Sutent

The recommended dose of Sutent (Sunitinib) to treat GIST or kidney cancer is 50 mg taken by mouth once daily for 4 weeks, followed by 2 weeks of no therapy. This 6-week cycle is then repeated.

To treat pancreatic neuroendocrine tumours the recommended dose is 37.5 mg taken by mouth once daily on the same cycle.

Daily doses should not be more than 50 mg or less than 25 mg. Sutent (Sunitinib) can be taken with or without food. Do not take Sutent (Sunitinib) with grapefruit juice, since this may interact with Sutent (Sunitinib) and increase the amount of Sutent (Sunitinib) in your blood.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Sutent (Sunitinib) exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Sutent (Sunitinib) at room temperature (between 15°C to 30°C) and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause diarrhea; it may cause unusual tiredness; it may cause nausea or, rarely, vomiting; it may lower your white blood cell count, which can lead to fever, chills, sore throat or infections - if you experience any of these symptoms, contact your doctor right away; it may cause pain in the mouth; it can lower blood platelet count, which could lead to increased bleeding. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

12.5 mg
Each hard gelatin capsule with orange cap and body, printed in white ink "Pfizer" on the cap and "STN 12.5 mg" on the body, contains Sutent (Sunitinib) malate equivalent to 12.5 mg of Sutent (Sunitinib). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, mannitol povidone (K-25), gelatin, red iron oxide, titanium dioxide, propylene glycol, shellac, and sodium hydroxide.

25 mg
Each hard gelatin capsule with caramel cap and orange body, printed with white ink "Pfizer" on the cap, "STN 25 mg" on the body, contains Sutent (Sunitinib) malate equivalent to 25 mg of Sutent (Sunitinib). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, mannitol, povidone (K-25), gelatin, red iron oxide, titanium dioxide, black iron oxide, yellow iron oxide, propylene glycol, shellac, and sodium hydroxide.

50 mg
Each hard gelatin capsule with caramel cap and body, printed with white ink "Pfizer" on the cap and "STN 50 mg" on the body contains Sutent (Sunitinib) malate equivalent to 50 mg of Sutent (Sunitinib). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, mannitol povidone (K-25), gelatin, red iron oxide, titanium dioxide, black iron oxide, yellow iron oxide, propylene glycol, shellac, and sodium hydroxide.

Do not use Sutent (Sunitinib) if you:

• are allergic to Sutent (Sunitinib) or any ingredients of the medication
• are pregnant

There may be an interaction between Sutent (Sunitinib) and any of the following:

• acetylsalicylic acid (Asa)
• Amiodarone
• androgens (e.g., testosterone)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• bacillus Calmette-Guérin (BCG)
• Baricitinib
• Bevacizumab
• Bicalutamide
• bisphosphonates (e.g., alendronate, etidronate)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, verapamil)
• cancer medications (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Carbamazepine
• chloroquine
• Cobicistat
• conivaptan
• Deferasirox
• Dexamethasone
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Digoxin
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• echinacea
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Fingolimod
• Flecainide
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Hydrocortisone
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• ledipasvir
• Leflunomide
• Loperamide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Rasagiline, Selegiline, Tranylcypromine)
• nefazodone
• Octreotide
• Pasireotide
• Pegvisomant
• pentamidine
• Phenobarbital
• Phenytoin
• Pimecrolimus
• primidone
• procainamide
• other protein kinase inhibitors (e.g., Bosutinib, Crizotinib, Dabrafenib, imatinib, Nilotinib)
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Ofloxacin,)
• rifampin
• Roflumilast
• St. John's wort
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Silodosin
• Sirolimus
• sotalol
• somatostatin acetate
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• tacrolimus
• Tocilizumab
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sutent (Sunitinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Sutent (Sunitinib).

Abnormal heart rhythms: Sutent (Sunitinib) can cause abnormal heart rhythms, which often have no symptoms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Sutent (Sunitinib). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Sutent (Sunitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sutent (Sunitinib), and whether any special monitoring is needed.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body’s organs, including how your body responds to injury or stress. On rare occasions, Sutent (Sunitinib) may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Bleeding: Sutent (Sunitinib) may increase your risk of bleeding. On rare occasions, tumour bleeding has occurred. If you experience signs of bleeding (e.g., nosebleeds, darkened urine or stools), contact your doctor as soon as possible. Your doctor will perform regular blood tests to monitor you while you are taking Sutent (Sunitinib).

Blood cell counts: Sutent (Sunitinib) may decrease the number of blood cells in your body. Your doctor will perform a blood test regularly to monitor your blood cell count while you are taking Sutent (Sunitinib).

Blood Clots: Sutent (Sunitinib) may cause blood clots in the legs (deep vein thrombosis) to form that can move to the lungs (pulmonary Embolism), heart (heart attack) or brain (stroke).

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Sutent (Sunitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sutent (Sunitinib), and whether any special monitoring is needed. If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, seek immediate medical attention.

Blood glucose: Sutent (Sunitinib) can cause large decreases in glucose levels in the blood. This can happen even if you do not have diabetes. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Sutent (Sunitinib). Changes to your medications may become necessary. If you experience symptoms of decreased blood sugar, such as cold sweats, cool, pale skin, headache, rapid heartbeat or unusual weakness, talk to your doctor. If you experience symptoms of dangerously low blood glucose, such as seizures, delirium, or loss of consciousness, this is a medical emergency and requires immediate medical attention.

Gastrointestinal perforation: Rarely, people using Sutent (Sunitinib) who have tumours that have spread to the digestive system develop a tear in the lining of the digestive tract. This may be related to the death of cancer cells in the stomach or intestines. If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.

High blood pressure: Your doctor may check your blood pressure before starting Sutent (Sunitinib) and then ask you to measure your blood pressure regularly while taking Sutent (Sunitinib). Some people taking Sutent (Sunitinib) develop very high blood pressure that requires adding blood pressure medications, changing the Sutent (Sunitinib) dose, or even stopping the medication for a period of time. Talk to your doctor if you have any concerns.

Heart problems: Sutent (Sunitinib) can decrease heart function, which may lead to heart failure. If you experience symptoms of heart failure such as unusual tiredness, shortness of breath, or swelling of the feet and ankles, contact your doctor.

If you have a history of decreased heart function (i.e., heart Arrhythmias, Congestive Heart Failure such as left ventricular dysfunction, heart attack, heart bypass surgery), discuss with your doctor how Sutent (Sunitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sutent (Sunitinib), and whether any special monitoring is needed.

Infection: Like other medications used to treat cancer, Sutent (Sunitinib) can cause a decrease in the number of blood cells that fight infection (white blood cells). Rarely, pneumonia or sepsis has been reported. These infections can be fatal. If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Jaw problems: On rare occasions, Sutent (Sunitinib) may cause severe jaw problems, especially in people who have had invasive dental procedures or are taking bisphosphonates (e.g., Alendronate, Risedronate). If you experience any pain in the jaw, contact your doctor immediately. Invasive dental procedures should be avoided if possible.

Kidney function: Sutent (Sunitinib) can cause decreased kidney function or kidney failure. If you experience puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, Sutent (Sunitinib) may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: Sutent (Sunitinib) may cause a decrease in liver function. Sutent (Sunitinib) has also been reported to cause liver failure, which has in some cases caused death. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Your doctor may want to test your liver function regularly with blood tests while you are taking Sutent (Sunitinib). This often allows reduced liver function to be identified before it becomes too severe.

Male contraception: Sutent (Sunitinib) can cause harm to the fetus if the female partner of a man taking Sutent (Sunitinib) becomes pregnant. Men should use effective contraception while taking Sutent (Sunitinib).

Muscle problems: On rare occasions, people have had severe muscle problems while taking Sutent (Sunitinib). If you have muscle aches or weakness, or dark-coloured urine, contact your doctor as soon as possible.

Pancreatitis: Sutent (Sunitinib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Sutent (Sunitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sutent (Sunitinib), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like Sutent (Sunitinib). If you have had a previous episode of RPLS, Sutent (Sunitinib) may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness, or vision changes, contact your doctor immediately.

Seizures: Rarely, there have been cases of people having seizures while taking Sutent (Sunitinib). If you have a history of seizures or seizure disorders, discuss with your doctor how Sutent (Sunitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sutent (Sunitinib), and whether any special monitoring is needed.

Thyroid problems: Sutent (Sunitinib) may decrease thyroid hormone levels. If you have symptoms of low thyroid such as dry skin, constipation, weight gain, or fatigue, go see your doctor.

Tumour lysis syndrome: Sutent (Sunitinib), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Sutent (Sunitinib) should not be used during pregnancy. If you become pregnant while taking Sutent (Sunitinib), contact your doctor immediately.

Breast-feeding: It is not known if Sutent (Sunitinib) passes into breast milk. If you are a breast-feeding mother and are taking Sutent (Sunitinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Sutent (Sunitinib) have not been established for children.

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. You should take this medication at approximately the same time each day. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.