What is a generic medication?
Generic medications are significantly discounted copies of brand name medication that have the same active ingredients, intended use, dosage, side effects, effects, and route of administration as the original brand name medication. In other words, generic medications have the same pharmacological effects as their brand-name counterparts. Over half of all prescribed medications are for generic medications.
What Sutent is and what it is used for
Sutent contains the active substance sunitinib, which is a protein kinase inhibitor. It is used to treat
cancer by preventing the activity of a special group of proteins which are known to be involved in the
growth and spread of cancer cells.
Sutent is used to treat adults with the following types of cancer:Gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel, where
imatinib (another anticancer medicine) no longer works or you cannot take imatinib.
•Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that has spread to other parts of the body.
•Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery. If you have any questions about how Sutent works or why this medicine has been prescribed for you, ask your doctor.
How to take Sutent
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated. If you are being treated for GIST or MRCC, the usual dose is 50 mg once daily taken for 28 days (4 weeks), followed by 14 days (2 weeks) of rest (no medicine), in 6-week cycles. If you are being treated for pNET, the usual dose is 37.5 mg once daily without a rest period. Your doctor will determine the appropriate dose you need to take, as well as if and when you need to stop treatment with Sutent. Sutent can be taken with or without food. If you take more Sutent than you should If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. If you forget to take Sutent Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must immediately contact your doctor if you experience any of those serious side effects (see
also What you need to know before you take Sutent):
Heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and
ankles. These may be symptoms of heart problems that may include heart failure and heart muscle
Lung or breathing problems. Tell your doctor if you develop cough, chest pain, sudden onset of
shortness of breath, or coughing up blood. These may be symptoms of a condition called pulmonary
embolism that occurs when blood clots travel to your lungs.
Kidney disorders. Tell your doctor if you experience altered frequency or absence of urination which
may be symptoms of kidney failure.
Bleeding. Tell your doctor if you have any of these symptoms or a serious bleeding problem during
treatment with Sutent: painful, swollen stomach (abdomen); vomiting blood; black, sticky stools;
bloody urine; headache or change in your mental status; coughing up of blood or bloody sputum from
the lungs or airway.
Tumour destruction leading to hole in the intestine. Tell your doctor if you have severe abdominal
pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Other side effects with Sutent may include:
Very common: may affect more than 1 in 10 people
• Reduction in the number of platelets, red blood cells and/or white blood cells (e.g. neutrophils).
• Shortness of breath.
• High blood pressure.
• Extreme tiredness, loss of strength.
• Swelling caused by fluid under the skin and around the eye, deep allergic rash.
• Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach, nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
• Decreased activity of thyroid gland (hypothyroidism).
• Nose bleeding.
• Back pain, joint pain.
• Pain in arms and legs.
• Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin.
• Difficulty in falling asleep.
Common: may affect up to 1 in 10 people
• Blood clots in the blood vessels.
• Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.
• Chest pain.
• Decreased in the amount of blood pumped by the heart.
• Fluid retention including around the lungs.
• Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
• Decreased blood sugar level (see section 2).
• Loss of protein in the urine sometime resulting in swelling.
• Influenza-like syndrome.
• Abnormal blood tests including pancreatic and liver enzymes.
• High level of uric acid in the blood.
• Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
• Burning or painful sensation in the tongue, inflammation of the digestive tract lining, excessive gas in the stomach or intestine.
• Weight loss.
• Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
• Nasal dryness, congested nose.
• Excessive tear flow.
• Abnormal sensation of the skin, itching, flaking and inflammation of the skin, blisters, acne, nail discolouration, hair loss.
• Abnormal sensations in extremities.
• Abnormally decreased/increased sensitivity, particularly to touch.
• Acid heartburn.
• Hot flushes.
• Abnormally coloured urine.
Uncommon: may affect up to 1 in 100 people
• Life-threatening infection of the soft tissue including the ano-genital region (see section 2).
• Heart attack caused by an interrupted or decreased blood supply to the heart.
• Changes in the electrical activity or abnormal rhythm of the heart.
• Fluid around the heart (pericardial effusion).
• Liver failure.
• Pain in the stomach (abdomen) caused by inflammation of the pancreas.
• Tumour destruction leading to hole in the intestine (perforation).
• Inflammation (swelling and redness) of the gallbladder with or without associated gallstones.
• Abnormal tube like passage from one normal body cavity to another body cavity or the skin.
• Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis), see section 2.
• Overproduction of thyroid hormones which increases the amount of energy the body uses at rest.
• Problems with wound healing after surgery.
• Increased blood level of enzyme (creatine phosphokinase) from muscle.
• Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
Rare: may affect up to 1 in 1,000 people
• Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• Tumour lysis syndrome (TLS) – TLS consists of a group of metabolic complications that can occur during treatment of cancer. These complications are caused by the break-down products of dying cancer cells and may include the following: nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure.
• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• Painful skin ulceration (pyoderma gangrenosum).
• Inflammation of the liver (hepatitis).
• Inflammation of the thyroid gland.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie E-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal
How to Store Sutent
Keep this medicine out of the sight and reach of children.
•Do not use this medicine after the expiry date which is stated on carton, bottle and blister foil after “EXP”. The expiry date refers to the last day of that month.
•This medicine does not require any special storage conditions.
•Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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