Claravis (Isotretinoin): Uses, Side Effects and Dosage

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

• Claravis 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 Claravis.

  • Because of the risk of birth defects, Claravis 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 Claravis.
  • Before you start treatment with Claravis, 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:

  • for 1 month before starting Claravis
  • during treatment with Claravis
  • for 1 month after stopping Claravis

  If you get pregnant during treatment with Claravis, 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:

  • FDA MedWatch at 1-800-FDA-1088, and
  • 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 Claravis 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 Claravis 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 Claravis?” for more information about side effects.

What is Claravis?

Claravis 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.

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

Claravis 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 Claravis is safe and effective in children less than 12 years of age.

Do not take Claravis if you:

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

Before taking Claravis, 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 Claravis.

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

Do not take the following medicines during treatment with Claravis:

• 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 Claravis 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 Claravis at a time. This is to make sure you are following the Claravis iPLEDGE REMS.

How should I take Claravis?

You must take Claravis exactly as prescribed. You must also follow all the instructions of the iPLEDGE REMS.

Before prescribing Claravis, 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 Claravis. You will take 2 pregnancy tests at least 30 days apart before starting treatment.

• The amount of Claravis you take has been specially chosen for you. It is based on your body weight and may change during treatment.
• Take Claravis two times a day with food. Swallow Claravis whole with a full glass of liquid. Do not split, crush, chew, or suck on the capsules. Claravis 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 Claravis.
• If you miss a dose, just skip that dose. Do not take two doses at the same time.
• If you take too much Claravis, 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 Claravis. 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 Claravis 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 Claravis, 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 Claravis.
  • 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 Claravis.
  • 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 Claravis and call your health care provider right away.

What should I avoid while taking Claravis?

• Do not give blood during treatment with Claravis and for 1 month after stopping Claravis. If someone who is pregnant gets your donated blood, Claravis may cause miscarriage, premature birth, birth defects, or death of the baby.
• Do not take other medicines or herbal products during treatment with Claravis unless you talk to your health care provider. See “Before taking Claravis”
• Do not drive at night until you know if Claravis have affected your vision. Claravis 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 Claravis and for at least 6 months after you stop. Claravis 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. Claravis may make your skin more sensitive to light.
• Do not share Claravis with other people. Claravis can cause life-threatening birth defects and other serious health problems.

What are the possible side effects of Claravis?

Claravis can cause serious side effects, including:

• See “What is the most important information I should know about Claravis”?
• increased pressure in the brain (intracranial hypertension). Claravis can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking Claravis 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 Claravis. Sometimes rash can be severe and may be life-threatening and lead to hospitalization or death. Stop taking Claravis 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 Claravis and can lead to death. Stop taking Claravis 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. Claravis 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 Claravis treatment is finished.
• hearing problems. Stop taking Claravis 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 Claravis. 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 Claravis 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). Claravis 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 Claravis 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 Claravis 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 Claravis and tell your health care provider right away if you have any vision changes. Claravis may affect your ability to see in the dark. This usually goes away after you stop taking Claravis, 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 Claravis.
• serious allergic reactions. Stop taking Claravis and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking Claravis 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 Claravis 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 Claravis.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Teva at 1-888-838-2872.

How should I store Claravis?

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

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

General information about the safe and effective use of Claravis

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

Claravis for a condition for which it was not prescribed. Do not give Claravis 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 Claravis 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 Claravis?

Active ingredient: isotretinoin

Inactive ingredients: Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium dioxide, white wax (beeswax), and vitamin E.

In addition, the 10 mg capsule contains black iron oxide and FD&C yellow no. 6. The 20 mg capsule contains black iron oxide, red iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and yellow iron oxide. The 40 mg capsule contains FD&C yellow no. 6.

The edible imprinting ink contains: 10 mg strength, D&C red no. 7 calcium lake, FD&C yellow no. 6 aluminum lake, propylene glycol, shellac glaze, and titanium dioxide; 20 mg strength, ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide; 30 mg strength, D&C yellow no. 10 aluminum lake, FD&C blue no.1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol, and shellac glaze; 40 mg strength, ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze.

Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. P 7/2026