How to Reconstitute Egrifta (Tesamorelin) for Travel and Transport Without Losing Potency

Can you mix Egrifta before you travel?

For Egrifta SV, the label points to no. Its reconstitution section says to administer 0.35 mL immediately following reconstitution and throw away any unused solution and diluent. It adds that if the solution is not used immediately it should be discarded, and that the reconstituted solution should not be frozen or refrigerated [1].

Egrifta WR works on a different schedule. Its label allows one reconstituted 11.6 mg vial to provide daily doses for 7 days, with unused solution discarded 7 days after mixing [2].

How to reconstitute Egrifta SV

The Egrifta SV label specifies Sterile Water for Injection as the diluent and 0.5 mL of it for one 2 mg vial, giving 2 mg per 0.5 mL [1]. It directs patients to read the Instructions for Use in the medication box and to mix by rolling the vial gently in the hands for 30 seconds rather than shaking it. The solution is used only if it is clear, colorless and free of particulate matter [1]. The dose is 0.35 mL injected subcutaneously into the abdomen, rotating sites and avoiding scar tissue, bruises and the navel [1].

How to reconstitute Egrifta WR

The Egrifta WR label specifies Bacteriostatic Water for Injection as the diluent and 1.3 mL of it for one 11.6 mg vial, giving 8 mg per mL [2]. It says to move the vial in a circle (swirl) to mix all the powder and liquid, and not to shake it [2]. The reconstituted solution should be clear and colorless; the label says not to use it if solid particles appear or if it is cloudy or colored [2]. The labeled dose is 1.28 mg, or 0.16 mL, subcutaneously into the abdomen once daily, rotating sites and avoiding scar tissue, bruises and the navel [2]. One reconstituted vial provides daily doses for 7 days, and unused solution is discarded 7 days after mixing [2].

Sterile water or bacteriostatic water?

The right diluent depends on which product is in the box. Egrifta SV is reconstituted with Sterile Water for Injection [1]. Egrifta WR is reconstituted with Bacteriostatic Water for Injection, which contains benzyl alcohol [2]. Each label says to use only the diluent provided with that product [1][2].

The labels state that Egrifta WR and Egrifta SV are not substitutable and that they differ in dosage, the number of vials needed, reconstitution instructions, and storage requirements [2].

What to pack and what to expect at the airport

Each label refers patients to the Instructions for Use enclosed in that product's box and tells them to use only the diluent provided with it [1][2]. Because the two kits differ in vial strength, diluent and dose, the instructions and diluent from one product do not apply to the other [2].

TSA's TSA Cares program provides information on security screening procedures for passengers with disabilities and medical conditions [3]. For international trips, athletes should know that WADA names tesamorelin in section S2.2.4 of its Prohibited List, where it is prohibited at all times, in and out of competition [4].

Doses and volumes, side by side

Egrifta SV is given as 1.4 mg (0.35 mL of a 2 mg per 0.5 mL solution) once daily [1]. Egrifta WR is given as 1.28 mg (0.16 mL of an 8 mg/mL solution) once daily [2]. Each label describes comparable bioavailability between its dose and the 2 mg dose of the original Egrifta 1 mg/vial formulation, but the two products are not substitutable [1][2].

What about compounded tesamorelin?

The Egrifta SV and Egrifta WR instructions above come from the labels of those FDA-approved products. FDA states that compounded drugs are not FDA-approved, meaning FDA does not review their safety, effectiveness or quality before they reach patients [6].