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Sermorelin Geriatric (65+) Caregiver Administration Guidance

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At a glance

  • Regulatory status / Geref discontinued in 2008; approvals withdrawn June 18, 2009 [1]
  • Historic approved uses / growth hormone deficiency in children; pituitary diagnostic test [1]
  • Sold now / compounded sermorelin, which is not FDA-approved [2]
  • Older-adult dosing studied / 0.5 mg or 1 mg subcutaneously twice daily, 14 days each dose, 10 men, mean age 68 [3]
  • Pediatric dosing studied / 30 micrograms/kg once daily at bedtime [4]
  • What it is / a GHRH analogue that prompts growth hormone release, not growth hormone [5]

Is there a sermorelin product with instructions a caregiver can follow?

No sermorelin product is FDA-approved today [1]. Sermorelin acetate was approved as Geref: a 0.05 mg/ampule product for testing the pituitary's ability to secrete growth hormone (1990) and 0.5 mg and 1 mg vials for treating idiopathic growth hormone deficiency in children with growth failure (1997) [1]. The manufacturer discontinued both in 2008, and FDA withdrew the approvals effective June 18, 2009, determining in 2013 that Geref was not withdrawn for safety or effectiveness reasons [1]. Geref was never approved for adults, anti-aging, weight loss or athletic performance [1].

Sermorelin sold in the US today is compounded, and compounded drugs are not FDA-approved; FDA does not review their safety, effectiveness or quality before marketing [2]. With no approved product, there is no current FDA label that gives reconstitution, storage or discard instructions for a caregiver. The published studies report subcutaneous doses and schedules [3][4], not handling instructions for a compounded product.

What dose has been tested in older adults?

One study: 10 healthy old men (mean age 68) took 0.5 mg and 1 mg GHRH(1-29) subcutaneously twice daily for 14 days each, in random order with a 14-day period between treatments, and were compared with nine young men (mean age 26) [3]. At the 1 mg dose, 24-hour growth hormone and IGF-I rose to levels not significantly different from the young men [3]. It was a short physiology study, not a trial of clinical benefit [3].

What safety data exists?

The 1-year pediatric study of 110 previously untreated children (86 evaluable for efficacy) followed height velocity, bone age and safety measures including clinical chemistry [4]. No adverse changes appeared in general biochemistry or hormone tests, fasting glucose did not change, IGF-I was not excessively raised, and the drug was well tolerated overall [4]. Because these were children, the findings do not establish a monitoring schedule for adults 65 and older.

Sermorelin is a 29-amino-acid analogue of GHRH, the shortest synthetic peptide with the full biological activity of GHRH; it is not growth hormone itself [5].

Frequently asked questions

Is there an FDA-approved sermorelin a caregiver can follow instructions from?
No. Geref, the only approved sermorelin, was discontinued in 2008 and its approvals were withdrawn in 2009 [1]. Sermorelin sold now is compounded [2].
What dose of sermorelin has been studied in older men?
Ten healthy men with a mean age of 68 received 0.5 mg and 1 mg subcutaneously twice daily for 14 days each [3]. That is a study dose, not a recommended dose.
What side effects were reported in the 1-year pediatric study?
In a 1-year study of 110 children given 30 micrograms/kg once daily at bedtime, no adverse changes appeared in general biochemistry or hormone tests, fasting glucose did not change and IGF-I was not excessively raised [4].
Is sermorelin the same as growth hormone?
No. Sermorelin is a 29-amino-acid analogue of growth hormone-releasing hormone; it prompts the pituitary to release growth hormone but is not growth hormone itself [5].

References

  1. Federal Register :: Request Access. Federal Register :: Request Access
  2. Official web page. Official web page
  3. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530-5. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men
  4. Thorner M, Rochiccioli P, Colle M, Lanes R, Grunt J, Galazka A, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-96. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group
  5. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-57. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency
Evidence overview for Sermorelin Geriatric (65+) Caregiver Administration Guidance