CutisCo iPLEDGE Informed Consents For Patients Who CAN Get Pregnant

To be completed by the patient (and parent or guardian if the patient is under age 18) and signed by the doctor.

Read each item below and initial in the space provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement.

Do not sign this agreement and do not take isotretinoin if there is anything that you do not understand about all the information you have received about using isotretinoin.

Patient's Full Name

Patient Address:

Street Number, Street, City, State, Zip Code

Email

For iPledge registration and login

Telephone:

Format: (000) 000-0000.

Patient's Age

1. I understand that isotretinoin is a medicine used to treat severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.

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2. My doctor has told me about my choices for treating my acne.

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3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second Patient Enrollment Form for Patients who can get Pregnant]

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4. I understand that some patients, while taking isotretinoin or soon after stopping isotretinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, "anxious" or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. No one knows if isotretinoin caused these behaviors or if they would have happened even if the person did not take isotretinoin. Some people have had other signs of depression while taking isotretinoin (see #7)

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5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.

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6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.

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7. Once I start taking isotretinoin, I agree to stop using isotretinoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. I:

Start to feel sad or have crying spells
Lose interest in activities I once enjoyed
Sleep too much or have trouble sleeping
Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
Have a change in my appetite or body weight
Have trouble concentrating
Withdraw from my friends or family
Feel like I have no energy
Have feelings of worthlessness or guilt
Start having thoughts about hurting myself or taking my own life (suicidal thoughts)
Start acting on dangerous impulses
Start seeing or hearing things that are not real

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8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and to check for signs of side effects.

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9. Isotretinoin will be prescribed just for me. I will not share isotretinoin with other people because it may cause serious side effects, including birth defects.

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10. I will not give blood while taking isotretinoin or for 1 month after l stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, their baby may be exposed to isotretinoin and may be born with serious birth defects.

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11. I have read the Fact Sheet for the iPLEDGE REMS and other materials my provider provided me containing important safety information about isotretinoin. I understand all the information I received.

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12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE REMS to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin.

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To be completed by the patient (and their parent or guardian* if the patient is under age 18) and signed by their doctor.

Read each item below and initial in the space provided to show that you understand each item and agree to follow your doctor's instructions. Do not sign this consent and do not take isotretinoin if there is anything that you do not understand.

*A parent or guardian of a minor patient (under age 18) must also read and initial each item before signing the consent.

1. I understand that there is a very high chance that my unborn baby could have life threatening birth defects if I am pregnant or become pregnant while taking isotretinoin. This can happen with any amount and even if taken for short periods of time. This is why I must not be pregnant while taking isotretinoin.

Patient (and Parent/Guardian) Initials

2. I understand that I must not get pregnant one month before, during the entire time of my treatment, and for one month after the end of my treatment with isotretinoin.

Patient (and Parent/Guardian) Initials

3. I understand that I must avoid having any sexual contact (penis-vaginal) with a partner who could get me pregnant completely, or I must use two separate, effective forms of birth control (contraception) at the same time. The only exceptions are if I have had surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.

Patient (and Parent/Guardian) Initials

4. I understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include skin patches, shots, under-the-skin implants, vaginal rings, and intrauterine devices (IUDs). Any method of birth control can fail. That is why I must use two different birth control forms at the same time, starting one month before, during, and for one month after stopping therapy every time I have sexual contact (penis-vaginal) with a partner who could get me pregnant, even if one of the forms I choose is hormonal birth control.

Patient (and Parent/Guardian) Initials

5. I understand that the follow are effective forms of birth control:

A diaphragm and cervical cap must each be used with spermicide, a special cream that kills sperm. I understand that at least one of my two forms of birth control must be a primary form.

Patient (and Parent/Guardian) Initials

6. I will talk with my doctor about any medicines including herbal products I plan to take during my isotretinoin treatment because hormonal birth control forms may not work if I am taking certain medicines or herbal products.

Patient (and Parent/Guardian) Initials

I may receive a free birth control counseling session from a doctor or other family planning expert. My isotretinoin doctor can give me an Isotretinoin Contraception Referral Form for this free consultation.

Patient (and Parent/Guardian) Initials

7. I must begin using the birth control forms I have chosen as described above at least one month before I start taking isotretinoin.

Patient (and Parent/Guardian) Initials

8. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have two negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstrual period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have one pregnancy test in a lab:

every month during treatment
at the end of treatment
and 1 month after stopping treatment

I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from two pregnancy tests, and the second test has been done in a lab.

Patient (and Parent/Guardian) Initials

9. I have read and understand the materials my doctor has provided to me, including the Guide for Patients who Can Get Pregnant and the Fact Sheet on the iPLEDGE REMS. I have received information on emergency birth control.

Patient (and Parent/Guardian) Initials

10. I must stop taking isotretinoin right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have any sexual contact (penis-vaginal) with a partner who could get me pregnant without using my two birth control forms at any time.

Patient (and Parent/Guardian) Initials

11. My doctor provided me with information about the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within one month of the last dose. I understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be shared with the makers of isotretinoin, authorized parties who maintain the iPLEDGE REMS for the makers of isotretinoin, and govemment health regulatory authorities.

Patient (and Parent/Guardian) Initials

12. I understand that being qualified to receive isotretinoin in the iPLEDGE REMS means that I:

• have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. tion. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I receive another isotretinoin prescription.

• have chosen and agreed to use two forms of effective birth control at the same time. At least one form must be a primary form of birth control unless I have chosen never to have sexual contact (penis-vaginal) with a partner who could get me pregnant (abstinence), or I have undergone a hysterectomy or bilateral oophorectomy, or I have been medically confirmed to be post-menopausal. I must use two forms of birth control at least one month before I start isotretinoin therapy, during therapy, and for one month after stopping therapy. I must receive counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy.

• have signed a Patient Enrollment Form for Patients who can get Pregnant that contains wamings about the chance of possible birth defects if I am pregnant or become pregnant and my unbom baby is exposed to isotretinoin.

• have been informed of and understand the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within 1 month of the last dose.

• have interacted with the iPLEDGE REMS before starting isotretinoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control.

Patient (and Parent/Guardian) Initials

My doctor has answered all my questions about isotretinoin and I understand that it is my responsibility not to get pregnant one month before, during isotretinoin treatment, or for one month after I stop taking isotretinoin.

Patient (and Parent/Guardian) Initials

I now allow my doctor to begin my treatment with isotretinoin.

Patient Signature:

Date:

Parent/Guardian Signature (if under age 18):

Date:

Informed Consent (For All Patients):

Informed Consent About Birth Defects (For Patients Who Can Get Pregnant):