SUNITINIB

(soo NIT in ib) Brand: Sutent

What is the most significant information I must know about sunitinib?

• To be certain this medicine is helping your condition and not causing deleterious effects, your blood and blood pressure may need to be tested at the beginning of every 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis, and you may also need frequent dental exams. Do not miss any follow-up visits to your doctor.

What is sunitinib?

• Sunitinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

• Sunitinib is used to treat determined types of advanced or progressive tumors of the digestive system, the pancreas, or the kidneys.

• Sunitinib may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till using sunitinib?

• You must not use this medicine if you are allergic to it.

• To create certain you can safely take sunitinib, speak your doctor if you have any of these another conditions:

· liver or kidney disease;

· heart malady, tall blood pressure, heart rhythm disorder;

· seizures;

· a bleeding or blood-clotting disorder;

· a mess of your thyroid or adrenal gland;

· a private or family history of Long QT syndrome; or

· a history of stroke, heart onslaught, congestive heart failure, a blood clot, or coronary artery disease.

• In rare cases, this medication may reason bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.

• Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Another risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

• FDA pregnancy category D. Do not use sunitinib if you are pregnant. It could harm the unborn child. Use effective birth control, and speak your doctor if you become pregnant during treatment.

• It is not known whether sunitinib passes into breast milk or if it could harm a nursing child. You must not breast-feed while you are using sunitinib.

How must I take sunitinib?

• Follow all directions on your prescription label. Your doctor may occasionally change your doze to create certain you get the excellent results. Do not take this medication in larger or less amounts or for longer than recommended.

• Sunitinib is generally taken once for day. Sunitinib is sometimes taken for 4 weeks followed by 2 weeks off the drug. Your doctor will determine how much complete treatment cycles you need based on your condition.

• Sunitinib may be taken with or without food.

• Do not crush, chew, or open a sunitinib capsule. Swallow it intact. The medication from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly.

• To be certain this medicine is helping your condition and not causing deleterious effects, your blood and blood pressure may need to be tested at the beginning of every 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis, and you may also need frequent dental exams. Do not miss any follow-up visits to your doctor.

• If you need surgery or a dental procedure, speak the surgeon or dentist onward of time that you are using sunitinib. You may need to stop using the medication for a short time.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking sunitinib?

• This medication can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a doze, avoid allowing your body fluids to come into contact with your hands or another surfaces. Patients and caregivers must wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands till and after removing gloves. Wash soiled clothing and linens apart from another laundry.

• Body fluids must not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

• Grapefruit and grapefruit juice may interact with sunitinib and lead to potentially dangerous effects. Discuss the use of grapefruit commodity with your doctor.

What are the possible side effects of sunitinib?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

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

· headache with chest pain and severe dizziness, fainting, quick or pounding heartbeats;

· feeling short of breath (even with mild exertion), swelling in your ankles or feet;

· sudden numbness or weakness, problems with vision, speech, or balance;

· numbness or tingly feeling near your mouth;

· slow heart course, weak pulse, confusion;

· muscle weakness, tightness, or contraction, overactive reflexes;

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum);

· lower back pain, blood in your urine;

· urinating smaller than normal or not at all;

· pain and swelling in your stomach, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

· nausea, upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

· missed menstrual periods;

· feeling depressed or very weary, loss of appetite, diarrhea, weight gain or loss, hair loss, sweating, heighten sensitivity to heat.

· fever, white patches or sores internal your mouth or on your lips; or

· redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet.

• General side effects may include:

· unusual or unpleasant taste in the mouth;

· cough;

· mild nausea, vomiting, upset stomach;

· constipation;

· dry skin, changes in skin or hair color; or

· joint pain, back pain.

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

What another drugs will affect sunitinib?

• Speak your doctor about all medicines you use, and those you start or stop using during your treatment with sunitinib, especially:

· dexamethasone;

· imatinib;

· isoniazid (for treating tuberculosis);

· nefazodone;

· St. John's wort;

· an antibiotic such as clarithromycin, erythromycin, rifabutin, rifampin, rifapentine, or telithromycin;

· antifungal medicine such as itraconazole, ketoconazole, miconazole, or voriconazole;

· a barbiturate such as phenobarbital, secobarbital, and others;

· heart or blood pressure medicine such as nicardipine or quinidine;

· HIV/AIDS medication such as atazanavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, nelfinavir, nevirapine, saquinavir, or ritonavir;

· medicines to treat narcolepsy, such as armodafinil or modafinil;

· medicine to treat osteoporosis or Paget's malady of bone, such as alendronate, etidronate, ibandronate, pamidronate, risedronate, tiludronate, or zoledronic acid; or

· seizure medicine such as carbamazepine, felbamate, oxcarbazepine, phenytoin, or primidone.

• This list is not complete. Another drugs may interact with sunitinib, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your pharmacist can provide more information about sunitinib.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.