How to Store Forzinity (Elamipretide) Vials
[Storage · Forzinity]

How to store Forzinity (elamipretide)

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

Short answer: Keep unopened Forzinity vials in the fridge at 36°F to 46°F (2°C to 8°C) and do not freeze them. After the first dose, an opened vial can stay in the fridge or at room temperature between 68°F and 77°F (20°C to 25°C). Throw it away 8 days after first opening, even if medicine is left. Source: Forzinity label, section 16.2 and Instructions for Use.

What does the Forzinity label say?

Section 16.2: “Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F). Discard vials 8 days after first opening.”

Forzinity US prescribing information, sections 16.1 and 16.2, and Instructions for Use.
QuestionLabel answer
Unopened vialsRefrigerated at 2°C to 8°C (36°F to 46°F)
Unopened vials at room temperatureNot stated
Opened vials (after the first dose)Refrigerated 2°C to 8°C (36°F to 46°F) or room temperature 20°C to 25°C (68°F to 77°F)
Throw away8 days after first opening, even if some medicine is still left
FreezingDo not freeze
LightNot stated
PackCarton of four 280 mg/3.5 mL (80 mg/mL) single-patient-use vials
PreservativeBenzyl alcohol

What do the Instructions for Use add?

Storing Forzinity: “Store unused vials of FORZINITY in the refrigerator between 36°F to 46°F (2°C to 8°C).” “After the first dose, store opened vials in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 68°F to 77°F (20°C to 25°C).” “Throw away FORZINITY vials 8 days after first opening, even if some medicine is still left in the vial.”

  • When you open a new vial, let it sit at room temperature for at least 10 minutes, write the “Discard After” date on the vial, and put the carton with the unused vials back in the fridge.
  • An opened vial kept in the fridge also sits at room temperature for at least 10 minutes before each dose.
  • Do not use it past the expiration date or the “Discard After” date you wrote. The liquid should be clear, colorless to yellow; do not use it if it is discolored or cloudy, or has lumps, flakes or particles, if the glass is cracked, or if the plastic cap on a new vial is broken or missing.

The label calls the vials “single-patient-use”, and the Instructions for Use say a vial “contains enough medicine for more than 1 dose.” Section 11 says each 0.5 mL dose contains 40 mg of elamipretide and 10 mg of benzyl alcohol as a preservative.

Does this apply to research SS-31?

No. These figures belong to Forzinity, an FDA-approved, ready-to-use solution. They do not transfer to research SS-31 vials, which have no label. The general guides cover how long mixed peptides last and what is known when there is no label.

Dosing and side effects: Forzinity dosing schedule, missed a Forzinity dose and Forzinity side effects.

How do you travel with it?

An opened vial may travel at room temperature between 68°F and 77°F (20°C to 25°C) within its 8 days. The label gives no room-temperature time for unopened vials, so they stay cold, and it says do not freeze.

  • 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 Forzinity need to be refrigerated?+
Unopened vials, yes: 36°F to 46°F (2°C to 8°C), not frozen. After the first dose, an opened vial can be kept in the fridge or at room temperature between 68°F and 77°F (20°C to 25°C).
How long does an opened Forzinity vial last?+
8 days after first opening. The label says throw it away then, even if some medicine is still left in the vial.
Can unopened Forzinity be left out of the fridge?+
The label does not say. It gives a room-temperature option only for opened vials, after the first dose.
Can I freeze Forzinity?+
No. The label says do not freeze.