트립토렐린아세트산염

is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )

Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH. ( 4 ) 4.1 Hypersensitivity TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH [ see Warnings and Precautions (5.1) ].

Hypersensitivity: Anaphylactic shock, hypersensitivity, and angioedema have been reported. In the event of a reaction, discontinue TRELSTAR and initiate appropriate medical management. ( 5.1 ) Tumor Flare: Transient increase in serum testosterone levels can occur within the first few weeks of treatment. This may worsen prostate cancer and result in spinal cord compression and urinary tract obstruction. Monitor patients at risk and manage as appropriate. ( 5.2 ) Metabolic Syndrome: The use of GnRH agonists may lead to an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease. Monitor for signs and symptoms of metabolic syndrome including lipids, blood glucose level and/or HbA1c and manage according to institutional guidelines. ( 5.3 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in men. Monitor for cardiovascular disease and manage according to current clinical practice. ( 5.4 ) Convulsions: Convulsions have occurred in patients treated with GnRH analogs (including TRELSTAR) with or without a history of predisposing factors. Manage patients who experience convulsions according to institutional guidelines. ( 5.5 ) Severe Cutaneous Adverse Reactions (SCARs): SCARs have been reported in patients receiving GnRH agonists, including triptorelin products. Interrupt TRELSTAR if signs or symptoms of SCARs develop. Permanently discontinue TRELSTAR …

8.1 Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, TRELSTAR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Expected hormonal changes that occur with TRELSTAR treatment increase the risk for pregnancy loss. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the …