Short answer: At the pharmacy, Gattex vials are kept in the fridge. Once dispensed, the kit is stored at room temperature up to 77°F (25°C) with a 90-day “use by” date. Do not freeze it. After you mix the powder with the diluent, inject within 3 hours and throw away what is left; do not store mixed Gattex. Source: Gattex label, sections 2.6 and 16, Medication Guide.
| Question | Label answer |
|---|---|
| Vials before the pharmacy dispenses them | Refrigerated at 2°C to 8°C (36°F to 46°F) |
| Kit after dispensing (at home) | Room temperature up to 25°C (77°F) |
| Use-by date | Dispensed with a 90-day "use by" dating; use by the "Use By" sticker on the kit |
| Lower temperature limit at home | Not stated, other than do not freeze |
| Freezing | Do not freeze (powder or mixed solution) |
| Light | Not stated |
| After mixing | Inject within 3 hours; discard any unused portion |
| Pack | One-vial kit or 30-vial kit: 5 mg single-dose vials, each with a 0.5 mL Sterile Water for Injection prefilled syringe |
Section 16, one-vial kit, prior to dispensing: “Store GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use beyond the expiration date on the label.” After dispensing by the pharmacist: “Store GATTEX 5 mg Strength one-vial kits at room temperature up to 25°C (77°F). Do not freeze. Dispense with a 90-day “use by” dating.” The 30-vial kit text is the same, and the carton of syringes and needles is kept at room temperature up to 25°C (77°F) before dispensing.
Three hours. Section 2.6: “Administer within 3 hours after reconstitution. Discard any unused portion. Do not shake or freeze the reconstituted solution.”
Medication Guide and Instructions for Use: “Store GATTEX powder at room temperature up to 77°F (25°C).” “Do not freeze GATTEX.” “Use the GATTEX powder by the expiration date on the “Use By” sticker on the kit.” “Use GATTEX within 3 hours after mixing it.” “Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial.” “Do not store any GATTEX you have mixed.”
The Instructions for Use also say: “Do not use a GATTEX vial more than 1 time, even if there is medicine left in the vial.”
Gattex is a freeze-dried powder mixed with the 0.5 mL of preservative-free Sterile Water for Injection in the kit (the diluent). Section 2.6, in order:
The two sections describe the mixed liquid differently. Section 2.6: “sterile, clear, colorless to light straw-colored solution”. Instructions for Use: “clear and colorless to pale yellow”. Both say do not use it if it has particles or did not dissolve.
Dosing and side effects: Gattex dosing schedule, missed a Gattex dose and Gattex side effects. More on reconstitution.
A dispensed Gattex kit is a room-temperature product, up to 77°F (25°C), so it does not need an ice pack. Keep it out of a hot car, do not let it freeze, and mix each vial only when you are ready to inject.
More in the travel guide.