See Supplemental Patient Information
- Therapy should be directed by physicians who are well trained in the diagnosis and management of SBS
- Somatropin therapy increases mortality in growth hormone-treated patients with acute critical illnesses due to complications following open heart surgery, abdominal surgery, acute respiratory failure, or multiple accidental trauma. The potential benefit of treatment continuation with GH in patients experiencing acute critical illnesses should be weighed against the potential risk
- 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
- Acute pancreatitis may be associated with recombinant human growth hormone therapy
- Therapy may be associated with cases of new onset impaired glucose intolerance, new onset type 2 diabetes mellitus and exacerbation of preexisting diabetes mellitus. Certain patients necessitated initiation or adjustment of antidiabetic treatment while on somatropin. Monitor glucose levels periodically in all patients receiving therapy, especially in those with risk factors for glucose intolerance
- The syndrome of intracranial hypertension with papilledema, visual changes, headache, and other signs has been rarely reported in children with growth failure receiving somatropin therapy; perform funduscopic examination before initiating treatment to exclude preexisting papilledema and periodically during the course of therapy
- Therapy may cause carpal tunnel syndrome; discontinue therapy if symptoms of carpal tunnel syndrome persist after dosage reduction
- Rotate injection sites to avoid localized tissue atrophy
- Therapy may be associated with increased tissue turgor and musculoskeletal discomfort, which may resolve spontaneously, with analgesic therapy, or after reducing the dose frequency
- Benzyl alcohol used as a preservative in Bacteriostatic Water for Injection may cause toxicity in newborns; reconstitute with Sterile Water for Injection if sensitivity to diluent occurs
Cautions: Use cautiously in
- Patients at risk for T2DM (e.g., obesity, family history of T2DM)
- Elderly patients
- Pregnancy
- Lactation
Supplemental Patient Information
- Inform patients 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:B
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 28 January 2011). Manufacturer advises caution.
