How do I reconstitute 12.87 mg of CJC-1295 (Growth Hormone Releasing Hormone (GHRH) analog) No DAC for a patient with adult growth hormone deficiency?

CJC-1295 No DAC Reconstitution Protocol

For a 12.87 mg vial of CJC-1295 No DAC, add 2.0-2.5 mL of bacteriostatic water to achieve a concentration of approximately 5 mg/mL, which allows for precise dosing based on the research-validated range of 30-60 mcg/kg administered subcutaneously. 1

Reconstitution Procedure

Materials Required

• 12.87 mg CJC-1295 No DAC lyophilized powder 1
• Bacteriostatic water for injection (0.9% benzyl alcohol) 1
• Sterile syringe (3 mL or 5 mL) 1
• Alcohol swabs 1

Step-by-Step Reconstitution

• Remove the plastic cap from the vial and clean the rubber stopper with an alcohol swab 1
• Draw 2.0-2.5 mL of bacteriostatic water into a sterile syringe 1
• Inject the water slowly down the side of the vial to avoid foaming and preserve peptide integrity 1
• Gently swirl (do not shake vigorously) until the powder is completely dissolved, resulting in a clear solution 1
• Final concentration: 12.87 mg ÷ 2.5 mL = approximately 5.15 mg/mL (5,150 mcg/mL) 1

Dosing Calculations for Adult Growth Hormone Deficiency

Evidence-Based Dosing Range

• The validated dose range is 30-60 mcg/kg administered subcutaneously, with 30 mcg/kg showing optimal safety and efficacy in clinical trials 1
• Single doses of CJC-1295 produced sustained GH elevation for 6+ days and IGF-I elevation for 9-11 days 1
• The estimated half-life is 5.8-8.1 days, supporting once-weekly or twice-weekly administration 1

Practical Dosing Example

For a 70 kg patient using the conservative 30 mcg/kg dose:

• Total dose needed: 70 kg × 30 mcg/kg = 2,100 mcg (2.1 mg) 1
• Volume to inject: 2,100 mcg ÷ 5,150 mcg/mL = 0.41 mL 1
• Administration frequency: Once weekly or every 5-7 days based on clinical response 1

For a 70 kg patient using 60 mcg/kg dose:

• Total dose needed: 70 kg × 60 mcg/kg = 4,200 mcg (4.2 mg) 1
• Volume to inject: 4,200 mcg ÷ 5,150 mcg/mL = 0.82 mL 1

Storage and Stability

Before Reconstitution

• Store lyophilized powder at 2-8°C (refrigerated) protected from light 1
• Stable for extended periods when stored properly 1

After Reconstitution

• Store reconstituted solution at 2-8°C (refrigerated) 1
• Use within 28 days of reconstitution when using bacteriostatic water 1
• Protect from light and avoid freezing 1

Administration Technique

Subcutaneous Injection Protocol

• Inject subcutaneously into the abdomen, thigh, or upper arm 1
• Rotate injection sites to prevent lipohypertrophy 1
• Administer at the same time of day for consistency, preferably in the evening 1, 2
• Use a 27-30 gauge insulin syringe for patient comfort 1

Monitoring Parameters

Initial Assessment

• Baseline IGF-I levels should be measured before initiating therapy 1, 3
• Document baseline body composition, lean mass, and fat mass 1, 3
• Assess for contraindications including active malignancy 3

Follow-Up Monitoring

• Measure IGF-I levels at 7-14 days after first dose to assess response, as peak IGF-I elevation occurs within 9-11 days 1
• Monitor for dose-dependent increases: expect 1.5-3 fold elevation in IGF-I with appropriate dosing 1
• Reassess at 4-6 weeks to determine if dose adjustment is needed 1
• Long-term monitoring should include body composition, lipid profile, glucose metabolism, and quality of life measures 3

Safety Considerations

Common Pitfalls to Avoid

• Do not shake the vial vigorously during reconstitution, as this can denature the peptide 1
• Do not use doses exceeding 60 mcg/kg without clear clinical justification, as higher doses increase side effect risk without proportional benefit 1
• Avoid daily dosing - the extended half-life makes this unnecessary and potentially increases adverse effects 1, 4

Adverse Effects Profile

• CJC-1295 at doses of 30-60 mcg/kg was safe and relatively well tolerated in clinical trials 1
• No serious adverse reactions were reported in the pivotal study 1
• Potential side effects of GH stimulation include fluid retention, arthralgias, and carpal tunnel syndrome, though these are less common with GHRH analogs than with direct GH administration 3
• Monitor for signs of excessive GH/IGF-I elevation including edema, joint pain, and glucose intolerance 3

Clinical Context

Advantages Over Direct GH Replacement

• Preserves physiologic pulsatile GH secretion rather than providing continuous supraphysiologic levels 2
• Lower risk of side effects compared to daily GH injections 2, 3
• More convenient dosing schedule (weekly vs. daily) 1
• The aging pituitary remains responsive to GHRH analogs, making this approach viable in older adults 2

Expected Outcomes

• Sustained GH elevation for 6+ days after single injection 1
• IGF-I normalization within younger adult ranges with repeated dosing 1, 2
• Increase in lean body mass with chronic treatment 2
• Potential reduction in body fat, though this requires several months of therapy 2