What is Roaccutane (isotretinoin)?
Roaccutane is a vitamin-A derivative. The liver naturally makes small quantities of isotretinoin from vitamin-A, but the drug we prescribe is made synthetically. It was developed in the 1950s, but only started being used in the mid 1970s. The original brand names were Accutane® and Roaccutane®, but there are now many generic versions on the market, of varying potency.
What is Roaccutane used for?
Isotretinoin is a very effective medication for the treatment of acne. Originally licensed for use in severe disease, it is increasingly prescribed for all grades of acne. Low dose Roaccutane is used by Dr Treacy for the following conditions.
It is also prescribed for many other skin diseases. Examples include:
- Discoid lupus erythematosus Granuloma annulare Grover disease Sarcoidosis
- Extensive actinic keratoses Prevention of squamous cell carcinoma
Contraindications to Roaccutane
Roaccutane must not be taken in pregnancy, or if there is a significant risk of pregnancy. Blood donation by males and females on isotretinoin is not allowed in case the blood is used for a pregnant woman.
Precautions when taking Roaccutane
- Isotretinoin should be used with caution during breastfeeding.
- Commercial pilots may be subject to flying restrictions if they take isotretinoin.
- High dose isotretinoin in very young children has been associated with premature epiphyseal closure, leading to shorter stature (not seen in low dose for the treatment of acne).
What is the usual dose of isotretinoin?
The range of doses used each day for acne is less than 0.1 to over 1 mg/kg body weight. A course of treatment may be completed in a few months or continue for several years. For acne, some prescribers have targeted a total cumulative dose of 120–140 mg/kg, in the hope of reducing relapse, but the evidence for this remains controversial.
How does Roaccutane work?
- Reduces sebum production * Shrinks the sebaceous glands * Reduces follicular occlusion
- Inhibits growth of bacteria * Has anti-inflammatory properties
For how long is Roaccutane taken?
Most patients should be treated until their skin condition clears and then for a further few months. However, courses have often been restricted to 16–30 weeks (4–7 months) to minimise risk of teratogenicity (risk of congenital abnormalities), and to comply with local regulatory authorities. Isotretinoin may be prescribed for years, usually in low dose or intermittently.
What are the side effects and risks of Roaccutane?
The side effects of Roaccutane are dose dependent; at 1 mg/kg/day, nearly all patients will have some side effects, whereas at 0.1 mg/kg/day, most patients will not. The range and severity of the side effects also depends on personal factors and the disease being treated. Patients with significant liver or kidney disease, high blood fats, diabetes and depression may be advised not to take isotretinoin or to be on a lower dose than usual and to have regular follow-up visits.
Skin and mucocutaneous side effects
The most common are listed here. When side effects are troublesome, roaccutane may need to be withheld or the dose reduced.
- Acne flare-up * Dry lips, cheilitis (sore, cracked or scaly lips) (100% of patients on 1 mg/kg/day)
- Dry skin, fragile skin, eczema. Note: atopic eczema may improve.
- Increased sweating * Dry nostrils, epistaxis (nose bleeds)
- Dry, watery or irritable eyes (especially in contact lens wearers), conjunctivitis, keratitis
- Dry anal mucosa, bleeding at the time of a bowel motion
- Dry genitals, dyspareunia (discomfort during intercourse)
- Facial erythema * Sunburn on exposure to the sun
- Temporary hair loss * Brittle nails
- Skin infections: impetigo, paronychia, pyogenic granuloma
Treatment of mucocutaneous side effects
- Reduce the dosage (eg to 5–10 mg/day)
- Emollients, Lip balm, petroleum jelly, sunscreen, eye drops and lubricants should be applied frequently
- Dermatitis can be treated with topical steroids. Take short, cool showers without using soap
- Use mild or diluted shampoo * Do not start wearing contact lenses for the first time
- Do not have elective eye surgery while on isotretinoin or for 6 months afterwards.
- Do not have ablative laser treatments (eg CO2 resurfacing) while on isotretinoin or for 6 months afterwards. Other laser and light treatments may be performed with care
Other common dose-related side effects of isotretinoin
- Headache * Myalgia (muscle aches) and arthralgia (joint aches), especially after exercise
- Tiredness (lethargy and drowsiness) * Disturbed night vision and slow adaptation to the dark. Drivers may experience increased glare from car headlights at night * Hypertriglyceridaemia (high levels of triglyceride in the blood), usually of no clinical relevance * Irregular or heavy menstrual periods
Rare side effects of isotretinoin
- Severe headache with blurred vision due to raised intracranial pressure
- Mood changes and depression. Note: depression is more often related to the skin condition being treated or other health or psychosocial problems. Antidepressant medications may be helpful
- Corneal opacities and cataracts * High-tone deafness
- Abnormal liver function tests or symptomatic hepatitis
- Diarrhoea or bleeding from the bowel * Pancreatitis
- Allergy to isotretinoin causing liver disease and a febrile illness
Contraception in females considering isotretinoin
Roaccutane must not be taken in pregnancy because of a very high risk of serious congenital abnormalities in the baby. Caution needs to be used during breast-feeding as it enters the breast milk and might affect the baby. All females who could biologically have a child should take the following precautions during treatment with isotretinoin and for four weeks after the medication has been discontinued.
No contraceptive precautions are necessary for men
Isotretinoin has no effect on sperm or male fertility and has not been shown to cause birth defects in children fathered by men taking it.
Does acne ever fail to clear on Roaccutane?
Although isotretinoin is usually very effective for acne, occasionally it responds unexpectedly slowly and incompletely.
Can isotretinoin be used again if acne recurs?
As many as ninety per cent of patients with acne have a long lasting response after a single adequate course of isotretinoin. In others, acne may recur a few months to a few years after the medication has been discontinued. Relapse is more common in females than in males, and in patients >25 years of age.
Author: Hon A/Prof Amanda Oakley, Dermatologist, Hamilton, New Zealand, 1999. Updated by Dr Amanda Oakley; Hon A/Prof Marius