CJC-1295 and NSAIDs (Ibuprofen, Naproxen): What You Need to Know About This Interaction

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Is there a known interaction between CJC-1295 and ibuprofen or naproxen?

No labeled or studied interaction exists. CJC-1295 is an investigational growth hormone-releasing hormone analogue with no approved label, so it has no interaction section, and FDA identified only three published human studies of it, all of the DAC form and all in healthy volunteers [1][3]. Untested is not the same as shown to be safe. Whether NSAIDs change CJC-1295's effect on growth hormone (GH) or IGF-I has not been established.

FDA's briefing also notes that the maker withdrew CJC-1295 DAC from clinical trials in 2006 after a participant in a phase 2 trial died. A causal link was neither shown nor excluded [1].

What the NSAID labels warn about

The prescription ibuprofen label carries boxed warnings for serious cardiovascular thrombotic events, including heart attack and stroke, which can be fatal, and for serious GI bleeding, ulceration and perforation, which can occur at any time and without warning symptoms [2]. Prescription naproxen labels carry the same boxed warnings, and over-the-counter products carry matching heart attack, stroke and stomach-bleeding warnings in their Drug Facts labels instead of a boxed warning.

The ibuprofen label says upper GI ulcers, bleeding or perforation occur in about 1% of patients treated for 3 to 6 months and about 2% to 4% of those treated for a year [2]. It also says long-term NSAID use has resulted in renal papillary necrosis, that NSAIDs can cause new or worsening hypertension and fluid retention, and that a meta-analysis showed about a two-fold increase in heart-failure hospitalizations versus placebo [2].

What CJC-1295 did in its human studies

In Teichman 2006, two randomized, placebo-controlled, double-blind trials of 28 and 49 days in healthy adults aged 21 to 61, a single subcutaneous injection raised mean GH 2- to 10-fold for 6 days or more and IGF-I 1.5- to 3-fold for 9 to 11 days, with an estimated half-life of 5.8 to 8.1 days [4]. Per FDA's summary, injection-site reactions occurred in about 70% of treated subjects in the first study and in all treated subjects in the second; no serious adverse reactions were reported [1][4].

In Ionescu and Frohman 2006, healthy men given one injection of 60 or 90 micrograms/kg had trough GH about 7.5-fold higher a week later and IGF-I 45% higher, with GH pulsatility preserved. Dose-dependent increases in heart rate were reported [1][5].

FDA's stated concern is that raising GH and IGF-I carries the risks listed on approved growth hormone labels, including glucose intolerance and diabetes, fluid retention and tumor growth concerns. FDA also said the human studies were short, small and mostly single-dose, so long-term safety is unknown [1].