Sutent Capsule 12.5 mg (Sunitinib Malate)

Adult dose

This drug should be administered under the supervision of a physician experienced in the use of anticancer agents. 1. Gastrointestinal stromal tumors and advanced renal cell carcinoma The recommended dose of this drug is 50 mg orally once daily for 4 weeks, followed by a 2-week rest period. Repeat treatment in 6-week cycles. This drug may be administered with or without food. 2. Adjuvant treatment after surgery for renal cell carcinoma The recommended dose of this drug as adjuvant treatment after surgery for renal cell carcinoma is 50 mg orally once daily for 4 weeks, followed by a 2-week rest period (4 weeks on treatment/2 weeks off treatment). Administer for 9 cycles of 6 weeks each. This drug may be administered with or without food. 3. Pancreatic neuroendocrine tumors Administer 37.5 mg once daily without a rest period. This drug may be administered with or without food. 4. Dosage and administration adjustments 1) Based on the safety and tolerability of each individual patient, dose increases or decreases in increments of 12.5 mg are recommended. For gastrointestinal stromal tumors and renal cell carcinoma, dose increases up to 87.5 mg or decreases to a minimum of 25 mg are recommended. In clinical trials of adjuvant treatment after surgery for renal cell carcinoma, the minimum dose administered was 37.5 mg. 2) Potent CYP3A4 inhibitors such as ketoconazole may increase the plasma concentration of this drug. If substituting another concomitant medication, consider switching to a medication with no or minimal potential for enzyme inhibition. If this drug must be administered concomitantly with a potent CYP3A4 inhibitor, consider reducing the dose of this drug to a minimum of 37.5 mg daily (gastrointestinal stromal tumors and advanced renal cell carcinoma) or 25 mg (pancreatic neuroendocrine tumors). 3) Potent CYP3A4 inducers such as rifampin may decrease the plasma concentration of this drug. If substituting another concomitant medication, consider switching to a medication with no or minimal potential for enzyme induction. If this drug must be administered concomitantly with a potent CYP3A4 inducer, consider increasing the dose of this drug to a maximum of 87.5 mg daily (gastrointestinal stromal tumors and advanced renal cell carcinoma) or 62.5 mg (pancreatic neuroendocrine tumors). If the dose is increased, carefully monitor the patient for potential toxicity. St. John's wort may decrease the plasma concentration of this drug to an unpredictable extent. Patients receiving this drug should not take St. John's wort concomitantly. 4) Temporary interruption of treatment may be necessary based on the safety and tolerability of each individual patient.

This drug may hinder normal vascular development in the fetus when used during pregnancy, increasing the risk of serious abnormalities. Therefore, women who are pregnant or may become pregnant should not take this drug and must use effective contraception during treatment. Patients with an allergic reaction or hypersensitivity to this medication should not use it. This drug can cause various side effects, with the most serious including pulmonary embolism, thrombocytopenia, tumor bleeding, high fever, neutropenia, hypertension, hepatic failure, and cardiac arrhythmias. The most common side effects include fatigue, diarrhea, nausea, stomatitis, dyspepsia, vomiting, abdominal pain, constipation, skin discoloration, rash, altered sensations in hands and feet, dry skin, hair color changes, taste alterations, loss of appetite, hypertension, and bleeding. Regular blood tests should be conducted during treatment to monitor blood cell counts and liver function, and appropriate treatment should be sought if hypertension occurs. Additionally, this drug can cause changes in skin and hair color, which should be communicated to patients. Severe skin adverse reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so if there are any blisters, severe rashes, or mucosal damage, you must stop taking the drug immediately and go to the hospital. This drug can increase the risk of bleeding, so if symptoms of bleeding appear such as nosebleeds, gum bleeding, bloody stools, or hemoptysis, inform healthcare personnel immediately. There may be signs of decreased heart function or heart failure, so patients with a history of heart disease or symptoms should be carefully monitored and adjust medication dosage if necessary. This drug can increase the risk of thrombosis and pulmonary embolism, so if there is leg pain or swelling, or sudden shortness of breath, you should go to the hospital immediately. Patients undergoing major surgery are advised to temporarily discontinue use of this drug before and after the surgery. Because there is a risk of osteonecrosis of the jaw, caution is advised when taking bisphosphonates or undergoing invasive dental treatments. There is also a risk of pancreatitis, liver function abnormalities, seizures, adrenal insufficiency, and hypoglycemia during treatment, so consult healthcare personnel if any unusual symptoms occur. Moreover, this drug has many drug interactions, so all medications and supplements being taken should be communicated to the doctor, especially caution is needed when combining with drugs that inhibit or induce CYP3A4 enzymes. Women who are pregnant or breastfeeding should not take this drug, and breastfeeding should be discontinued if breastfeeding. Safety has not been established for children, so this medication is not for use in pediatric patients.

Pulmonary embolism, thrombocytopenia, tumor bleeding, febrile neutropenia, hypertension, liver failure, torsades de pointes, fatigue, diarrhea, nausea, stomatitis, dyspepsia, vomiting, abdominal pain, constipation, skin discoloration, rash, erythema multiforme of the hands and feet, dry skin, hair discoloration, mucosal inflammation, asthenia, dysgeusia, anorexia, bleeding, anemia, neutropenia, hypothyroidism, deep vein thrombosis, epistaxis, pleural effusion, chromaturia, oral pain, tongue pain, dry mouth, gastroesophageal reflux disease, limb pain, arthralgia, myalgia, edema, decreased hemoglobin, increased serum creatine phosphokinase, decreased cardiac output, increased lipase, decreased platelet count, leukopenia, periorbital edema, increased tearing, dehydration, dizziness, sensory abnormalities, dyspnea, abdominal distension, erythema, alopecia, exfoliative dermatitis, vesicles, insomnia, depression, sore throat, weight loss, increased blood amylase, decreased WBC, eyelid edema, aphthous stomatitis, gum bleeding, nail abnormalities, jaundice, fever, chills, influenza-like symptoms, abnormal cardiac output, increased blood amylase, heart failure, congestive heart failure, QT interval prolongation, hyperthyroidism, gastrointestinal perforation, esophagitis, colitis, ischemic colitis, pancreatitis, cholecystitis, seizures, reversible posterior leukoencephalopathy syndrome, adrenal dysfunction, venous thromboembolism, impaired wound healing, jaw necrosis, tumor lysis syndrome, necrotizing fasciitis, thrombotic microangiopathy, proteinuria, hypoglycemia, angioedema, severe infection, pneumonia, bronchitis, urinary tract infection, skin infection, sepsis, abscess, myopathy, rhabdomyolysis, fistula formation, ageusia, hyperammonemic encephalopathy, cardiomyopathy, myocardial ischemia, myocardial infarction, renal impairment, renal failure, nephrotic syndrome, arterial thromboembolism, cerebrovascular accident, transient ischemic attack, cerebral infarction, aneurysm, aortic dissection, necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome, liver dysfunction, thyroiditis, angioedema, thrombotic thrombocytopenic purpura, thromboembolism, pleural effusion, hiccups, peritonitis, hyponatremia, hyperkalemia, ascites, pharyngitis, azotemia, chest pain, cough, pain, gingivitis, expectoration disorder, increased alkaline phosphatase, gastritis, melena, hematuria, weight gain, toothache, rhinitis, malnutrition, oral bleeding, cheilitis, tinnitus, voice disorders, purpura, urinary abnormalities, neuropathy, hypoalbuminemia, dysuria, acne, hyperglycemia, muscle weakness, tinnitus, voice disorders, deterioration of condition, visual disturbances, neuropathy, malignant hyperthermia, dysphagia, hemorrhoids, retrosternal pain, hypophosphatemia, drowsiness, tremors, colitis, menstrual disorders, hypoalbuminemia, hypocalcemia, hypoglycemia, hearing loss, dermatitis, urinary disorders, pigmentary disorder, gynecomastia, dysphagia, gastric ulcer, increased lactate dehydrogenase, herpes zoster, increased bowel movements, hyperkeratosis, thirst, sensory impairment, sensory reduction, exacerbation of hyperthyroidism, infection with tuberculosis bacteria, hypercalcemia, exacerbation of hypertension, testicular disease, skeletal pain, exacerbation of arthritis, hearing impairment, pustular rash, simplex herpes, cholelithiasis, diabetes, palpitations, urticaria, sweat gland disease, lymphadenopathy, unspecified bleeding, folliculitis, agranulocytosis, amenorrhea, vesicular rash, ascites, sinusitis, furuncle, wart, unspecified ear disease, unspecified leukocyte anomaly, genital edema, bradycardia, delirium, decreased urine output, peptic ulcer, deep venous thrombosis, cardiac effusion, cardiac hypertrophy, malignant hyperthermia, dry eye syndrome, ocular abnormalities, urethral disorders, pressure ulcers, intestinal obstruction, excessive sneezing, hypoalbuminemia, mental deficiency, drowsiness, proctitis, periodontal destruction, hematemesis, septic shock, skin irritation, oliguria, anal disorders

This medication should be kept tightly closed in a container to prevent air or moisture from entering, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a long time.

Appearance

Hard capsule containing granules that are yellow to orange in color, with an orange-colored upper and lower part.

Package unit

28 capsules per bottle