EGRIFTA SV Solution for injection Ref.[108542] Active ingredients: Tesamorelin

2.1 Dosage and Administration

• The dosage and administration recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin for injection) 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.
• The dose of EGRIFTA SV is 1.4 mg, 0.35 mL of the reconstituted solution [see Dosage and Administration (2.2)], injected subcutaneously once daily.
• Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen [see Warnings and Precautions (5.5)]. Do not inject into scar tissue, bruises or the navel.

2.2 Reconstitution Procedure

• Instruct patients to read the Instructions for Use enclosed in the EGRIFTA SV Medication Box.
• Use only the diluent provided, Sterile Water for Injection, USP, to reconstitute EGRIFTA SV.
• Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL). Mix by rolling the vial gently in your hands for 30 seconds. Do not shake.
• Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter.
• Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. If not used immediately, discard the reconstituted solution. Do not freeze or refrigerate the reconstituted solution.

Protect EGRIFTA SV from light and keep in the original box until time of use. Store EGRIFTA SV 2 mg/vial up to 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store the Sterile Water for Injection, USP, syringes and needles at controlled room temperature of 20°C to 25°C (68°F to 77°F).