iPledge Requirements for Females Who Can Get Pregnant

Talk to Your Healthcare Provider

Before starting treatment, your healthcare provider will talk to you about the proper use of this medication. You'll also go over possible side effects of isotretinoin.

It's important you understand all the risks involved before committing to treatment. Take this time to ask questions. If you're unsure about something or don't understand something, let your healthcare provider know.

Read and Sign the Patient Information/Informed Consent

Your healthcare provider will give you documents outlining patient information/informed consent to review and sign. These documents are basically a review of what you and your healthcare provider have talked about regarding isotretinoin use.

Read through the information. The goal of the patient information/informed consent is to ensure you fully understand how isotretinoin works, its side effects, and your responsibilities while taking this drug.

After reading, you'll sign the documents. Again, if you're not clear on something, don't be afraid to ask before you sign.

Submit to Regular Pregnancy Testing

You must have two negative pregnancy tests before you receive your first month's supply of isotretinoin. The first pregnancy test will be done by your healthcare provider before you're accepted into the program; the second must be done by a Clinical Laboratory Improvement Amendments-certified laboratory (CLIA).

Going forward, monthly pregnancy tests must be done by a CLIA-certified lab. Your healthcare provider will give you information on approved labs in your area.

Use Two Forms of Contraception at All Times

You must use two forms of contraception one month prior to receiving your medication, the entire time during treatment, and for one month after stopping treatment. Birth control forms must be used together, at the same time (i.e. condoms along with oral contraceptives).

Not all forms of birth control are approved by the iPledge program. Talk to your healthcare provider about accepted forms of contraception. This appointment may be paid for by the program.

See Your Healthcare Provider Every Month

You'll be seeing a lot of your healthcare provider during your isotretinoin treatment. You'll have an appointment every month to discuss your questions and concerns, talk about any side effects you're experiencing, and take blood tests as needed.

Answer Questions in the iPledge System

Each month, before you pick up your medication, you'll need to access the iPledge system via your computer. Once there, you will be asked random questions about the iPledge program. You will also confirm the two birth control methods you are using.

You cannot skip this step. Your pharmacist can't fill your prescription until you have completed all necessary steps.

Pick up Your Prescription Within a 7-Day Window

Count Day 1 as the day of your pregnancy test. You will have to pick up your prescription within the next seven days.

If, for some reason, you can't get your isotretinoin within this window, you will have to re-qualify to receive your medication. This means you will have to do another pregnancy test and answer questions in the iPledge system again. Unless this is your first prescription, you can immediately begin the qualifying process.

Don't Donate Blood

Do not donate blood while taking isotretinoin. If your blood is given to a woman who is pregnant, the fetus could be exposed to the drug and develop birth defects.