### FOLLISTATIN 334 (follistatin 334) for Injection
**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use FOLLISTATIN 334 safely and effectively. See full prescribing information for FOLLISTATIN 334.
FOLLISTATIN 334 injection, for subcutaneous use
**INDICATIONS AND USAGE**
FOLLISTATIN 334 is a peptide indicated for investigational use in inhibiting myostatin to promote significant muscle hypertrophy and strength 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: 100 mcg to 200 mcg per day.
– Adult females: 50 mcg to 100 mcg per day (2.1).
– Cycle duration: Typically 4 to 8 weeks.
**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 1 mg per vial (3).
**CONTRAINDICATIONS**
– Hypersensitivity to follistatin 334 or any component of the formulation (4).
– Active malignancy due to potential muscle growth promotion (4).
**WARNINGS AND PRECAUTIONS**
– Immunogenicity: Potential for antibody formation; monitor for allergic reactions (5.1).
– Unregulated muscle growth: Risk of excessive hypertrophy; monitor muscle function (5.2).
– Limited long-term safety data: Use cautiously in chronic conditions (5.3).
**ADVERSE REACTIONS**
Common adverse reactions include injection site pain, fatigue, and muscle discomfort (6).
**DRUG INTERACTIONS**
– Growth inhibitors: May reduce efficacy; use cautiously (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**
FOLLISTATIN 334 is indicated for investigational use in adults to block myostatin, a protein that limits muscle growth, thereby promoting significant muscle hypertrophy, increased muscle mass and density, enhanced strength and power output, improved recovery from training, and support for bone and tendon strength. It is commonly used in bodybuilding to surpass genetic muscle potential. 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: 100 mcg to 200 mcg daily, in one or two divided doses.
– Females: 50 mcg to 100 mcg daily, in one or two divided doses.
– Cycle duration: Typically 4 to 8 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 follistatin 334 per single-use vial.
**4 CONTRAINDICATIONS**
FOLLISTATIN 334 is contraindicated in:
– Patients with known hypersensitivity to follistatin 334 or excipients (e.g., mannitol).
– Patients with active malignancy due to potential promotion of muscle growth, which may
