FLUTAMIN

What it is

FLUTAMIN is a tablet containing 250 mg of flutamide as the active ingredient. Flutamide demonstrates potent antiandrogenic effects by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues, with specific antiandrogenic effects largely directed to the prostate as target organ.

Approved indications

— Management of advanced prostatic carcinoma in previously untreated patients, for use in combination with an LHRH agonist. — Prevention of disease flare associated with the use of LHRH agonists.

Dosing overview

The recommended dosage is one tablet three times a day at 8 hourly intervals. FLUTAMIN should be started up to 24 hours prior to the initiation of the LHRH agonist.

Key safety warnings

Combined androgen blockade with an anti-androgen plus LHRH analogue may increase risk of cardiovascular disease including heart attack, cardiac failure and sudden cardiac death, and adversely affects independent cardiovascular risk factors. Physicians should carefully consider whether the benefits of combined androgen blockade outweigh the potential cardiovascular risk. Post-marketing reports of hospitalisation and rarely death due to liver failure have occurred in patients taking flutamide, with evidence of hepatic injury including elevated serum transaminase levels, jaundice, hepatic necrosis, hepatic encephalopathy and death related to acute hepatic failure. Approximately half of the reported cases of hepatic injury occurred within the initial three months of treatment with flutamide. Periodic liver function tests must be performed in all patients, with appropriate laboratory testing done monthly for the first 4 months and periodically thereafter. A reduction in glucose tolerance and/or glycated haemoglobin has been observed in males receiving combined androgen blockade, which may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes. Consideration should be given to monitoring blood glucose and/or glycated haemoglobin in patients receiving FLUTAMIN in combination with LHRH analogues. Decreased bone mineral density can be anticipated with long-term combined androgen blockade, with associated increased risks of osteoporosis and skeletal bone fractures. The risk of skeletal fracture increases with the duration of combined androgen blockade.

Contraindications

FLUTAMIN is contraindicated in patients exhibiting sensitivity reactions to flutamide or any components of this preparation. FLUTAMIN is also contraindicated in patients with severe hepatic impairment.

PBS listing

FLUTAMIN 250 mg tablet is listed on the PBS as a single item under streamlined restriction, with an ex-manufacturer price of A$148.14.

Regulatory history

FLUTAMIN flutamide 250 mg tablet blister pack was first approved on 24 March 1999.