The iPLEDGE Program Patient Introductory Brochure

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Most Recent Modification: April 2012




                    The iPLEDGE Program

             Patient Introductory
                  Brochure
                                                                          The important
                                                                          information you
                                                                          need to know about
                                                                          isotretinoin and the
                                                                          iPLEDGE program
                                                                          before starting
                                                                          treatment


WARNING
For your health and safety, please read this booklet
carefully. Also, be sure you understand what your doctor
has told you about isotretinoin before starting treatment.
Do not take isotretinoin if you are pregnant, plan to
become pregnant, or become pregnant during
isotretinoin treatment. Isotretinoin causes severe birth
defects (deformed babies), loss of a baby before birth
(miscarriage), death of a baby and early (premature)
births. There is no accurate means of determining
whether an exposed fetus has been affected.
IMPORTANT NOTICE
Use only isotretinoin products approved by the US Food
and Drug Administration.
Fill and pick up your isotretinoin prescriptions only at
pharmacies that are licensed in the United States and are
registered with and activated in the iPLEDGE program.
    Are you thinking about taking
    isotretinoin (eye-soh-tret-in-OH-in)
    for acne? Read this brochure to
    learn more about isotretinoin and
    the iPLEDGE program.




1
Isotretinoin treats a type of severe acne called nodular acne.
It is used after other treatments, including antibiotics, have not
helped. It comes in a capsule you take by mouth. Treatment
usually lasts 4 to 5 months.
There is a very high chance of birth defects if an unborn baby's
mother takes isotretinoin. The goal of the iPLEDGE program
is to prevent pregnancies in females taking isotretinoin and to
prevent pregnant females from taking isotretinoin. The iPLEDGE
program requires birth control for female patients who can get
pregnant for at least 1 month before, during, and 1 month after
stopping treatment and pregnancy tests before, during, and
after treatment.
Before starting isotretinoin, you should know about its other
serious side effects. Talk with your doctor about how bad your
acne is and how isotretinoin can help your skin.
Decide if isotretinoin is right for you. Your doctor will ask
you to read and sign forms that say you understand the serious
risks of isotretinoin. It is important for you to know how to
take isotretinoin correctly and what to expect.




                                                                     2
    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 your
          prescriptions. Treatment usually lasts 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 iPLEDGE if:
         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




3
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 your
    prescriptions. Treatment usually lasts 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?

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. Treatment usually lasts
    4 to 5 months.
   Each prescription is for up to a maximum 1-month supply.


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 a birth control expert. The
    iPLEDGE program will pay for a visit for you to learn about birth control.




                                                                                  4
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