Abiraterone

[otw_shortcode_tabslayout tabs=”9″ tab_1_title=”Overview” tab_1_content=”Abiraterone in combination with prednisone or prednisolone for the treatment of metastatic debulk-resistant prostate cancer (mCRPC), newly diagnosed high-risk metastatic treatment-sensitive prostate cancer (mHSPC), including those that have not received endocrine therapy or have received endocrine therapy for up to 5 months.” tab_2_title=”Indications” tab_2_content=”This product is used in combination with prednisone for the treatment of metastatic debulk-resistant prostate cancer (mCRPC).” tab_3_title=”Dosage” tab_3_content=”Abiraterone Acetate Tablets is a prescription drug. The recommended dose is 1000 mg orally once daily, in combination with prednisone 5 mg orally twice daily. This product should be taken on an empty stomach. No food should be taken at least 2 hours before and 1 hour after taking this product. This product should be swallowed whole with water. Do not break or chew. For patients with hepatic impairment:: No dose adjustment is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, the recommended dose of this product should be reduced to 250 mg once daily. For patients with renal impairment: No dose adjustment is required for patients with renal impairment. However, there is no clinical experience in patients with prostate cancer with severe renal impairment. Caution is advised in such patients. There is limited experience with overdose of this product. There is no specific antidote for this product. In the event of an overdose event, you should discontinue this product and go to the hospital, where your doctor may take comprehensive supportive measures, including monitoring for arrhythmias, heart failure, and evaluation of liver function.” tab_4_title=”Precautions” tab_4_content=”1. This product may cause hypertension, hypokalemia, and fluid retention because it causes elevated levels of salt corticosteroids. Combining with corticosteroids may inhibit adrenocorticotropic hormone (ACTH), thereby reducing the incidence and severity of these adverse reactions. You should use this product with caution if you have underlying medical conditions that may be exacerbated by increased blood pressure, hypokalemia and fluid retention, such as heart failure, recent myocardial infarction or ventricular arrhythmia. This product should also be used with caution in patients with a history of cardiovascular disease. You should control hypertension and correct hypokalemia before and during treatment with this product. During treatment, you should monitor your blood pressure, potassium, fluid retention (weight gain, peripheral edema) and other signs and symptoms of congestive heart failure every 2 weeks for the first 3 months and monthly thereafter. If clinically significant deterioration of cardiac function occurs, discontinuation of this product should be considered. Adrenocortical insufficiency: Adrenocortical insufficiency has been reported in patients receiving this drug in combination with prednisone when daily steroids are discontinued and/or in the presence of infection or stress. You should monitor for signs and symptoms of adrenocortical insufficiency and use this product with caution, especially in patients who have discontinued prednisone, had their prednisone dose reduced, or are experiencing abnormal stress. Adverse reactions associated with salt corticosteroid overdose due to this treatment may mask the signs and symptoms of adrenocortical insufficiency. Perform appropriate tests as clinically indicated to confirm the diagnosis of adrenocortical insufficiency. Corticosteroid doses may have to be increased before, during and after stressful situations. 3. Hepatotoxicity: You should monitor serum transaminases (ALT and AST) and bilirubin levels prior to initiation of therapy, every 2 weeks for the first 3 months after initiation of therapy, and monthly thereafter. For patients receiving a low dose of 250 mg for moderate hepatic impairment at baseline, monitor ALT, AST and bilirubin levels prior to initiation of therapy, once weekly for the first month of therapy, once every 2 weeks for the next 2 months, and once monthly thereafter. Serum total bilirubin, AST and ALT levels should be monitored promptly if clinical signs or symptoms suggestive of hepatotoxicity are present. If AST, ALT or bilirubin are elevated from baseline values, the frequency of monitoring should be increased. Once AST or ALT rises above 5×ULN or bilirubin rises above 3×ULN, the product should be temporarily discontinued and liver function should be closely monitored. Reintroduce treatment at a low dose level only after liver function tests have returned to your baseline level or after AST and ALT are ≤ 2.5 x ULN and total bilirubin is ≤ 1.5 x ULN. If you are still unsure about the dose adjustment for impaired liver function, we recommend that you seek medical advice. 4. Food may increase exposure: This product should be taken on an empty stomach. Fast for at least 2 hours before and 1 hour after dosing. A single dose of abiraterone with a meal increases the exposure to the drug in the body by tens of times compared to a single dose taken on an empty stomach. The safety of the increased exposure resulting from multiple concomitant doses with food has not been evaluated. 5. Bone Density: Patients with advanced metastatic prostate cancer (desmoresistant prostate cancer) may experience decreased bone density. This effect may be enhanced by the combination of this product with glucocorticoids. 6. Patients with prostate cancer previously treated with ketoconazole may have a lower remission rate. 7. The use of glucocorticoids increases the risk of hyperglycemia and therefore blood glucose should be measured frequently in patients with diabetes. 8. Several myopathic events have been reported in patients treated with this product. Some patients developed rhabdomyolysis accompanied by renal failure. Most cases occurred within the first month of the treatment period and recovered after discontinuation of the product. This product should be used with caution in patients treated with a combination of drugs known to be associated with myopathy/rhabdomyolysis. 9. The safety and efficacy of this product in combination with cytotoxic chemotherapy have not been established. 10. This product contains lactose. Patients with rare genetic problems such as galactose intolerance, Lapp (Lapp) lactase deficiency or glucose-galactose absorption disorder should not take this product. This product also contains sodium in excess of 1 mmol (or 27.2 mg) per 4-tablet dose. Patients with restricted sodium intake should be considered. 11. Other Potential Risks: Men with metastatic desmoid-resistant prostate cancer (including those being treated with this product) may be at risk for anemia and sexual dysfunction. Please keep out of the reach of children.” tab_5_title=”Contraindications” tab_5_content=”1. Contraindicated in persons with hypersensitivity reactions to the active ingredient or excipients of this product. 2. Contraindicated in women who are pregnant or at risk of pregnancy. 3. contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).” tab_6_title=”Adverse Reactions” tab_6_content=”In the course of using a drug, in addition to treating your disease, the drug may also cause you some discomfort, which is an adverse drug reaction. All drugs have adverse reactions, but they do not happen to everyone. Some of the adverse reactions may disappear in the course of drug use. When you encounter adverse reactions that affect your life, you should promptly communicate with your doctor and pharmacist. 1. Common: The most common are weekly edema, hypokalemia, hypertension, and urinary tract infections. Other important adverse reactions include cardiac disorders, hepatotoxicity, fractures and allergic alveolitis. 2. Due to the pharmacokinetic effects caused by the mechanism of action, this product may cause hypertension, hypokalemia, and fluid retention. Usually, adverse reactions to salt corticosteroids can be effectively controlled after treatment. The incidence and severity of these adverse drug reactions can be reduced with the combination of corticosteroids. Other precautions can be found.” tab_7_title=”Interactions” tab_7_content=”If you are taking other drugs at the same time, tell your doctor and take them as directed by your doctor. 1. CYP3A4 enzyme inhibitors or inducers in; Because this product is a substrate for CYP3A4, strong CYP3A4 inducers should be avoided during treatment with this product. If strong CYP3A4 inducers must be combined, the frequency of administration of this product needs to be increased, and you can consult your doctor or pharmacist for the specific dosage. 2. Effects of abiraterone on drug metabolizing enzymes: This product is an inhibitor of CYP2D6. Avoid combining this product with CYP2D6 substrates that have a narrow therapeutic window (e.g., thioridazine). If no other therapy is available, use with caution and consider lowering the dose of the combined CYP2D6 substrate; you may consult your doctor or pharmacist for the exact dosage. 3. This product inhibited CYP2C8 in in vitro studies and no clinically meaningful increase in exposure is expected when this product is used in combination with drugs that rely primarily on CYP2C8 elimination, but the manifestation of toxicity of CYP2C8 substrates with a narrow therapeutic index should be monitored when the two are combined.” tab_8_title=”Special Populations” tab_8_content=”Pregnant/Nursing Elderly Infants ” tab_9_title=”Other” tab_9_content=”Drug properties Abiraterone acetate tablets: white or off-white tablets. Common Specifications Abiraterone Acetate Tablets: 250 mg. Reference Price $20.00 – $98.33 Storage Between 15-30°C.”] [/otw_shortcode_tabslayout]