### CJC1295 DAC (CJC-1295 with DAC) for Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use CJC1295 DAC safely and effectively. See full prescribing information for CJC1295 DAC.
CJC1295 DAC injection, for subcutaneous use
**INDICATIONS AND USAGE**
CJC1295 DAC is a growth hormone-releasing hormone (GHRH) analog indicated for investigational use in stimulating growth hormone production, promoting muscle growth, fat loss, and recovery in performance enhancement settings. Not approved for human therapeutic use in many jurisdictions; consult local regulations (1).
**DOSAGE AND ADMINISTRATION**
– Reconstitute lyophilized powder with bacteriostatic water.
– Adults (males and females): 1 mg to 2 mg per week, administered in one or two divided doses (2.1).
– Cycle duration: Typically 8 to 12 weeks.
**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 2 mg per vial (3).
**CONTRAINDICATIONS**
– Hypersensitivity to CJC-1295 DAC or any component of the formulation (4).
– Active malignancy due to growth hormone-promoting effects (4).
**WARNINGS AND PRECAUTIONS**
– Insulin resistance: May affect glucose metabolism; monitor blood sugar (5.1).
– Injection site reactions: Monitor for irritation or swelling (5.2).
– Elevated GH/IGF-1: Risk of acromegaly-like symptoms with overuse (5.3).
– Cardiovascular effects: Monitor heart rate and blood pressure (5.4).
**ADVERSE REACTIONS**
Common adverse reactions include injection site pain, flushing, headache, and fatigue (6).
**DRUG INTERACTIONS**
– Growth hormone secretagogues: May amplify effects; use cautiously (7.1).
– CYP3A4 inhibitors: May alter metabolism (7.2).
**USE IN SPECIFIC POPULATIONS**
– Pregnancy: Insufficient data; avoid use (8.1).
– Lactation: Excretion unknown; not recommended (8.2).
– Pediatric use: Safety not established (8.4).
– Geriatric use: Monitor for organ dysfunction (8.5).
Revised: 08/2025
**FULL PRESCRIBING INFORMATION**
**1 INDICATIONS AND USAGE**
CJC1295 DAC is indicated for investigational use in adults to increase growth hormone and IGF-1 secretion, promote fat loss, enhance lean muscle development, improve skin elasticity, bone density, recovery, sleep quality, immune function, and overall metabolic health. It is commonly used in peptide cycles for performance enhancement and anti-aging. This product is not approved for clinical use and should be administered under medical supervision.
**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Reconstitute 2 mg vial with 1-2 mL bacteriostatic water. Administer subcutaneously, preferably in the abdomen or thigh.
– Adults (males and females): 1 mg to 2 mg weekly, in one or two divided doses.
– Cycle duration: 8 to 12 weeks. Adjust dosage based on response and tolerance. Discontinue if adverse effects occur.
**2.2 Preparation and Handling**
Use sterile technique to reconstitute and draw doses. Inspect reconstituted solution for clarity; do not use if discolored or particulate matter is present.
**3 DOSAGE FORMS AND STRENGTHS**
Supplied as lyophilized powder containing 2 mg CJC-1295 DAC per single-use vial.
**4 CONTRAINDICATIONS**
CJC1295 DAC is contraindicated in:
– Patients with known hypersensitivity to CJC-1295 DAC or excipients (e.g., mannitol).
– Patients with active malignancy due to potential stimulation of growth hormone and IGF-1, which may promote tumor growth.
**5 WARNINGS AND PRECAUTIONS**
**5.1 Insulin Resistance**
CJC1295 DAC may reduce insulin sensitivity, increasing the risk of hyperglycemia, particularly in patients with diabetes or prediabetes. Monitor blood glucose levels regularly and adjust antidiabetic therapy as needed.
**5.2 Injection Site Reactions**
May cause localized pain, redness, or swelling at the injection site. Rotate injection sites to minimize irritation and monitor for signs of infection or severe reactions.
**5.3 Elevated GH/IGF-1 Levels**
Prolonged or excessive use may lead to acromegaly-like symptoms, such as joint pain, swelling, or carpal tunnel syndrome. Monitor IGF-1 levels and discontinue if symptoms occur.
**5.4 Cardiovascular Effects**
May cause transient increases in heart rate or blood pressure due to vasodilation. Monitor cardiovascular parameters, especially in patients with pre-existing heart conditions.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– General: Flushing, fatigue, warmth sensation.
– Nervous System: Headache, dizziness, lightheadedness.
– Local: Injection site pain, erythema, or swelling.
– Musculoskeletal: Joint discomfort (rare with high doses).
Serious reactions may include hypersensitivity reactions or tachycardia.
**7 DRUG INTERACTIONS**
**7.1 Growth Hormone Secretagogues**
Concurrent use with other GHRH or GHRP peptides (e.g., GHRP-6) may amplify growth hormone release, increasing the risk of side effects. Use with caution and monitor closely.
**7.2 CYP3A4 Inhibitors**
May alter metabolism of CJC-1295 DAC; monitor for changes in efficacy or side effects when used with strong CYP3A4 inhibitors (e.g., ketoconazole).
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
No adequate studies in pregnant women; potential risks to the fetus are unknown due to growth hormone effects. Avoid use during pregnancy.
**8.2 Lactation**
Excretion in breast milk is unknown; breastfeeding is not recommended due to potential risks to the infant.
**8.4 Pediatric Use**
Safety and efficacy not established in pediatric patients; use is not recommended due to potential effects on growth plates.
**8.5 Geriatric Use**
Limited data available; monitor for age-related organ dysfunction, particularly renal or hepatic impairment, and cardiovascular risks.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with CJC1295 DAC, but misuse for performance enhancement may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include excessive growth hormone effects, such as joint pain, swelling, or fatigue. No specific antidote exists; treat symptomatically and discontinue use immediately.
**11 DESCRIPTION**
CJC1295 DAC is a synthetic growth hormone-releasing hormone analog designed to extend growth hormone release. It is supplied as a white lyophilized powder, soluble in bacteriostatic water for injection. Each vial contains 2 mg CJC-1295 DAC, with mannitol as a stabilizer. Half-life: Approximately 6-8 days. Note: Ethyl oleate and ricinus oil are not used in this formulation, as it is water-based.
**12 CLINICAL PHARMACOLOGY**
**12.1 Mechanism of Action**
CJC1295 DAC binds to GHRH receptors in the pituitary, stimulating prolonged release of growth hormone and IGF-1, promoting anabolism, fat metabolism, and tissue repair.
**12.3 Pharmacokinetics**
Absorbed after subcutaneous injection; peak plasma levels reached within hours; half-life approximately 6-8 days due to DAC technology. Metabolized and excreted primarily via urine.
**13 NONCLINICAL TOXICOLOGY**
Animal studies suggest potential for growth-related effects; no human carcinogenicity data available. Caution advised due to potential tumor promotion via IGF-1.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
2 mg lyophilized powder in single-use vials. Store refrigerated at 2°-8°C (36°-46°F). Reconstituted solution stable for up to 7 days refrigerated. Protect from light. Keep out of reach of children.
*Manufactured by: Medi Pharma*
