ROACCUTANE

What it is

ROACCUTANE contains isotretinoin 10 mg or 20 mg as the active ingredient in capsule form. Isotretinoin is a retinoid that inhibits sebaceous gland function and keratinisation.

Approved indications

— Severe cystic acne.

Dosing overview

All patients should initially receive doses up to 0.5 mg/kg bodyweight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. In most cases complete or near complete suppression of acne is achieved with a 16 week course of treatment. Satisfactory initial responses have been reported from 0.05 mg/kg/day, though relapse rates on the lower doses are higher (a second course may be required in about two-thirds of patients on 0.1 mg/kg/day for 16 weeks), but there is decreased incidence and severity of adverse reactions at lower doses. Doses up to 1 mg/kg/day may be used in patients refractory to initial treatment at lower doses. The daily dosage should be taken with food in the nearest number of whole capsules, either as a single dose or in two divided doses during the day, whichever is more convenient.

Key safety warnings

Isotretinoin must not be used by females who are pregnant or who may possibly become pregnant while undergoing treatment. Major human foetal abnormalities related to isotretinoin administration have been reported, including hydrocephalus, microcephalus, abnormalities of the external ear, eye abnormalities, cardiovascular abnormalities, facial dysmorphia, cleft palate, thymus gland abnormality, parathyroid gland abnormalities and cerebellar malformation. There is also an increased incidence of spontaneous abortion. An effective form of contraception should be used for at least one month before and throughout isotretinoin therapy, and it is recommended that contraception be continued for one month following discontinuation of isotretinoin therapy. There have been post-marketing reports of severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) associated with isotretinoin therapy. These reactions may be serious and result in death, life-threatening events, hospitalisation or disability. Patients should be monitored closely for severe skin reactions and discontinuation of isotretinoin should be considered if warranted. Isotretinoin use has been associated with cases of benign intracranial hypertension (pseudotumour cerebri). Early signs and symptoms include papilloedema, headache, nausea and vomiting, and visual disturbances. Patients who develop benign intracranial hypertension should discontinue isotretinoin immediately. Depression, depression aggravated, psychotic symptoms, anxiety, aggressive tendencies, mood alterations, psychosis and, rarely, suicide, suicidal ideation and suicide attempts have been reported with isotretinoin. All patients should have an assessment of their mental health, and of family history of mental health conditions, before starting treatment. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. If symptoms of depression develop or worsen, the drug should be discontinued promptly and the patient referred for appropriate psychiatric treatment. Isotretinoin causes elevation of serum triglycerides and cholesterol as well as a decrease in high-density lipoprotein (HDL). At doses of greater than 1 mg/kg/day, approximately one in four patients have been found to develop elevated triglycerides. Acute pancreatitis, which is potentially fatal, sometimes associated with serum triglyceride levels greater than 8 g/L, has been reported. Hence isotretinoin should be discontinued if uncontrolled hypertriglyceridaemia or symptoms of pancreatitis occur.

Contraindications

Isotretinoin must not be used by females who are pregnant or who may possibly become pregnant while undergoing treatment. Isotretinoin is contraindicated in patients who are breast-feeding, in patients with severely impaired liver function and in patients with chronic abnormally elevated blood lipid values. Isotretinoin is contraindicated in patients who have pre-existing hypervitaminosis A and in patients with hypersensitivity to the drug or any of the other ingredients or to other retinoids. Isotretinoin contains soya oil and partially hydrogenated soya oil, therefore isotretinoin is contraindicated in patients allergic to soya. Rare cases of benign intracranial hypertension have been reported after isotretinoin and after tetracyclines. Concomitant treatment with tetracyclines is therefore contraindicated.

PBS listing

ROACCUTANE 20 mg capsule is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$12.39.

Regulatory history

ROACCUTANE isotretinoin 20 mg capsule was first listed on the Australian Register of Therapeutic Goods on 13 December 1994.