Adult Dosing
Pediatric Dosing
Growth failure due to growth hormone deficiency (GHD)
- Administer up to 0.1 mg/kg (0.3 IU/kg) SC injections 3 times/wk; discontinue when epiphyses close or when patient reaches satisfactory height
Notes:- 1 mg of somatropin is equivalent to approximately 3 IU
- Rotate injection sites regularly to help prevent lipoatrophy
[Outline]
See Supplemental Patient Information
- Somatropin therapy may increase mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, acute respiratory failure, or multiple accidental trauma. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk
- Fatalities have been reported following therapy initiation in pediatric patients with Prader-Willi syndrome (PWS) having one or more of the following risk factors such as severe obesity, unidentified respiratory infection, or history of upper airway obstruction or sleep apnea; male patients with one or more of these factors are more prone to such fatalities
- Evaluate patients with PWS for signs of upper airway obstruction and sleep apnea before treatment initiation with somatropin; interrupt therapy if such signs develop during treatment
- Effective weight control measures should be considered in patients with PWS treated with somatropin. Monitor for signs of respiratory infection, which should be diagnosed at the earliest and treated aggressively
- Therapy should not be used in pediatric patients with growth failure due to genetically confirmed PWS
- Rare cases of pancreatitis have been reported in children and adults receiving therapy; girls with Turner syndrome are more susceptible to this risk
- Regularly examine patients with preexisting tumors or GHD secondary to an intracranial lesion for progression or recurrence of the underlying disease process. Increased risk of a second neoplasm has been reported in childhood cancer survivors treated with somatropin following their first neoplasm. Intracranial tumors, particularly meningiomas, have occurred in patients treated with radiation to the head for their first neoplasm
- Carefully monitor patients for any malignant transformation of skin lesions
- Therapy may decrease insulin sensitivity, particularly at higher doses in susceptible patients. Monitor glucose levels periodically in all patients receiving therapy, especially in those with risk factors for diabetes mellitus, including obesity, Turner syndrome, or a family history of diabetes mellitus
- Closely monitor patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance; if required, adjust doses of antihyperglycemic drugs when somatropin therapy is initiated in these patients
- Therapy not indicated for growth promotion in pediatric patients with closed epiphyses
- Closely monitor patients with hypopituitarism (multiple pituitary hormone deficiencies) during somatropin treatment
- Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, particularly, the growth response in children. Patients with Turner syndrome posses an increased risk of developing autoimmune thyroid disease and primary hypothyroidism
- Periodically perform thyroid function tests during therapy; initiate thyroid hormone replacement therapy or appropriately adjust the dose when indicated
- Pediatric patients with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated, as slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders, including GHD
- Intracranial hypertension (IH) with papilledema, visual changes, headache, and other signs have been reported in certain patients receiving somatropin therapy; perform funduscopic examination before initiating treatment to exclude preexisting papilledema and periodically during the course of somatropin therapy
- Discontinue treatment if papilledema is observed by funduscopy and restart at a lower dose after IH-associated signs and symptoms have resolved
- Patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis as somatropin increases growth rate
- Rotate the injection site of somatropin as it can cause tissue atrophy if administered subcutaneously at the same site over a long period of time
- Local or systemic allergic reactions may occur during therapy. Inform parents/patients that such reactions are possible and prompt medical attention should be sought on occurrence of these allergic reactions
- Monitor bone age regularly during somatropin administration, particularly in patients who are pubertal and/or receiving concomitant thyroid hormone replacement therapy
- Serum levels of inorganic phosphorus, alkaline phosphatase, and IGF-I may increase following somatropin therapy
- Therapy should be directed by physicians who are well trained in the diagnosis and management of pediatric patients with growth hormone deficiency
- Benzyl alcohol used as a preservative in bacteriostatic normal saline may be associated with toxicity in newborns; consider reconstituting the product with sterile normal saline for injection in such patients. Use the reconstituted solution immediately and discard any unused portion
Cautions: Use cautiously in
- Neonates
- Geriatric patients
Supplemental Patient Information
- Inform patients and caregivers about the potential benefits and risks associated with somatropin therapy
- Instruct patients and caregivers regarding the importance of proper disposal of used needles and syringes; strongly recommend a puncture-resistant container for the disposal of such materials
Pregnancy Category:C
Breastfeeding: Safety unknown. Limited data indicate that exogenous somatropin is not expected to cause any adverse effects in breastfed infants of mothers who receive somatropin. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 27 January 2011). Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Tev-Tropin 5 MG SOLR [Vial] (GATE)
1 mg = $273.99
3 mg = $798.95
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
