ORATANE

What it is

Oratane contains isotretinoin. Isotretinoin is a retinoid that inhibits sebaceous gland function and keratinisation. Oratane 20 mg is presented as a half brown-red soft capsule half opaque white, imprinted with ROA 20.

Approved indications

— Treatment of severe cystic acne, where a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients.

Dosing overview

All patients initially should receive Oratane at doses up to 0.5 mg/kg/day bodyweight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. Doses up to 1 mg/kg/day may be used in patients refractory to initial treatment at lower doses. The above daily dosages of Oratane should be continued for 16 weeks to complete the course of treatment. 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

Oratane must not be used by females who are pregnant or who may possibly become pregnant while undergoing treatment, as major human fetal abnormalities 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. An effective form of contraception should be used for at least one month before and also throughout Oratane therapy, and it is recommended that contraception be continued for one month following discontinuation of therapy. Depression, psychotic symptoms, and, rarely, suicide, suicidal ideation and attempts have been reported with Oratane. All patients should have an assessment of their mental health, and of family history of mental health conditions, before starting treatment with Oratane, and particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression. There have been post-marketing reports of severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) associated with Oratane use, which may be serious and result in death, life-threatening events, hospitalisation, or disability. Oratane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders, and patients experiencing abdominal pain, rectal bleeding or severe (hemorrhagic) diarrhea should discontinue Oratane immediately.

Contraindications

Oratane must not be used by females who are pregnant or who may possibly become pregnant while undergoing treatment. Oratane is contraindicated in patients who are breast-feeding. Oratane is contraindicated in patients with severely impaired liver function and in patients with chronic abnormally elevated blood lipid values. Oratane is contraindicated in patients who have pre-existing hypervitaminosis A. Concomitant treatment with tetracyclines is contraindicated. Oratane is also contraindicated in people who are hypersensitive to the drug or other ingredients in Oratane capsules or to other retinoids.

PBS listing

Oratane capsule 5 mg is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$11.01. Oratane capsule 30 mg is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$46.47.

Regulatory history

Oratane was first approved on 5 December 1994. The 20 mg strength was first listed on the ARTG on 1999-08-16. The 10 mg strength was first listed on 2001-02-12, the 40 mg strength on 2006-07-05, the 5 mg strength on 2009-02-09, and the 30 mg strength on 2019-05-08. In November 2018, the PBAC recommended a streamlined authority required listing for a new strength for severe cystic acne.