藥品新增

<17S226> Somatrogon(Ngenla®) (60mg/1.2ml).pen.自費

新藥介紹

<17S226> Somatrogon(Ngenla®) (60mg/1.2ml).pen.自費

藥理作用/作用機轉

Somatrogon is a glycoprotein of recombinant DNA origin; it contains the sequence of amino acids with one copy of the C-terminal peptide found in human growth hormone. Somatrogon binds to the growth hormone receptor initiating changes in growth and metabolism and has also been shown to increase insulin-like growth factor serum concentrations.

適應症/

劑量

SC

【Pediatric】Children 3-11 years

Growth hormone deficiency (GHD): 0.66 mg/kg/dose QW; individualize dose based on growth velocity, body weight, and insulin-like growth factor-1 (IGF-1); treat with the lowest effective dose. Discontinue treatment if there is evidence of epiphysial growth plate closure.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to Ngenla ; acute critical illness after open heart/abdominal surgery, multiple accidental trauma, or acute respiratory failure; closed epiphyses; active malignancy; diabetic retinopathy; Prader-Willi syndrome with severe obesity, severe respiratory impairment, history of upper airway obstruction/sleep apnea.

警告/預防

Fluid retention, Glucose intolerance, Hypersensitivity, Intracranial hypertension, Lipoatrophy, Neoplasm, Pancreatitis, Slipped capital femoral epiphyses

不良反應

【>10%】Eosinophilia, antibody development, injection-site reaction, headache, nasopharyngitis, fever

【1% to 10%】 Skin rash, hypothyroidism, abdominal pain, vomiting, anemia, arthralgia, bronchitis, cough, oropharyngeal pain

懷孕用藥分級(FDA)

B /可能安全

健保規範

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  • 藥品理由：

 

其他

核對用法: SC 注射部位: 腹部、大腿、臀部或上臂

>30mg請分兩次施打

使用期間請冷藏保存

可在32°C以下保存最長4小時後回冰

最多可回冰5次

開封後可用28天