Medication Guide

Important: ABSORICA LD is not the same as ABSORICA or other isotretinoin products. Do not change between ABSORICA LD and ABSORICA or other isotretinoin products.

Read the Medication Guide that comes with ABSORICA or ABSORICA LD 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 healthcare provider about your medical condition or your treatment.

    Your healthcare provider may tell you to see a mental healthcare professional if you get any of these symptoms.

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

What are ABSORICA and ABSORICA LD?

ABSORICA and ABSORICA LD are prescription medicines 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. ABSORICA and ABSORICA LD can cause serious side effects (see “What is the most important information I should know about ABSORICA and ABSORICA LD?”).

ABSORICA and ABSORICA LD can only be:

• prescribed by healthcare 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 ABSORICA and ABSORICA LD are safe and effective in children less than 12 years of age.

Who should not take ABSORICA or ABSORICA LD?

Do not take ABSORICA or ABSORICA LD if you:

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

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

• mental health problems
• asthma
• liver problems
• diabetes
• heart disease
• increased 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
• food or medicine allergies, including aspirin or FD&C Yellow No. 5 (tartrazine)

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

Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements, including St. John’s wort. ABSORICA and ABSORICA LD and certain other medicines can affect each other, sometimes causing serious side effects.

Do not take the following medicines during treatment with ABSORICA or ABSORICA LD:

• vitamin A supplements
• tetracycline antibiotics

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

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

How should I take ABSORICA or ABSORICA LD?

You must take ABSORICA or ABSORICA LD exactly as prescribed. You must also follow all the instructions of the iPLEDGE REMS. Before prescribing ABSORICA or ABSORICA LD, your healthcare 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.
• give you pregnancy tests to make sure you are not pregnant before you start ABSORICA or ABSORICA LD. You will receive 2 pregnancy tests at least 30 days apart before starting treatment.

• The amount of ABSORICA or ABSORICA LD you take has been specially chosen for you. It is based on your body weight and may change during treatment.
• Take ABSORICA or ABSORICA LD  2 times a day with or without meals, unless your healthcare provider tells you otherwise.
• Swallow ABSORICA or ABSORICA LD capsules whole with a full glass of liquid. Do not split, crush, chew, or suck on the capsules. ABSORICA and ABSORICA LD can hurt the tube that connects your mouth to your stomach (esophagus) if not swallowed whole.
• Your healthcare provider will tell you how long you will receive treatment with ABSORICA or ABSORICA LD.
• If you miss a dose, just skip that dose. Donot take 2 doses at the same time.
• If you take too much ABSORICA or ABSORICA LD, call your healthcare provider or Poison Help line at 1-800-222-1222 right away.
• Your acne may get worse when you first start taking ABSORICA or ABSORICA LD. This should last only a short while. Talk with your healthcare provider if this is a concern for you. Your acne may continue to improve after treatment.
• You must return to your healthcare provider as directed to make sure you don’t have signs of serious side effects. Your healthcare provider may do blood tests to check for serious side effects from ABSORICA or ABSORICA LD 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 ABSORICA or ABSORICA LD, when you stop treatment, and 1 month after you stop treatment.
• You must get your prescription within 7 days of receiving your pregnancy test.
• Patients who can get pregnant must:

• Talk about birth control options with your healthcare provider or go for a free visit to talk about birth control with another healthcare provider or family planning expert. Your healthcare provider can arrange this free visit, which will be paid for by the company that makes ABSORICA and ABSORICA LD.
• Use your chosen pregnancy prevention methods. You must choose to use 2 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 ABSORICA or ABSORICA LD.
• Access the iPLEDGE REMS system to answer questions about the REMS requirements and enter your chosen pregnancy prevention methods (2 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 youhave sex at any time without using 2 forms of birth control 1 month before, during, or 1 month after treatment, get pregnant, or miss your expected period, stop taking ABSORICA or ABSORICALD and tell your healthcare provider right away.

What should I avoid while taking ABSORICA or ABSORICA LD?

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

These are not all of the possible side effects of ABSORICA and ABSORICA LD.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Sun Pharmaceutical Industries, Inc. at 1- 800-818-4555.

How should I store ABSORICA and ABSORICA LD?

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

Keep ABSORICA and ABSORICA LD and all medicines out of the reach of children.

General information about the safe and effective use of ABSORICA and ABSORICA LD.

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

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