How to Reconstitute Egrifta (Tesamorelin): Storage Stability After Mixing

The answer depends on which Egrifta box you have

Mixing and storage instructions differ between the two current Egrifta products, and the labels say the two are not substitutable [2].

Egrifta SV is a 2 mg vial. It is reconstituted with 0.5 mL of the Sterile Water for Injection provided with the kit, which gives 2 mg per 0.5 mL, and the daily dose is 1.4 mg, drawn as 0.35 mL [1]. Egrifta WR is an 11.6 mg vial. It is reconstituted with 1.3 mL of Bacteriostatic Water for Injection to 8 mg per mL, and the daily dose is 1.28 mg, drawn as 0.16 mL [2].

So "how long does mixed Egrifta keep" has two answers: the SV label allows no hold time, and the WR label allows seven days.

Egrifta SV: mix, inject, discard

The Egrifta SV label says to use only the diluent provided, Sterile Water for Injection. It describes reconstituting one vial of lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL) and mixing by gently rolling the vial in the hands for 30 seconds, without shaking. The label says the solution should be inspected and used only if it is clear, colorless and free of particles. It says the 0.35 mL (1.4 mg) dose is administered immediately after reconstitution and that any unused solution and diluent are thrown away [1].

On storage after mixing, the label says to discard the reconstituted solution if it is not used immediately and not to freeze or refrigerate it [1]. In practice that means one vial makes one dose, with no carry-over to the next day.

Egrifta WR: one vial, seven doses

Egrifta WR is built for a week of dosing from a single vial. The label says to reconstitute one 11.6 mg vial with 1.3 mL of Bacteriostatic Water for Injection, which gives 8 mg per mL; the vial is moved in a circle to swirl the powder and liquid, and the label says not to shake it [2]. The solution is described as clear and colorless, and the label says not to use it if solid particles appear or if it is cloudy or colored [2].

One reconstituted vial provides daily doses for 7 days, and unused solution is discarded 7 days after mixing [2]. The daily dose is 1.28 mg, or 0.16 mL of the 8 mg per mL solution, injected subcutaneously into the abdomen once daily [2].

The WR diluent, Bacteriostatic Water for Injection, contains benzyl alcohol [2]. The SV label names Sterile Water for Injection as the only diluent to use [1], while Bacteriostatic Water for Injection is the labeled diluent for Egrifta WR [2].

Injection technique the labels specify

Both labels say to inject into the abdomen and to rotate injection sites to different areas, and neither allows injection into scar tissue, bruises or the navel [1][2].

Injection-site reactions occurred in 25% of tesamorelin-treated patients and 14% of placebo-treated patients during the first 26 weeks of the trials, and the label says rotating sites decreases them [1]. Hypersensitivity reactions occurred in 4% of patients treated with tesamorelin in clinical trials and included itching, redness, flushing, hives and rash; the label advises patients to seek prompt medical attention and to discontinue treatment if such a reaction is suspected [1].

Compounded tesamorelin is a different product

Egrifta's only approved use is reduction of excess abdominal fat in HIV-infected adults with lipodystrophy [1]. Compounded tesamorelin is not Egrifta: compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness or quality before they reach patients [3]. FDA has not placed tesamorelin on its list of bulk substances that may present significant safety risks, and tesamorelin appears in no category of FDA's lists for state-licensed pharmacies and physicians or for outsourcing facilities, so FDA has made no category-based statement about compounding it [4][5][6]. The seven-day instruction above comes from the Egrifta WR label and applies to that product only [2].