Patient Information/Informed Consent About Birth Defects
(for female patients who can get pregnant)
To be completed by the patient (and her parent or guardian* if patient is under age 18) and signed by her 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 severe 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.
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.
3. I understand that I must avoid sexual intercourse 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.
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 form of birth control can fail. That is why I must use two different birth control methods at the same time, starting one month before, during, and for one month after stopping therapy every time I have sexual intercourse, even if one of the methods I choose is hormonal birth control.
5. I understand that the following are effective forms of birth control:
|Primary forms||Secondary forms|
I understand that at least one of my two forms of birth control must be a primary method.
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 methods may not work if I am taking certain medicines or herbal products.
7. 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 Patient Referral Form for this free consultation.
8. I must begin using the birth control methods I have chosen as described above at least one month before I start taking isotretinoin.
9. 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.
10. I have read and understand the materials my doctor has given to me, including The iPLEDGE Program Guide for Isotretinoin for Female Patients Who Can Get Pregnant, The iPLEDGE Birth Control Workbook and The iPLEDGE Program Patient Introductory Brochure.
My doctor gave me and asked me to watch the DVD containing a video about birth control and a video about birth defects and isotretinoin.
I was told about a private counseling line that I may call for more information about birth control. I have received information on emergency birth control.
11. 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 sexual intercourse without using my two birth control methods at any time.
12. My doctor gave me information about the purpose and importance of providing information to the iPLEDGE program should I become pregnant while taking isotretinoin or within one month of the last dose. I also understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be shared with the maker of isotretinoin and their authorized parties who maintain the iPLEDGE program and government health regulatory authorities.
13. I understand that being qualified to receive isotretinoin in the iPLEDGE program means that I:
- have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. 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 method must be a primary form of birth control, unless I have chosen never to have sexual contact with a male (abstinence), or I have undergone a hysterectomy. I must use two forms of birth control for 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 Information/Informed Consent About Birth Defects (for female patients who can get pregnant) that contains warnings about the chance of possible birth defects if I am pregnant or become pregnant and my unborn baby is exposed to isotretinoin.
- have been informed of and understand the purpose and importance of providing information to the iPLEDGE program should I become pregnant while taking isotretinoin or within one month of the last dose.
- have interacted with the iPLEDGE program 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.
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.
I now authorize my doctor ________________ to begin my treatment with isotretinoin.
Patient Signature:_____________________________________ Date: ______
Parent/Guardian Signature (if under age 18):________________ Date:______
Please print: Patient Name and Address_______________________________
______________________________ Telephone _______________________
I have fully explained to the patient, __________________, the nature and purpose of the treatment described above and the risks to female patients of childbearing potential. I have asked the patient if she has any questions regarding her treatment with isotretinoin and have answered those questions to the best of my ability.
Doctor Signature: __________________________________ Date: ______
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.
Patient Information/Informed Consent (for all patients):
To be completed by patient (and parent or guardian if 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.
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.
2. My doctor has told me about my choices for treating my acne.
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 Information/Informed Consent About Birth Defects (for female patients who can get pregnant)].
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 below).
5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7 below), 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.
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.
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
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.
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.
10. I will not give blood while taking isotretinoin or for one month after I stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, her baby may be exposed to isotretinoin and may be born with serious birth defects.
11. I have read The iPLEDGE Program Patient Introductory Brochure, and other materials my provider gave me containing important safety information about isotretinoin. I understand all the information I received.
12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE program 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.
I now allow my doctor ___________________________ to begin my treatment with isotretinoin.
Patient Signature: ____________________________________ Date: ______
Parent/Guardian Signature (if under age 18): _______________ Date: ______
Patient Name (print) ___________________________________
Patient Address ___________________________ Telephone (___.___.___)
I have: ___________________________________
- fully explained to the patient, __________________, the nature and purpose of isotretinoin treatment, including its benefits and risks
- given the patient the appropriate educational materials, The iPLEDGE Program Patient Introductory Brochure and asked the patient if he/she has any questions regarding his/her treatment with isotretinoin
- answered those questions to the best of my ability
Doctor Signature: _________________________________ Date: ______
PLACE THE ORIGINAL SIGNED DOCUMENTS IN THE PATIENT'S MEDICAL RECORD. PLEASE PROVIDE A COPY TO THE PATIENT.MEDICATION GUIDE
(ZEN – a – tan)
Read the Medication Guide that comes with Zenatane before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Zenatane?
- Zenatane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
- Because Zenatane can cause birth defects, Zenatane is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
- Zenatane may cause serious mental health problems.
1. Birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Female patients who are pregnant or who plan to become pregnant must not take Zenatane. Female patients must not get pregnant:
- for one month before starting Zenatane
- while taking Zenatane
- for one month after stopping Zenatane
If you get pregnant while taking Zenatane, stop taking it right away and call your doctor. Doctors and patients should report all cases of pregnancy to:
- FDA MedWatch at 1-800-FDA-1088, and
- the iPLEDGE pregnancy registry at 1-866-495-0654
2. Serious mental health problems. Zenatane may cause:
- psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking Zenatane 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.
Stop Zenatane and call your doctor right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:
- start to feel sad or have crying spells
- lose interest in activities you 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 your appetite or body weight
- have trouble concentrating
- withdraw from your friends or family
- feel like you have no energy
- have feelings of worthlessness or guilt
- start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
- start acting on dangerous impulses
- start seeing or hearing things that are not real
After stopping Zenatane, you may also need follow-up mental health care if you had any of these symptoms.
What is Zenatane?
Zenatane is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Zenatane can cause serious side effects (see “What is the most important information I should know about Zenatane?”). Zenatane can only be:
- prescribed by doctors that are registered in the iPLEDGE program
- dispensed by a pharmacy that is registered with the iPLEDGE program
- given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.
Who should not take Zenatane?
- Do not take Zenatane if you are pregnant, plan to become pregnant, or become pregnant during Zenatane treatment. Zenatane causes severe birth defects. See “What is the most important information I should know about Zenatane?”
- Do not take Zenatane if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Zenatane.
What should I tell my doctor before taking Zenatane?
Tell your doctor if you or a family member has any of the following health conditions:
- mental problems
- liver disease
- heart disease
- bone loss (osteoporosis) or weak bones
- an eating problem called anorexia nervosa (where people eat too little)
- food or medicine allergies
Tell your doctor if you are pregnant or breast-feeding. Zenatane must not be used by women who are pregnant or breast feeding.
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Zenatane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
- Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Zenatane. Taking both together may increase your chance of getting side effects.
- Tetracycline antibiotics. Tetracycline antibiotics taken with Zenatane can increase the chances of getting increased pressure in the brain.
- Progestin-only birth control pills (mini-pills). They may not work while you take Zenatane. Ask your doctor or pharmacist if you are not sure what type you are using.
- Dilantin (phenytoin). This medicine taken with Zenatane may weaken your bones.
- Corticosteroid medicines. These medicines taken with Zenatane may weaken your bones.
- St. John's Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Zenatane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
How should I take Zenatane?
- You must take Zenatane exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Zenatane, your doctor will:
- explain the iPLEDGE program to you
- have you sign the Patient Information/Informed Consent Form (for all patients). Female patients who can get pregnant must also sign another consent form.
You will not be prescribed Zenatane if you cannot agree to or follow all the instructions of the iPLEDGE program.
- You will get no more than a 30 day supply of Zenatane at a time. This is to make sure you are following the Zenatane iPLEDGE program. You should talk with your doctor each month about side effects.
- The amount of Zenatane you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
- Take Zenatane 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Zenatane capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Zenatane can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
- If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
- If you take too much Zenatane or overdose, call your doctor or poison control center right away.
- Your acne may get worse when you first start taking Zenatane. This should last only a short while. Talk with your doctor if this is a problem for you.
- You must return to your doctor as directed to make sure you don't have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Zenatane. Female patients who can get pregnant will get a pregnancy test each month.
- Female patients who can get pregnant must agree to use
two separate forms of effective birth control at the same time one month
before, while taking, and for one month after taking Zenatane. You must
access the iPLEDGE system to answer questions about the program requirements
and to enter your two chosen forms of birth control. To access the iPLEDGE
system, go to www.ipledgeprogram.com or call 1-866-495-0654.
You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Zenatane.
If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Zenatane and call your doctor right away.
What should I avoid while taking Zenatane?
- Do not get pregnant while taking Zenatane and for one month after stopping Zenatane. See “What is the most important information I should know about Zenatane?”
- Do not breast feed while taking Zenatane and for one month after stopping Zenatane. We do not know if Zenatane can pass through your milk and harm the baby.
- Do not give blood while you take Zenatane and for one month after stopping Zenatane. If someone who is pregnant gets your donated blood, her baby may be exposed to Zenatane and may be born with birth defects.
- Do not take other medicines or herbal products with Zenatane unless you talk to your doctor. See “What should I tell my doctor before taking Zenatane?”
- Do not drive at night until you know if Zenatane has affected your vision. Isotretinoin may decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Zenatane and for at least 6 months after you stop. Zenatane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Zenatane may make your skin more sensitive to light.
- Do not share Zenatane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Zenatane?
- Zenatane can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What is the most important information I should know about Zenatane?”
- Zenatane may cause serious mental health problems. See “What is the most important information I should know about Zenatane?”
- serious brain problems. Zenatane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Zenatane and call your doctor right away if you get any of these signs of increased brain pressure:
- skin problems. Skin rash can occur in patients taking Zenatane. In some patients a rash can be serious. Stop using Zenatane and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, lik “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
- stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Zenatane. Stop taking Zenatane and call your doctor if you get:
- bone and muscle problems. Zenatane may affect
bones, muscles, and ligaments and cause pain in your joints or muscles. Tell
your doctor if you plan hard physical activity during treatment with Zenatane.
Tell your doctor if you get:
- back pain
- joint pain
- broken bone. Tell all healthcare providers that you take
Zenatane if you break a bone.
Stop Zenatane and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Zenatane may stop long bone growth in teenagers who are still growing.
- hearing problems. Stop using Zenatane and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- vision problems. Zenatane may affect your ability to see in the dark. This condition usually clears up after you stop taking Zenatane, but it may be permanent. Other serious eye effects can occur. Stop taking Zenatane and call your doctor right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Zenatane and after treatment.
- lipid (fats and cholesterol in blood) problems. Zenatane can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Zenatane treatment is finished.
- serious allergic reactions. Stop taking isotretinoin and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Zenatane and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
- blood sugar problems. Zenatane may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
- decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
- The common, less serious side effects of Zenatane are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Zenatane. Your doctor or pharmacist can give you more detailed information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Dr. Reddys at 1-866-733-3952.
How should I store Zenatane?
- Store at 68° to 77°F (20° to 25°C). Protect from light.
- Keep Zenatane and all medicines out of the reach of children.
General Information about Zenatane
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Zenatane for a condition for which it was not prescribed. Do not give Zenatane to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Zenatane. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zenatane that is written for healthcare professionals.
You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Zenatane?
Active Ingredient: isotretinoin
Inactive Ingredients: butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain gelatin, glycerin, methylparaben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, and opacode black S-1-27794 containing iron oxide black, N-butyl alcohol, propylene glycol, industrial methylene spirit and shellac.
This Medication Guide has been approved by the U.S. Food and Drug Administration. To reorder additional Medication Guides contact Dr. Reddy's Customer Service at 1-866-733-3952.
Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Zenatane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.