December 19, 2013

FDA Hepatitis Update - New PegIntron Selectdose

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On December 18, 2013, FDA approved a new single-use, dual-chamber pre-filled pen injector, PegIntron Selectdose (peginterferon alfa-2b), with recommendations for dose reductions, an updated Medication Guide and Instructions for Use (IFU).

The full revised label, including Instructions for Use with the Selectdose single-use pre-filled pen can be found at Drugs@FDA.

Healthcare providers should show patients how to prepare and inject PegIntron properly using the Selectdose pre-filled pen before it is used for the first time. Patients should make sure they have the correct strength of Selectdose pre-filled penprescribed by their healthcare provider.

Patients should properly dispose of the pre-filled pen after use. Instructions for Disposal of used needles and pre-filled pens are provided in the "in the Instructions for Use.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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