TB-500 10

### TB-500 (thymosin beta-4) for Injection

**HIGHLIGHTS OF PRESCRIBING INFORMATION**
These highlights do not include all the information needed to use TB-500 safely and effectively. See full prescribing information for TB-500.

TB-500 injection, for subcutaneous or intramuscular use

**INDICATIONS AND USAGE**
TB-500 is a peptide indicated for investigational use in promoting tissue healing, reducing inflammation, and enhancing 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): 2 mg to 5 mg per week, divided into two doses (2.1).
– Cycle duration: Typically 4 to 6 weeks for healing.

**DOSAGE FORMS AND STRENGTHS**
Lyophilized powder: 5 mg per vial (3).

**CONTRAINDICATIONS**
– Hypersensitivity to thymosin beta-4 or any component of the formulation (4).

**WARNINGS AND PRECAUTIONS**
– Immunogenicity: Potential for antibody formation; monitor for allergic reactions (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, mild fatigue, and localized redness (6).

**DRUG INTERACTIONS**
– Limited known interactions; monitor with other peptides (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**
TB-500 is indicated for investigational use in adults to promote healing of injuries, reduce inflammation, enhance flexibility, support muscle growth and recovery, improve endurance, and stimulate hair growth. It is commonly used in athletes for tissue repair and recovery. This product is not approved for clinical use and should be used under medical supervision.

**2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
Reconstitute 5 mg vial with 1-2 mL bacteriostatic water. Administer subcutaneously or intramuscularly, preferably near the site of injury if applicable.
– Adults (males and females): 2 mg to 5 mg weekly, divided into two doses (e.g., 2.5 mg twice weekly).
– Cycle duration: Typically 4 to 6 weeks, adjusted based on healing needs. 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 5 mg thymosin beta-4 per single-use vial.

**4 CONTRAINDICATIONS**
TB-500 is contraindicated in:
– Patients with known hypersensitivity to thymosin beta-4 or excipients (e.g., mannitol).

**5 WARNINGS AND PRECAUTIONS**
**5.1 Immunogenicity**
As a synthetic peptide, TB-500 may induce antibody formation, potentially leading to hypersensitivity reactions such as rash or anaphylaxis. Monitor for signs of allergic response and discontinue if severe reactions occur.
**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:
– Local: Injection site pain, erythema, or swelling.
– General: Mild fatigue, headache.
– Musculoskeletal: Transient muscle soreness.
Serious reactions may include hypersensitivity responses.

**7 DRUG INTERACTIONS**
**7.1 Other Peptides**
Concurrent use with other healing or growth peptides may alter effects. Monitor for unexpected interactions and adjust therapy as needed.

**8 USE IN SPECIFIC POPULATIONS**
**8.1 Pregnancy**
No adequate studies in pregnant women; potential risks to the fetus are unknown. 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.
**8.5 Geriatric Use**
Limited data available; monitor for age-related organ dysfunction, particularly musculoskeletal or immune issues.

**9 DRUG ABUSE AND DEPENDENCE**
No evidence of abuse or dependence potential with TB-500, but misuse for performance enhancement may occur. Monitor for inappropriate use.

**10 OVERDOSAGE**
No specific data on overdose; symptoms may include exaggerated fatigue or injection site reactions. Treat symptomatically and discontinue use immediately.

**11 DESCRIPTION**
TB-500 contains thymosin beta-4, a synthetic peptide that promotes tissue repair and reduces inflammation. It is supplied as a white lyophilized powder, soluble in bacteriostatic water for injection. Each vial contains 5 mg thymosin beta-4, with mannitol as a stabilizer. Half-life: Approximately 2 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**
Thymosin beta-4 promotes cell migration, angiogenesis, and tissue repair, reducing inflammation and supporting recovery.
**12.3 Pharmacokinetics**
Absorbed after subcutaneous or intramuscular injection; half-life approximately 2 days; metabolized and excreted primarily via urine.

**13 NONCLINICAL TOXICOLOGY**
Limited data available; animal studies suggest low toxicity. No human carcinogenicity data available.

**16 HOW SUPPLIED/STORAGE AND HANDLING**
5 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*