Vildagliptin with metformin tablets (Galvumet) were listed on the Pharmaceutical Benefits Scheme (PBS) on 1 April 2011. Fixed-dose vildagliptin–metformin combinations of 50/500 mg, 50/850 mg and 50/1000 mg are available. The authority required (streamlined) listing is for the treatment of people with type 2 diabetes who:
- have an HbA1c > 7% despite use of metformin, and when a combination of metformin and a sulfonylurea is contraindicated or not tolerated,
- are stabilised on a regimen that includes metformin and vildaglitpin as separate tablets.1
The fixed-dose combination tablets are not approved by the Therapeutic Goods Administration or subsidised on the PBS for initial drug therapy. They are not subsidised for use as part of triple oral therapy (combined with a sulfonylurea, a thiazolidinedione or a glucagon-like peptide-1).
Starting or switching to the fixed-dose combination tablets
Vildagliptin with metformin fixed-dose combination tablets are taken twice daily with meals.2
People who have inadequate glycaemic control with metformin alone should be started on the combination tablet equivalent to their current dose of metformin.
For people who are already taking vildagliptin and metformin, a fixed-dose combination tablet may be prescribed at the dose of each medicine that was used separately.
Advise patients prescribed the combination tablets to stop taking their single-ingredient tablets and to return them to a pharmacy for disposal.
Consider whether the available strengths of the combination tablets allow the appropriate dose of metformin to be given. Patients taking metformin doses of more than 2000 mg/day should not be prescribed the combination tablet, as they would exceed the maximum recommended vildagliptin daily dose of 100 mg/day.
For more information on vildagliptin see the NPS RADAR review on Dipeptidyl peptidase-4 inhibitors (‘gliptins’) for type 2 diabetes mellitus.
- Pharmaceutical Benefits Advisory Committee. Positive Recommendations made by the PBAC — November 2010. Canberra: Australian Government Department of Health and Ageing, 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-nov10-positive (accessed 18 January 2011).
- Novartis Pharmaceuticals Australia Pty Ltd. Galvumet product information. 8 December 2010.