### IGF-1 LR3 (IGF-1 LR3) for Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use IGF-1 LR3 safely and effectively. See full prescribing information for IGF-1 LR3.
IGF-1 LR3 injection, for subcutaneous use
**INDICATIONS AND USAGE**
IGF-1 LR3 is a long-acting insulin-like growth factor-1 analog indicated for investigational use in promoting muscle hyperplasia, hypertrophy, 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.
– Adult males: 20 mcg to 60 mcg per day.
– Adult females: 10 mcg to 40 mcg per day (2.1).
– Cycle duration: Typically 4 to 6 weeks.
**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 1 mg per vial (3).
**CONTRAINDICATIONS**
– Hypersensitivity to IGF-1 LR3 or any component of the formulation (4).
– Active malignancy due to growth-promoting effects (4).
**WARNINGS AND PRECAUTIONS**
– Hypoglycemia: Risk of low blood sugar; monitor glucose levels (5.1).
– Injection site reactions: Monitor for irritation or swelling (5.2).
– Limited long-term safety data: Use cautiously in chronic conditions (5.3).
**ADVERSE REACTIONS**
Common adverse reactions include injection site pain, hypoglycemia, and fatigue (6).
**DRUG INTERACTIONS**
– Insulin or hypoglycemics: May enhance effects; monitor glucose (7.1).
**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**
IGF-1 LR3 is indicated for investigational use in adults to induce muscle cell proliferation and growth, enhance protein synthesis, improve recovery, reduce body fat, improve nutrient uptake, strengthen bones and connective tissue, and boost overall anabolism and endurance. It is commonly used in bodybuilding for muscle hypertrophy 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 1 mg vial with 1-2 mL bacteriostatic water. Administer subcutaneously, preferably in the abdomen or thigh.
– Males: 20 mcg to 60 mcg daily, in one dose post-workout.
– Females: 10 mcg to 40 mcg daily, in one dose post-workout.
– Cycle duration: Typically 4 to 6 weeks, adjusted 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 1 mg IGF-1 LR3 per single-use vial.
**4 CONTRAINDICATIONS**
IGF-1 LR3 is contraindicated in:
– Patients with known hypersensitivity to IGF-1 LR3 or excipients (e.g., mannitol).
– Patients with active malignancy due to potential promotion of cell growth, which may exacerbate tumor progression.
**5 WARNINGS AND PRECAUTIONS**
**5.1 Hypoglycemia**
May cause low blood sugar, particularly in patients on insulin or oral hypoglycemics. 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 and monitor for signs of infection or severe reactions.
**5.3 Limited Long-Term Safety Data**
Long-term effects in humans are not well-established; use with caution in patients with chronic conditions or for prolonged periods. Regular monitoring is recommended.
**6 ADVERSE REACTIONS**
Reported adverse reactions include:
– Metabolic: Hypoglycemia, transient energy fluctuations.
– Local: Injection site pain, erythema, or swelling.
– General: Fatigue, headache.
Serious reactions may include severe hypoglycemia or hypersensitivity responses.
**7 DRUG INTERACTIONS**
**7.1 Insulin or Hypoglycemics**
Concurrent use with insulin or oral hypoglycemics may enhance hypoglycemic effects, increasing the risk of low blood sugar. Monitor glucose levels closely and adjust doses as needed.
**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
No adequate studies in pregnant women; potential risks to the fetus are unknown due to growth-promoting 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 metabolic or cardiovascular issues.
**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with IGF-1 LR3, but misuse for performance enhancement may occur. Monitor for inappropriate use.
**10 OVERDOSAGE**
Symptoms of overdose may include severe hypoglycemia, fatigue, or injection site reactions. Treat symptomatically, including glucose administration if needed, and discontinue use.
**11 DESCRIPTION**
IGF-1 LR3 is a long-acting analog of insulin-like growth factor-1, designed for enhanced bioavailability. It is supplied as a white lyophilized powder, soluble in bacteriostatic water for injection. Each vial contains 1 mg IGF-1 LR3, with mannitol as a stabilizer. Half-life: Approximately 20-30 hours. 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**
IGF-1 LR3 binds to IGF-1 receptors, promoting muscle cell proliferation, protein synthesis, and fat metabolism while enhancing nutrient uptake and bone strength.
**12.3 Pharmacokinetics**
Absorbed after subcutaneous injection; half-life approximately 20-30 hours; metabolized and excreted primarily via urine.
**13 NONCLINICAL TOXICOLOGY**
Limited data available; animal studies suggest potential for growth-related effects. No human carcinogenicity data available.
**16 HOW SUPPLIED/STORAGE AND HANDLING**
1 mg lyophilized powder in single-use vials. Store refrigerated at 2°-8°C (36°-46°F). Reconstituted solution stable for up to 14 days refrigerated. Protect from light. Keep out of reach of children.
*Manufactured by: Medi Pharma*
