Patient information: uses, side effects, how to take - Amnesteem

What is the most important information I should know about Amnesteem?

Amnesteem 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 Amnesteem.
- Because of the risk of birth defects, Amnesteem is only available through a special program called the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS).
- Your healthcare provider must be enrolled in the iPLEDGE REMS for you to be prescribed Amnesteem.
- Before you start treatment with Amnesteem, you must enroll in the iPLEDGE REMS.
- You must understand and agree to do everything required in the iPLEDGE REMS.
Patients must not get pregnant:
1. o for 1 month before starting Amnesteem
2. o during treatment with Amnesteem
3. o for 1 month after stopping Amnesteem
If you get pregnant during treatment with Amnesteem, stop taking it right away and tell your health care provider. Health care providers and patients should report all cases of pregnancy that happen during treatment or 1 month after stopping treatment to:
1. o FDA MedWatch at 1-800-FDA-1088, and
2. o the iPLEDGE Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com
If you have any questions about the iPLEDGE REMS, ask your healthcare provider, or go to www.ipledgeprogram.com or call 1-866-495-0654.
Serious mental health problems, including:
- depression
- psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking Amnesteem have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. Some people have ended their own lives.
Stop taking Amnesteem and tell your health care provider right away if you or a family member notices that you get 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
suicide attempts

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

Your health care provider may tell you to see a mental health care professional if you have any of these symptoms.

See “What are the possible side effects of Amnesteem?” for more information about side effects.

What is Amnesteem?

Amnesteem is a prescription medicine used in patients 12 years of age and older, who are not pregnant, for the treatment of severe acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Amnesteem can cause serious side effects (see “What is the most important information I should know about Amnesteem?”).

Amnesteem can only be:

prescribed by health care providers that are enrolled in the iPLEDGE REMS
dispensed by a pharmacy that is enrolled in the iPLEDGE REMS
given to patients who are enrolled in the iPLEDGE REMS and agree to do everything required in the program.

It is not known if Amnesteem is safe and effective in children less than 12 years of age.

Do not take Amnesteem if you:

are pregnant, plan to become pregnant, or become pregnant during Amnesteem treatment. Amnesteem can cause life-threatening birth defects. See “What is the most important information I should know about Amnesteem?”
are allergic to isotretinoin, vitamin A, or any of the ingredients in Amnesteem. See the end of this Medication Guide for a complete list of ingredients in Amnesteem.

Before taking Amnesteem, tell your health care provider if you or a family member has any of the following health conditions:

mental health problems
asthma
liver problems
diabetes
heart disease
increase blood fat levels (cholesterol and triglycerides)
bone loss (osteoporosis), weak bones or any other bone problems
an eating problem called anorexia nervosa (where people eat too little)
bowel or digestion problems

Tell your health care provider if you are pregnant or breastfeeding. Do not breastfeed during treatment or for at least 8 days after the last dose of Amnesteem.

Tell your health care provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Amnesteem and certain other medicines can affect each other, sometimes causing serious side effects.

Do not take the following medicines during treatment with Amnesteem:

vitamin A supplements
tetracycline antibiotics

Know the medicines you take. Keep a list of them to show to your health care provider and pharmacist. Do not take any new medicine without talking with your healthcare provider.

You will not be prescribed Amnesteem 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 Amnesteem at a time. This is to make sure you are following the Amnesteem iPLEDGE REMS.

How should I take Amnesteem?

You must take Amnesteem exactly as prescribed. You must also follow all the instructions of the iPLEDGE REMS. Before prescribing Amnesteem, your health care provider will:

explain the iPLEDGE REMS to you
have you sign the Patient Informed Consent form (for all patients). Patients who can get pregnant must also sign another consent form.
get pregnancy tests to make sure you are not pregnant before you start Amnesteem. You will take 2 pregnancy tests at least 30 days apart before starting treatment.
The amount of Amnesteem you take has been specially chosen for you. It is based on your body weight and may change during treatment.
Take Amnesteem two times a day with food. Swallow Amnesteem whole with a full glass of liquid. Do not split, crush, chew, or suck on the capsules. Amnesteem can hurt the tube that connects your mouth to your stomach (esophagus) if not swallowed whole.
Your health care provider will tell you how long you will receive treatment with Amnesteem.
If you miss a dose, just skip that dose. Do not take two doses at the same time.
If you take too much Amnesteem, call your health care provider or Poison Help line at 1-800-222-1222 right away.
Your acne may get worse when you first start taking Amnesteem. This should last only a short while. Talk with your health care provider if this is a concern for you. Your acne may continue to improve after treatment.
You must return to your health care provider as directed to make sure you don’t have signs of serious side effects. Your health care provider may do blood tests to check for serious side effects from Amnesteem and may stop treatment if you get certain side effects.
Patients who can get pregnant will get a pregnancy test before each prescription is given during treatment with Amnesteem, when you stop treatment, and 1 month after you stop treatment.
You must get your prescription within seven days of receiving your pregnancy test.
Patients who can get pregnant must:
- Talk about birth control options with your health care provider or go for a free visit to talk about birth control with another health care provider or family planning expert. Your health care provider can arrange this free visit, which will be paid for by the company that makes Amnesteem.
- Use your chosen pregnancy prevention methods. You must choose two separate forms of birth control at the same time or commit to not having sexual contact with a partner that could result in pregnancy for at least 1 month before treatment, during treatment, and for 1 month after treatment with Amnesteem.
- Access the iPLEDGE REMS system to answer questions about the REMS requirements and enter your two chosen pregnancy prevention methods (two separate forms of birth control or commitment to not having sexual contact with a partner that could result in pregnancy). To access the iPLEDGE REMS system, go to www.ipledgeprogram.com or call 1-866-495-0654.
If you have sex at any time without using two forms of birth control 1 month before, during, or 1 month after treatment, get pregnant, or miss your expected period, stop taking Amnesteem and call your health care provider right away.

What should I avoid while taking Amnesteem?

Do not give blood during treatment with Amnesteem and for 1 month after stopping Amnesteem. If someone who is pregnant gets your donated blood, Amnesteem may cause miscarriage, premature birth, birth defects, or death of the baby.
Do not take other medicines or herbal products during treatment with Amnesteem unless you talk to your health care provider. See “Before taking Amnesteem”.
Do not drive at night until you know if Amnesteem has affected your vision. Amnesteem may decrease your ability to see in the dark.
Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, during treatment with Amnesteem and for at least 6 months after you stop. Amnesteem can increase your chance of scarring from these procedures. Check with your health care provider for advice about when you can have cosmetic procedures.
Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Amnesteem may make your skin more sensitive to light.
Do not share Amnesteem with other people. Amnesteem can cause life-threatening birth defects and other serious health problems.

What are the possible side effects of Amnesteem?

Amnesteem can cause serious side effects, including:

See “What is the most important information I should know about Amnesteem?”
increased pressure in the brain (intracranial hypertension). Amnesteem can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking Amnesteem and tell your health care provider right away if you get any of these signs of increased brain pressure:

bad headache
blurred vision or other visual problems
dizziness

nausea or vomiting
seizures (convulsions)
stroke

serious skin problems. Skin rash can happen in patients taking Amnesteem. Sometimes rash can be severe and may be life-threatening and lead to hospitalization or death. Stop taking Amnesteem and tell your health care provider right away if you get:

conjunctivitis (red or inflamed eyes, like “pink eye”)
rash with a fever
blisters on legs, arms or face

sores in your mouth, throat, nose or
eyes
peeling of your skin

inflammation of your pancreas (pancreatitis) can happen in patients who take Amnesteem and can lead to death. Stop taking Amnesteem and tell your health care provider right away if you get any of the following symptoms of pancreatitis:

severe upper stomach (abdomen) pain
swelling of your stomach

nausea and vomiting
fever

increased blood fat (lipid) levels. Amnesteem can raise blood fat levels (cholesterol and triglycerides). Your health care provider will do blood tests to check your lipids before and during treatment. These problems usually go away when Amnesteem treatment is finished.
hearing problems. Stop taking Amnesteem and tell your health care provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
liver problems, including hepatitis. Your health care provider will do tests to check your liver before and during treatment with Amnesteem. Tell your health care provider right away if you get:

yellowing of your skin or the whites
of your eyes
pain on the right side of your stomach
area (abdomen)

dark urine
bleeding or bruising more easily
than normal

inflammation of your digestive tract (inflammatory bowel disease). Stop taking Amnesteem right away and tell your health care provider right away if you get:

severe stomach, chest or bowel pain
nausea or vomiting
trouble swallowing or painful swallowing

new or worsening heartburn
diarrhea
rectal bleeding

bone and muscle problems including bone pain, softening or thinning of bones (which may lead to fractures). Amnesteem may stop long bone growth in teenagers who are still growing. Teenagers who participate in sports with hard physical activity and repeated actions during treatment with Amnesteem may have a higher risk of bone fractures or injuries.. Tell your health care provider if you get:
- bone pain
- back pain
- broken bone (fracture).
- muscle problems. Stop taking Amnesteem and tell your health care provider right away if you have muscle or joint pain or weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
vision problems. Stop taking Amnesteem and tell your health care provider right away if you have any vision changes. Amnesteem may affect your ability to see in the dark. This usually goes away after you stop taking Amnesteem, but it may be permanent. Some patients get dry eyes during treatment. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Amnesteem.
serious allergic reactions. Stop taking Amnesteem and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking Amnesteem and tell your health care provider if you get a fever, rash, or red patches or bruises on your legs.
blood sugar problems, including diabetes. Tell your health care provider if you are very thirsty or urinate more than usual.

The most common side effects of Amnesteem include:

dry lips
dry skin
back pain
dry eyes
joint pain
nose bleeds

headache
upper respiratory tract infection (common cold)
chapped lips or swelling of the lips
skin reactions
muscle problems
eye problems, including decreased vision

These are not all of the possible side effects of Amnesteem.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

How should I store Amnesteem?

Store Amnesteem at room temperature, 68° to 77°F (20° to 25°C). Protect from light.

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

General information about the safe and effective use of Amnesteem

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Amnesteem for a condition for which it was not prescribed. Do not give Amnesteem to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or health care provider for information about Amnesteem that is written for health professionals.

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

What are the ingredients in Amnesteem?

Active ingredient: isotretinoin

Inactive ingredients: butylhydroxyanisole, gelatin, glycerol, hydrogenated partially vegetable oil, medium chain triglycerides, sodium edetate, soy lecithin, soybean oil and yellow beeswax. The 10 mg, 20 mg and 40 mg capsules also contain red iron oxide in glycerin, and the 20 mg, 30 mg and 40 mg capsules also contain titanium dioxide in glycerin and yellow iron oxide in glycerin. The black imprinting ink contains ammonium hydroxide, black iron oxide, polyethylene glycol, propylene glycol and polyvinyl acetate phthalate.

Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Manufactured by: Catalent Pharma Solutions, 67930 Beinheim France

AMNESTEEM is a registered trademark of Mylan Bertek Pharmaceuticals, Inc., a Viatris Company.

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

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Manufactured by:

Catalent Pharma Solutions

74 rue Principale

67930 Beinheim

France

Revised: 8/2026

CAT:ISOTFR:R11

Amnesteem (Isotretinoin): Uses, Side Effects and Dosage