国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TRIPTORELIN PAMOATE (UNII: 08AN7WA2G0) (TRIPTORELIN - UNII:9081Y98W2V)
Allergan, Inc.
TRIPTORELIN PAMOATE
TRIPTORELIN 3.75 mg in 2 mL
PRESCRIPTION DRUG
TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical Studies (14) ]. 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) ]. 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 potential risk to the fetus. Dat
TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5. TRELSTAR 3.75 mg –NDC 0023-5902-04 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery system) TRELSTAR 11.25 mg –NDC 0023-5904-12 (TRELSTAR 11.25 mg with MIXJECT single-dose delivery system) TRELSTAR 22.5 mg –NDC 0023-5906-23 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery system) Storage Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Do not freeze TRELSTAR with MIXJECT.
New Drug Application
TRELSTAR- TRIPTORELIN PAMOATE ALLERGAN, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRELSTAR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRELSTAR. TRELSTAR (TRIPTORELIN PAMOATE FOR INJECTABLE SUSPENSION), FOR INTRAMUSCULAR USE INITIAL U.S. APPROVAL: 2000 RECENT MAJOR CHANGES Warnings and Precautions, Embryo-Fetal Toxicity (5.9) 12/2018 INDICATIONS AND USAGE TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer. (1) DOSAGE AND ADMINISTRATION TRELSTAR is administered as a single intramuscular injection in either buttock. Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule. (2.1) 3.75 mg every 4 weeks. (2.1) 11.25 mg every 12 weeks. (2.1) 22.5 mg every 24 weeks. (2.1) DOSAGE FORMS AND STRENGTHS Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg. (3) CONTRAINDICATIONS Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH. (4) WARNINGS AND PRECAUTIONS 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 and 5.3) Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits. (5.4) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. (5.5) Cardiovascular Diseases: Increased risk of myocardial infarction, sudd 阅读完整的文件