Accutane

Isotretinoin is the active ingredient in a prescription drug available under the brand names Sortret, Zenatane, Myorisane, Claravis, Amnesteem, and Absorica.

Doctors prescribe isotretinoin to treat a severe form of acne called recalcitrant nodular or cystic acne.

The Food and Drug Administration (FDA) originally approved isotretinoin as the brand name Accutane in 1982. Hoffmann La Roche manufactured it.

Hoffmann La Roche stopped making Accutane in 2009, partly due to numerous class action lawsuits filed against the company for birth defects caused by the drug.

In addition, plaintiffs' complaints included Crohn's disease, depression, suicide, and disabilities that caused them to miss work and lose wages.

Isotretinoin and Birth Defects

Today, women and men must agree to follow guidelines in iPLEDGE program before taking isotretinoin.

iPLEDGE requires that you and your doctor and pharmacist follow certain detailed steps to ensure your safety and prevent pregnancy while you are being treated with the drug.

Although requirements vary according to your gender and stage of life, iPLEDGE requires that people who are able to reproduce use two forms of birth control while taking isotretinoin.

Your doctor will enroll you in the iPLEDGE program. Then, before filling your prescription, your pharmacist will verify your enrollment and make sure you meet the program's requirements.

Isotretinoin and Hair Loss

One major side effect of isotretinoin is that it dries tissues, causing dry skin, cracked lips, dry mucous membranes, and dry scalp.

It may thin hair or cause it to become dry, brittle, and fragile.

This happens because isotretinoin slows down or blocks the production and secretion of the body's on own natural oils.

According to anecdotal reports, isotretinoin may not only thin hair on the head but also on the face, causing a loss of eyelashes and eyebrows.

Some people may become bald.

Although hair may regrow a few months after stopping isotretinoin, some people report that it took several years.

Others say isotretinoin caused permanent hair loss.

Isotretinoin Warnings

The FDA has issued two black-box warnings for isotretinoin.

One requires anyone taking it comply with the iPLEDGE program.

The second bans isotretinoin from being prescribed to women who are either pregnant or are able to become pregnant.

The FDA also cautions people who use isotretinoin that it can cause serious skin reactions, some of which can be life threatening.

You should not take isotretinoin if you are:

• Pregnant or planning on getting pregnant
• Allergic to isotretinoin or any other ingredients found in the drug
• Allergic to soybean oil
• Breastfeeding

Talk to your doctor before taking isotretinoin if you have:

• Certain mood or mental conditions
• Bone cancer
• Soft or brittle bones and are prone to bone breaks (osteomalacia or osteoporosis)
• Diabetes mellitus
• Anorexia
• High cholesterol

Pregnancy and Isotretinoin

Isotretinoin can cause severe birth defects and miscarriages. It should never be taken during pregnancy.

Isotretinoin passes into breast milk, so it also isn't safe to take while breastfeeding.

Your doctor prescribes your dose and course of treatment based on your body weight.

Take isotretinoin quickly with a full glass of water, which prevents it from lodging in your esophagus and irritating it.

Some brands should be taken with food or milk.

Isotretinoin Overdose

If you suspect an overdose, you should contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Isotretinoin

If you miss a dose of Isotretinoin, try to take it as soon as you remember.

If it's almost time for the next dose, just skip the missed dose and take your next dose as you normally would.

Don't take two doses of isotretinoin at the same time.

In the U.S.

• Absorica
• Accutane
• Amnesteem
• Claravis
• Myorisan
• Sotret
• Zenatane

Available Dosage Forms:

• Capsule
• Capsule, Liquid Filled

Therapeutic Class: Antiacne

Chemical Class: Retinoid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established.

This medicine should be used with caution in teenagers, especially those with bone problems or diseases.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients may have a greater risk of problems and side effects when taking isotretinoin.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Chlortetracycline
• Demeclocycline
• Desogestrel
• Dienogest
• Doxycycline
• Drospirenone
• Estradiol Cypionate
• Estradiol Valerate
• Ethinyl Estradiol
• Ethynodiol Diacetate
• Etonogestrel
• Levonorgestrel
• Lymecycline
• Meclocycline
• Medroxyprogesterone Acetate
• Mestranol
• Methacycline
• Minocycline
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oxytetracycline
• Rolitetracycline
• Tetracycline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcoholism, severe or
• Allergy to aspirin, history of or
• Diabetes or
• Metabolism disorder, family history of or
• Severe weight problems—Use with caution. May increase risks for more serious problems.

• Anorexia (eating disorder) or
• Epiphyseal closure, premature or
• Osteomalacia (softening of the bones) or
• Osteoporosis (brittle bones), childhood or family history of or
• Other bone disorders or diseases—Use with caution. It is not known whether this medicine affects bone loss.

• Asthma or
• Depression, history of or
• Eye or vision problems or
• Hearing problems or
• Heart disease or
• Hepatitis or
• Hypertriglyceridemia (high triglycerides in the blood) or
• Intestinal disorders, history of or
• Pancreatitis (inflammation of the pancreas) or
• Pseudotumor cerebri (swelling in the brain) or
• Psychosis, history of or
• Vitamin A overdose (too much vitamin A in the body)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Isotretinoin causes birth defects in humans if taken during pregnancy. If you suspect that you may have become pregnant, stop taking this medicine and check with your doctor right away.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant one month before beginning treatment, while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap.

Isotretinoin must not be taken by women of reproductive age unless two effective forms of birth control have been used for at least 1 month before the start of treatment. Contraception must be continued during the period of treatment, which is up to 20 weeks, and for 1 month after isotretinoin is stopped. Be sure you have discussed this information with your doctor.

If you are a woman who is able to have children, you must have 2 pregnancy tests before beginning treatment with isotretinoin to make sure you are not pregnant. The second pregnancy test must be taken at least 19 days after the first test and during the first 5 days of the menstrual period immediately prior to beginning treatment. In addition, you must have a pregnancy test each month while you are taking this medicine and 1 month after treatment is completed.

Do not take vitamin A or any vitamin supplement containing vitamin A while taking this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, and prescription or nonprescription (over-the-counter [OTC]) medicines. Some medicines or nutritional supplements (eg, St. John's wort) may cause your birth control pills to not work as well.

During the first 3 weeks you are taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within 1 to 2 months after starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop taking isotretinoin and may take up to 6 months. Your doctor can help you choose the right skin products to reduce skin dryness and irritation.

You or your child should not donate blood to a blood bank while using isotretinoin or for 30 days after you stop taking it. This is to prevent a pregnant patient from receiving blood that contains the medicine.

In some patients, isotretinoin may cause a decrease in night vision. This problem may occur suddenly. If it does occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Also, check with your doctor.

Isotretinoin may cause dryness of the eyes. If you or your child wear contact lenses, your eyes may be more sensitive to them during the time you are taking isotretinoin and for up to 2 weeks after you stop taking it. To help relieve dryness of the eyes, check with your doctor about using a lubricating solution, such as artificial tears. If eye inflammation occurs, check with your doctor right away.

Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to sunlight, wind, or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks of treatment. However, you or your child should not stop taking this medicine unless the skin irritation becomes too severe. Do not use a sunlamp or tanning beds.

To help isotretinoin work properly, use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

Isotretinoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

This medicine may increase pressure in your head. This may increase your risk of vision loss or serious brain problems. Check with your doctor right away if you have a bad headache, blurred vision, dizziness, nausea or vomiting, or seizures.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may heal more slowly. If this medicine is for your child, tell the doctor if you think your child is not growing properly.

It is very important that you or your child not use wax epilation to remove hair while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from wax epilation.

It is very important that you or your child not have any cosmetic procedures to smooth your skin (eg, dermabrasion, laser) while you are taking isotretinoin and for 6 months after stopping it. Isotretinoin can increase your chance of scarring from these procedures.

This medicine may affect blood sugar levels. If you or your child are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Isotretinoin may cause some people to have hearing problems within a few weeks after they start taking it. Check with your doctor right away if you or your child have hearing loss, a continuing ringing or buzzing, or any other unexplained noise in the ears.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you or your child have abdominal or stomach pain, rectal bleeding, or severe diarrhea. These may be symptoms of a serious condition called inflammatory bowel disease.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, redness, soreness, or itching skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine contains FD&C Yellow No.5 (tartrazine) which may cause an allergic reaction, including asthma, in some people. This reaction is more often seen in people who also have an allergy to aspirin.

This medicine lowers the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

CAUSES BIRTH
DEFECTS

DO NOT GET
PREGNANT

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Accutane, Accutane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).

Pregnancy: Category X. See Boxed CONTRAINDICATIONS AND WARNINGS.

Allergic Reactions

Accutane is contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule (see PRECAUTIONS: Hypersensitivity).

1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.
2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.
3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.
4. Jones H, Blanc D, Cunliffe WJ. 13-cis-retinoic acid and acne. Lancet 2:1048-1049, 1980.
5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980.
6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984.
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.

OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.

To be completed by the patient (and her parent or guardian1 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.

______________________________________________________________
                                              (Patient's Name)

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.
   
   Initial: ______
     
2. I understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 1 month after the end of my treatment with isotretinoin.
   
   Initial: ______
     
3. I understand that I must avoid sexual intercourse completely, or I must use 2 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.
   
   Initial: ______
     
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 2 different birth control methods at the same time, starting 1 month before, during, and for 1 month after stopping therapy every time I have sexual intercourse, even if 1 of the methods I choose is hormonal birth control.
   
   Initial: ______
     
5. I understand that the following are effective forms of birth control:
   

   Primary forms tubal sterilization (tying my tubes) partner's vasectomy intrauterine device hormonal (combination birth control pills, skin patches, shots, under-the-skin implants, or vaginal ring)

   Secondary forms Barrier: male latex condom with or without spermicide diaphragm with spermicide cervical cap with spermicide Other: vaginal sponge (contains spermicide)

   A diaphragm and cervical cap must each be used with spermicide, a special cream that kills sperm
   
   I understand that at least 1 of my 2 forms of birth control must be a primary method.
   
   Initial: ______
     
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.
   
   Initial: ______
     
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.
   
   Initial: ______
     
8. I must begin using the birth control methods I have chosen as described above at least 1 month before I start taking isotretinoin.
   
   Initial: ______
     
9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have 2 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 1 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 2 pregnancy tests, and the second test has been done in a lab.
   
   Initial: ______
     
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.
    
    Initial: ______
      
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 2 birth control methods at any time.
    
    Initial: ______
      
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 1 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.
    
    Initial: ______
      
13. I understand that being qualified to receive isotretinoin in the iPLEDGE program means that I:
    • have had 2 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 2 forms of effective birth control at the same time. At least 1 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 2 forms of birth control for at least 1 month before I start isotretinoin therapy, during therapy, and for 1 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 1 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.
      
      Initial: ______
        

My doctor has answered all my questions about isotretinoin and I understand that it is my responsibility not to get pregnant 1 month before, during isotretinoin treatment, or for 1 month after I stop taking isotretinoin.

Initial: ______

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.

1. I, ______________________________________________________________,
                                                       (Patient's Name)
   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.
   
   Initials: ______
     
2. My doctor has told me about my choices for treating my acne.
   
   Initials: ______
     
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)].
   
   Initials: ______
     
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).
   
   Initials: ______
     
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.
   
   Initials: ______
     
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.
   
   Initials: ______
     
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
   
   
   Initials: ______
     
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.
   
   Initials: ______
     
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.
   
   Initials: ______
     
10. I will not give blood while taking isotretinoin or for 1 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.
    
    Initials: ______
      
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.
    
    Initials: ______
      
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.
    
    Initials: ______
      

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.

Isotretinoin, a retinoid, is available as Accutane (isotretinoin) in 10-mg, 20-mg and 40-mg soft gelatin capsules for oral administration. Each capsule contains 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.

Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:

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.

______________________________________________________________

(Patient's Name)

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.

Initial: ______

2. I understand that I must not get pregnant 1 month before, during the entire time of my treatment, and for 1 month after the end of my treatment with isotretinoin.

Initial: ______

3. I understand that I must avoid sexual intercourse completely, o r I must use 2 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.

Initial: ______

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 2 different birth control methods at the same time, starting 1 month before, during, and for 1 month after stopping therapy every time I have sexual intercourse, even if 1 of the methods I choose is hormonal birth control.

Initial: ______

5. I understand that the following 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 1 of my 2 forms of birth control must be a primary method.

Initial: ______

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.

Initial: ______

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.

Initial: ______

8. I must begin using the birth control methods I have chosen as described above at least 1 month before I start taking isotretinoin.

Initial: ______

9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have 2 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 1 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 2 pregnancy tests, and the second test has been done in a lab.

Initial: ______

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.

Initial: ______

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 2 birth control methods at any time.

Initial: ______

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 1 month of the last dose. If I become pregnant, I agree to be contacted by the iPLEDGE program and be asked questions about my pregnancy. I also understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be given to the maker of isotretinoin and government health regulatory authorities.

Initial: ______

13. I understand that being qualified to receive isotretinoin in the iPLEDGE program means that I:

• have had 2 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 2 forms of effective birth control at the same time. At least 1 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 2 forms of birth control for at least 1 month before I start isotretinoin therapy, during
• therapy, and for 1 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 1 month of the last dose. I agree to be contacted by the iPLEDGE program and be asked questions about my pregnancy.
• 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.

Initial: ______

My doctor has answered all my questions about isotretinoin and I understand that it is my responsibility not to get pregnant 1 month before, during isotretinoin treatment, or for 1 month after I stop taking isotretinoin.

Initial: ______

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 _______________________ 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.

1. I, ______________________________________________________,

(Patient's Name)

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.

Initials: ______

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

Initials: ______

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)].

Initials: ______

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).

Initials: ______

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.

Initials: ______

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.

Initials: ______

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

Initials: ______

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.

Initials: ______

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.

Initials: ______

10. I will not give blood while taking isotretinoin or for 1 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.

Initials: ______

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.

Initials: ______

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.

Initials: ______

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

ACCUTANE (ACK-U-TANE)
(isotretinoin capsules)

Read the Medication Guide that comes with Accutane (isotretinoin) 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 (isotretinoin) ?

• Accutane (isotretinoin) is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because Accutane (isotretinoin) can cause birth defects, Accutane (isotretinoin) is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program.
• Accutane (isotretinoin) 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 (isotretinoin) . Female patients must not get pregnant:

• for 1 month before starting Accutane (isotretinoin)
• while taking Accutane (isotretinoin)
• for 1 month after stopping Accutane (isotretinoin) .

If you get pregnant while taking Accutane (isotretinoin) , 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 (isotretinoin) may cause:

• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking Accutane (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.

Stop Accutane (isotretinoin) 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 (isotretinoin) , you may also need follow-up mental health care if you had any of these symptoms.

What is Accutane (isotretinoin) ?

Accutane (isotretinoin) 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 (isotretinoin) can cause serious side effects (see “What is the most important information I should know about Accutane (isotretinoin) ?”). Accutane (isotretinoin) 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 (isotretinoin) ?

• Do not take Accutane (isotretinoin) if you are pregnant, plan to become pregnant, or become pregnant during Accutane (isotretinoin) treatment. Accutane (isotretinoin) causes severe birth defects. See “What is the most important information I should know about Accutane (isotretinoin) ?”
• Do not take Accutane (isotretinoin) if you are allergic to anything in it. Accutane (isotretinoin) contains parabens as the preservative. See the end of this Medication Guide for a complete list of ingredients in Accutane (isotretinoin) .

What should I tell my doctor before taking Accutane (isotretinoin) ?

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 (isotretinoin) 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 (isotretinoin) 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 (isotretinoin) . Taking both together may increase your chance of getting side effects.
• Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane (isotretinoin) 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 (isotretinoin) . Ask your doctor or pharmacist if you are not sure what type you are using.
• Dilantin (phenytoin). This medicine taken with Accutane (isotretinoin) may weaken your bones.
• Corticosteroid medicines. These medicines taken with Accutane (isotretinoin) 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 (isotretinoin) 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 Accutane (isotretinoin) ?

• You must take Accutane (isotretinoin) exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Accutane (isotretinoin) , 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 (isotretinoin) 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 (isotretinoin) at a time. This is to make sure you are following the Accutane (isotretinoin) iPLEDGE program. You should talk with your doctor each month about side effects.
• The amount of Accutane (isotretinoin) you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take Accutane (isotretinoin) 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Accutane (isotretinoin) capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Accutane (isotretinoin) 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 (isotretinoin) or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking Accutane (isotretinoin) . 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 (isotretinoin) . 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 (isotretinoin) . 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 expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Accutane (isotretinoin) .
  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 (isotretinoin) and call your doctor right away.

What should I avoid while taking Accutane (isotretinoin) ?

• Do not get pregnant while taking Accutane (isotretinoin) and for 1 month after stopping Accutane (isotretinoin) . See “What is the most important information I should know about Accutane (isotretinoin) ?”
• Do not breast feed while taking Accutane (isotretinoin) and for 1 month after stopping Accutane (isotretinoin) . We do not know if Accutane (isotretinoin) can pass through your milk and harm the baby.
• Do not give blood while you take Accutane (isotretinoin) and for 1 month after stopping Accutane (isotretinoin) . If someone who is pregnant gets your donated blood, her baby may be exposed to Accutane (isotretinoin) and may be born with birth defects.
• Do not take other medicines or herbal products with Accutane (isotretinoin) unless you talk to your doctor. See “What should I tell my doctor before taking Accutane (isotretinoin) ?”
• Do not drive at night until you know if Accutane (isotretinoin) has affected your vision. Accutane (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 Accutane (isotretinoin) and for at least 6 months after you stop. Accutane (isotretinoin) 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 (isotretinoin) may make your skin more sensitive to light.
• Do not share Accutane (isotretinoin) with other people. It can cause birth defects and other serious health problems.

What are the possible side effects of Accutane (isotretinoin) ?

• Accutane (isotretinoin) 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 (isotretinoin) ?”
• Accutane (isotretinoin) may cause serious mental health problems. See “What is the most important information I should know about Accutane (isotretinoin) ?”
• serious brain problems. Accutane (isotretinoin) can increase t he pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane (isotretinoin) 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 (isotretinoin) . Stop taking Accutane (isotretinoin) 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 (isotretinoin) 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 (isotretinoin) . Tell your doctor if you get:
  • back pain
  • joint pain
  • broken bone. Tell all healthcare providers that you take Accutane (isotretinoin) if you break a bone.
    Stop Accutane (isotretinoin) 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 (isotretinoin) may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Accutane (isotretinoin) 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 (isotretinoin) may affect your ability to see in the dark. This condition usually clears up after you stop taking Accutane (isotretinoin) , but it may be permanent. Other serious eye effects can occur. Stop taking Accutane (isotretinoin) 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 Accutane (isotretinoin) and after treatment.
• lipid (fats and cholesterol in blood) problems. Accutane (isotretinoin) 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 (isotretinoin) treatment is finished.
• serious allergic reactions. Stop taking Accutane (isotretinoin) and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane (isotretinoin) and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Accutane (isotretinoin) 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 (isotretinoin) 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 (isotretinoin) . 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 Roche at 1-800-526-6367.

How should I store Accutane (isotretinoin) ?

• Store Accutane (isotretinoin) at room temperature, between 59° and 86°F. Protect from light.
• Keep Accutane (isotretinoin) and all medicines out of the reach of children.

General Information about Accutane (isotretinoin)

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Accutane (isotretinoin) for a condition for which it was not prescribed. Do not give Accutane (isotretinoin) 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 (isotretinoin) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Accutane (isotretinoin) that is written for health care professionals. You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.

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.

Tell your doctor if you have 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.

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 form (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 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 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 two 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 two separate forms of effective birth control at the same time one month before, while taking and for one month after taking Accutane. 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 Accutane.

If you have sex at any time without using two forms of effective birth control, get pregnant or miss your expected period, stop using Accutane and call your doctor right away.

What you should avoid while taking Accutane:

• Do not get pregnant while taking Accutane and for one month after stopping Accutane. See “Accutane Precautions" section.
• Do not breastfeed while taking Accutane and for one month after stopping Accutane. It is not known if Accutane can pass through your milk and harm the baby.
• Do not give blood while you take Accutane and for one 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.
• 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.