Orapred response regarding refrigeration from Company

[Guest guest]

This is the email I received regarding ORAPRED and refrigeration from the

company... read on.

Dear Ms. Bulone,

Thank you for your medical inquiry regarding the stability of Orapred.® The

approved labeling for Orapred® states to store the product at refrigerated

temperatures between 2°- 8° C (36° - 46° F). Storage at these temperatures is

required both before and after opening to ensure the stability of Orapred®

through the approved 36-month expiry date.

We do not recommend that Orapred® be stored at room temperature but instead be

kept under refrigerated storage conditions as indicated in the package insert.

Additionally, in instances where Orapred® is removed from refrigeration; the lot

expiration, temperature exposure, duration and the condition of the container,

should be taken into consideration to determine its viability.

I hope this information is helpful to you. If you have any additional questions

please feel free to contact me.

Sincerely,

Turbeville, Ph.D.

Manager, Medical Information

BioMarin Pharmaceutical Inc.

Tel 415-506-6345

Fax 415-382-7427

sturbeville@...

www.bmrn.com

Orapred and refrig

Hey,

I am an RN who runs a medical board for Periodic Fever Syndrome... and the

children with the disorders are given Prednisone.... I have always read in the

insert that Orapred needs refrigeration. It is in the PDF... file on your site

too.

Many parents are being told by pharamacists recently that Orapred does not

need to be refrig'd.

Does the medication decompensate??

Would like to get some accurate documentation since the parents seem to be

confused.

Thanks

Fran

Fran Bulone RN

Mom to ph 7yr

Waxhaw NC

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