FDA revised Single use Vials- Reference ID: 3225634
Read this Medication Guide:
If Omontys used Once in a month how can you DISCARD MULTI DOSE VIAL AFTER 28DAYS ?
16.2 Stability and Storage
The recommended storage temperature is refrigerated at 2 °C to 8 °C (36 °F to 46 °F). Protect from light. Retain in carton until time of use.
Storage of single use vials, single use pre-filled syringes or multiple use vials over the recommended temperature (2 °C to 8 °C), when necessary, is permissible only for temperatures up to 25 °C (77 °F) and for no more than 30 days.
After first use, the multiple use vials should be stored at 2 °C to 8 °C, and then discarded after 28 days.
Type messageHow should I store OMONTYS?
Keep OMONTYS in the original package.
Protect OMONTYS from light.
Store OMONTYS in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
Reference ID: 3225634
If a refrigerator is not available, OMONTYS vials and pre-filled syringes can be stored at 77 °F or less (25 °C or less) for up to 30 days. Throw away multiple use vials of OMONTYS no later than 28 days from the first day that you put a needle into the vial.
OMONTYS single use vials and pre-filled syringes should be used only one time. Dispose of the single use vial and the pre-filled syringe after use even if there is medicine left in the container.
FULL PRESCRIBING INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION,
STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND
TUMOR PROGRESSION OR RECURRENCE.
Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks [see Warnings and Precautions (5.1)].
Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions (5.1)].