Nexavar (Sorafenib)

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Nexavar 200mg

Product of Canada
Manufactured by: Bayer Inc.
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Nexavar 200mg
Product of Canada
Manufactured by Bayer Inc.
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Sorafenib 200mg

Product of India
Manufactured by: Cipla Ltd
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Sorafenib 200mg
Product of India
Manufactured by Cipla Ltd
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Nexavar (Sorafenib) Dosage and Side Effects

NEXAVAR is used to treat liver cancer (hepatocellular carcinoma) which cannot be removed by surgery.

NEXAVAR is used to treat kidney cancer (locally advanced/metastatic renal cell (clear cell) carcinoma) in adults who failed or are intolerant to prior systemic therapy. It is not known whether NEXAVAR prolongs overall survival or improves the quality of life of patients with kidney cancer.

NEXAVAR is also used to treat thyroid cancer in patients who are no longer responding to radioactive iodine.

Proper Use of this medication

Usual dose:

The usual dose of NEXAVAR in adults is two 200 mg tablets, twice daily.

How to take NEXAVAR:

Swallow NEXAVAR tablets with a glass of water, without food or with a low-fat to moderate-fat meal. Always take NEXAVAR exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure. It is important to take NEXAVAR at about the same times each day. Never exceed the prescribed dose.

Overdose:

Tell your doctor immediately or contact the nearest poison control center or the emergency room of the nearest hospital if you (or anyone else) have taken more than your prescribed dose.

Missed dose:

If you have missed a dose, take it as soon as you remember. If it is nearly time for the next dose, forget about the missed one and carry on as normal. Do not take a double dose to make up for forgotten individual doses.

How long will I take NEXAVAR?

Your doctor will continue to treat you with NEXAVAR as long as you are thought to be benefiting from therapy.

Side Effects

NEXAVAR can have side effects, like all medicines, but not everybody gets them. For further information about any of these effects, ask a doctor or pharmacist.

If you experience any symptom that bothers you or does not go away, or severe side effects such as high blood pressure, bleeding or skin reactions, contact your doctor or seek medical attention as soon as possible.

The following side effects have been observed during clinical trials involving men and women taking NEXAVAR:

Very common side effects (may affect 10 or more in every 100 people):

  • diarrhea
  • feeling sick (nausea)
  • throwing up (vomiting)
  • dry skin
  • constipation
  • loss of appetite
  • loss of weight
  • feeling weak or tired
  • pain (including mouth pain, abdominal pain, headache, bone pain, joint pain and muscle pain)
  • a sudden, uncontrollable tightening of a muscle
  • hair loss
  • flushed or painful palms or soles (hand-foot skin reaction)
  • itching or rash
  • inflamed, dry or scaly skin that sheds
  • bleeding (hemorrhage) including bleeds from the mouth, nose, stomach or gut, rectum or back passage, lungs or windpipe, bleeding nail beds and blood blisters
  • high blood pressure, or increases in blood pressure
  • infection
  • breathlessness
  • inflamed or dry mouth, tongue pain

Common side effects (may affect 1 to 9 in every 100 people):

  • flushing
  • acne
  • flu-like illness
  • inflammation at the base of hairs
  • fever
  • indigestion or heartburn
  • difficulty swallowing
  • voice changes
  • underactive thyroid gland (hypothyroidism)
  • skin cancer
  • change in the sense of taste
  • runny nose
  • low blood levels of sodium
  • depression
  • erection problems (impotence)
  • hoarseness
  • heart attack (severe chest pain, shortness of breath, cold sweat, etc.)
  • kidney failure
  • infection/inflammation of the gallbladder and/or bile ducts

The following side effects have been observed outside of clinical trials:

  • heart failure (weakening of the heart muscle)
  • decreased blood flow to the heart and heart attack
  • severe skin condition with rash, skin peeling and sores of the mucous membranes
  • life-threatening or fatal interstitial lung disease (changes within your lungs causing shortness of breath and coughing)
  • increase in thyroid activity (may lead to nervousness, fast heart beat, anxiety, sweating and weight loss)
  • severe allergic reaction due to increased sensitivity to NEXAVAR, which may lead to flushing, rashes, hives, itching, swelling, breathing difficulty, dizziness and chest discomfort
  • swelling of the tissues underneath the skin (welts) due to an allergic reaction, often affecting the facial region
  • inflammation of the lung which may lead to breathing problems
  • inflammation of the liver
  • inflammatory reaction of the skin in a body part previously exposed to radiation
  • inflammation of small blood vessels in the skin resulting in rash, erythema, and small blood spots under the skin (known as leukocytoclastic vasculitis). This condition may be painful, itchy or may not cause discomfort at all.
  • muscle problems including symptoms of unexplained muscle injury, such as muscle cramps, pain, tenderness, stiffness, weakness or spasm. This may be an early sign of a rare muscle problem (rhabdomyolysis) that could lead to serious kidney problems.
  • changes in your blood tests may show:
    • low blood counts (white cells, red cells, or platelets) (leukopenia, neutropenia, anemia, thrombocytopenia)
    • temporary increase in certain liver tests (transient increase in transaminases)
    • low blood levels of calcium (hypocalcaemia)
    • low blood levels of potassium (hypokalemia)
    • abnormally high levels of protein in urine (proteinuria)
    • low or high levels of thyroid stimulating hormone (TSH) (hypothyroidism or hyperthyroidism)

Warnings and Precautions

Serious Warnings and Precautions

This drug should be prescribed and managed only by a doctor experienced in anticancer drugs.

NEXAVAR has not been studied in patients who have severe liver problems.

Possible serious side-effects with NEXAVAR include:

  • high blood pressure
  • bleeding
  • heart attack
  • gastrointestinal (bowel) perforation
  • liver injury

BEFORE you use NEXAVAR talk to your doctor or pharmacist if:

  • You have high blood pressure. NEXAVAR can raise blood pressure. Your doctor will instruct you to monitor your blood pressure and may give you medicine to treat your high blood pressure.
  • You have bleeding problems, or are taking warfarin. Treatment with NEXAVAR may lead to a higher risk of bleeding. If you are taking warfarin, which thins the blood to prevent blood clots, there may be a greater risk of bleeding.
  • You are going to have surgery, or a dental procedure, or if you had an operation recently. NEXAVAR might affect the way your wounds heal. You will usually be taken off NEXAVAR if you are having an operation. Your doctor will decide when to start withNEXAVAR again.
  • You have kidney or liver problems (in addition to cancer). If you have severe liver problems, you may experience more severe side effects when taking NEXAVAR.
  • You are pregnant, may be pregnant or are thinking about becoming pregnant. NEXAVAR may reduce fertility in both men and women. NEXAVAR can harm an unborn baby. You must use effective contraception while you take NEXAVAR.
  • You are breastfeeding. You should not breastfeed during NEXAVAR treatment because it could harm the baby.
  • You have had a history of heart problems.
  • You have QT/QTc prolongation or a family history of QT/QTc prolongation.
  • You have a personal history of fainting spells.
  • You have a family history of sudden cardiac death at <50 years.
  • You have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration).
  • You have an eating disorder or are following a strict diet.
  • You have diabetes.
  • You have thyroid cancer, as your doctor will monitor blood calcium and thyroid hormone levels.

NEXAVAR has an effect on the electrical activity of the heart known as QT/QTc prolongation. This effect can be measured as a change in the electrocardiogram (ECG). In very rare cases, drugs with this effect on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. In general, females and people more than 65 years in age are at higher risk. It is important to follow the instructions of your doctor with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.

Electrocardiograms (ECGs) and blood tests may be required periodically to monitor the risk of potentially serious side effects during treatment with NEXAVAR.

Your thyroid gland may become underactive or overactive while you take NEXAVAR. Your doctor will check your thyroid with blood tests.

NEXAVAR should not be given to children.

Interactions with this medication

Drugs that may interact with NEXAVAR include:

  • Rifampin (ROFACT, RIFADIN), an antibiotic
  • St. John's Wort, a herbal treatment for depression
  • Phenytoin (DILANTIN), carbamazepine (TEGRETOL), dexamethasone (MAXIDEX) or phenobarbital (BELLERGAL SPACETABS), treatments for epilepsy and other conditions
  • Warfarin (COUMADIN), an anticoagulant used to prevent blood clots
  • Doxorubicin (ADRIAMYCIN PFS, CAELYX, MYOCET), docetaxel (TAXOTERE), and irinotecan (CAMPTOSAR), paclitaxel (TAXOL), carboplatin, and capecitabine (XELODA), which are other cancer treatments
  • Neomycin, an antibiotic
  • Drugs to treat heart rhythm disturbances
  • Antidepressants
  • Antipsychotics
  • Painkillers
  • Antibiotics
  • Drugs to treat nausea and vomiting
  • Other cancer drugs
  • Diuretics (water pills)

This list includes some, but not all, of the drugs that may increase the risk of side effects while receiving NEXAVAR.

Tell your doctor or pharmacist if you are taking these or any other medicines, even those not prescribed (including any over-the-counter drugs, vitamins, or herbal medicines).

Other related products

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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