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What to mix Tesamorelin with?: An Essential Guide to Safe Reconstitution

3 min read

According to the FDA's prescribing information, Tesamorelin (EGRIFTA SV®) must be reconstituted exclusively with the specific Sterile Water for Injection provided with the medication. Following these precise instructions for what to mix Tesamorelin with is critical for ensuring the drug's safety and effectiveness.

Quick Summary

Tesamorelin must be reconstituted with the specific diluent included in its kit, which may be Sterile Water for Injection or Bacteriostatic Water depending on the formulation. Correct preparation involves careful, gentle mixing, not shaking, to maintain potency and safety. Failure to follow the manufacturer’s precise instructions or using an incorrect diluent can render the medication unsafe or ineffective.

Key Points

  • Use Only Provided Diluent: Tesamorelin must be mixed exclusively with the Sterile Water or Bacteriostatic Water included with the medication kit.

  • Do Not Substitute: Using any liquid other than the approved diluent can render the medication unsafe or ineffective.

  • Never Shake: The Tesamorelin vial should be gently rolled between the hands to dissolve the powder, as shaking can damage the peptide.

  • Different Diluents for Formulations: Daily EGRIFTA SV® uses Sterile Water and must be used immediately, while weekly EGRIFTA WR® uses Bacteriostatic Water and can be stored.

  • Discard Unused Medication: The reconstituted solution for the daily EGRIFTA SV® must be discarded, as it is a single-use preparation.

  • Maintain Sterility: Always use an aseptic technique with new, sterile syringes and needles for every dose to prevent infection.

  • Inspect the Solution: Before injection, check the mixed solution; it should be clear, colorless, and free of particles. Do not use if it is cloudy or discolored.

In This Article

Using Only the Manufacturer-Provided Diluent

The most important rule when preparing Tesamorelin for injection is to use only the diluent provided with the product. Depending on the specific formulation you have been prescribed, this will be either Sterile Water for Injection or Bacteriostatic Water for Injection. The manufacturer includes this specific diluent for a reason: it is tested to be compatible with the lyophilized (freeze-dried) powder, ensuring stability, potency, and safety. Substituting with any other liquid, including other types of sterile water or saline, can compromise the drug's effectiveness or introduce harmful contaminants.

EGRIFTA SV® (Daily Formulation)

For the daily 1.4 mg dose of EGRIFTA SV®, the manufacturer provides Sterile Water for Injection as the diluent. This single-dose diluent is mixed with the Tesamorelin powder immediately before administration. Any leftover reconstituted solution must be discarded, as this form is not preserved for multi-day use.

EGRIFTA WR® (Weekly Formulation)

For the weekly EGRIFTA WR® formulation, the diluent provided is Bacteriostatic Water for Injection. The bacteriostatic agent (typically benzyl alcohol) allows the reconstituted vial to be stored for up to 7 days, providing enough doses for the entire week. It is essential to use this specific diluent and not substitute with non-preserved sterile water, which would require the reconstituted solution to be used immediately and discarded.

The Reconstitution Process: A Step-by-Step Guide

Preparing Tesamorelin involves a precise, careful process to ensure the peptide's integrity. Always follow your healthcare provider's instructions and the detailed guide provided in the medication box.

  1. Gather Supplies: Ensure you have the tesamorelin vial, the correct diluent vial, a syringe, and alcohol swabs.
  2. Sterilize Vials: Clean the rubber stoppers of both the diluent and tesamorelin vials with alcohol swabs.
  3. Draw Diluent: Using the syringe, draw the exact amount of diluent specified in your instructions. For EGRIFTA SV®, this is 0.5 mL. For EGRIFTA WR®, this is 1.3 mL.
  4. Inject Diluent: Slowly inject the diluent into the tesamorelin vial. Angle the needle to let the water run down the side of the vial to prevent foaming, which can damage the peptide.
  5. Gently Mix: Do not shake the vial. Shaking can degrade the sensitive peptide molecule. Instead, gently roll the vial between your hands for 30 seconds until the powder is completely dissolved. The resulting solution should be clear and colorless.
  6. Withdraw Dose: Draw the prescribed amount of the mixed solution into the syringe for injection.
  7. Store (if applicable): If using EGRIFTA WR®, the reconstituted vial can be stored for the week at room temperature as instructed. If using EGRIFTA SV®, discard any unused solution and the vial immediately.

Comparison of Tesamorelin Formulations and Diluents

Feature EGRIFTA SV® (Daily) EGRIFTA WR® (Weekly)
Diluent Used Sterile Water for Injection Bacteriostatic Water for Injection
Purpose of Diluent Single-use sterile dilution Multi-use, preserved dilution
Storage of Mixed Vial Discard immediately after use Can be stored for up to 7 days
Mixing Volume Reconstitute 2 mg vial with 0.5 mL diluent Reconstitute 1 vial with 1.3 mL diluent
Frequency of Reconstitution Every day, before each dose Once per week

The Dangers of Improper Mixing

Using an incorrect diluent or improper mixing technique poses significant risks. First, it can lead to a less potent or inactive medication, meaning the patient will not receive the full therapeutic effect. Second, using non-sterile liquids can introduce bacteria, leading to a dangerous infection at the injection site or even systemically. Finally, shaking the solution vigorously can cause the peptide to denature and lose its therapeutic properties. Always adhere to the precise instructions to ensure the medication works as intended and is safe to use.

Conclusion: Prioritizing Safety in Tesamorelin Preparation

To summarize, knowing what to mix Tesamorelin with is non-negotiable for safe and effective treatment. Whether you are using the daily EGRIFTA SV® with Sterile Water for Injection or the weekly EGRIFTA WR® with Bacteriostatic Water for Injection, the golden rule remains the same: follow the manufacturer's exact instructions and only use the provided diluent. Avoid all substitutions and ensure gentle mixing to preserve the delicate peptide structure. Following these steps helps safeguard your health and maximizes the benefits of your medication. For additional guidance, always consult the official manufacturer's instructions or your prescribing physician.

For more detailed information and patient guides, see the official EGRIFTA SV® website at hcp.egriftasv.com.

Frequently Asked Questions

The manufacturer includes a specific diluent based on the formulation. The daily EGRIFTA SV® uses single-dose Sterile Water, while the weekly EGRIFTA WR® uses Bacteriostatic Water, which contains a preservative for multi-day storage. Using the wrong one can compromise sterility or medication stability.

Tesamorelin is a delicate peptide molecule. Vigorously shaking the vial can cause the peptide to denature or break down, reducing its therapeutic effectiveness. The gentle rolling method is used to dissolve the powder safely.

No, you should never use saline or any other liquid to mix Tesamorelin. Only use the specific diluent (Sterile Water or Bacteriostatic Water) provided by the manufacturer to ensure the medication remains safe and potent.

Storage depends on the formulation. The daily EGRIFTA SV® mixed solution must be used immediately and discarded. The weekly EGRIFTA WR® mixed solution can be stored at room temperature (20-25°C or 68-77°F) for up to 7 days.

Contact your prescribing physician or pharmacist immediately. The diluent is a critical part of your prescription and must be used for safe administration. Never attempt to use a substitute.

After mixing, visually inspect the solution. It should be clear, colorless, and free of any visible particles. If it appears cloudy, discolored, or has particles, do not use it and contact your healthcare provider.

Only if you are using the EGRIFTA WR® weekly formulation, which is specifically designed with a preservative for multi-dose use over 7 days. Once opened, any Bacteriostatic Water vial should be discarded after 28 days.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.