Adult Dosing
HIV-associated wasting or cachexia
- <35 kg (<75 lb): 0.1 mg/kg SC qd at bedtime
- 35-45 kg (75-99 lb): 4 mg SC qhs
- 45-55 kg (99-121 lb): 5 mg SC qhs
- >55 kg (>121 lb): 6 mg SC qhs
- Max: 6 mg/day SC at bedtime
- When starting therapy with Serostim, especially in patients at increased risk for adverse effects related to recombinant human growth hormone therapy (e.g., glucose intolerance), administer 0.1 mg/kg SC every other day
Notes: - 1 mg of somatropin is equivalent to approximately 3 IU
- Rotate the site of injections regularly to help prevent lipoatrophy
Pediatric Dosing
- Safety and effectiveness in pediatric patients with HIV have not been established
[Outline]
See Supplemental Patient Information
- Consider reconstituting the product with Sterile Water for Injection if sensitivity to the diluent (benzyl alcohol) occurs. Use the reconstituted solution immediately and discard any unused portion
- 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 somatropin in patients experiencing acute critical illnesses should be weighed against the potential risk
- Therapy may cause increased tissue turgor (swelling in the hands and feet) and musculoskeletal discomfort that may resolve spontaneously with analgesic therapy or after reducing the frequency of dosing
- Carpal tunnel syndrome may occur during therapy. Discontinue treatment if symptoms of carpal tunnel syndrome persist after dosage reduction
- Local or systemic allergic reactions may occur during therapy. Inform caregivers/patients that such reactions are possible and prompt medical attention should be sought on occurrence of these allergic reactions
- Reevaluate if weight loss persists after 2 weeks of therapy
- Recombinant human growth hormone (rhGH) therapy has been associated with acute pancreatitis
- 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
- 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 should be directed by physicians who are well trained in the diagnosis and management of HIV infection
- Monitor glucose levels and perform fundoscopic examination at baseline and periodically during the course of somatropin therapy
Cautions: Use cautiously in
- Impaired glucose tolerance or diabetes mellitus
- Patients at risk for type 2 diabetes mellitus (e.g., obesity, family history of T2DM)
- Hypopituitarism
- Neonates
- Elderly patients
Supplemental Patient Information
- Instruct patients to rotate injection sites to avoid localized tissue atrophy
- 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: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 1 February 2011). Manufacturer advises caution.
