Important Note on Tesamorelin Formulations
It is critical to understand that there are no FDA-approved 10 mg tesamorelin products. The brand-name drug, Egrifta, is approved in different dosages (2 mg for EGRIFTA SV and 11.6 mg for EGRIFTA WR) for HIV-related lipodystrophy. This guide specifically addresses the reconstitution of 10 mg tesamorelin, which is typically a compounded or research-grade peptide and requires the use of bacteriostatic water for multi-dose viability. Always follow the specific instructions from your prescribing clinic or research provider.
Materials Needed for Reconstitution
Before beginning, gather all required materials to ensure a smooth and sterile process:
- One vial of tesamorelin (10 mg) in lyophilized (freeze-dried) powder form.
- Bacteriostatic water for injection (the recommended diluent for multi-use peptides).
- Syringe for mixing (e.g., 2.5 mL or 3 mL) with an attached needle.
- Insulin syringe(s) for drawing and injecting individual doses.
- Alcohol preparation pads for sanitation.
- A sharps container for safe disposal of used needles and syringes.
Step-by-Step Instructions to Reconstitute Tesamorelin 10 mg
Follow these steps carefully to ensure the peptide is mixed properly and remains stable for administration:
1. Sanitize Your Workspace
Thoroughly wash your hands with soap and water. Clean your work surface and lay out all materials. Put on sterile gloves if available, though proper aseptic technique with clean hands is also acceptable for self-administration.
2. Prepare the Vials
Remove the plastic cap from both the tesamorelin powder vial and the bacteriostatic water vial. Take an alcohol prep pad and vigorously scrub the rubber stopper of each vial for several seconds. Allow the stoppers to air dry completely to prevent alcohol from contaminating the solution. Do not touch the stoppers after cleaning.
3. Withdraw the Diluent
Using the mixing syringe, pull back the plunger to draw air equal to the amount of bacteriostatic water you intend to inject into the tesamorelin vial (e.g., 2 mL). Carefully insert the needle into the bacteriostatic water vial and inject the air. Invert the vial and withdraw the desired amount of bacteriostatic water by slowly pulling back the plunger.
4. Inject the Diluent into the Peptide
Insert the needle into the tesamorelin powder vial. Aim the needle so that the tip is directed at the glass wall of the vial, not directly onto the powder. Slowly and steadily push the plunger to inject the bacteriostatic water. This technique helps prevent foaming, which can damage the delicate peptide molecules. The vacuum seal may pull the water into the vial automatically.
5. Mix the Solution
With the needle and syringe still attached to the vial, gently roll the vial between your hands for 30 seconds. Do not shake the vial, as this can denature the peptide. Continue to roll the vial until the white powder is completely dissolved and the solution is clear and colorless, without any particles. Some formulations may take a few minutes to fully dissolve.
6. Store the Reconstituted Vial
Remove the mixing syringe and recap the vial. Immediately place the reconstituted tesamorelin vial in a refrigerator (between 2–8°C or 36–46°F), away from light. Reconstituted peptides are more fragile and have a limited lifespan compared to their lyophilized form.
Dosage Calculation for a 10 mg Vial
When reconstituting with a specific amount of bacteriostatic water, the resulting concentration will determine how to measure doses using an insulin syringe. For example, if 2 mL of bacteriostatic water is used to reconstitute 10 mg of tesamorelin, the concentration is 5 mg/mL. A 100-unit insulin syringe typically has 1 mL divided into 100 units.
- Remember: Always consult your healthcare provider or prescribing clinic for specific dosage recommendations and instructions on how to measure your required dose based on the reconstitution volume you use.
Comparison of Tesamorelin Formulations
Understanding the differences between formulations is vital for correct handling and administration.
Feature | Compounded/Research (10 mg) | EGRIFTA SV (2 mg) | EGRIFTA WR (11.6 mg) |
---|---|---|---|
Approval Status | Not FDA-approved for human use | FDA-approved | FDA-approved |
Diluent | Bacteriostatic Water | Sterile Water for Injection | Bacteriostatic Water |
Concentration (after mixing) | Depends on diluent volume | 2 mg/0.5 mL (4 mg/mL) | 8 mg/mL (with 1.3 mL) |
Reconstitution Frequency | As needed (e.g., weekly) | Daily | Weekly |
Storage After Mixing | Refrigerated (2–8°C); typical use within ~30 days | Use immediately; do not refrigerate | Room temp (20–25°C); use within 7 days |
Safe Injection and Post-Reconstitution Handling
After successfully reconstituting the peptide, observe the following safe practices:
- Inspect the solution: Always visually inspect the reconstituted solution before each injection. It should be clear, colorless, and free of any particulate matter. If it appears cloudy, discolored, or contains solid particles, do not use it.
- Rotate injection sites: For subcutaneous injections, rotate sites on the abdomen away from the navel. Avoid injecting into areas that are scarred, bruised, or hardened from previous injections to minimize irritation.
- Dispose of sharps: Used needles and syringes should be placed immediately into a designated sharps container to prevent accidental needle sticks.
- Protect from light: Keep the reconstituted vial protected from direct light to help maintain its stability.
Conclusion
Reconstituting tesamorelin 10 mg requires careful attention to detail and a strict commitment to aseptic technique. While not an FDA-approved formulation, this compounding or research-grade peptide can be safely mixed using bacteriostatic water and stored in a refrigerator for a limited period, typically up to 30 days. Always verify the correct diluent and volume with your prescribing clinic or provider, and be mindful of the significant differences from commercially available products like Egrifta SV or WR. By following these guidelines, you can ensure accurate dosing and maximum potency of your peptide solution. For further information and patient resources on tesamorelin, refer to authoritative sources such as MedlinePlus and Drugs.com.