Sorafenib

Brand(s)

• Soranib

Manufacturer

• Cipla Limited

Disease(s)

Sorafenib tablet

What is this medicine?

Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body. Sorafenib is used to treat liver cancer, thyroid cancer, or a type of kidney cancer called advanced renal cell carcinoma.

Sorafenib may also be used for purposes not listed in this medication guide.

What should I tell my health care providers before I take this medicine?

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 sorafenib is safe for you, tell your doctor if you have:

• kidney or liver problems other than cancer;

• lung cancer;

• 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.

Do not use sorafenib if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are receiving sorafenib, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either parent is taking this medication. Keep using birth control for at least 2 weeks after your treatment ends.

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

How should I use this medicine?

Sorafenib is usually taken 2 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take sorafenib on an empty stomach, at least 1 hour before or 2 hours after eating.

Do not crush, chew, or break a sorafenib tablet. Swallow it whole with water. Your blood pressure will need to be checked often. If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using sorafenib. You may need to stop using the medicine for a short time.

What 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 may interact with this medicine?

Tell your doctor about all other cancer medicines you use, especially cisplatin, cyclophosphamide, docetaxel, doxorubicin, fluorouracil, gemcitabine, irinotecan, paclitaxel, or tamoxifen.

Many drugs can interact with sorafenib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with sorafenib, especially:

• dexamethasone;

• neomycin;

• St. John's wort;

• a blood thinner (warfarin, Coumadin);

• seizure medication--carbamazepine, fosphenytoin, phenobarbital, phenytoin; or

• tuberculosis medicine--rifabutin, rifampin.

This list is not complete and many other drugs can interact with sorafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

What side effects may I notice from this medicine?

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

Stop using sorafenib and call your doctor at once if you have:

• mouth sores;

• blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;

• heavy menstrual periods, easy bruising, unusual bleeding, or any bleeding that will not stop;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• dry cough, wheezing;

• chest pain and severe dizziness, fainting, sweating, swelling, rapid weight gain, feeling short of breath (even with mild exertion);

• rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;

• 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.

Common side effects may include:

• tired feeling;

• vomiting, diarrhea, mild stomach pain;

• mild itching or rash; or

• weight loss, thinning hair.

This is not a complete list of side effects and others may occur.

What should I watch for while using this medicine?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Where should I keep this medicine?

Store at room temperature away from moisture, heat, and light.