Monograph Details
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Endocrine System
> Pituitary disorders
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SAIZEN |
| Manufacturer |
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EMD Serono, Inc. |
| 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 (rDNA origin) 5mg, 8.8mg; per vial; pwd for SC or IM inj after reconstitution; diluent contains benzyl alcohol. |
| Indications |
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Long-term treatment of children with growth failure due to inadequate GH secretion. Adults with childhood-onset or adult-onset GH deficiency. |
| Children |
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Rotate inj site. Give by SC or IM inj. Individualize; usually 0.06mg/kg 3 times/week. |
| Adults |
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Rotate inj site. Give by SC or IM inj. Initial max 0.005mg/kg per day; may increase after 4 weeks to max 0.01mg/kg per day. |
| Contraindications |
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Acute critical illness. Acute respiratory failure. Fused epiphyses. Active neoplasia or intracranial lesions. Diabetic retinopathy. Prader-Willi syndrome (severely obese or w. respiratory impairment); see literature. |
| Precautions |
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Monitor thyroid function, glucose tolerance, bone age, gait, for hip or knee pain, for leukemia, and for intracranial hypertension (do baseline and periodic funduscopic exams). Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratory infection. Discontinue if signs of upper airway obstruction or sleep apnea occur. Diabetes. Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
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May be antagonized by glucocorticoids. Antidiabetic medications may need to be adjusted. May affect CYP3A4 substrates. |
| Adverse Reactions |
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Headache, inj site reactions, hypothyroidism, hypoglycemia, seizures, exacerbation of psoriasis, fluid balance disturbances, elevated serum phosphate, antibody formation. Long-term overdose may cause gigantism and/or acromegaly. |
| Extra Text |
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Note: May be given using cool.click, a needle-free delivery device (except hemophiliacs, children who bruise or bleed easily, or who are on anticoagulants or other drugs that may cause bleeding or bruising). |
| How Supplied |
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Vial—1 (w. diluent) |
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