Monograph Details
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Endocrine System
> Pituitary disorders
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HUMATROPE |
| Manufacturer |
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Lilly, Eli and Company |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Growth hormone (GH). |
| Generic Name |
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Somatropin 5mg (rDNA origin); pwd for SC or IM inj after reconstitution; diluent contains m-cresol. |
| Indications |
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Long-term treatment of growth failure in children due to GH deficiency (GHD). Treatment of short stature associated with Turner syndrome in children whose epiphyses are not closed. Long-term treatment of idiopathic short stature. Replacement therapy in adults. |
| Children |
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GHD: 0.18mg/kg per week SC or IM divided into equal doses on 3 alternate days or 6 times per week or daily; max 0.3mg/kg per week. Turner syndrome: up to 0.375mg/kg per week SC divided into equal doses daily or on 3 alternate days. Idiopathic short stature: up to 0.37mg/kg per week SC divided into equal doses given 6 to 7 times per week. |
| Adults |
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Give by SC inj once daily; rotate inj site. <65 years: Initially up to 0.006mg/kg per day, may increase to max 0.0125mg/kg per day. |
| Contraindications |
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Children with fused epiphyses. Active neoplasias. Acute critical illness due to surgical complications or multiple trauma. Acute respiratory failure. Diabetic retinopathy. Prader-Willi syndrome (severely obese or w. respiratory impairment): see literature. |
| Precautions |
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Monitor gait, thyroid function, glucose tolerance (esp. in diabetes), and for leukemia, scoliosis progression, malignant transformation of skin lesions, intracranial lesion progression or recurrence or intracranial hypertension (do funduscopic exam at baseline then periodically). Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratroy infection. Discontinue if signs of upper airway obstruction or sleep apnea occur. Monitor Turner syndrome patients for ear or cardiovascular disorders. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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May be antagonized by glucocorticoids. May affect CYP3A4 substrates. |
| Adverse Reactions |
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Edema, ear disorders, myalgia, arthralgia, hyperlipidemia, gynecomastia, headache, weakness, glucosuria, antibody formation, elevated serum phosphate. Long-term overdose may cause gigantism and/or acromegaly. |
| How Supplied |
Vials (5 mg)—6 (w. diluent)
Cartridge kit (6 mg, 12 mg, 24 mg)—1 (w. diluent in prefilled syringe)
HumatroPen (device for use with cartridge)—1 |
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