How to store Setmelanotide

Comes as: Imcivree ready-to-use 10 mg/mL solution in a 1 mL multiple-dose vial..

Mixed with: None. The approved product is a ready-to-use solution; do not add bacteriostatic water..

Common vial sizes: 10 mg. Common water amounts: mL.

• 10 mg in 1 mL is the labeled vial, not a powder mixing recipe.
• EU/UK: do not freeze; after opening keep at 2–30°C for no more than 28 days.
• US label, section 2.5: for labeled 0.5–3 mg doses, use a 1 mL syringe with a 28- or 29-gauge needle suited for subcutaneous injection.
• EU, 0.25 mg (0.025 mL): use a 0.3 mL syringe with 0.5-unit (half-unit) increments and a 29–31-gauge, 6–13 mm needle. EMA Table 12.
• EU, 0.5–3 mg (0.05–0.3 mL): use a 1 mL syringe with 0.01 mL increments and a 28–29-gauge, 6–13 mm needle. EMA Table 12.
• Warm for about 15 minutes outside the refrigerator or gently roll between palms for 60 seconds.
• Inspect for particles or abnormal discoloration. Each injection needs a new sterile needle and syringe.
• No reliable noncommercial source established common powder vial sizes, water volumes or mixed-product shelf life.

Before mixing: Unopened vial: 2–8°C in its carton until expiry. Outside refrigeration, 2–25°C for up to 30 days; brief excursions to 30°C allowed. Discard above 30°C.

After mixing: US vial: after first puncture, discard after 30 days or at expiry, whichever comes first. EU/UK vial: discard 28 days after opening. No mixing is needed.