英文药名：Triptodur(Triptorelin for Extended-release Injectable Suspension)
中文药名：曲普瑞林缓释注射悬浮液
生产厂家：Arbor制药
药品简介
Triptodur (triptorelin曲普瑞林)是一种促性腺激素释放激素（GnRH）激动剂，适用于治疗儿童中枢性性早熟（CPP）。
Triptodur是首个在美国获批用于治疗CPP、每六个月注射一次的GnRH药物。在一次三期临床试验中，Triptodur在93%的受试者上展现了回复青春期前促黄体激素（LH）水平的作用。这其中，98%受试者身上的LH抑制效果可以达到12个月。
“早熟对于孩子来说会产生明显的生理及心理影响，包括成年后身高较矮、社会、心理和情绪影响，”加利福尼亚大学San Diego and Rady儿童医院儿科内分泌学专家Karen Klein博士表示。“经过合理治疗，CPP儿童的荷尔蒙水平将回归正常，其早熟特征的发展也会放缓到适当年龄。”
Triptodur由Debiopharm研发，Debiopharm Research & Manufacturing SA负责其在瑞士的生产工作
Triptodur (Triptorelin for Extended-release Injectable Suspension)
TRIPTODUR Rx
Generic Name and Formulations:
Triptorelin pamoate 22.5mg; lyophilized microgranules for ext-rel IM inj after reconstitution; contains mannitol.
Company:
Arbor Pharmaceuticals, LLC
Indications for TRIPTODUR:
Treatment of central precocious puberty.
Adult:
Not applicable.
Children:
<2yrs: not established. Give as IM inj in buttock or thigh. ≥2yrs: 22.5mg once every 24 weeks. Discontinue at appropriate time point for onset of puberty. Consider switching to alternative GnRH agonist if Triptodur dose is inadequate.
Contraindications:
Pregnancy.
Warnings/Precautions:
Use aseptic technique. Must administer under physician supervision. Initial transient rise in gonadotropins and sex steroids may result in increased signs/symptoms of puberty. Monitor LH and sex steroid levels at 1–2 months after treatment initiation, during, and with each subsequent dose. Assess height every 3–6 months and bone age periodically. Monitor for psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Renal or hepatic impairment. Discontinue if overdosage occurs. Nursing mothers.
Interactions:
Concomitant hyperprolactinemic drugs: not recommended. Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs). May interfere with pituitary gonadotropic and gonadal function tests.
Pharmacological Class:
GnRH agonist.
Adverse Reactions:
Inj site reactions, menstrual bleeding, hot flush, headache, cough, infections (eg, bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, upper respiratory tract infection); psychiatric events, convulsions.
Generic Availability:
NO
How Supplied:
Single-use kit—1