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Affymax, Inc. Message Board

  • dinepat203 dinepat203 Apr 5, 2013 10:03 AM Flag

    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.

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    • Can they administer in more than once a month? With better monitoring? Just some thoughts, don't see any reason to pull off market.

      Sentiment: Strong Buy

    • 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
      4
       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.

      • 2 Replies to dinepat203
      • 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)].

      • I'm thinking administration fault and not Omontys. We go back up.

        Sentiment: Strong Buy

 
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