AVODART

What it is

AVODART contains dutasteride 500 μg in soft gelatin capsules. The capsules are yellow, opaque, oblong soft gelatin capsules marked with GX CE2. Dutasteride inhibits the conversion of testosterone to 5-dihydrotestosterone (DHT), the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland.

Approved indications

— Management of symptomatic benign prostatic hyperplasia (BPH) as monotherapy. — Management of symptomatic benign prostatic hyperplasia (BPH) as combination therapy with an alpha blocker which is approved for use in BPH and which has been dose titrated in accordance with the relevant recommendations in the product information for that alpha blocker.

Dosing overview

The recommended dose is one 500 μg capsule daily for adult males including elderly. The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa, and AVODART may be taken with or without food. Although early improvements in symptoms may be seen in some patients, treatment for at least 6 months is generally necessary to assess whether a beneficial response in symptom relief has been achieved.

Key safety warnings

In a 4-year study of over 8000 men aged 50 to 75 with a prior negative biopsy for prostate cancer and baseline PSA between 2.5 ng/mL and 10.0 ng/mL (the REDUCE study), there was a higher incidence of Gleason 8-10 prostate cancers in the dutasteride group (n=29, 0.9%) compared to the placebo group (n=19, 0.6%), but there was no increased incidence in Gleason 5-6 or 7-10 prostate cancers. No causal relationship between dutasteride and high grade prostate cancer has been established. Digital rectal examination and other evaluations for prostate cancer should be performed prior to initiating therapy with dutasteride and periodically thereafter, as serum prostate-specific antigen (PSA) concentration is an important component of the screening process to detect prostate cancer and AVODART causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment, so patients receiving AVODART should have a new PSA baseline established after 6 months of treatment. In two 4 year clinical studies, the incidence of cardiac failure was higher among subjects taking the combination of dutasteride and an alpha blocker than among subjects not taking the combination, with incidence ≤1% in these two trials, though the reason for the imbalance is not known. No causal relationship between dutasteride alone or in combination with an alpha blocker and cardiac failure has been established. There have been reports of male breast cancer in men taking dutasteride in clinical trials and during the post-marketing period, however epidemiological studies showed no statistically significant increase in the risk of developing male breast cancer with the use of 5-ARIs. Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Dutasteride is absorbed through the skin, therefore women and children must avoid contact with leaking capsules, and if contact is made with leaking capsules the contact area should be washed immediately with soap and water. Men being treated with AVODART should not donate blood until at least 6 months have passed following their last dose, as the purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.

Contraindications

AVODART is contraindicated in patients with known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or any component of the preparation; in women and children; and in patients with severe hepatic impairment.

PBS listing

No source information available for this section.

Regulatory history

AVODART dutasteride 500 microgram soft capsule blister pack was first listed on the ARTG on 14 November 2002.