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ABOUT THE iPLEDGE® PROGRAM
The iPLEDGE® program is a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA. You may also learn about the iPLEDGE® program online at www.ipledgeprogram.com.2,4
The program strives to ensure that:
- No female patient starts isotretinoin therapy if pregnant
- No female patient on isotretinoin therapy becomes pregnant
This enhanced program is a risk management program for prescribing and dispensing all isotretinoin products (brand and generic products). The iPLEDGE® program requires registration of all wholesalers distributing isotretinoin, all healthcare professionals prescribing isotretinoin, all pharmacies dispensing isotretinoin, and all patients prescribed isotretinoin. This program is designed to verify the patient's negative pregnancy test in order to approve the dispensing of the isotretinoin prescription to females of reproductive potential. The iPLEDGE® program requires that all patients meet qualification criteria and monthly program requirements. Before the patient receives his/her isotretinoin prescription each month, the prescriber must counsel the patient and document in the iPLEDGE® program that the patient has been counseled about the risks of isotretinoin.
As part of the ongoing risk management of isotretinoin products, it is crucial that females of reproductive potential select and commit to use 2 forms of effective contraception simultaneously for 1 month before, during, and for 1 month after isotretinoin therapy. Females of reproductive potential 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. The first pregnancy test is a screening test and can be conducted in the prescriber's office. The second pregnancy test must be done in a CLIA-certified laboratory according to the package insert. Each month of therapy, the patient must have a negative result from a urine or blood (serum) pregnancy test conducted by a CLIA-certified laboratory 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® program. The iPLEDGE® program verifies that all criteria have been met by the prescriber, patient, and pharmacy prior to granting the pharmacy authorization to fill and dispense isotretinoin. The pharmacist must obtain authorization from the iPLEDGE® program via the program's web site or phone system prior to dispensing each isotretinoin prescription for both male and female patients.
You are encouraged to report all side effects or Adverse Drug Events (ADEs) of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. You are also encouraged to report side effects or ADEs to our Drug Safety Department at 1‑800‑406‑7984 or drug.safetyUSA@sunpharma.com (preferred) with as much information as available.