Generic Sorafenib

This medication is used to treat kidney or liver cancer. Sorafenib stops or slows the growth of cancer cells (tumors). It also works by slowing the growth of new blood vessels within the tumor.

Read the Patient Information Leaflet provided by your pharmacist before you start using sorafenib and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor. Do not chew or crush the tablets. Swallow tablets whole with a full glass of water (8 ounces or 240 milliliters). Take this medication exactly as prescribed. The dosage is based on your medical condition and response to therapy. You will usually take this medication continuously (without break periods) as directed by your doctor. If you have certain side effects, your doctor may adjust your dose or stop treatment for some time. Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

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. Sorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using sorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sorafenib safely. 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.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anti-cancer drugs (e.g., docetaxel, doxorubicin, irinotecan), "blood thinners" (anticoagulants such as warfarin, heparins), drugs affecting liver enzymes that remove sorafenib from your body (such as carbamazepine, dexamethasone, phenobarbital, phenytoin, rifamycins including rifampin/rifabutin, St John's wort), neomycin taken by mouth. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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), severe dizziness, fainting, fast/irregular heartbeat. 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.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.