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Drugs & Medications

Nexavar

GENERIC NAME(S): SORAFENIB TOSYLATE

Uses

This medication is used to treat kidney or liver cancer. It may also be used to treat a certain type of thyroid cancer (differentiated thyroid carcinoma). Sorafenib stops or slows the growth of cancer cells (tumors). It also works by slowing the growth of new blood vessels within the tumor.

How to use Nexavar

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, usually twice a day. 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.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

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 right away if you notice skin problems (such as rash, blisters, redness, swelling, pain), especially on the palms of your hands or the soles of your feet. Your doctor may prescribe medication for your skin or change your treatment plan.

Tell your doctor right away if you have any serious side effects, including: bone/muscle pain, depression, easy bruising or bleeding, headache, tongue/mouth sores or pain, numbness/tingling of the hands/feet, shortness of breath, swollen hands/ankles/feet, signs of liver problems (such as stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 (such as 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 cause QT prolongation. 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.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

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.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other anti-cancer drugs (such as docetaxel, doxorubicin, irinotecan), "blood thinners" (anticoagulants such as warfarin, heparins), neomycin taken by mouth.

Other medications can affect the removal of sorafenib from your body, which may affect how sorafenib works. Examples include dexamethasone, rifamycins (such as rifampin/rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure, calcium/phosphate/potassium levels, lipase, amylase, complete blood counts, liver/thyroid function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

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.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Images

NEXAVAR 200 MG TABLET
NEXAVAR 200 MG TABLET
View Larger Picture
color
red
shape
round
imprint
BAYER BAYER, 200
NEXAVAR 200 MG TABLET
NEXAVAR 200 MG TABLET

Identification

color
red
shape
round
imprint
BAYER BAYER, 200
This medicine is a red, round, film-coated tablet imprinted with "BAYER BAYER" and "200".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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