Short answer: Before mixing, keep Serostim cartons, vials and diluent included, at room temperature, 59-86°F (15-30°C). A 4 mg vial mixed with its bacteriostatic water keeps in the fridge at 36-46°F (2-8°C) for up to 14 days. A 5 mg or 6 mg vial mixed with sterile water is used immediately and the rest discarded. Do not freeze mixed vials. Source: Serostim label, section 16.2.
Section 16.2: “Before reconstitution: Store cartons containing SEROSTIM vials and diluent vials at room temperature between 15°C to 30°C (59°F to 86°F).” After reconstitution, 4 mg vials mixed with Bacteriostatic Water for Injection (0.9% benzyl alcohol): “store refrigerated between 2°C to 8° C (36°F to 46°F) for up to 14 days”. “Do not freeze reconstituted SEROSTIM vials.”
| Vial | Diluent in the carton | Before mixing | After mixing |
|---|---|---|---|
| 4 mg single-patient-use vial | Bacteriostatic Water for Injection (0.9% benzyl alcohol), 3.5 mL multiple-dose vials | Room temperature, 59-86°F (15-30°C) | Refrigerated, 36-46°F (2-8°C), up to 14 days. Do not freeze |
| 5 mg or 6 mg single-dose vial | Sterile Water for Injection, 1 mL single-dose vials | Room temperature, 59-86°F (15-30°C) | Use immediately. Discard any unused portion |
Section 2.2: aim the stream of diluent against the vial wall to prevent foaming, swirl gently until dissolved, and do not shake. Do not inject Serostim if the solution is cloudy.
Section 2.2 also says not to use the benzyl alcohol diluent for people with a known benzyl alcohol hypersensitivity, or in pregnant or lactating women; for them, the 4 mg vial is reconstituted with Sterile Water for Injection and only one dose is used per vial. More in bacteriostatic vs sterile water. See Serostim side effects and the Serostim dosing schedule.
Unmixed Serostim is a room-temperature product, 59-86°F (15-30°C), so it needs no ice pack. A mixed 4 mg vial is the exception: it stays refrigerated, so carry it cold in an insulated bag without letting it freeze.
More in the travel guide.