iPLEDGE Program Information

What is the iPLEDGE Program?

The iPLEDGE Program is a set of steps all patients, doctors, and pharmacists must follow. The main goal is preventing pregnancy and birth defects, but both male patients and female patients must follow the iPLEDGE Program.

To get isotretinoin, all patients must:

  • Sign the Patient Information/Informed Consent form(s)
  • Be able to keep appointments
  • Agree to follow the iPLEDGE Program steps

What do male patients need to know about the iPLEDGE Program?

  • Talk with your doctor about the iPLEDGE program and the possible side effects of taking isotretinoin.
  • Keep your appointments. You must be able to see your doctor for you prescriptions. Treatments usually last 4 to 5 months.
  • Each prescription is for up to a maximum 1-month supply.

What do all female patients need to know about the iPLEDGE Program?

Are you a female patient who can get pregnant? This includes all female patients who have menstrual periods. It includes young female patients who have not started having menstrual periods. Even a female patient who has had her tubes tied can still get pregnant.

If you are able to get pregnant, you need to know how to keep from becoming pregnant. Your doctor has information to help you learn about effective birth control for iPLEDGE.

You would not have to follow the birth control requirements of iPLEDGEit:

  • You have stopped having periods for 12 months in a row (menopause) and your doctor says you are in menopause
  • You had both of your ovaries or uterus taken out by surgery
  • Your ovaries do not work and you cannot get pregnant (confirmed by your doctor)
  • You commit to not having any sexual contact with a male at any time for at least 1 month before, during, and 1 month after your last dose

What do female patients who cannot get pregnant need to know about the iPLEDGE Program?

  • Talk with your doctor about the iPLEDGE program and the possible side effects of taking isotretinoin.
  • Keep your appointments. You must be able to see your doctor for you prescriptions. Treatments usually last 4 to 5 months.
  • Each prescription is for up to a maximum 1-month supply.

What do female patients who can get pregnant need to do for the iPLEDGE Program?

1. Plan For Your Isotretinoin Treatment

  • Talk with your doctor about the iPLEDGE program and the risks of isotretinoin for unborn babies.
  • Keep your appointments. You must be able to see your doctor for your prescriptions and to get monthly pregnancy tests. Treatments usually lasts 4 to 5 months.
  • Each prescription is for up to a maximum 1-month supply.

2. Choose 2 Effective Forms Of Birth Control

  • Not all birth control is acceptable for the iPLEDGE Program. Not all forms of birth control can be used together.
  • Learn what birth control will work for the iPLEDGE program. Choose 2 forms that you really will use together
  • Even if you are already using birth control, get this information from your dermatologist, gynecologist, family doctor, or birth control expert. The iPLEDGE Program will pay for a visit for you to learn about birth control.

3. Use The 2 Effective Forms Of Birth Control Together

  • You must use both forms together all the time for at least 1 month before you start taking isotretinoin. (There is a 30 day mandatory waiting period during which you must be using both chosen forms of birth control before you are eligible to begin treatment with isotretinoin)
  • You must use both forms together while you are taking isotretinoin
  • You must use both forms together for 1 month after isotretinoin treatment

4. Get Blood Or Urine Tests For Pregnancy

You must have a negative pregnancy test:

  • To enter the iPLEDGE Program
  • Before you start isotretinoin
  • Performed in an approved lab each month before you can fill and pick up your prescription
  • Right after you finish your last isotretinoin dose
  • 1 month after you finish your last isotretinoin dose

5. Each Month Before You Can Fill and Pick Up Your Prescription

  • Your doctor must enter your pregnancy test results in the iPLEDGE system
  • You must access the iPLEDGE system to answer different questions about the iPLEDGE Program and confirm the 2 forms of birth control that you are using

Talk with your doctor about the iPLEDGE Program. This information does not replace talking with your doctor about acne or your treatment. If you have any questions, write them down. Ask your doctor before starting isotretinoin. Be sure you understand the answers to all your questions.

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