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IMPORTANT SAFETY INFORMATION FOR ISOTRETINOIN (GENERIC ACCUTANE)

CONTRAINDICATIONS AND WARNINGS


Isotretinoin (Accutane) must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Isotretinoin (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 Isotretinoin (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.

CAUSE BIRTH DEFECTS

DO NOT GET PREGNANT

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 patient who is taking Isotretinoin (Accutane), Isotretinoin (Accutane) must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.


Special Prescribing Requirements Because of Isotretinoin (Accutane)'s teratogenicity and to minimize fetal exposure, Isotretinoin (Accutane) is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE®.Isotretinoin (Accutane) must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Isotretinoin (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).

Important Safety Information for Isotretinoin (Generic Accutane)


What is the most important information I should know about Isotretinoin (Accutane)?

Isotretinoin (Accutane) is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics

Isotretinoin (Accutane) can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Isotretinoin (Accutane).


Patients must not get pregnant:

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

    • If you get pregnant while taking Isotretinoin (Accutane), stop taking it right away and call your healthcare provider.

    Isotretinoin (Accutane) is only for patients who can understand and agree to follow all the instructions in the iPLEDGE® Program. Patients taking Isotretinoin (Accutane) must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further information.

    Isotretinoin (Accutane) can cause serious mental health problems, including:

  • depression
  • psychosis (seeing or hearing things that are not real)
  • suicide. Some patients taking Isotretinoin (Accutane) have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.

    • Stop Isotretinoin (Accutane) and call your healthcare provider right away if you or a family member notices that you have any 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 Isotretinoin (Accutane), you may also need follow-up mental health care if you had any of these symptoms.

    Who should not take Isotretinoin (Accutane)?

    • Do not take Isotretinoin (Accutane) if you are pregnant, plan to become pregnant, or become pregnant during Isotretinoin (Accutane) treatment. Isotretinoin (Accutane) causes severe birth defects. See “What is the most important information I should know about Isotretinoin (Accutane)?”

    • Do not take Isotretinoin (Accutane) if you are allergic to anything in it.See the end of this Medication Guide for a complete list of ingredients in Isotretinoin (Accutane). Isotretinoin (Accutane) contains parabens as the preservatives.


    What should I tell my doctor before taking Isotretinoin (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. Isotretinoin (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 nonprescription medicines, vitamins and herbal supplements. Isotretinoin (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 Isotretinoin (Accutane). Taking both together may increase your chance of getting side effects.
    • Tetracycline antibiotics. Tetracycline antibiotics taken with Isotretinoin (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 Isotretinoin (Accutane). Ask your doctor or pharmacist if you are not sure what type you are using.
    • Dilantin (phenytoin). This medicine taken with Isotretinoin (Accutane) may weaken your bones.
    • Corticosteroid medicines. These medicines taken with Isotretinoin (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 Isotretinoin (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


    What should I avoid while taking Isotretinoin (Accutane)?

    • Do not get pregnant while taking Isotretinoin (Accutane) and for one month after stopping Isotretinoin (Accutane). See “What is the most important information I should know about Isotretinoin (Accutane)?”

    • Do not breast feed while taking Isotretinoin (Accutane) and for one month after stopping Isotretinoin (Accutane). We do not know if Isotretinoin (Accutane) can pass through your milk and harm the baby.

    • Do not give blood while you take Isotretinoin (Accutane) and for one month after stopping Isotretinoin (Accutane). If someone who is pregnant gets your donated blood, their baby may be exposed to Isotretinoin (Accutane) and may be born with birth defects.

    • Do not take other medicines or herbal products with Isotretinoin (Accutane) unless you talk to your doctor. See “What should I tell my doctor before taking Isotretinoin (Accutane)?”

    • Do not drive at night until you know if Isotretinoin (Accutane) has affected your vision.Isotretinoin (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 Isotretinoin (Accutane) and for at least 6 months after you stop Isotretinoin (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. Isotretinoin (Accutane) may make your skin more sensitive to light.

    • Do not share Isotretinoin (Accutane) with other people. It can cause birth defects and other serious health problems.


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

  • Isotretinoin (Accutane) can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births.
  • Isotretinoin (Accutane) can cause serious mental health problems.
  • Serious brain problems. Isotretinoin (Accutane) can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Isotretinoin (Accutane) and call your healthcare provider right away if you get any of these signs of increased brain pressure:
    • bad headache
    • blurred vision
    • dizziness
    • nausea or vomiting
    • seizures (convulsions) o stroke
  • Skin problems. Skin rash can occur in patients taking Isotretinoin (Accutane). In some patients a rash can be serious. Stop using Isotretinoin (Accutane) and call your healthcare provider immediately if you develop:
    • conjunctivitis (red or inflamed eyes, like “pink eye”)
    • rash with a fever
    • blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
    • skin begins to peel
  • Stomach area (abdomen) problems. Certain symptoms may mean your internal organs are being damaged, such as 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 Isotretinoin (Accutane). Stop Isotretinoin (Accutane) and call your healthcare provider if you get:
    • severe stomach, chest or bowel pain
    • trouble swallowing or painful swallowing
    • new or worsening heartburn
    • diarrhea o rectal bleeding
    • yellowing of your skin or eyes o dark urine
  • Bone or muscle problems. Isotretinoin (Accutane) may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Isotretinoin (Accutane) and call your healthcare provider immediately if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage. Isotretinoin (Accutane) may stop long bone growth in teenagers who are still growing.
  • Hearing problems. Stop using Isotretinoin (Accutane) and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
  • Vision problems. Isotretinoin (Accutane) may affect your ability to see in the dark. Stop taking Isotretinoin (Accutane) and call your healthcare provider right away if you have 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 during and after you stop treatment with Isotretinoin (Accutane).
  • Lipid (fats and cholesterol in blood) problems. Isotretinoin (Accutane) can raise the level of fats and cholesterol in your blood. These problems usually go away when Isotretinoin (Accutane) treatment is finished.
  • Serious allergic reactions. Stop taking Isotretinoin (Accutane) and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Isotretinoin (Accutane) and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
  • Blood sugar problems. Isotretinoin (Accutane) may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
  • Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.

    • The common, less serious side effects of Isotretinoin (Accutane) include:

  • Dry skin
  • Chapped lips
  • Dry eyes
  • Dry nose that may lead to nosebleeds


    • These are not all of the possible side effects of Isotretinoin (Accutane). Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.