Claravis

Claravis is a type of vitamin A that treats severe nodular acne that has not improved with other treatments, including antibiotics.

You can only get Claravis from a certified pharmacy that participates in a special program called iPLEDGE.

Claravis may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take Claravis with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking Claravis with or without food.

Use Claravis for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Claravis can cause serious birth defects or death of a baby with just one dose. Never use Claravis if you are pregnant or can become pregnant.

You must have a negative pregnancy test before starting Claravis. You will need to use two forms of birth control to prevent pregnancy while taking this medicine. If you think you might be pregnant, stop using this medicine and call your doctor immediately.

Claravis can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use this medicine if you are pregnant or able to become pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be able to get pregnant. You must have 2 negative pregnancy tests before you start taking Claravis, before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Claravis and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

• tubal ligation (tubes tied);
• vasectomy of the male sexual partner;
• an IUD (intrauterine device);
• estrogen-containing birth control pills (not mini-pills); and
• hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

• a male latex condom with or without spermicide;
• a diaphragm plus a spermicide;
• a cervical cap plus a spermicide; and
• a vaginal sponge containing a spermicide.

Stop using Claravis and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking this medicine, call the iPLEDGE pregnancy registry at 1-866-495-0654.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

You should not use Claravis if you are allergic to it.

Tell your doctor if you have ever had:

• depression or mental illness;
• asthma;
• liver disease;
• diabetes;
• heart disease or high cholesterol;
• osteoporosis or low bone mineral density;
• an eating disorder such as anorexia;
• a food or drug allergy; or
• an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for use by anyone younger than 12 years old.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Claravis may cause serious side effects. Stop using Claravis and call your doctor right away if you have:

• problems with your vision or hearing;
• muscle or joint pain, bone pain, back pain;
• increased thirst, increased urination;
• hallucinations (seeing or hearing things that are not real);
• symptoms of depression—unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• signs of liver or pancreas problems—loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• severe stomach problems—severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or
• increased pressure inside the skull—severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects of Claravis may include:

• dryness of your skin, lips, eyes, or nose (you may have nosebleeds);
• vision problems;
• headache, back pain, joint pain, muscle problems;
• skin reactions; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Symptoms of an overdose may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

Do not take any vitamin or mineral supplement that contains vitamin A unless your doctor advises you to.

Do not donate blood while taking Claravis and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could cause birth defects in her baby if the blood has any level of isotretinoin.

While you are taking Claravis and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. This could lead to scarring.

Claravis could make you more sensitive to the sun. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Avoid driving or doing dangerous activities until you know how Claravis will affect you. Claravis may affect your vision, especially at night.

Tell your doctor about all your other medicines, especially:

• phenytoin;
• St. John's wort (may make birth control pills less effective);
• vitamin or mineral supplements;
• progestin-only birth control pills (mini-pills, may not work as well when taken with Claravis);
• steroid medicine; or
• a tetracycline antibiotic, including doxycycline or minocycline.

This list is not complete. Other drugs may affect Claravis, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.