Monograph Details
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Endocrine System
> Pituitary disorders
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GENOTROPIN MINIQUICK |
| Manufacturer |
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Pfizer Labs |
| 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) 0.2mg, 0.4mg, 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg, 2mg; per 0.25mL; lyophilized pwd for SC inj after reconstitution; preservative-free. |
| Also |
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• GENOTROPIN
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| Indications |
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Long-term treatment of growth failure in children, due to inadequate GH secretion or Prader-Willi Syndrome (PWS), or in those born small for gestational age (SGA) who do not manifest catch-up growth by 2 years of age. Long-term replacement therapy in adults with GH deficiency (GHD) confirmed by appropriate GH stimulation test. |
| Children |
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Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Individualize; give weekly dose in 6 or 7 divided doses. GHD: 0.16–0.24mg/kg per week. PWS: 0.24mg/kg per week. SGA: 0.48mg/kg per week. |
| Adults |
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Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Individualize; give weekly dose in 6 or 7 divided doses. Initially up to 0.04mg/kg per week, may increase at 4–8 week intervals to max 0.08mg/kg per week. |
| Contraindications |
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Children with fused epiphyses. Active neoplasia. Acute critical illness due to surgical complications or multiple trauma. Acute respiratory failure. Severe obesity or severe respiratory impairment in PWS patients. |
| Precautions |
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Monitor gait, thyroid function, glucose tolerance, 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). PWS: evaluate for upper airway obstruction before starting; monitor weight, for sleep apnea, respiratory impairment/obstruction (eg, snoring; suspend therapy if occurs) or respiratory infection (treat aggressively if occurs). Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
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May be antagonized by glucocorticoids. Monitor drugs metabolized by CYP450 (eg, steroids, anticonvulsants, cyclosporine). |
| Adverse Reactions |
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Antibody formation, local reactions. Pediatric GHD: headache, hematuria, hypothyroidism. PWS: edema, aggressiveness, arthralgia, hair loss, headache, myalgia. SGA: jaw prominence, progression of pigmented nevi. Adult GHD: edema, arthralgia, extremity pain/stiffness, paresthesia, myalgia. |
| How Supplied |
Intra-Mix Device (1.5mg)—5
Intra-Mix Device (5.8mg)—1, 5
Pen or Mixer device (5.8mg, 13.8mg)—1, 5
MiniQuick (0.25mL)—7
All: as two-chambered cartridge w. diluent |
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