Information on OMNITROPE

Indications and safety information
Omnitrope is a recombinant human growth hormone indicated for the treatment of children with growth failure due to growth hormone deficiency (GHD) and for the treatment of adults with either adult onset or childhood onset GHD.

Somatropin should not be used for patients with acute critical illness. Somatropin should not be used for children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients. Somatropin should not be used for patients with active malignancy. Somatropin should not be used for patients with active proliferative or severe non-proliferative diabetic retinopathy. Somatropin should not be used for children with closed epiphyses.
Somatropin should not be used for patients with known hypersensitivity to somatropin or excipients. Formulations containing benzyl alcohol (5 mg/1.5 mL Omnitrope Cartridges and the Bacteriostatic Water for Injection diluent for the 5.8 mg/vial Omnitrope) should not be used in premature babies or neonates.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against potential risk.

Patients with preexisting tumors or GHD secondary to an intracranial lesion should be monitored routinely for progression or recurrence of the underlying disease process.
Impaired Glucose Tolerance and Diabetes Mellitus may be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment.
Intracranial Hypertension may develop and is usually reversible after discontinuation or dose reduction. Exclude preexisting papilledema.

Fluid retention (i.e., edema, arthralgia, carpal tunnel syndrome, especially in adults) may occur frequently. Reduce dose as necessary.
Hypothyroidism may first become evident or worsen during somatropin treatment.
Slipped Capital Femoral Epiphysis may develop.
Evaluate children with the onset of a limp or hip/knee pain.
Progression of preexisting Scoliosis may develop.

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy and headaches. The following events were observed during clinical studies with Omnitrope conducted in children with GHD: hypothyroidism, elevated HgbA1c, eosinophilia, hemotoma, headache, hypertriglyceridemia and leg pain.
In clinical trials with somatropin on GHD adults, the majority of the adverse events consisted of mild to moderate symptoms of fluid retention, including peripheral swelling, arthralgia, pain and stiffness of the extremities, peripheral edema, myalgia, paresthesia and hypoesthesia.

Somatropin inhibits 11ßhydroxysteroid dehydrogenase type I and may require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid for previously diagnosed hypoadrenalism may require an increase in their maintenance doses. Glucocorticoid replacement should be carefully adjusted.
Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes.
In adult women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.
In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral agent may require adjustment when somatropin therapy is initiated.

OMNITROPE

[通用药名]基因重组人生长激素　
[药品成分]本品是由191个氨基酸残基或N端有一甲硫氨酸的192个氨基酸残基组成的蛋白。　
[作用与用途]本品具有与人体生长激素同等的作用，即能促进骨骼、内脏和全身生长，促进蛋白质合成，影响脂肪和矿物质代谢，在人体生长发育中起着关键性作用。皮下注射约80％被吸收，5小时后达高峰血浓度，t1/2约4小时。主要用于内源性脑垂体生长激素分泌不足而引起的生长障碍、躯体矮小的侏儒症、短小病患儿。此外，尚可用于治疗烧伤、骨折、创伤、出血性溃疡、组织坏死、肌肉萎缩症、骨质疏松等疾病。
[用法与用量]本品给药剂量个体差异很大，采用肌内注射或皮下注射，一般用量为每周0．5—0．7单位／kg或每周12单位／m2，分6—7次给药。
[注意事项]偶可引进皮肤过敏、注射部位发红和皮下脂肪萎缩、氨基转移酶升高、呕吐及腹痛等。
1．肿瘤患者、糖尿病患者、颅内进行性损伤者禁用。
2. 对脑肿瘤的垂体抹儒病者、心脏或肾脏病者、孕妇和哺乳妇女等慎用。
3．使用前，需对脑垂体功能作详细检查，准确诊断后才能应用。
4．应临用时配制，用注射用水溶解，轻轻摇动，切勿振荡，以免变性。