; dark urine; decreased urine output; depressed mood; difficulty in moving; dry skin and hair; feeling cold; enlarged pupils; fever; hair loss; hearing loss; hives; hoarseness or husky voice; increased sensitivity of eyes to light; increased sweating, possibly with fever or cold; clammy skin; increased thirst; indigestion; itching; joint pain; loss of appetite; lower back or side pain; muscle cramps and stiffness; muscle pain or cramps; nausea or vomiting; pains in stomach, side, or abdomen, possibly radiating to the back; pain or discomfort in arms, jaw, back or neck; painful or difficult urination; pale skin; pinpoint red spots on skin; reddening of the skin, especially around ears; severe chest pain; severe headache; stiff or sore neck; sore throat; sores, ulcers, or white spots on lips or in mouth; stomach discomfort upset or pain; sweating; swelling of eyes, face, or inside of nose; swelling of face, ankles, or hands; swollen glands; swollen joints; troubled breathing with exertion; unpleasant breath odor; unusual bleeding or bruising; unusual tiredness or weakness; vomiting of blood; weight gain; yellow eyes or skin

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Diarrhea; flushing; impaired wound healing; increased sweating; suppressed reaction to skin tests; thin, fragile skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common

Blistering, peeling, redness, and/or swelling of palms of hands or bottoms of feet; burning, tingling, numbness or pain in the hands, arms, feet, or legs; diarrhea; difficulty having a bowel movement (stool); dry skin; numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet; sensation of pins and needles; stabbing pain ; thinning of hair; tightness in chest; weight loss; wheezing

Reported during clinical trials

Acid or sour stomach; acne; belching; blistering, peeling, loosening of skin; bloating; bone pain; burning feeling in chest or stomach; burning, itching, and pain in hairy areas; cracked lips; cracks in the skin; decreased appetite; decreased interest in sexual intercourse; decreased urination; difficulty in moving; discouragement; dry mouth; fainting; feeling of warmth, redness of the face, neck, arms and occasionally, upper chest; feeling sad or empty; flushing, redness of skin; gas; general feeling of discomfort or illness; heartburn; inability to have or keep an erection; increase in heart rate; irritability; lack or loss of strength; lightheadedness; loss in sexual ability, desire, drive, or performance; loss of ability to use or understand speech or language; loss of heat from the body; loss of interest or pleasure; mouth pain; pus at root of hair; rapid breathing; red irritated eyes; red, swollen skin, scaly skin; rough, scratchy sound to voice; runny nose; shivering; skin rash encrusted, scaly and oozing; sore throat; sores, ulcers, or white spots in mouth or on lips; sunken eye; swelling of the breasts or breast soreness in both females and males; swelling or inflammation of the mouth; tenderness in stomach area; thirst; trouble concentrating; trouble sleeping; unusually warm skin; wrinkled skin

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/30/2005

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Typical mistypes for Sorafenib
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