Botrient Tablets 400mg (Pazopanib Hydrochloride)

Adult dose

Administer 800mg orally once daily. Take on an empty stomach (at least 1 hour before or 2 hours after a meal), swallowing whole without crushing or cutting. Renal cell carcinoma: The first dose reduction is to 400mg; any further reduction or increase should be in 200mg increments based on individual tolerability. The dose of this medicine should not exceed 800mg. Soft tissue sarcoma: Dose reduction or increase should be in 200mg increments based on individual tolerability. The dose of this medicine should not exceed 800mg. For patients with mild hepatic impairment (defined as normal bilirubin levels and ALT elevation of any grade, or bilirubin elevation up to 1.5 times the upper limit of normal (direct bilirubin elevation greater than 35%), regardless of ALT levels), an initial dose of 800mg once daily is recommended. For patients with moderate hepatic impairment (defined as bilirubin elevation greater than 1.5 times and up to 3 times the upper limit of normal, regardless of ALT levels), a reduced dose of 200mg once daily is recommended. There are no clinical data in patients with severe hepatic impairment (defined as total bilirubin elevated to more than 3 times the upper limit of normal (ULN), regardless of ALT levels). Therefore, this medicine is not recommended for these patients.

This medication can cause serious harm to the fetus if taken during pregnancy. It may specifically affect the process of blood vessel formation and pose a risk of reproductive system abnormalities or malformations in the fetus, so women who are pregnant or may become pregnant should not take this medication and must use appropriate contraception during treatment. It may affect liver function, so regular liver function tests should be conducted while taking this medication. If severe liver dysfunction occurs, treatment with this medication should be discontinued or the dosage adjusted, and it is not recommended for patients with severe liver impairment. Patients with a known allergy to this medication should not take it, and those with poor liver function or suspected cardiac rhythm abnormalities (QT interval prolongation) should use it cautiously. Common side effects when taking this medication include diarrhea, hypertension, nausea, vomiting, fatigue, hair discoloration, among others, and serious side effects such as hepatotoxicity, cardiac dysfunction, bleeding, thrombosis, and hypothyroidism may also occur. If any unusual symptoms occur, seek medical advice immediately. This medication may interact with other drugs, especially inhibitors or inducers of CYP3A4, P-gp, and BCRP, and grapefruit juice should be avoided. Additionally, combining it with simvastatin may increase the risk of liver damage. The absorption of this medication increases when taken with food, so it is recommended to take it at least 1 hour before or 2 hours after meals. The safety of this medication has not been established in breastfeeding women, so it is recommended to discontinue breastfeeding while taking this medication. It is not recommended for use in children and adolescents under 18 years of age, especially not in children under 24 months. For elderly patients, special dosage adjustments are not required, but liver function and cardiac status should be monitored closely. In case of overdose, there is no specific antidote; general supportive care should be implemented, and it is not removed by hemodialysis. This medication may interfere with wound healing; therefore, it should be discontinued at least 7 days prior to any planned surgery and resumed only after the surgical site has healed well. Blood pressure should be monitored frequently during treatment, and antihypertensive medication may be used as needed or the dosage of this medication may be adjusted, and if blood pressure rises severely or is uncontrolled, treatment should be discontinued. There may be an increased risk of bleeding while taking this medication, so patients with recent bleeding history should be cautious and report any bleeding symptoms to their healthcare professional immediately. Serious side effects such as cardiac dysfunction, thrombosis, pneumonia, hepatotoxicity, and gastrointestinal perforation have been reported, so if any of these symptoms are suspected, seek medical care immediately. Women planning to become pregnant and their partners must practice strict contraception during and for a period after treatment with this medication.

Diarrhea, hypertension, hair discoloration, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain, headache, hair loss, chest pain, taste disorder, indigestion, facial edema, hand-foot syndrome, proteinuria, rash, skin depigmentation, weight loss, voice disorder, heart dysfunction, ischemic stroke, gastrointestinal perforation, gastrointestinal fistula, gastrointestinal bleeding, venous thromboembolism, liver dysfunction, hyperbilirubinemia, bradycardia, elevated ALT, elevated AST, neutropenia, thrombocytopenia, elevated lipase, clinical pancreatitis, tumor pain, hypothyroidism, decreased appetite, dizziness, headache, insomnia, cardiac dysfunction, bradycardia, myocardial infarction, hypertension, venous embolism, cough, voice disorder, dyspnea, pneumothorax, nausea, stomatitis, alopecia, dry skin, exfoliative rash, hair color change, nail disorders, hand-foot palm erythema paresthesia syndrome, rash, skin hypopigmentation, musculoskeletal pain, myalgia, proteinuria, hematuria, blurred vision, weakness, chest pain, chills, fatigue, peripheral edema, weight loss, QT prolongation on ECG, increased alanine aminotransferase, increased aspartate aminotransferase, infection, tumor lysis syndrome, erythrocytosis, thrombotic microangiopathy, reversible posterior leukoencephalopathy syndrome, retinal detachment, retinal tear, interstitial lung disease, pneumonia, abdominal distension, pancreatitis, liver failure, arthralgia, muscle cramps, aneurysm, arterial dissection, skin ulcer, increased gamma-glutamyl transferase, constipation, mucositis, pain, edema, fever, pruritus, oropharyngeal pain, rhinorrhea, oropharyngeal discomfort, dysuria, insomnia, peptic ulcer, ascites, dysphagia, dry mouth, rectal pain, toothache, anal inflammation, cheilitis, stool discoloration, retroperitoneal edema, frequent bowel movements, inguinal hernia, duodenal ulcer, gastroesophageal reflux disease, gum pain, tooth mobility, tongue cyst, tongue pain, generalized edema, mass, axillary pain, localized edema, gait disturbance, implant site inflammation, mucosal vesicles, leukocytosis, reduced red blood cell count, decreased hematocrit, increased serum triglycerides, increased serum cholesterol, increased low-density lipoprotein, increased neutrophil count, increased urine protein/creatinine ratio, increased thyroid hormone, increased lymphocyte count, positive urinary leukocytes, increased red blood cell distribution width, weight gain, decreased total protein, increased total protein, prolonged prothrombin time, decreased serum ALKP, decreased serum chloride, decreased serum uric acid, increased serum insulin, increased serum calcium, increased eosinophil count, prolonged activated partial thromboplastin time, hypercalcemia, hypoalbuminemia, hyperphosphatemia, hypercholesterolemia, hypokalemia, hyperuricemia, hyperlipidemia, diabetes mellitus, metabolic acidosis, dehydration, gout, acquired mixed hyperlipidemia, pressure ulcer, dermatitis, skin erosion, urticaria, vesicles, hyperkeratosis, psoriasis, exfoliative dermatitis, macules, seborrheic dermatitis, skin lesions, erythema, hiccups, pulmonary cyst, pleural pain, osteopenia, osteoporosis, pathological fractures, muscle wasting, limb discomfort, chondropathy, sensory disturbances, peripheral neuropathy, sensory impairment, decreased sensation, seizures, syncope, senile dementia, brain edema, loss of taste, focal seizures, neuropathy, aphasia, facial spasm, movement disorders, drowsiness, cubital tunnel syndrome, tremors, concentration difficulties, dementia, incomplete paralysis of the lower body, hypotension, aortic dissection, atherosclerosis, shock, facial flushing, pallor, hematoma, pelvic pain, erectile dysfunction, benign prostatic hyperplasia, gynecomastia, penile pain, scrotal ulcer, scrotal pain, prostate disorder, jaundice, dry eye, increased tear secretion, adrenal insufficiency, hyperthyroidism, ear discomfort, tinnitus, ear impairment, vestibular disorders, dizziness, cardiac hypertrophy, contrast agent allergy, device malfunction

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White oblong film-coated tablet

Package unit

30 tablets (30 tablets per bottle x 1)