TB-500 Adverse Effects
Critical Safety Information
TB-500 (N-acetylated LKKTETQ peptide) can cause hypersensitivity reactions including life-threatening anaphylaxis, particularly after repeated injections, with documented cases of collapse and death. 1
Documented Adverse Reactions
Severe/Life-Threatening Effects
- Anaphylactic reactions - especially with repeated administration 1
- Cardiovascular collapse and death - reported in susceptible individuals 1
- Pulmonary edema 1
- Angioneurotic edema 1
- Cyanosis 1
Common Adverse Effects
- Hypersensitivity manifestations: warmth sensation, pruritus, urticaria 1
- Autonomic symptoms: sweating, weakness, restlessness 1
- Gastrointestinal effects: nausea, gastrointestinal hemorrhage 1
- Respiratory symptoms: throat tightness 1
- Local injection site reactions: tenderness and induration following intramuscular administration 1
Important Clinical Context
Metabolism and Detection
- TB-500 undergoes extensive metabolism, with Ac-LK as the primary metabolite detected at highest concentrations 0-6 hours post-administration 2
- Ac-LKK serves as a long-term metabolite detectable up to 72 hours 2
- The metabolite Ac-LKKTE demonstrates significant wound healing activity, suggesting therapeutic effects may be attributable to metabolites rather than the parent compound 2
Cytotoxicity Profile
- No cytotoxicity was observed for TB-500 or its metabolites in fibroblast studies 2
Critical Monitoring Considerations
Patients with history of hypersensitivity reactions should not receive TB-500, as repeated exposure increases anaphylaxis risk 1. Healthcare providers must be prepared for immediate management of anaphylactic reactions, particularly in settings where repeated dosing occurs 1.
The severity spectrum ranges from minor local reactions to fatal systemic responses, making careful patient selection and monitoring essential 1.