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------------------------- ------------------------- -------------


MEDICATION GUIDE


ACCUTANE


(ACK-U-TANE)


(isotretinoin capsules)


Read the Medication Guide that comes with Accutane 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


Accutane?


Accutane is used to treat a type of severe acne (nodular acne) that has not


been helped by other treatments, including antibiotics.


Because Accutane can cause birth defects, Accutane is only for patients


who can understand and agree to carry out all of the instructions in the


iPLEDGE program.


Accutane 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 Accutane. Female


patients must not get pregnant:


for 1 month before starting Accutane


while taking Accutane


for 1 month after stopping Accutane.


If you get pregnant while taking Accutane, 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. Accutane may cause:


depression


psychosis (seeing or hearing things that are not real)


suicide. Some patients taking Accutane 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.


2


Stop Accutane 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 Accutane, you may also need follow-up mental health care if you


had any of these symptoms.


What is Accutane?


Accutane 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. Accutane can cause serious side effects (see “What is the most


important information I should know about Accutane?”). Accutane 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 Accutane?


Do not take Accutane if you are pregnant, plan to become pregnant, or


become pregnant during Accutane treatment. Accutane causes severe birth


defects. See “What is the most important information I should know


about Accutane?”


3


Do not take Accutane if you are allergic to anything in it. Accutane


contains parabens as the preservative. See the end of this Medication Guide


for a complete list of ingredients in Accutane.


What should I tell my doctor before taking Accutane?


Tell your doctor if you or a family member has any of the following health


conditions:


mental problems


asthma


liver disease


diabetes


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 breastfeeding. Accutane must not be


used by women who are pregnant or breastfeeding.


Tell your doctor about all of the medicines you take including prescription


and non-prescription medicines, vitamins and herbal supplements. Accutane


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 Accutane. Taking both together may increase your chance of getting


side effects.


Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane 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 Accutane. Ask your doctor or pharmacist if you are not sure what


type you are using.


Dilantin (phenytoin). This medicine taken with Accutane may weaken your


bones.


Corticosteroid medicines. These medicines taken with Accutane 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 Accutane 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.


4


How should I take Accutane?


You must take Accutane exactly as prescribed. You must also follow all the


instructions of the iPLEDGE program. Before prescribing Accutane, your


doctor will:


explain the iPLEDGE program to you


have you sign the Patient Information/Informed Consent (for all patients).


Female patients who can get pregnant must also sign another consent


form.


You will not be prescribed Accutane 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 Accutane at a time. This is to


make sure you are following the Accutane iPLEDGE program. You should


talk with your doctor each month about side effects.


The amount of Accutane you take has been specially chosen for you. It is


based on your body weight, and may change during treatment.


Take Accutane 2 times a day with a meal, unless your doctor tells you


otherwise. Swallow your Accutane capsules whole with a full glass of


liquid. Do not chew or suck on the capsule. Accutane 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 Accutane or overdose, call your doctor or poison control


center right away.


Your acne may get worse when you first start taking Accutane. 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 Accutane. Female patients who can get pregnant will get a


pregnancy test each month.


Female patients who can get pregnant must agree to use 2 separate forms of


effective birth control at the same time 1 month before, while taking, and for 1


month after taking Accutane. You must access the iPLEDGE system to


answer questions about the program requirements and to enter your 2


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


5


expert. Your doctor can arrange this free visit, which will be paid for by the


company that makes Accutane.


If you have sex at any time without using 2 forms of effective birth


control, get pregnant, or miss your expected period, stop using Accutane


and call your doctor right away.


What should I avoid while taking Accutane?


Do not get pregnant while taking Accutane and for 1 month after stopping


Accutane. See “What is the most important information I should know


about Accutane?”


Do not breast feed while taking Accutane and for 1 month after stopping


Accutane. We do not know if Accutane can pass through your milk and harm


the baby.


Do not give blood while you take Accutane and for 1 month after stopping


Accutane. If someone who is pregnant gets your donated blood, her baby may


be exposed to Accutane and may be born with birth defects.


Do not take other medicines or herbal products with Accutane unless you


talk to your doctor. See “What should I tell my doctor before taking


Accutane?”


Do not drive at night until you know if Accutane has affected your vision.


Accutane 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 Accutane and for


at least 6 months after you stop. Accutane 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. Accutane may make your skin more sensitive to light.


Do not share Accutane with other people. It can cause birth defects and


other serious health problems.


What are the possible side effects of Accutane?


Accutane 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


Accutane?”


Accutane may cause serious mental health problems. See “What is the


most important information I should know about Accutane?”


6


serious brain problems. Accutane can increase the pressure in your brain.


This can lead to permanent loss of eyesight and, in rare cases, death. Stop


taking Accutane and call your doctor right away if you get any of these signs


of increased brain pressure:


bad headache


blurred vision


dizziness


nausea or vomiting


seizures (convulsions)


stroke


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


Accutane. Stop taking Accutane and call your doctor if you get:


severe stomach, chest or bowel pain


trouble swallowing or painful swallowing


new or worsening heartburn


diarrhea


rectal bleeding


yellowing of your skin or eyes


dark urine


bone and muscle problems. Accutane 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 Accutane. Tell your doctor if


you get:


back pain


joint pain


broken bone. Tell all healthcare providers that you take Accutane if you


break a bone.


Stop Accutane 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.


Accutane may stop long bone growth in teenagers who are still growing.


hearing problems. Stop using Accutane 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. Accutane may affect your ability to see in the dark. This


condition usually clears up after you stop taking Accutane, but it may be


permanent. Other serious eye effects can occur. Stop taking Accutane and call


7


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 Accutane and after treatment.


lipid (fats and cholesterol in blood) problems. Accutane 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 Accutane treatment is


finished.


serious allergic reactions. Stop taking Accutane and get emergency care


right away if you develop hives, a swollen face or mouth, or have trouble


breathing. Stop taking Accutane and call your doctor if you get a fever, rash,


or red patches or bruises on your legs.


blood sugar problems. Accutane 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 Accutane 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 Accutane. Your doctor or


pharmacist can give you more detailed information.


How should I store Accutane?


Store Accutane at room temperature, between 59° and 86°F. Protect from


light.


Keep Accutane and all medicines out of the reach of children.


General Information about Accutane


Medicines are sometimes prescribed for conditions that are not mentioned in


Medication Guides. Do not use Accutane for a condition for which it was not


prescribed. Do not give Accutane 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


Accutane. If you would like more information, talk with your doctor. You can ask


your doctor or pharmacist for information about Accutane that is written for


health care professionals. You can also call iPLEDGE program at 1-866-495-


0654 or visit www.ipledgeprogram.com.


8


What are the ingredients in Accutane?


Active Ingredient: Isotretinoin


Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium,


hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil.


Gelatin capsules contain glycerin and parabens (methyl and propyl), with the


following dye systems: 10 mg — iron oxide (red) and titanium dioxide; 20 mg —


FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg — FD&C


Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.


This Medication Guide has been approved by the U.S. Food and Drug


Administration.


Dilantin is a registered trademark of Warner-Lambert Company LLC.


Distributed by:


27898955


Revised: August 2005


Copyright © 2001-2005 by Roche Laboratories Inc. All rights reserved.

 


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