Tesamorelin (20mg Vial) Dosage Protocol

Tesamorelin (20 mg Vial) Dosage Protocol

Quickstart Highlights

Tesamorelin (a GHRH analog) is administered as a once-daily subcutaneous injection. Two clinically referenced daily regimens appear in the literature and labeling history.

  • Standard (Current label-based): 1.4 mg once daily (EGRIFTA SV® formulation)
  • Alternative (Legacy trials): 2 mg once daily (earlier studies/initial labeling)
  • Reconstitute the 20 mg research vial with 3 mL to keep syringe measurements practical (≈6.67 mg/mL)
  • After reconstitution (storage depends on formulation):

    Multi-dose BAC system (WR-like): may be kept at room temperature (20–25 °C) for up to 7 days; do not refrigerate.

    Single-dose (SV-like): use immediately after mixing; do not store or refrigerate; discard unused solution.

  • Unmixed vials: store at controlled room temperature and protect from light (follow product-specific guidance).
Tesamorelin Vial

Dosing & Reconstitution Guide

Educational guide for reconstitution and dosing protocol

Standard / Gradual Approach — Label-Based (3 mL = ≈6.67 mg/mL)

Week Daily Dosage Units (mL) per injection
Weeks 1–12 1.4 mg (1400 mcg) once daily (7×/week) 21 units (0.21 mL)
Weeks 13–16 (Optional) 1.4 mg once daily (7×/week) 21 units (0.21 mL)

Reconstitute a 20 mg vial with 3.0 mL to yield ≈6.67 mg/mL. Each 1.4 mg dose equals ~0.21 mL (21 units) on a 100-unit insulin syringe (≥10 units target achieved).

  1. Using aseptic technique, draw 3.0 mL diluent (Sterile or Bacteriostatic Water, per lab SOP).
  2. Direct the stream down the vial wall; gently swirl to dissolve (avoid vigorous shaking/foaming).
  3. After mixing:

    • If using a multi-dose BAC system (WR-like), keep at room temperature (20–25 °C) and use for up to 7 days; do not refrigerate; discard after day 7.

    • If using a single-dose system (SV-like), administer immediately; do not store or refrigerate; discard any unused solution.

Advanced / Aggressive Approach — Legacy Trials (3 mL = ≈6.67 mg/mL)

Week Daily Dosage Units (mL) per injection
Weeks 1–12 2 mg (2000 mcg) once daily (7×/week) 30 units (0.30 mL)
Weeks 13–16 (Optional) 2 mg once daily (7×/week) 30 units (0.30 mL)

This higher-dose regimen reflects earlier clinical trials/initial labeling. With the same 3.0 mL reconstitution (≈6.67 mg/mL), each 2 mg dose equals ~0.30 mL (30 units), maintaining practical syringe readability.

  1. Reconstitute with 3.0 mL as above for easy measurement (units ≥10).
  2. Gently swirl until clear; avoid foaming.
  3. After mixing:

    WR-like multi-dose: room temperature use for up to 7 days; do not refrigerate; discard after day 7.

    SV-like single-dose: inject immediately; do not store or refrigerate; discard remainder.

Note: Two evidence-based daily regimens are described: 1.4 mg once daily (current SV labeling) and 2 mg once daily (legacy trials). Select one; do not combine. This educational guide is not medical advice.

Supplies Needed

Estimate vials based on your chosen regimen and cycle length (daily injections, 7×/week).

  • Peptide Vials (20 mg each):

    1.4 mg daily — 8 wks (56 days) ≈ 4 vials; 12 wks (84 days) ≈ 6; 16 wks (112 days) ≈ 8

    2 mg daily — 8 wks ≈ 6 vials; 12 wks ≈ 9; 16 wks ≈ 12

  • Insulin Syringes: 1 per injection (e.g., 56 for 8 weeks of daily use)
  • Bacteriostatic Water: 10 mL vials (for reconstitution). Note: Storage after mixing depends on system: WR-like up to 7 days at room temp; SV-like immediate use only.
  • Alcohol Swabs: For vial stoppers and skin prep

Protocol Overview

Evidence supports once-daily subcutaneous dosing of tesamorelin for ≥8–12 weeks.

  • Goal: Reduce visceral adipose tissue and improve metabolic parameters
  • Schedule: Daily injections (choose either 1.4 mg or 2 mg)
  • Dose Range: 1.4 mg (SV label) or 2 mg (legacy trials)
  • Reconstitution: Prefer 3 mL for practical measurement (21–30 units per dose)
  • Storage after mixing: WR-like multi-dose — up to 7 days at room temp; SV-like single-dose — use immediately; in both, do not refrigerate reconstituted solution.

Dosing Protocol

Choose one daily regimen and remain consistent.

  • Regimen A (Standard): 1.4 mg once daily (7×/week)
  • Regimen B (Alternative): 2 mg once daily (7×/week)
  • Cycle Length: Commonly 8–12 weeks; may extend to 16+ weeks based on goals/tolerance
  • Timing: Consistency matters; morning or evening is acceptable per SOP

Storage Instructions

Follow formulation-specific instructions; do not refrigerate reconstituted tesamorelin.

  • Unmixed (lyophilized) vials: Store at controlled room temperature (≈20–25 °C / 68–77 °F), protected from light in original packaging.
  • After reconstitution:

    WR-like multi-dose (BAC): store at room temperature and use for up to 7 days; do not refrigerate; discard remaining solution after day 7.

    SV-like single-dose: use immediately; do not store or refrigerate; discard any unused solution.

  • Avoid temperature excursions and protect from light; never freeze reconstituted solution.

Important Notes

Key considerations when working with tesamorelin.

  • Use new, sterile insulin syringes; rotate injection sites (abdomen; avoid navel, scars, bruised areas).
  • Common reactions include injection-site redness/itching, arthralgia, edema, or paresthesias; monitor and seek professional advice for concerning symptoms.
  • Monitor glucose in those at risk; review contraindications (e.g., active malignancy) against official labeling.
  • Units shown assume a 100-unit insulin syringe; if a dose ever falls <10 units in other scenarios, consider 50- or 30-unit syringes for precision.

How This Works

Tesamorelin is a synthetic analog of growth hormone–releasing hormone (GHRH) that binds pituitary GHRH receptors, increasing pulsatile GH secretion and raising IGF-1. Clinical studies demonstrated reductions in visceral adipose tissue and favorable effects on certain metabolic markers in indicated populations.

  • Pathway: GHRH receptor activation → ↑ GH → ↑ IGF-1 → enhanced lipolysis and altered fat distribution
  • Key Outcomes: Reduced visceral fat; generally neutral glycemic control in long-term analyses; improvements in patient-reported abdominal appearance in HIV-associated lipodystrophy cohorts.

Potential Benefits & Side Effects

Observed in clinical research; individual responses vary.

  • Potential Benefits: Reduction in visceral adipose tissue; improvements in triglycerides and other lipid measures in some studies; increases in IGF-1.
  • Common Side Effects: Injection-site reactions, arthralgia/myalgia, edema, paresthesias; usually reversible upon dose adjustment or discontinuation.
  • Precautions: Not for active malignancy; consider pituitary axis conditions and glycemic status; review full safety information in official labeling.

Lifestyle Factors

Support favorable outcomes with fundamentals:

  • Prioritize a nutrient-dense diet with adequate protein; moderate added sugars and alcohol.
  • Incorporate resistance and aerobic training; ensure recovery and sleep hygiene.

Injection Technique

General subcutaneous administration considerations.

  • Clean vial stopper and skin with alcohol pads; use a fresh needle and syringe.
  • Pinch subcutaneous tissue; inject at 45–90° depending on needle length and body fat.
  • Inject slowly; apply gentle pressure after withdrawing the needle; do not rub.
  • Dispose of sharps properly; never reuse needles.

Important Note

This guide is for educational and research purposes only. It does not provide medical advice or directions for patient care. Always follow applicable regulations and consult qualified professionals.

References

  • EGRIFTA SV® Prescribing Information (tesamorelin 2 mg) — daily 1.4 mg; reconstitute and use immediately; do not refrigerate reconstituted solution
  • EGRIFTA WR™ Prescribing Information (2025) — multi-dose vial with BAC; one reconstituted vial provides daily doses for 7 consecutive days at room temperature
  • EGRIFTA SV® HCP — Reconstitution — “Once reconstituted, administer immediately”
  • EGRIFTA SV® HCP — Storage — store vials at room temperature; no refrigeration required (pre-mix)
  • Drugs.com — Tesamorelin / EGRIFTA WR — patient storage note: discard unused WR after 7 days; room-temperature storage
  • Infectious Disease Advisor (2025) — WR formulation overview; not substitutable with SV; room-temperature storage after reconstitution
  • N Engl J Med (Falutz et al., 2007) — randomized trial showing VAT reduction with daily tesamorelin
  • J Clin Endocrinol Metab (2010) — pooled/extension analyses of efficacy and safety
  • JAMA (2014) — effects on visceral and hepatic fat metrics
  • Lancet HIV (2019) — NAFLD/fibrosis outcomes with tesamorelin in HIV
  • Mayo Clinic — Tesamorelin — patient monograph; “use the mixed solution right away” (SV-like instruction)
  • FDA Label (2010 & 2019) — historical SV labeling indicating immediate use and no refrigeration after mixing