How to Store Imcivree (Setmelanotide) Vials
[Storage · Imcivree]

How to store Imcivree (setmelanotide)

Quoted from the US label · Unopened vs in use · Travel · Sources · Reviewed

Short answer: Store unopened Imcivree vials in the fridge at 36-46°F (2-8°C), in the carton. After leaving the fridge, a vial may be kept anywhere from 36°F to 77°F (2-25°C) for up to 30 days, with brief excursions to 86°F (30°C). Once a vial is punctured, discard it after 30 days. Throw away Imcivree stored above 86°F. Source: Imcivree label, section 16, Table 19.

What does the Imcivree label say?

Section 16: “Store unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. After removal from the refrigerator, vials may be kept at temperatures ranging from refrigerated to room temperature (2°C to 25°C [36°F to 77°F]) for up to 30 days with brief excursions up to 30°C (86°F). After the vial is punctured (opened), discard after 30 days.”

Imcivree US prescribing information, Table 19 (10 mg/mL, 1 mL multiple-dose vial).
StorageUnopened vialOpened vial
36-46°F (2-8°C)Until the expiration dateUp to 30 days, or expiry if sooner
36-77°F (2-25°C), excursions to 86°FUp to 30 days, or expiry if soonerUp to 30 days, or expiry if sooner
Above 86°F (30°C)Discard and do not useDiscard and do not use

How do you handle an Imcivree vial day to day?

Section 2.5: take it out of the fridge about 15 minutes before injecting, or roll the vial gently between your palms for 60 seconds. Keep opened and unopened vials in the carton to protect them from light. Vials may go back into the fridge.

Setmelanotide is a melanocortin-4 receptor agonist, related in class to bremelanotide. The reconstitution calculator can convert mg to syringe units for a 10 mg/mL solution.

What if Imcivree got too warm?

Instructions for Use: “Throw away IMCIVREE that has been stored above 86°F (30°C).” Also throw away a vial 30 days after it first left the fridge, even if never opened.

How do you travel with it?

Imcivree can travel between 36°F and 77°F (2-25°C) for up to 30 days, which covers most trips without a fridge. Keep it in the carton and away from hot cars.

  • TSA allows medically necessary liquids over 3.4 oz in carry-on bags; declare them at the checkpoint for inspection.
  • Unused syringes and pen needles are allowed when they travel with the injectable medicine.
  • Ice packs and gel packs that keep medicine cool may go through frozen, partly frozen or melted.
  • Keep medicine in your carry-on, not checked luggage, where you cannot control the temperature. Do not let it touch an ice pack directly, since most labels say do not freeze.

More in the travel guide.

Quoted from the current US label on DailyMed, not personalized advice. Labels change; the leaflet in your own carton, your pharmacist and your prescriber are the final word on how to store it.

Frequently asked questions

Does Imcivree need to be refrigerated?+
Unopened vials are stored refrigerated, but may be kept at 36-77°F (2-25°C) for up to 30 days after leaving the fridge.
How long is an opened Imcivree vial good for?+
Discard it 30 days after it is first punctured, or at expiry if sooner.
What if Imcivree got hotter than 86°F?+
The label says throw it away.