How to Reconstitute Egrifta (Tesamorelin): Step-by-Step Guide

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Which Egrifta do you have?

Egrifta (tesamorelin acetate) was first approved on November 10, 2010, as application BLA 022505 [3]. The two versions now labeled are Egrifta SV, a 2 mg vial, and Egrifta WR, an 11.6 mg vial; both labels are dated July 29, 2026, and both are once-daily subcutaneous injections [1][2].

The Egrifta WR label says directly that Egrifta WR and Egrifta SV are not substitutable, and that the two differ in dose, in how many vials are needed to prepare a dose, in reconstitution instructions and in storage requirements [2]. That is why the instructions below are split by product.

Both products share the same approved use: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy [1][2]. The label states that long-term cardiovascular safety has not been established, that the drug is not indicated for weight loss management (its effect on weight is neutral), and that there are no data showing improved adherence to antiretroviral therapy [1].

Reconstituting Egrifta SV, step by step

The Egrifta SV label gives the mixing sequence in its dosage section [1]:

1. Use only the diluent provided in the box, Sterile Water for Injection [1].
2. Add 0.5 mL of that diluent to one vial of Egrifta SV lyophilized powder. The label describes the resulting solution as 2 mg per 0.5 mL [1].
3. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake [1].
4. Inspect the vial visually for particulate matter and discoloration. The label says to use it only if the solution is clear, colorless and free of particles [1].
5. Administer 0.35 mL immediately after reconstitution [1].
6. Throw away any unused solution and diluent. The label says that if the dose is not used immediately, the reconstituted solution is discarded, and it says not to freeze or refrigerate the reconstituted solution [1].

Both labels direct patients to read the Instructions for Use enclosed in the medication box [1][2].

Reconstituting Egrifta WR, step by step

The Egrifta WR label gives a different sequence [2]:

1. Use only the diluent provided, Bacteriostatic Water for Injection, USP [2].
2. Add 1.3 mL of that diluent to one vial of Egrifta WR lyophilized powder. The label describes the resulting solution as 8 mg per mL [2].
3. Move the vial in a circle (swirl) to mix all the powder and liquid. Do not shake [2].
4. Inspect the vial. Egrifta WR is a clear, colorless solution; the label says not to use it if solid particles appear or if the solution is cloudy or colored [2].
5. Inject 0.16 mL (1.28 mg) subcutaneously once daily. One reconstituted vial provides daily doses for 7 days, and unused solution is discarded 7 days after mixing [2].

How many milligrams is one dose?

The current labels do not use a 2 mg dose. Egrifta SV is 1.4 mg and Egrifta WR is 1.28 mg, each injected once daily [1][2]. The 2 mg daily dose belongs to the original 1 mg-per-vial product used in the pivotal trials. The Egrifta SV label says its effectiveness was established from studies of that original product plus a demonstration of comparable bioavailability between the 1.4 mg SV dose and the 2 mg dose [1].

Both labels express the dose as a volume of the mixed solution: 0.35 mL for Egrifta SV and 0.16 mL for Egrifta WR [1][2].

Where the injection goes

Both labels say to inject into the abdomen and to rotate injection sites to different areas of the abdomen, and not to inject into scar tissue, bruises or the navel [1][2].

Injection-site reactions are common. In the combined trial data, injection-site reactions (erythema, itching, rash, hives, pain, swelling, irritation and bleeding) occurred in 25% of tesamorelin-treated patients and 14% of placebo-treated patients during the first 26 weeks [1]. The label says rotating injection sites decreases injection site reactions [1].

What the labels say to watch for

Hypersensitivity reactions occurred in 4% of patients treated with Egrifta 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 a hypersensitivity reaction is suspected [1].

The Egrifta SV and Egrifta WR labels also warn about increased risk of neoplasms, elevated IGF-1 (with monitoring during therapy), fluid retention including edema, joint pain and carpal tunnel syndrome, and glucose intolerance or diabetes. In the trials, HbA1c of 6.5% or higher developed in 5% of tesamorelin-treated patients versus 1% on placebo by week 26, a hazard ratio of 3.3 (95% CI 1.4 to 9.6) [1]. Among patients treated for 26 weeks, 47% had IGF-1 above 2 SDS and 36% above 3 SDS; among those treated 52 weeks, 34% and 23% [1].

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