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Genotropin(somatropin [rDNA origin] for injection)
2016-07-01 10:58:45 来源: 作者: 【 】 浏览:362次 评论:0

Genotropin(somatropin [rDNA origin] for injection)
Audience: Pediatricians, endocrinologists and other healthcare professionals
Pharmacia and FDA revised the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Genotropin, indicated for the long-term treatment of pediatric patients who have growth failure. Fatalities have been reported with the use of growth hormone in pediatric patients with Prader-Willi syndrome with one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection. Male patients with these factors may be at increased risk.
GENOTROPIN Rx
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GENOTROPIN
Pituitary disorders  Only 4 drugs may be compared at once
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Generic Name and Formulations:
Somatropin (rDNA origin) lyophilized pwd 5.8mg (5mg/mL after reconstitution, preserved with m-Cresol), 13.8mg (12mg/mL after reconstitution, preserved with m-Cresol); for SC inj.
Company:
Pfizer Inc.

Select therapeutic use: Pituitary disorders
Indications for GENOTROPIN:
Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Small for Gestational Age (SGA), Turner syndrome (TS), and Idiopathic Short Stature (ISS). Treatment of adults with either adult onset or childhood onset GHD.

Adult:
Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Non-weight based dosing: initially 0.2mg/day (range: 0.15–0.3mg/day) may be used and gradually increased every 1–2 months by increments of approx. 0.1–0.2mg/day. Weight based dosing: initially not more than 0.04mg/kg/week; dose may be increased as tolerated to not more than 0.08mg/kg/week at 4–8 week intervals.

Children:
Give by SC inj into thigh, buttocks, or abdomen; rotate inj site. Individualize based on growth response. GHD: 0.16–0.24mg/kg/week. PWS: 0.24mg/kg/week. SGA: up to 0.48mg/kg/week. TS: 0.33mg/kg/week. ISS: up to 0.47mg/kg/week.

Contraindications:
Children with closed epiphyses. Active malignancy. Acute critical illness due to surgical complications or multiple trauma. Acute respiratory failure. Severe obesity or severe respiratory impairment in PWS patients. Active proliferative or severe non-proliferative diabetic retinopathy.

Warnings/Precautions:
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: eva luate 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). Monitor preexisting tumors for progression or recurrence; increased risk of second neoplasm in childhood cancer survivors (in particular meningiomas in patients treated with radiation to head for first neoplasm). Slipped capital femoral epiphyses (in ped patients). TS patients: may increase occurrence of otitis media and cardiovascular disorders. Pregnancy (Cat.B). Nursing mothers.

Interactions:
May be antagonized by glucocorticoids. Monitor drugs metabolized by CYP450 (eg, steroids, anticonvulsants, cyclosporine). Concomitant oral estrogen replacement: may require larger dose of somatropin. Antidiabetic agents may require adjustment.

See Also:
GENOTROPIN MINIQUICK

Pharmacological Class:
Growth hormone (GH).

Adverse Reactions:
Inj site reactions/rashes, lipoatrophy, headaches; fluid retention (esp. in adults), rare: pancreatitis.

How Supplied:
Pen (5mg/mL, 12mg/mL)—1; MiniQuick (0.25mL)—7 ; All: as two-chambered cartridge w. diluent

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