For all patients:

Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects (physical problems that are present at birth).

A program called iPLEDGE has been set up to make sure that pregnant women do not take isotretinoin and that women do not become pregnant while taking isotretinoin. All patients, including women who cannot become pregnant and men, can get isotretinoin only if they are registered with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE and fill the prescription at a pharmacy that is registered with iPLEDGE. Do not buy isotretinoin over the internet.

You will receive information about the risks of taking isotretinoin and must sign an informed consent sheet stating that you understand this information before you can receive the medication. You will need to see your doctor every month during your treatment to talk about your condition and the side effects you are experiencing. At each visit, your doctor may give you a prescription for up to a 30-day supply of medication with no refills. If you are a woman who can become pregnant, you will also need to have a pregnancy test in an approved lab each month and have your prescription filled and picked up within 7 days of your pregnancy test. If you are a man or if you are a woman who cannot become pregnant, you must have this prescription filled and picked up within 30 days of your doctor visit. Your pharmacist cannot dispense your medication if you come to pick it up after the allowed time period has passed.

Tell your doctor if you do not understand everything you were told about isotretinoin and the iPLEDGE program or if you do not think you will be able to keep appointments or fill your prescription on schedule every month.

Your doctor will give you an identification number and card when you start your treatment. You will need this number to fill your prescriptions and to get information from the iPLEDGE website and phone line. Keep the card in a safe place where it will not get lost. If you do lose your card, you can ask for a replacement through the website or phone line.

Do not donate blood while you are taking isotretinoin and for 1 month after your treatment.

Do not share isotretinoin with anyone else, even someone who has the same symptoms that you have.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with isotretinoin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs), the manufacturer’s website, or the iPLEDGE program website (http://www.ipledgeprogram.com) to obtain the Medication Guide.

Talk to your doctor about the risks of taking isotretinoin.

For female patients:

If you can become pregnant, you will need to meet certain requirements during your treatment with isotretinoin. You need to meet these requirements even if you have not started menstruating (having monthly periods) or have had a tubal ligation (‘tubes tied’; surgery to prevent pregnancy). You may be excused from meeting these requirements only if you have not menstruated for 12 months in a row and your doctor says you have passed menopause (change of life) or you have had surgery to remove your uterus and/or both ovaries. If none of these are true for you, then you must meet the requirements below.

You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You can also have a free visit with a doctor or family planning expert to talk about birth control that is right for you. You must use these two forms of birth control at all times unless you can promise that you will not have any sexual contact with a male for 1 month before your treatment, during your treatment, and for 1 month after your treatment.

If you choose to take isotretinoin, it is your responsibility to avoid pregnancy for 1 month before, during, and for 1 month after your treatment. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control at all times. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.

If you plan to use oral contraceptives (birth control pills) while taking isotretinoin, tell your doctor the name of the pill you will use. Isotretinoin interferes with the action of micro-dosed progestin (‘minipill’) oral contraceptives (Ovrette, Micronor, Nor-QD). Do not use this type of birth control while taking isotretinoin.

If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, rings, or intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John’s wort if you are using any type of hormonal contraceptive.

You must have two negative pregnancy tests before you can begin to take isotretinoin. Your doctor will tell you when and where to have these tests. You will also need to be tested for pregnancy in a laboratory each month during your treatment, when you take your last dose and 30 days after you take your last dose.

You will need to contact the iPLEDGE system by phone or the internet every month to confirm the two forms of birth control you are using and to answer two questions about the iPLEDGE program. You will only be able to continue to get isotretinoin if you have done this, if you have visited your doctor to talk about how you are feeling and how you are using your birth control and if you have had a negative pregnancy test within the past 7 days.

Stop taking isotretinoin and call your doctor right away if you think you are pregnant, you miss a menstrual period, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the iPLEDGE program, the manufacturer of isotretinoin, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby’s health will be used to help doctors learn more about the effects of isotretinoin on unborn babies.

For male patients:

A very small amount of isotretinoin will probably be present in your semen when you take prescribed doses of this medication. It is not known if this small amount of isotretinoin may harm the fetus if your partner is or becomes pregnant. Tell your doctor if your partner is pregnant, plans to become pregnant, or becomes pregnant during your treatment with isotretinoin.

Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

Isotretinoin comes as a capsule to take by mouth. Isotretinoin is usually taken twice a day with meals for 4 to 5 months at a time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a full glass of liquid. Do not chew, crush, or suck on the capsules.

Your doctor will probably start you on an average dose of isotretinoin and increase or decrease your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully and ask your doctor or pharmacist if you are not sure how much isotretinoin you should take.

It may take several weeks or longer for you to feel the full benefit of isotretinoin. Your acne may get worse during the beginning of your treatment with isotretinoin. This is normal and does not mean that the medication is not working. Your acne may continue to improve even after you finish your treatment with isotretinoin.

Isotretinoin has been used to treat certain other skin conditions and some types of cancer. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking isotretinoin,

• Tell your doctor and pharmacist if you are allergic to isotretinoin, vitamin A, any other medications, or any of the ingredients in isotretinoin capsules. Ask your pharmacist or check the Medication Guide for a list of the inactive ingredients.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, herbal products, and nutritional supplements you are taking or plan to take. Be sure to mention medications for seizures such as phenytoin (Dilantin); medications for mental illness; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone; tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others); and vitamin A supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you or anyone in your family has thought about or attempted suicide and if you or anyone in your family has or has ever had depression, mental illness, diabetes, asthma, osteoporosis (a condition in which the bones are fragile and break easily), osteomalacia (weak bones due to a lack of vitamin D or difficulty absorbing this vitamin), or other conditions that cause weak bones, a high triglyceride (fats in the blood) level, a lipid metabolism disorder (any condition that makes it difficult for your body to process fats), anorexia nervosa (an eating disorder in which very little is eaten), or heart or liver disease. Also tell your doctor if you are overweight or if you drink or have ever drunk large amounts of alcohol.
• Do not breast-feed while you are taking isotretinoin and for 1 month after you stop taking isotretinoin.
• Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Isotretinoin may make your skin sensitive to sunlight.
• You should know that isotretinoin may cause changes in your thoughts, behavior, or mental health. Some patients who took isotretinoin have developed depression or psychosis (loss of contact with reality), have become violent, have thought about killing or hurting themselves, and have tried or succeeded in doing so. You or your family should call your doctor right away if you experience any of the following symptoms: anxiety,sadness, crying spells, loss of interest in activities you used to enjoy, poor performance at school or work, sleeping more than usual, difficulty falling asleep or staying asleep, irritability, anger, aggression, changes in appetite or weight, difficulty concentrating, withdrawing from friends or family, lack of energy, feelings of worthlessness or guilt, thinking about killing or hurting yourself, acting on dangerous thoughts, or hallucinations (seeing or hearing things that do not exist). Be sure that your family members know which symptoms are serious so that they can call the doctor if you are unable to seek treatment on your own.
• You should know that isotretinoin may cause your eyes to feel dry and make wearing contact lenses uncomfortable during and after your treatment.
• You should know that isotretinoin may limit your ability to see in the dark. This problem may begin suddenly at any time during your treatment and may continue after your treatment is stopped. Be very careful when you drive or operate machinery at night.
• Plan to avoid hair removal by waxing, laser skin treatments, and dermabrasion (surgical smoothing of the skin) while you are taking isotretinoin and for 6 months after your treatment. Isotretinoin increases the risk that you will develop scars from these treatments. Ask your doctor when you can safely undergo these treatments.
• Talk to your doctor before you participate in hard physical activity such as sports. Isotretinoin may cause the bones to weaken or thicken abnormally and may increase the risk of certain bone injuries in people who perform some types of physical activity. If you break a bone during your treatment, be sure to tell all your healthcare providers that you are taking isotretinoin.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Red, cracked, and sore lips
• Dry skin, eyes, mouth, or nose
• Nosebleeds
• Changes in skin color
• Peeling skin on the palms of the hands and soles of the feet
• Changes in the nails
• Slowed healing of cuts or sores
• Bleeding or swollen gums
• Hair loss or unwanted hair growth
• Sweating
• Flushing
• Voice changes
• Tiredness
• Cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, stop taking isotretinoin and call your doctor or get emergency medical treatment immediately:

• Headache
• Blurred vision
• Dizziness
• Nausea
• Vomiting
• Seizures
• Slow or difficult speech
• Weakness or numbness of one part or side of the body
• Stomach pain
• Chest pain
• Difficulty swallowing or pain when swallowing
• New or worsening heartburn
• Diarrhea
• Rectal bleeding
• Yellowing of the skin or eyes
• Dark colored urine
• Back, bone, joint or muscle pain
• Muscle weakness
• Difficulty hearing
• Ringing in the ears
• Vision problems
• Painful or constant dryness of the eyes
• Unusual thirst
• Frequent urination
• Trouble breathing
• Fainting
• Fast or pounding heartbeat
• Red, swollen, itchy, or teary eyes
• Fever
• Rash
• Peeling or blistering skin, especially on the legs, arms, or face
• Sores in the mouth, throat, nose, or eyes
• Red patches or bruises on the legs
• Swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• Difficulty swallowing or pain when swallowing

Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child’s doctor about the risks of giving this medication to your child.

Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• Vomiting
• Flushing
• Severe chapped lips
• Stomach pain
• Headache
• Dizziness
• Loss of coordination

Anyone who has taken an overdose of isotretinoin should know about the risk of birth defects caused by isotretinoin and should not donate blood for 1 month after the overdose. Pregnant woman should talk to their doctors about the risks of continuing the pregnancy after the overdose. Women who can become pregnant should use two forms of birth control for 1 month after the overdose. Men whose partners are or may become pregnant should use condoms or avoid sexual contact with that partner for 1 month after the overdose because isotretinoin may be present in the semen.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to isotretinoin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.