MEDICATION GUIDE

Isotretinoin (EYE so TRET i noyn)Capsules

Read the Medication Guide that comes with isotretinoin capsules 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 aboutisotretinoin capsules?

• Isotretinoin capsules are used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
• Because isotretinoin capsules can cause birth defects, isotretinoin capsules are only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE REMS.
• Isotretinoin capsules 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. Patients who are pregnant or who plan to become pregnant must not take isotretinoin capsules. Patients must not get pregnant:

• for 1 month before starting isotretinoin capsules
• while taking isotretinoin capsules
• for 1 month after stopping isotretinoin capsules.

  If you get pregnant while takingisotretinoin capsules, 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

1. Serious mental health problems. Isotretinoin capsules may cause:

• depression
• psychosis (seeing or hearing things that are not real)
• suicide. Some patients taking isotretinoin capsules 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 isotretinoin capsulesand 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 isotretinoin capsules, you may also need follow-up mental health care if you had any of these symptoms.

What areisotretinoin capsules?

Isotretinoin capsules are 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. Isotretinoin capsules can cause serious side effects (see “What is the most important information I should know about isotretinoin capsules?”). Isotretinoin capsules can only be:

• prescribed by doctors that are enrolled in the iPLEDGE REMS
• dispensed by a pharmacy that is enrolled with the iPLEDGE REMS
• given to patients who are enrolled in the iPLEDGE REMS 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 isotretinoin capsules?

• Do not take isotretinoin capsules if you are pregnant, plan to become pregnant, or become pregnant during isotretinoin capsules treatment. Isotretinoin capsules cause life-threatening birth defects. See “What is the most important information I should know about isotretinoin capsules?”
• Do not take isotretinoin capsules if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in isotretinoin capsules.

What should I tell my doctor before taking isotretinoin capsules?

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

• You must take isotretinoin capsules exactly as prescribed. You must also follow all the instructions of the iPLEDGE REMS. Before prescribing isotretinoin capsules, your doctor will:
• explain the iPLEDGE REMS to you
• have you sign the Patient Enrollment Form for Patients who cannot get Pregnant. Patients who can get pregnant must also sign another enrollment form.

You will not be prescribed isotretinoin capsules if you cannot agree to or follow all the instructions of the iPLEDGE REMS.

• You will get no more than a 30-day supply of isotretinoin capsules at a time. This is to make sure you are following the isotretinoin capsules iPLEDGE REMS. You should talk with your doctor each month about side effects.
• The amount of isotretinoin capsules you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
• Take isotretinoin capsules 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your isotretinoincapsules whole with a full glass of liquid. Do not chew or suck on the capsule. Isotretinoin capsules 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 isotretinoin capsules or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking isotretinoin capsules. 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 isotretinoin capsules. Patients who can get pregnant will get a pregnancy test each month.
• 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 isotretinoin capsules. You must access the iPLEDGE REMS system to answer questions about the program requirements and to enter your two chosen forms of birth control. To access the iPLEDGE REMS system, go to www.ipledgeprogram.com or call 1-866-495-0654.

You must talk about effective birth control forms 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 isotretinoin capsules.

If you have sex at any time without using two forms of effective birth control, get pregnant, or

miss your expected period, stop using isotretinoin capsulesand call your doctor right away.

What should I avoid while takingisotretinoin capsules?

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

What are the possible side effects ofisotretinoin capsules?

• Isotretinoin capsulescan 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 aboutisotretinoin capsules?”
• Isotretinoin capsulesmay cause serious mental health problems. See “What is the most important information I should know aboutisotretinoin capsules?”
• serious brain problems. Isotretinoin capsules can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking isotretinoin capsules 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
• skin problems. Skin rash can occur in patients taking isotretinoin capsules. In some patients a rash can be serious. Stop using isotretinoin capsules and call your doctor right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”), a rash with a fever, blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes, or if your skin begins to peel.
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking isotretinoin capsules. Stop taking isotretinoin capsules 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. Isotretinoin capsules 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 isotretinoin capsules. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take isotretinoin capsules if you break a bone.

Stop isotretinoin capsulesand call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.

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

• hearing problems. Stop using isotretinoin capsules 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. Isotretinoin capsules may affect your ability to see in the dark. This condition usually clears up after you stop taking isotretinoin capsules, but it may be permanent. Other serious eye effects can occur. Stop taking isotretinoin capsules 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 isotretinoin capsules and after treatment.
• lipid (fats and cholesterol in blood) problems. Isotretinoin capsules 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 isotretinoin capsules treatment is finished.
• serious allergic reactions. Stop taking isotretinoin capsules and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking isotretinoin capsules and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Isotretinoin capsules 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 isotretinoin capsules 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 isotretinoin capsules. 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 Amneal Pharmaceuticals at 1-877-835-5472.

How should I storeisotretinoin capsules?

• Store isotretinoin capsules at 20° to 25°C (68° to 77°F). Protect from light.
• Keep isotretinoin capsulesand all medicines out of the reach of children.

General Information aboutisotretinoin capsules.

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use isotretinoin capsules for a condition for which it was not prescribed. Do not give isotretinoin capsules 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 isotretinoin capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about isotretinoin capsules that is written for healthcare professionals.

You can also call iPLEDGE REMS at 1-866-495-0654 or visit www.ipledgeprogram.com.

What are the ingredients inisotretinoin capsules?

Active Ingredient: Isotretinoin

Inactive Ingredients: Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium dihydrate, gelatin, glycerin, hydrogenated vegetable oil, purified water, soybean oil, titanium dioxide and white wax (beeswax).

In addition, the 10 mg capsule contains iron oxide black and iron oxide yellow. The 20 mg capsule contains iron oxide black, iron oxide red and iron oxide yellow. The 30 mg capsule contains FD&C yellow #6 aluminum lake. The 40 mg capsule contains FD&C yellow #6 aluminum lake.

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

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

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 03-2022-04