藥品新增

<17T328> Triptorelin pamoate(Pamorelin®) (22.5mg).針

新藥介紹

<17T328> Triptorelin pamoate(Pamorelin®) (22.5mg).針

藥理作用/作用機轉

Triptorelin is an agonist analog of GnRH and causes suppression of ovarian and testicular steroidogenesis due to decreased levels of LH and FSH with subsequent decrease in testosterone (male) and estrogen (female) levels. After chronic and continuous administration, usually 2 to 4 weeks after initiation, a sustained decrease in LH and FSH secretion occurs. When used for assisted reproductive technologies (ART), prevents premature LH surge in women undergoing controlled ovarian hyperstimulation.

適應症/

劑量

IM

【Adult】

　●Prostate cancer, advanced: 22.5 mg once every 24 weeks.

【Pediatric】Children ≥2 years

　●Central precocious puberty: 22.5 mg once every 24 weeks; discontinue therapy at appropriate age of onset of puberty.

『Renal Impairment』

No dosage adjustment necessary

『Hepatic Impairment』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to triptorelin or any component of the formulation, other gonadotropin-releasing hormone (GnRH) agonists or GnRH; pregnancy.

警告/預防

Cardiovascular effects, decreased bone density, hypersensitivity reactions, metabolic syndrome, ovarian hyperstimulation syndrome, pituitary apoplexy, pseudotumor cerebri, psychiatric effects, seizures, spinal cord compression, symptom flare

不良反應

For children and adolescents:

【>10%】Erythema/pain at injection site, headache, nasopharyngitis

【1% to 10%】 Hot flash, menstruation, gastroenteritis, influenza, injection-site pruritus, swelling at injection site, anxiety, mood changes, otitis externa, bronchitis, cough, pharyngitis, sinusitis, URTI

For adults:

【>10%】Hot flash ,↑serum glucose,↑serum AST/ALT,↑serum transaminases, skeletal pain,↑blood urea nitrogen

【1% to 10%】Chest pain, dependent edema, hypertension, lower extremity edema, peripheral edema, pruritus, skin rash,↓libido, gynecomastia, abdominal pain, anorexia, constipation , diarrhea, dyspepsia, nausea, vomiting, dysuria, erectile dysfunction, mastalgia, testicular atrophy, urinary retention, UTI, anemia, hepatic impairment,↑serum alkaline phosphatase, pain at injection site, asthenia, dizziness, emotional lability, fatigue, headache, insomnia, pain, arthralgia, back pain, lower extremity pain, lower limb cramp, myalgia, conjunctivitis , eye pain, cough, dyspnea, pharyngitis

懷孕用藥分級(FDA)

X / 致畸胎性

健保規範

l 藥品說明：理由二:限兒科內分泌學次專科、兒科醫學遺傳學及新陳代謝學次專

科醫師或新陳代謝專科醫師。

l 藥品理由：

01)前列腺癌患者

02)(需專審)中樞性早熟

其他

核對用法:IM 注射部位:臀部

每 24週注射1劑。

以2ml無菌注射用水進行配製。

配製後應立即使用，且不可保存超過24小時。

孕婦/哺乳婦禁用