Isotretinoin (AccutaneŽ)

Isotretinoin (AccutaneŽ) is a retinoid or vitamin A analog, which means that its molecular structure is similar to Vitamin A. It was first approved in the US in 1982 for treating severe nodular acne that has not been helped by other treatments. Capsules come in either 10mg or 40mg doses.

Severe nodular acne is defined by many red, swollen, tender lumps that have formed in the skin. These can be the size of a pea or larger. Nodular acne can cause permanent scars if it goes untreated.

For women who can get pregnant, AccutaneŽ can only be

• prescribed by doctors that are registered in the iPLEDGE program
• dispensed by a pharmacy that is registered with the iPLEDGE program
• given to patients who are registered in the iPLEDGE program and agree to do everything required in that program.

The iPLEDGE program is a comprehensive program that can help you get prepared, plan your AccutaneŽ treatments and ensure that you don't get pregnant during the course of therapy.

How Should I Take AccutaneŽ?

• You must take AccutaneŽ exactly as your doctor prescribed it.
• The amount of AccutaneŽ you take has been specially chosen for you, based on your body weight, and may change during treatment.
• Take AccutaneŽ 2 times a day with a meal, unless your doctor tells you otherwise. It is important to swallow your isotretinoin capsules whole with a full glass of liquid so that the medication is not released until it reaches your stomach, because it can damage the cell lining of your esophagus.
• If you miss a dose, just skip that dose. Do not take 2 doses at the same time.
• If you take too much isotretinoin, or overdose, call your doctor or poison control center right away.
• Your acne may get worse when you first start taking this drug. However, this should last only a short while. Talk with your doctor if this is a problem for you.
• You will get no more than a 30-day supply of AccutaneŽ at a time.
• It's important that you 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 this. Female patients who can get pregnant will get a pregnancy test each month. See "Isotretinoin - Side Effects That Need Medical Monitoring By Your Physician"

Special Instructions for Women Who Can Get Pregnant

• You must also follow all the instructions of the iPLEDGE program. Before prescribing AccutaneŽ, your doctor will:
  
  • explain the iPLEDGE program to you
  • have you sign the Patient Information/Informed Consent (for all patients).
  • Female patients who can get pregnant must also sign another consent form.
  • You will not be prescribed AccutaneŽ if you cannot agree to or follow all the instructions of the iPLEDGE program.
• You must agree to use 2 separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after taking isotretinoin. You must access the iPLEDGE system to answer questions about the program requirements and enter your 2 chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.
• You must talk about effective birth control methods 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 AccutaneŽ.

If you have sex at any time without using 2 forms of effective birth control, get pregnant, or miss your expected period, stop using AccutaneŽ and call your doctor immediately.

What Should I Avoid While Taking AccutaneŽ?

• Do not get pregnant while taking isotretinoin and for 1 month after stopping AccutaneŽ.
• Do not breast feed while taking isotretinoin and for 1 month after stopping it. It is not known whether isotretinoin can pass through your milk and harm the baby.
• Do not donate blood while you take isotretinoin and for 1 month after stopping this product. If the person getting your donated blood is pregnant, her baby may be exposed to this drug and may be born with birth defects.
• Do not take other medicines or herbal products with isotretinoin unless you talk to your doctor about them beforehand. See "What should I tell my doctor before taking AccutaneŽ?"
• Isotretinoin may decrease your ability to see in the dark, so do not drive at night until you know if it has affected your vision.
• Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are taking isotretinoin and for at least 6 months after you stop. Isotretinoin can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
• Isotretinoin may make your skin more sensitive to light. Avoid sunlight and ultraviolet lights as much as possible. Keep in mind that tanning machines use ultraviolet lights, so they should be avoided as well.
• Do not share AccutaneŽ with other people. It can cause birth defects and other serious health problems.

What Should I Tell My Doctor Before Taking AccutaneŽ?

• ˇ Tell your doctor if you or a family member has any of the following health conditions:
• ˇ mental problems
• ˇ asthma
• ˇ liver disease
• ˇ diabetes
• ˇ heart disease
• ˇ bone loss (osteoporosis) or weak bones
• ˇ anorexia nervosa
• ˇ food or medicine allergies
• ˇ Tell your doctor if you are pregnant or breastfeeding. AccutaneŽ must not be used by women who are pregnant or breastfeeding.
• ˇ Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Isotretinoin and certain other medicines can interact with each other, sometimes causing serious side effects.
• ˇ Especially tell your doctor if you take:
  
  • Vitamin A supplements. Vitamin A in high doses has many of the same side effects as AccutaneŽ, so taking both together could increase your chance of experiencing side effects.
  • Tetracycline antibiotics when taken with AccutaneŽ can increase your chances of developing increased intracranial (in the brain) pressure.
  • Progestin-only birth control pills (mini-pills): they may not work while you take AccutaneŽ. Ask your doctor or pharmacist if you are not sure what type you are using.
  • Dilantin (phenytoin). This medicine taken with AccutaneŽ may weaken your bones.
  • Corticosteroid medicines. These medicines taken with AccutaneŽ may weaken your bones.

These medicines should not be used with AccutaneŽ unless your doctor says it's okay. Know the medicines you take and keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without first talking with your doctor.

Who Should Not Take AccutaneŽ?

• AccutaneŽ causes severe birth defects. Do not take this medication if you are pregnant, plan to become pregnant, or become pregnant during AccutaneŽ treatment.
• Do not take this medication if you are allergic to anything in it.

What Are The Ingredients In AccutaneŽ?

Active Ingredient: Isotretinoin

Inactive Ingredients: beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

How Well Does It Work?

For severe acne, AccutaneŽ cures approximately 35%-38% of patients after one course of treatment, and 70% of those who take AccutaneŽ experience long-term remission. Adult women have higher relapse rates than teenagers. One course of treatment will take on average, 4-6 months.

The daily dose is most often determined at 0.5 - 1mg per kg of your body weight. The total dose, that is, the total amount taken over the whole treatment period should be not less than 120mg per kg of body weight for long lasting benefit. If you have very oily skin and giant blackheads, are a younger teenager, or have acne on your chest and back, then you have a greater chance of having a relapse of your acne.
Most dermatologists believe it is a remarkable acne medication, some people's acne clears quickly while in others improvement is gradual. Multiple courses can be taken.

How Does It Work?

Isotretinoin basically helps the sebaceous gland to mature; it does so in several ways. Testosterone drives this oil gland to produce a number of different oils that influence the lining of the hair follicle. AccutaneŽ brings the amount of oils to a more normal level and helps to change the composition of the oil so that it does not allow the pores to clog up. It prevents an excess of keratin from being produced, which means that comedones are not so readily formed.

This is the most effective therapy currently available. It can be used to treat your acne, if it is severe, and will reduce the risk of scarring. However, only doctors who have experience in its use should prescribe this medication. This is because regular monitoring, including periodic blood testing, is necessary. Women and girls who can become pregnant and are using this medication must follow the iPLEDGE Program.

How Should I Store AccutaneŽ?

• Store AccutaneŽ at room temperature, between 59° and 86°F. Protect from light.
• Keep AccutaneŽ and all medicines out of the reach of children.

What Conditions Are Treated By This Medication?

HPB-approved:

• Acne
• Severe recalcitrant nodular cystic acne that is not responsive to other therapy

General Information About AccutaneŽ

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use AccutaneŽ for a condition for which it was not prescribed. Do not give AccutaneŽ to other people, even if they have the same symptoms that you have. It may harm them.

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