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Protropin Side Effects

Generic Name: somatrem

Note: This page contains side effects data for the generic drug somatrem. It is possible that some of the dosage forms included below may not apply to the brand name Protropin.

Applies to somatrem: injectable powder for injection

General

Somatrem (the active ingredient contained in Protropin) has been generally well tolerated with minimal adverse effects.[Ref]

Oncologic

Oncologic side effects have included rare reports of leukemia, however, the association with human growth hormone is uncertain.[Ref]

Immunologic

Immunologic side effects have included the rare development of persistent antibodies. The development of antibodies may be greater with the use of somatrem (the active ingredient contained in Protropin) than with somatropin, although the overall incidence is low.[Ref]

An IgG antibody has been identified. No antibodies to the IgE class has been detected. Growth hormone antibody binding capacities less than 2 mg/L have not led to growth attenuation. Testing for antibodies should be carried out in any patient failing to respond to treatment.

Primate studies have failed to reveal evidence of histopathological changes due to immune complex formation.[Ref]

Nervous system

Nervous system side effects have been infrequent, but have included headaches and weakness.[Ref]

Endocrine

Serum levels of inorganic phosphorus, alkaline phosphatase and parathyroid hormone (PTH) may increase during treatment with somatrem (the active ingredient contained in Protropin) The mechanism is unknown. These potential changes should be considered when evaluating patient laboratory measurements.[Ref]

Endocrine side effects have included mild hyperglycemia or gynecomastia. Elevations in IGF-1 (insulin-like growth factor 1) and insulin levels occur consistently in adults. Alterations in thyroid hormone metabolism may occur. Recombinant human growth hormone may reveal diabetes mellitus in a patient, but is not the cause.[Ref]

Cardiovascular

Cardiovascular side effects have included mild, transient, peripheral edema in up to 2.5% of patients during early treatment with somatrem (the active ingredient contained in Protropin) Intracranial hypertension is a rare effect that may present with papilledema, visual changes, headache, nausea and vomiting.[Ref]

Edema occurs more often in adults, appears to be dose-related, and is due to the antinatriuretic effect of growth hormone.[Ref]

Other

Other side effects have included acromegaly following the chronic use of human growth hormone by athletes.

There is no risk of acquiring Creutzfeldt-Jakob disease from recombinant human growth hormone, as with the previously marketed pituitary-derived human growth hormone.[Ref]

Athletes using human growth hormone for doping purposes may experience cardiac, renal, and splenic hypertrophy, cardiac myopathy, fluid retention, glucose intolerance, abnormal bone growth, and an increased risk of cancers.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of increased growth of preexisting nevi (hereditary malformation of the skin).[Ref]

Metabolic

Metabolic side effects have included lipolysis resulting in a statistically significant decrease in total body fat (14% to 20%) in adults. Significant reductions in total cholesterol and/or LDL have been reported. No changes in HDL have been observed. Elderly patients have exhibited triglyceride elevations. The long-term effect of recombinant human growth hormone on lipid metabolism is unknown.[Ref]

Musculoskeletal

Musculoskeletal side effects have rarely included localized muscle pain, carpal tunnel syndrome and slipped capital femoral epiphysis.[Ref]

Local

Localized side effects have included infrequent injection site pain in children.[Ref]

References

1. Hintz RL "Untoward events in patients treated with growth hormone in the USA." Horm Res 38 Suppl 1 (1992): 44-9

2. Ritzen EM, Czernichow P, Preece M, Ranke M, Wit JM "Safety of human growth hormone therapy." Horm Res 39 (1993): d92-3;isc. 94

3. Endo M, Kaneko Y, Shikano T, Minami H, Chino J "Possible association of human growth hormone treatment with an occurrence of acute myeloblastic leukemia with an inversion of chromosome 3 in a child of pituitary dwarfism." Med Pediatr Oncol 16 (1988): 45-7

4. Allen DB "Safety of human growth hormone therapy: current topics." J Pediatr 128 (suppl (1996): s8-13

5. Shulman L, Miller JL, Rose LI "Growth hormone therapy." Am Fam Physician 41 (1990): 1541-6

6. Ritzen EM "Does growth hormone increase the risk of malignancies?" Horm Res 39 (1993): 99-101

7. Stahnke N "Leukemia in growth-hormone-treated patients: an update, 1992." Horm Res 38 Suppl 1 (1992): 56-62

8. "Product Information. Protropin (somatrem)." Genentech, South San Francisco, CA.

9. Cohn L, Feller AG, Draper MW, Rudman IW, Rudman D "Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations." Clin Endocrinol (Oxf) 39 (1993): 417-25

10. "Recombinant human growth hormone." Med Lett Drugs Ther 36 (1994): 77-8

11. Strobl JS, Thomas MJ "Human growth hormone." Pharmacol Rev 46 (1994): 1-34

12. Jorgensen JO, Moller J, Skakkebaek NE, Weeke J, Christiansen JS "Thyroid function during growth hormone therapy." Horm Res 38 Suppl 1 (1992): 63-7

13. Brown P "The decline and fall of Creutzfeldt-Jakob disease associated with human growth hormone therapy." Neurology 38 (1988): 1135-7

14. Kato Y, Hu HY, Sohmiya M "Short term treatment with different doses of human growth hormone in adult patients with growth hormone deficiency." Endocr J 43 (1996): 177-83

15. Holloway L, Butterfield G, Hintz RL, Gesundheit N, Marcus R "Effects of recombinant human growth hormone on metabolic indices, body composition, and bone turnover in healthy elderly women." J Clin Endocrinol Metab 79 (1994): 470-9

16. Bengtsson BA "Growth hormone deficiency in adults: a new indication for recombinant human growth hormone." J Intern Med 239 (1996): 283-6

17. Ranke MB "Effects of growth hormone on the metabolism of lipids and water and their potential in causing adverse events during growth hormone treatment." Horm Res 39 (1993): 104-6

It is possible that some side effects of Protropin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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