CJC-1295 Pre-Surgery Hold Window: How Long to Stop Before Your Procedure
At a glance
- Human studies of CJC-1295 / Three, all DAC form, all healthy volunteers [1]
- Estimated half-life, one DAC dose / 5.8 to 8.1 days [2]
- GH after one dose / 2- to 10-fold rise for 6 days or more [2]
- IGF-I after one dose / 1.5- to 3-fold rise for 9 to 11 days [2]
- IGF-I after repeated doses / Above baseline up to 28 days [2]
- Forms FDA describes / CJC-1295 and CJC-1295 DAC [1]
How long a dose keeps GH and IGF-I raised
In two randomized, placebo-controlled trials lasting 28 and 49 days, healthy adults aged 21 to 61 received either one subcutaneous injection or two or three injections given weekly or every two weeks [2]. After a single injection of CJC-1295 DAC, mean GH rose 2- to 10-fold for at least 6 days, mean IGF-I rose 1.5- to 3-fold for 9 to 11 days, and the estimated half-life was 5.8 to 8.1 days [2]. After multiple doses, mean IGF-I stayed above baseline for up to 28 days [2]. The doses tested were single injections of about 30 to 250 micrograms/kg, or two to three doses weekly or every two weeks; they are study doses, not recommended ones [1][2].
A second study measured GH overnight in healthy men aged 20 to 40 before and one week after a single 60 or 90 microgram/kg injection [3]. Between-pulse GH was about 7.5-fold higher, mean GH 46% higher and IGF-I 45% higher, with pulse frequency and size unchanged [3].
Product details that bear on timing
CJC-1295 has no approved product label, so there is no labeled pre-procedure instruction [1]. The form (DAC or non-DAC), the dose per injection and the date of the last injection are the details that determine how the timing data above apply. FDA describes CJC-1295 as a 29-amino-acid GHRH analogue, and CJC-1295 DAC as the same peptide with an extra maleimidopropionic acid-lysine unit that lets it bind blood albumin and last much longer [1][4]. All three published human studies used the DAC form [1].
What FDA has flagged
FDA's posted concerns include possible immunogenicity for certain routes, impurity and characterization problems, serious adverse events including increased heart rate and a systemic vasodilatory reaction, and limited clinical data [5]. In the trials, injection-site reactions occurred in about 70% of treated subjects in study 1 and in all treated subjects in study 2, and headache in 63% versus 14% on placebo in study 1 [1][2]. FDA also said raised GH and IGF-I carries risks listed on approved growth hormone labels, including glucose intolerance and diabetes and fluid retention [1].
Frequently asked questions
How long before surgery should I stop CJC-1295?
Does CJC-1295 interact with anesthetic drugs?
Is CJC-1295 FDA approved?
Does the non-DAC form behave differently?
References
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799-805. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults
- Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog
- Jetté L, Léger R, Thibaudeau K, Benquet C, Robitaille M, Pellerin I, et al. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog. Endocrinology. 2005;146(7):3052-8. Human growth hormone-releasing factor (hGRF)1-29-albumin bioconjugates activate the GRF receptor on the anterior pituitary in rats: identification of CJC-1295 as a long-lasting GRF analog
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
- U.S. Food and Drug Administration. U.S. Food and Drug Administration