Tesamorelin Overdose: A Product-and-Exposure Triage Record

The Direct Authority Answer Is Triage, Not a “Safe Excess”

The National Library of Medicine's tesamorelin monograph states:

“In case of overdose, call the poison control helpline at 1-800-222-1222.”

MedlinePlus is a U.S. government health-information service. Its instruction routes an exposure to real-time toxicology assessment; it does not define a toxic dose, predict a benign course, or endorse tesamorelin or HealthRX.com (MedlinePlus, “In case of emergency/overdose”).

The same monograph directs 911 for collapse, seizure, breathing difficulty, or inability to awaken. Those are emergency triage criteria, not claimed tesamorelin-specific symptoms.

The Exposure Record That Changes the Answer

This record is useful because Poison Control or an emergency clinician can update the plan as product details and symptoms become clearer. It is not a home-monitoring protocol.

What the Current Label Does—and Does Not—Supply

The March 2025 EGRIFTA WR prescribing information includes dosing, warnings, adverse reactions, drug interactions, and specific-population sections, but no section 10 overdosage instructions. The label does warn about hypersensitivity, glucose intolerance, elevated IGF-1, fluid retention, and injection-site reactions in ordinary labeled exposure (EGRIFTA WR prescribing information).

Those labeled hazards are clinically relevant questions after an error. Their therapeutic-dose incidence cannot be converted into an overdose probability, and the absence of a label section cannot be converted into proof of safety.

The pivotal evidence pooled 740 treated adults with HIV and abdominal lipodystrophy under controlled protocols; it was not an escalating-dose toxicology study (PMID 20554713; DOI 10.1210/jc.2010-0490).

Why the Formulation Error Matters

EGRIFTA WR uses an 11.6 mg multi-dose vial and a labeled 1.28 mg daily dose. EGRIFTA SV uses 2 mg single-dose vials and different preparation instructions. FDA-approved labeling says the formulations are not substitutable. A numeric comparison detached from the label, vial, and concentration can therefore magnify an error rather than clarify it.

The older-adult dosing evidence audit keeps formulation and population claims separate. The food and supplement interaction map organizes possible coexposures, while the levothyroxine interaction review shows why mechanism alone cannot establish a dose adjustment.

Figure 1

EGRIFTA WR or SV? The product decides what a syringe volume means

Text version of this diagram

1. Which product does the carton or vial label say?
   • EGRIFTA WR: 11.6 mg vial mixed with 1.3 mL of diluent; one mixed vial gives daily doses for 7 days. One dose is 1.28 mg in 0.16 mL.
   • EGRIFTA SV: 2 mg single-dose vial mixed with 0.5 mL. One dose is 1.4 mg in 0.35 mL.
   • No EGRIFTA label: Neither label applies: identity and strength are unknown.
2. Not substitutable: The label states that EGRIFTA WR and EGRIFTA SV are not substitutable. Mixed WR solution holds about 8 mg per mL and SV about 4 mg per mL, so the same volume of WR carries about twice as much tesamorelin.
3. What the labels say about overdose: Neither current label includes an overdosage section. MedlinePlus: for an overdose call Poison Control at 1-800-222-1222; for collapse, seizure, trouble breathing or not waking, call 911.
4. What to report: Product name, when and how the vial was mixed, the volume drawn, the time, symptoms so far, and other medicines.

Overdose Claims the Evidence Does Not Support

No cited human overdose series establishes that tesamorelin overdose is free of life-threatening toxicity, that a “ceiling effect” applies, that a short half-life limits severity, that any IGF-1 rise is only transient, or that a set monitoring schedule fits every exposure, and none defines a dose-response boundary.

The defensible conclusion is narrower: capture the exposure, use Poison Control for case-specific triage, and escalate emergency symptoms immediately. This page cannot clear an exposure or replace that assessment.

Medical review of this revision is pending. NLM, FDA, Poison Control, trial investigators, institutions, and authors do not endorse tesamorelin, HealthRX.com, or this page.