Androcur Special Precautions

During treatment liver function, adrenocortical function and red blood cell count should be checked regularly.
The long term effects on female fertility are not known with certainty.
In men of procreative age, for whom fertility could be important after conclusion of the medication, it is advisable to make at least one control spermatogram as a precaution before the start of treatment in order to counter any unjustified claims of later infertility as a result of the antiandrogen therapy. Spermatogenesis has taken 3-20 months to return to normal after discontinuing therapy.
As with other antiandrogenic treatments, in male patients long-term androgen deprivation with Androcur may lead to osteoporosis.
Use in hepatic impairment: Liver: 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 reported fatal cases were 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. If hepatotoxicity is confirmed, Androcur should be withdrawn, unless hepatotoxicity can be explained by another cause, e.g. metastatic disease, in which case Androcur should be continued only if the perceived benefit outweighs the risk.
Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of Androcur. 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.
Meningioma: The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate primarily at doses of 25mg and above. The risk of meningioma increases with increasing cumulative doses of cyproterone acetate. High cumulative doses can be reached with prolonged use (several years) or shorter duration with high daily doses. Patients should be monitored for meningiomas in accordance with clinical practice. If a patient treated with Androcur is diagnosed with meningioma, treatment with Androcur and other cyproterone containing products must be permanently stopped. There is some evidence that the meningioma risk may decrease after treatment discontinuation of cyproterone. (See Contraindications.)
Diabetes: Strict medical supervision is necessary if the patient suffers from diabetes because the requirement for oral antidiabetics or insulin can change during Androcur treatment (see Contraindications).
Shortness of breath: A sensation of shortness of breath may occur under high-dosed treatment with Androcur. The differential diagnosis in such cases must include the stimulating effect on breathing known for progesterone and synthetic progestogens which is accompanied by hypocapnia and compensated respiratory alkalosis and which is not considered to require treatment.
Thromboembolic events: The occurrence of thromboembolic events has been reported in patients using Androcur although a causal relationship has not been established. Patients with previous arterial or venous thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or with a history of cerebrovascular accidents or with advanced malignancies are at increased risk of further thromboembolic events.
Adrenocortical function: During treatment adrenocortical function should be checked regularly, as preclinical data suggest a possible suppression due to the corticoid-like effect of Androcur with high doses.
Anaemia: Anaemia has been reported during treatment with Androcur. Therefore, the red-blood cell count should be checked regularly during treatment.
Other conditions: Androcur tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose mal-absorption should not take this medicine.
Specifically to be observed in women: Before the start of therapy a thorough general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out. Serious organic causes of androgenisation, e.g. Cushing's syndrome, ovarian tumours, adrenal carcinoma and adrenogenital syndrome should be excluded. Pregnancy must be excluded at the time of commencing treatment in women of child-bearing potential. If, during the combined treatment, spotting occurs during the 3 weeks in which the tablets are being taken, tablet-taking should not be interrupted. However, if persistent or recurrent bleeding occurs at irregular intervals, a gynaecological examination must be carried out to exclude organic diseases.
With regard to the additional use of a combined oral contraceptive preparation, attention is drawn to all the data contained in the product information for this product.
Specifically to be observed in men: The sexual drive-reducing effect of Androcur can be diminished under the influence of alcohol.
In patients with inoperable carcinoma of the prostate presenting with a history of thromboembolic processes or suffering from sickle-cell anaemia or from severe diabetes with vascular changes, a careful risk: benefit evaluation must be carried out in each individual case before Androcur is prescribed.
Effects on laboratory tests: No data available.
Effects on ability to drive and use machines: It should be pointed out to patients whose occupation demands great concentration (e.g. road users, machine operators) that Androcur can lead to tiredness and diminished vitality and can impair the ability to concentrate (see Adverse Reactions).
Use in the elderly: See Dosage & Administration.
Use in children: See Dosage & Administration.