sorafenib

Pronunciation: sor a FEN ib

Brand: NexAVAR

What is the most important information I should know about sorafenib?

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Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects.

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Do not breast-feed while using this medication.

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You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

Before you take sorafenib, tell your doctor if you have kidney or liver problems (other than cancer), a bleeding or blood clotting disorder, high blood pressure, heart disease, slow heartbeats, congestive heart failure, a personal or family history of Long QT syndrome, a history of stroke or heart attack, or any allergies.

There are many other drugs that can interact with sorafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking sorafenib.

What is sorafenib?

Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells 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 purposes not listed in this medication guide.

What should I discuss with my health care provider before taking sorafenib?

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You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

To make sure you can safely take sorafenib, tell your doctor if you have any of these other conditions:

  • kidney or liver problems other than cancer;
  • lung cancer, especially if you are receiving gemcitabine (Gemzar) and cisplatin (Platinol);
  • a bleeding or blood clotting disorder such as hemophilia;
  • high blood pressure (hypertension), heart disease, slow heartbeats, congestive heart failure, chest pain;
  • a personal or family history of Long QT syndrome;
  • a history of stroke or heart attack; or
  • any allergies.
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FDA pregnancy category D. Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects.

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It is not known whether sorafenib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medication.

How should I take sorafenib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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Take sorafenib on an empty stomach, at least 1 hour before or 2 hours after eating.

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Do not crush, chew, or break a sorafenib tablet. Swallow it whole with water.

To be sure this medication is not causing harmful side effects, your blood pressure will need to be checked often. Visit your doctor regularly.

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If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking sorafenib. You may need to stop taking the medicine for a short time.

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Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but at least 2 hours since your last meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe diarrhea or severe skin rash.

What should I avoid while taking sorafenib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of sorafenib?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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Stop using sorafenib and call your doctor at once if you have a serious side effect such as:

  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
  • mouth sores;
  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • dry cough, wheezing;
  • swelling, rapid weight gain, feeling short of breath (even with mild exertion);
  • sudden numbness or weakness, especially on one side of the body;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • sudden weight loss, increased appetite, trouble sleeping, increased bowel movements, feeling hot, feeling nervous or anxious, swelling in your neck (goiter);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, confusion, uneven heartbeats, seizure); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • tired feeling;
  • vomiting, diarrhea, mild stomach pain;
  • mild itching or rash; or
  • thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sorafenib?

Tell your doctor about all other cancer medicines you use, especially cyclophosphamide (Cytoxan, Neosar), docetaxel (Taxotere), doxorubicin (Adriamycin, Rubex), fluorouracil (Adrucil, Carac, Efudex, Fluoroplex), irinotecan (Camptosar), paclitaxel (Taxol) or tamoxifen (Soltamox).

Tell your doctor about all other medicines you use, especially:

  • arsenic trioxide (Trisenox);
  • bosentan (Tracleer);
  • dexamethasone (Decadron, Hexadrol);
  • montelukast (Singulair) or zafirlukast (Accolate);
  • promethazine (Phenergan, Adgan, Anergan, Antinaus, Pentazine);
  • selegiline (Eldepryl, Emsam, Zelapar);
  • St. John's wort;
  • tacrolimus (Prograf);
  • voriconazole (Vfend);
  • an antibiotic such as clarithromycin (Biaxin), levofloxacin (Levaquin), neomycin (Mycifradin, Neo Fradin, Neo Tab), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
  • an antidepressant;
  • anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);
  • a barbiturate such as pentobarbital (Nembutal) and others;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • heart or blood pressure medications;
  • HIV medication;
  • medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
  • medicines to treat narcolepsy;
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), and others;
  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) and others;
  • narcotic medication such as methadone (Methadose, Diskets, Dolophine);
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others; or
  • type 2 diabetes medications such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase).

This list is not complete and other drugs may interact with sorafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sorafenib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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