What is the iPledge Program

The iPLEDGE program is a public program designed to ensure that:

• No female patient starts isotretinoin therapy if pregnant
  
• No female patient on isotretinoin therapy becomes pregnant

The iPLEDGE program restricts access to isotretinoin because the use of this medication during pregnancy can lead to severe birth defects.

All male and female patients that are prescribed isotretinoin must enroll for the iPLEDGE program.

This program is designed to ensure that a female patient of childbearing potential has a negative pregnancy test each month prior to receiving isotretinoin.

Before the patient receives his/her isotretinoin prescription each month, the doctor or other prescriber must document in the iPLEDGE system that the patient has been counseled about the risks of isotretinoin.

It is crucial that a female of childbearing potential selects and commits to use TWO forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy. She must have 2 negative urine or blood (serum) pregnancy tests with a sensitivity of at least 25 mIU/ml before receiving the initial isotretinoin prescription.

Each month of therapy, the patient must have a negative result from a urine or blood (serum) pregnancy test conducted prior to receiving each prescription.

Each month, the prescriber must enter the female patient’s pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE system.

The iPLEDGE system verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin.

Isotretinoin Manufacturer’s Toll Free Numbers

Product Name        Company                          Phone Number

• Accutane®        Roche Laboratories Inc.          1-800-526-6367
• Amnesteem®    Mylan Pharmaceuticals Inc.    1-800-796-9526
• Claravis®          Barr Laboratories, Inc.             1-800-227-7522
• Sotret®              Ranbaxy Laboratories, Inc.     1-800-472-4467

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© 2010 Vivacare. Last updated May 26, 2010.

This information is for general educational uses only. It may not apply to you and your specific medical needs. This information should not be used in place of a visit, call, consultation with or the advice of your physician or health care professional. Communicate promptly with your physician or other health care professional with any health-related questions or concerns.

Be sure to follow specific instructions given to you by your physician or health care professional.