Anterone

What it is

Anterone is cyproterone acetate, available as 100 mg tablets. The tablets are capsule shaped, biconvex white tablets with 'CPA 100' marked on one side and scored on the other. Anterone is an anti-androgenic hormone preparation that inhibits competitively the effect of androgens at androgen-dependent target organs, shielding the prostate from the effect of androgens originating from the gonads and the adrenal cortex.

Approved indications —

Inoperable prostatic carcinoma to suppress flare with initial LHRH analogue therapy — Inoperable prostatic carcinoma in long-term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred — Treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy

Dosing overview

The maximum daily dose is 300 mg. Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred.

Key safety warnings

Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been observed in patients treated with cyproterone acetate. At dosages of 100 mg and above, cases with fatal outcome have been reported, most commonly in men with advanced carcinoma of the prostate. Toxicity is dose-related and develops usually several months after treatment has begun. Liver function tests should be performed pre-treatment, at regular intervals during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. Meningiomas have been reported in association with long-term use (years) of cyproterone acetate at doses of 25 mg per day and above. The risk of meningioma increases with increasing cumulative doses. If a patient treated with Anterone is diagnosed with meningioma, treatment with cyproterone containing products must be permanently stopped. Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnostic considerations. Thromboembolic events have been reported in patients using Anterone although a causal relationship has not been established. Patients with previous arterial or venous thrombotic or thromboembolic events or with advanced malignancies are at increased risk. In patients with a history of thromboembolic processes or suffering from sickle-cell anaemia or severe diabetes with vascular changes, a careful risk-benefit evaluation must be carried out. Long-term androgen deprivation with Anterone may lead to osteoporosis.

Contraindications

Anterone is contraindicated in liver diseases; Dubin-Johnson syndrome and Rotor syndrome; previous or existing liver tumours (except those due to metastases from carcinoma of the prostate); presence or history of meningioma; wasting diseases (except inoperable carcinoma of the prostate); severe chronic depression; existing thromboembolic processes; and hypersensitivity to any components of Anterone.

PBS listing

No information regarding PBS listing is contained in the provided documents.

Regulatory history

Anterone 100 was first listed on the ARTG on 19 October 2016 under licence AUST R 278778.