Isotretinoin

This leaflet has been written to help you understand more about isotretinoin. It tells you what it is, how it works, how it is used, and where you can find out more about it.

Isotretinoin (brand name Roaccutane) belongs to a group of drugs called retinoids, which are closely related to vitamin A. It works in various ways, targeting different factors that cause acne, including the production of sebum (an oily substance produced by the skin) and the production of keratin (outer scales of skin) that block the pores of the hair follicle. 

Isotretinoin is licensed to treat severe acne, often where there is a risk of scarring. Your dermatologist may occasionally use isotretinoin to treat other skin conditions such as hidradenitis suppurativa and rosacea.

A large proportion of patients (about 9 out of 10) see a significant improvement in their acne with a single course of isotretinoin, although, during the first few weeks of treatment, the acne may worsen before it starts to improve. A small number of patients continue to have milder (although improved) acne following isotretinoin controlled with conventional therapies, such as antibiotics. Others may relapse after stopping treatment with isotretinoin, and occasionally, a prolonged or further course of treatment is required. 

Your dermatologist will calculate the amount of isotretinoin you need according to your body weight and decide on an appropriate starting dose. At future appointments, the dose of isotretinoin may be changed as it depends on the side effects and your response to the medication. Most patients take between 20 mg and 40 mg of isotretinoin each day, and a course commonly lasts between 16 and 24 weeks. With doses in the lower end of this range, which are often better tolerated, a course may last longer than 24 weeks.

Your acne may continue to improve for up to 8 weeks after treatment. The benefits of isotretinoin may continue in the skin for several years after treatment. 

As isotretinoin is better absorbed into the body with food containing some fat, it is best to take the medication after a meal. The capsules need to be swallowed whole and should not be crushed or split open. Keep the capsules in the cold (5 to 25°C) dark place away from children. 

Caution for patients of child-bearing potential Patients must not take isotretinoin in pregnancy. If a person becomes pregnant while taking isotretinoin or four weeks after they finish the course, there is a high risk that the baby will be harmed with severe and profound defects (such as abnormal appearance or intellectual disability) and an increased risk of miscarriage. If you become pregnant or suspect that you may be pregnant, you must stop the medication immediately and contact your doctor to be referred to a specialist pregnancy clinic. Termination of pregnancy will be recommended. You should not breastfeed while taking isotretinoin and for a month after completing treatment.

Isotretinoin does not affect fertility. One month after finishing a course of isotretinoin, you may get pregnant with no additional risk to the unborn baby. There has been no known adverse effect on the pregnancy if a man taking isotretinoin fathers a child even though small amounts of isotretinoin are found in semen. Peanut or soya allergy Isotretinoin contains soya oil. Occasionally, patients with soya allergy might react to the trace levels of soya proteins in soya oil. Extremely rarely, patients with peanut allergy might also react to the soya proteins in soya oil. You should inform your doctor and pharmacist if you think you may have an allergy to soya or peanut.

In general, dryness of the skin, lips, and eyes is the most common side effect. Using a non-comedogenic moisturizer (one that does not block the skin pores) and lip balm regularly will help. In more severe cases, this can turn into eczema and may require additional treatment. Nosebleeds may occur if the inside of the nose becomes very dry.

Dry eyes may make the wearing of contact lenses a little uncomfortable and maybe helped by using artificial tears eye drops available over the counter. As a result of the skin becoming dry and cracked, the risk of skin infection is increased. 

Wounds may also take longer to heal, and the skin may feel fragile and peel with friction. While taking isotretinoin, and for 1-2 months afterward, your skin will be more delicate than usual, hair removal using waxing, epilation, dermabrasion, or laser treatment, as well as tattoos and piercings should be avoided. 

Shaving is normally tolerated, but the use of a moisturizer afterward is advisable. Isotretinoin may increase your skin’s sensitivity to the sun. You should, therefore, avoid direct sun exposure while taking this medication. 

Where necessary, a sun-protection product with a high protection factor of at least SPF 30 should be used. You should also avoid the use of sunbeds.

Muscles and joints may ache, especially after exercise. Temporary hair thinning may occasionally occur.  Isotretinoin can rarely affect your vision, particularly the ability to see at night (less than 1 in 10,000 chance). If you develop difficulties seeing at night or in dark situations, you should avoid driving or operating heavy machinery. Patients whose jobs may be impacted by this, such as drivers, airline pilots, people in the military, and those who operate heavy machinery, are advised to discuss this with their employer before starting the medication and check with current Civil Aviation guidelines. 

These night-vision changes may be permanent in extremely rare circumstances.

Isotretinoin may sometimes cause an increase in the levels of fats in your blood (which can lead to inflammation of the pancreas) or inflammation of the liver.

Blood tests will be requested during treatment to monitor any potential side-effects.

Several more severe side effects may occur, although these are rare. Isotretinoin can lead to mood swings or behavior (between 1 in 1,000 and 1 in 10,000 chance) and, less commonly, unusual experiences, including thoughts of self-harm and suicide. There have also been reports of patients attempting suicide (less than 1 in 10,000 chance).

If you have ever had low mood, suicidal ideas, or any other mental health problem, please discuss this with your dermatologist before starting treatment. If you have a history of depression, your dermatologist may ask a psychiatrist to see you before starting isotretinoin to determine if it is safe for you to take. If you or your friends/relatives feel that your mood or behavior is changing, or if you start having thoughts of self-harm while taking isotretinoin, please inform your doctor and stop taking it immediately. Your dermatologist will then discuss it with you and advise if it is safe to take in the future.

A very rare side effect is raised pressure in the brain (less than 1 in 10,000 chance), this causes severe headache, nausea, vomiting, and blurred vision. Sexual side effects, such as erectile dysfunction, vaginal dryness, and decreased libido, may also occur; these are understood to be rare but may persist despite completing the course of treatment. 

You must never share your tablets with other people. You cannot donate blood when taking isotretinoin, and for at least one month after stopping the medication in case, the blood is given to a pregnant woman. 

Most drugs can be taken safely with isotretinoin, but some medications may interact. It is essential that you tell your doctor and pharmacist what you are currently taking before taking any new prescription or over-the-counter drugs (including herbal remedies).

Medications to avoid while taking isotretinoin include • Tetracycline antibiotics • Methotrexate • Vitamin A supplements (including multivitamins containing vitamin A). This is not a complete list, and it is crucial that you always inform your doctor and pharmacist that you are taking isotretinoin and read the in-pack leaflet.