重组生长激素注射剂 SOMATROPIN 商标名：HUMATROPE 儿童生长激素缺陷症新药，美国新药，一次性进口，平价供应。
英文名：SOMATROPIN
商标名：HUMATROPE
中文名：重组生长激素注射剂
生产商：LILLY ELI & CO
包装规格[注：本品除下面价以外，运费另付500]
HUMATROPE 5MG VL 1 SOMATROPIN LILLY ELI & CO NDC:2733511 $982.29
HUMATROPE 6MG CRT SOMATROPIN LILLY ELI & CO NDC:2814701 $1138.75
HUMATROPE 12MG CRT SOMATROPIN LILLY ELI & CO NDC:2814801 $2,077.49
HUMATROPE 24MG CRT SOMATROPIN LILLY ELI & CO NDC:2814901 $3,977.98
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a774e1ae-3997-49ee-8b0e-99a2b315d409
HUMATROPE[somatropin (rDNA ORIGIN)] for injection, for subcutaneous use
Initial U.S. Approval: 1987
RECENT MAJOR CHANGES
Contraindications, Hypersensitivity：12/2016
Warnings and Precautions, Severe Hypersensitivity：12/2016
Warnings and Precautions, Hypoadrenalism：12/2016
Warnings and Precautions, Lipoatrophy：12/2016
INDICATIONS AND USAGE
Humatrope® is a recombinant human growth hormone (somatropin) indicated for:
Pediatric Patients: Treatment of children with short stature or growth failure associated with growth hormone (GH) deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and failure to catch up in height after small for gestational age birth. (1.1)
Adult Patients: Treatment of adults with either childhood-onset or adult-onset GH deficiency.
DOSAGE AND ADMINISTRATION
Humatrope should be administered subcutaneously.
Injection sites should always be rotated regularly to avoid lipoatrophy.
For pediatric patients, the recommended weekly dosages in milligrams (mg) per kilogram (kg) of body weight (given in divided doses 6 to 7 times per week) are:
Pediatric GH deficiency: 0.18 to 0.30 mg/kg/week
Turner syndrome: Up to 0.375 mg/kg/week
Idiopathic short stature: Up to 0.37 mg/kg/week
SHOX deficiency: 0.35 mg/kg/week
Small for gestational age: Up to 0.47 mg/kg/week
Adult GH deficiency: Either a non-weight based or a weight-based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations.
Non-weight based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day.
Weight-based dosing: The recommended initial daily dose is not more than 0.006 mg/kg (6 μg/kg); the dose may be increased to a maximum of 0.0125 mg/kg (12.5 μg/kg) daily.
DOSAGE FORMS AND STRENGTHS
5mg vial and 5-mL vial of Diluent for Humatrope
6mg (gold), 12mg (teal) and 24mg (purple) cartridge, and prefilled syringe of Diluent for Humatrope
Humatrope cartridges should be used only with the appropriate corresponding pen device
CONTRAINDICATIONS
Acute critical illness.
Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death.
Active malignancy.
Hypersensitivity to somatropin or excipients.
Active proliferative or severe non-proliferative diabetic retinopathy.
Children with closed epiphyses.
WARNINGS AND PRECAUTIONS
Acute Critical Illness: eva luate potential benefit of treatment continuation against potential risk. (5.1)
Prader-Willi Syndrome: eva luate for signs of upper airway obstructi |
