CABASER(R) (Cabergoline) Product Information Update

Main Category: Parkinson's Disease
Article Date: 11 Sep 2008 - 2:00 PDT

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Pfizer Australia is due to release new safety updates to the Cabaser® (cabergoline) Product Information which will come into effect on November 1, 2008.

Ongoing review of clinical studies suggests that fibrosis and valvulopathy are associated with ergot-derived dopamine agonists, including Cabaser (cabergoline) and could be linked to cumulative doses of the medicine.

Product Physician, Dr Louise Canny explained that as a result of these studies Pfizer Australia has decided to reduce the maximum daily dose of Cabaser (cabergoline) from 6mg per day to 3 mg per day. "It is anticipated that the reduction in the recommended maximum daily dose of Cabaser along with the current recommendations for assessment of patients prior to commencing therapy and during maintenance therapy included in the Cabaser Product Information, should help reduce the risk of fibrotic reactions," explained Dr Canny.

These changes do not affect the availability of Cabaser 1mg and 2mg tablets which will continue to be available through the Pharmaceutical Benefits Scheme (PBS) but the 4mg tablet will be deleted from the available dosage presentations and existing stock will no longer be PBS reimbursed as of November 1 2008.

Healthcare professionals and Parkinson's Australia have been sent a letter outlining the new update to the Product Information.

Cabaser remains an important treatment option for patients with Parkinson's disease and Pfizer Australia is committed to patient safety.

PBS Information: Restricted Benefit - Parkinson's Disease.

About Pfizer Australia

Pfizer Australia is the nation's leading research-based health care company, investing over $A50m in local research and development annually. It develops, manufactures and markets innovative medicines for both humans and animals.

Pfizer Australia