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INTRODUCTION
SUTYKINE 12.5 CAPSULE contains Sunitinib which belongs to the group of medicines called Protein Kinase Inhibitors. It is used in the treatment of gastrointestinal stromal tumor (GIST) (a type of cancer of the stomach and bowel) where another anticancer medicine (imatinib) no longer works or you cannot take it and metastatic renal cell carcinoma (MRCC) (type of kidney cancer that has spread to other parts of the body).
SUTYKINE 12.5 CAPSULE is also used to treat pancreatic neuroendocrine tumors (pNET) (tumors of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery. Your doctor might ask you to take blood tests, check your blood pressure and take your ECG during treatment with SUTYKINE 12.5 CAPSULE and as clinically indicated.
Before taking SUTYKINE 12.5 CAPSULE, inform your doctor if you have heart, kidney, liver, blood, thyroid or pancreatic problems, seizures and diabetes or if you recently had or are going to undergo any surgery.
Ask your doctor before taking SUTYKINE 12.5 CAPSULE during pregnancy. You should not breastfeed while taking SUTYKINE 12.5 CAPSULE so, consult your doctor before taking it. It is not known if SUTYKINE 12.5 CAPSULE is safe and effective in children and it should be used with caution in elderly patients (65 years and above).
The most common side effects of taking SUTYKINE 12.5 CAPSULE are rashes, itching, muscle cramps, bone pain weakness, tiredness, diarrhea, nausea, vomiting, stomach pain, etc. Contact your doctor if any of the symptoms worsen or persists.
USES OF SUTYKINE 12.5 CAPSULE
SUTYKINE 12.5 CAPSULE treats:
- gastrointestinal stromal tumor (GIST)
- metastatic renal cell carcinoma (MRCC)
- pancreatic neuroendocrine tumors (pNET)
HOW SUTYKINE 12.5 CAPSULE WORKS
SUTYKINE 12.5 CAPSULE helps control cancer advancement by inhibiting the activity of a special group of proteins which are found to be involved in the growth and spread of cancer cells.
DIRECTIONS FOR USE
Take SUTYKINE 12.5 CAPSULE as advised by your physician. Swallow with enough water. Do not crush or chew it. Your doctor will decide the correct dose and duration of SUTYKINE 12.5 CAPSULE treatment depending on your age, body weight and disease condition. Do not stop taking SUTYKINE 12.5 CAPSULE unless your doctor advises you to stop.
SIDE EFFECTS OF SUTYKINE 12.5 CAPSULE
COMMON
- reduced platelets, red blood cells or white blood cells
- shortness of breath
- high blood pressure
- extreme tiredness, weakness
- swelling due to fluid under the skin and around the eye, deep allergic rash
- upset stomach, nausea, vomiting, diarrhea, constipation, stomach pain/swelling, loss of appetite
- mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances
- decreased thyroid activity
- dizziness, headache
- nose bleeding
- pain in joints, back, arms, legs
- yellow skin/skin discoloration, excess pigmentation of the skin, hair color change, rash on the palms of the hands and soles of the feet, dry skin
- cough, fever
- difficulty sleeping
- deficiency of blood supply to the heart muscle, obstruction or constriction of the coronary arteries, chest pain, decrease in the amount of blood pumped by the heart
- fluid retention including around the lungs
- infections, influenza-like syndrome
- complication of severe bloodstream infection that can lead to tissue damage or organ failure
- decreased blood sugar and uric acid level
- loss of protein in the urine sometimes causing swelling
- elevated pancreatic and liver enzymes
- hemorrhoids, pain in the back passage, bleeding in gums, difficulty in swallowing or inability to swallow
- burning or painful sensation in the tongue, inflammation of the gut lining, excessive gas in the stomach or bowel
- weight loss
- pain in muscles and bones, muscular weakness, fatigue, pain or spasms
- nasal dryness, congested nose
- excessive tear flow
- abnormal sensation or inflammation of the skin, itching, flaking, blisters, acne, nail discoloration, hair loss, unusually decreased/increased sensitivity, especially to touch
- abnormal feeling in extremities
- acid heartburn
- dehydration, hot flushes, chills
- abnormally coloured urine
- depression
UNCOMMON
- serious soft tissue infection including the anogenital area
- stroke
- heart problems (heart attack, abnormal heart rhythm, fluid around the heart)
- liver failure
- inflamed pancreas (stomach pain)
- gallbladder inflammation (swelling and redness) with or without associated gallstones
- abnormal tubes like a passage from one normal body cavity to another body cavity or the skin
- osteonecrosis (pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw or loosening of a tooth)
- overactive thyroid which increases the amount of energy used by the body at rest
- increased blood level of a muscle enzyme (creatine phosphokinase)
- allergic reaction to an allergen (hay fever, skin rash or itching, hives, swelling of body parts, trouble breathing)
- inflammation of the colon (colitis, colitis ischemic)
RARE
- tumor lysis syndrome (nausea, breathlessness, irregular heartbeat, muscular cramps, fits, clouding of urine, tiredness associated with abnormal laboratory test results)
- abnormal muscle breakdown
- abnormal changes in the brain (headache, confusion, fits, vision loss)
- painful skin ulceration
- inflammation of the liver or thyroid gland
- thrombotic microangiopathy (scarring of the smallest blood vessels)
Stop taking SUTYKINE 12.5 CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- heart problems like heart failure and heart muscle problems (feeling very tired or breathless, swollen feet and ankles)
- lung or breathing problems like pulmonary embolism (cough, chest pain, sudden onset of breathlessness, coughing up blood)
- kidney disorders like kidney failure (altered frequency or absence of urination)
- bleeding problems (painful, swollen stomach, vomiting blood, black, sticky stools, bloody urine, headache, change in the mental status, coughing up blood or bloody sputum from the lungs or airway)
- tumor destruction leading to a hole in the intestine (severe abdominal pain, fever, nausea, vomiting, blood in your stool, change in bowel habits)
- blood clot in blood vessels (chest pain or pressure, pain in your arms, back, neck or jaw, breathlessness, numbness or weakness on one side of your body, trouble talking, headache or dizziness)
- getting tired more easily, feeling colder than other people, voice deepening
- skin conditions like pyoderma gangrenosum or necrotizing fasciitis (fever, pain, redness, swelling, drainage of pus or blood)
- toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome (reddish target-like spots or circular patches often with central blisters on the trunk, rash that may progress to widespread blistering or peeling of the skin)
- low blood sugar (fatigue, throbbing sensation, sweating, hunger)
- severe liver problems (itching, yellow eyes or skin, dark urine, pain or discomfort in the right upper stomach area)
- protein in urine
- wound healing problems
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Take SUTYKINE 12.5 CAPSULE with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.
Diarrhea:
To avoid dehydration of your body, drink plenty of fluids such as water, fruit juices or electrolytes. If symptom persists, contact your doctor.
Constipation:
Eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals and drink more water. Exercise more regularly. If symptom persists, contact your doctor.
Headache:
Apply hot or cold-water bag on your head. Try to rest and relax in a quiet and dark room. Massage the scalp or head gently. Avoid the consumption of excessive alcohol, as it could make your headache worse. If symptom persists, contact your doctor.
Dizziness:
Lie or sit down promptly when you feel dizzy. If you're feeling severe episode of spinning, lie in a dark and quite place and close your eyes. Try to avoid vehicle driving. If symptom persists, contact your doctor.
Skin rash:
Avoid hot showers as it can irritate your skin more. Do not scratch the affected area. Use protective clothing when going outdoors and moisturize your skin regularly. If symptom persists, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
SUTYKINE 12.5 CAPSULE should be used with caution in women who are pregnant or planning to become pregnant. Effective contraception should be used during treatment and for at least 4 weeks after the last dose of SUTYKINE 12.5 CAPSULE. Inform your doctor immediately if you become pregnant or think you got pregnant during treatment with SUTYKINE 12.5 CAPSULE.
BREASTFEEDING
Breastfeeding is not recommended during treatment with SUTYKINE 12.5 CAPSULE and for at least 4 weeks after the last dose. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or unusually tired after taking SUTYKINE 12.5 CAPSULE.
KIDNEY
SUTYKINE 12.5 CAPSULE should be used with caution in patients with kidney problems. Consult your doctor before taking SUTYKINE 12.5 CAPSULE.
LIVER
SUTYKINE 12.5 CAPSULE should be used with caution in patients who have or had liver problems. Consult your doctor before taking SUTYKINE 12.5 CAPSULE.
ALLERGY
Do not take SUTYKINE 12.5 CAPSULE if you are allergic to Sunitinib or any of the other ingredients of SUTYKINE 12.5 CAPSULE.
HEART DISEASE
SUTYKINE 12.5 CAPSULE should be used with caution in patients with heart attack, high blood pressure, abnormal heart rhythm changes and other heart problems. Consult your doctor for advice. Consult your doctor before taking SUTYKINE 12.5 CAPSULE.
OTHERS
Before taking SUTYKINE 12.5 CAPSULE, inform your doctor if you:
- have or had blood disease, bleeding problems or bruising
- recently had blood clots in the veins or arteries
- have or had extension and weakening of a blood vessel wall or a tear in a blood vessel wall
- have or had thrombotic microangiopathy (damage to the smallest blood vessels)
- have thyroid problems
- have or had pancreatic or gallbladder disorders like their inflammation
- are going to have any surgery or recently had an operation
- have or had pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a heavy feeling in the jaw or loosening of a tooth
- have or had skin and subcutaneous tissue disorders
- have or had fits
- have diabetes
Use in pediatrics:
It is not known if SUTYKINE 12.5 CAPSULE is safe and effective for use in children. Consult your child’s doctor for advice.
Use in geriatrics:
SUTYKINE 12.5 CAPSULE should be used with caution in elderly patients (aged 65 years and above) as they might be at higher risk of getting side effects. Consult your doctor before taking SUTYKINE 12.5 CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking SUTYKINE 12.5 CAPSULE, inform your doctor if you are taking any of the following medicines:
- medicines used for fungal infections (Ex. itraconazole, ketoconazole)
- medicines used for bacterial infections (Ex. erythromycin, rifampicin, clarithromycin)
- ritonavir (used to treat HIV)
- dexamethasone (used to treat allergic/breathing disorders or skin diseases)
- medicines used to treat epilepsy and other neurological conditions (Ex. phenytoin, carbamazepine, phenobarbital)
- herbal preparations containing St. John’s Wort (used to treat depression and anxiety)
- medicines used to prevent blood clots (Ex. warfarin, acenocoumarol)
- medicines used to treat osteoporosis (Ex. risedronate, alendronate)
B. Drug-Food interaction:
Do not drink grapefruit juice or eat grapefruit during treatment with SUTYKINE 12.5 CAPSULE.
Overdosage:
If you or anyone else accidentally take too much of SUTYKINE 12.5 CAPSULE, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Sunitinib |
| Pharmacological Category | : | Protein Kinase Inhibitors |
| Therapeutic Indication | : | Gastrointestinal stromal tumor, Metastatic renal cell carcinoma and Pancreatic neuroendocrine tumors |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep SUTYKINE 12.5 CAPSULE out of reach of children
- Store SUTYKINE 12.5 CAPSULE at room temperature
FAQs ABOUT SUTYKINE 12.5 CAPSULE
Is it safe to use SUTYKINE 12.5 CAPSULE in elder people?
SUTYKINE 12.5 CAPSULE should be used with caution in elderly patients (aged 65 years and above) as they might be at higher risk of getting side effects. Consult your doctor before taking SUTYKINE 12.5 CAPSULE.
Can I use SUTYKINE 12.5 CAPSULE if I have heart problems?
SUTYKINE 12.5 CAPSULE should be used with caution in patients with heart attack, high blood pressure, abnormal heart rhythm changes and other heart problems. Consult your doctor for advice. The doctor will determine a proper dose of SUTYKINE 12.5 CAPSULE or select a suitable alternative treatment for you.
Can I take SUTYKINE 12.5 CAPSULE if I have diabetes?
SUTYKINE 12.5 CAPSULE may decrease blood sugar levels. Therefore, if you are a diabetic, you need to be extra careful since blood sugar levels may become so low that you may become unconscious. Keep a regular check on the blood sugar levels, based on which your dose of anti-diabetics may be changed by your doctor.
Can SUTYKINE 12.5 CAPSULE cause any change in blood pressure?
Generally, SUTYKINE 12.5 CAPSULE is known to cause an increase in blood pressure. So, it is important to keep a regular check on blood pressure levels. Inform your doctor if you have severe headaches, dizziness, lightheadedness or a change in vision.
Can I stop taking SUTYKINE 12.5 CAPSULE on my own?
Do not stop taking SUTYKINE 12.5 CAPSULE on your own. You are advised to take SUTYKINE 12.5 CAPSULE for as long as your doctor has prescribed it for you, depending on your medical condition. Do not hesitate to talk to your doctor if you experience any difficulty while taking SUTYKINE 12.5 CAPSULE.
REFERENCES
1. KD. Tripathi. Anticancer Drugs. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 871.
2. Robert J. Motzer, Bernard Escudier, Andrew Gannon and Robert A. Figlin. Sunitinib: Ten Years of Successful Clinical Use and Study in Advanced Renal Cell Carcinoma. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. January 2017 [Accessed on 27th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5313263/
3. Miriam Argyropulo-Palmer, Aaron Jenkins, Davinder Singh Theti, James Larkin and David Montgomery. Sunitinib in Metastatic Renal Cell Carcinoma: A Systematic Review of UK Real World Data. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. August 2015 [Accessed on 27th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4548684/
4. Remedica Limited. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 27th August 2022] https://www.medicines.org.uk/emc/files/pil.13233.pdf
5. Pfizer Laboratories Div Pfizer Inc. Sutent (Sunitinib malate capsule). [Revised in August 2021] [Accessed on 27th August 2022] https://labeling.pfizer.com/showlabeling.aspx?id=607
USEFUL DIAGNOSTIC TESTS
- Complete Blood Count
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