FDA Approves Qtern for Diabetes

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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According to The American Diabetes Association, as of 2012, type 2 diabetes affected 29.1 million Americans, 9.3% of the population. Every year another 1.4 million Americans are diagnosed with type 2 diabetes, which can lead to live-threatening complications like high-blood pressure, kidney disease, high cholesterol, or loss of vision.

Recently, the FDA approved Qtern (dapagliflozin and saxagliptin), a new combination prescription medication for adults with type 2 diabetes.

What is Qtern indicated for?

Qtern is a once-daily combination medication used in conjunction with diet and exercise for blood sugar control in adults with type 2 diabetes. Qtern is specifically indicated for adults who have already been inadequately treated with Farxiga (dapagliflozin) or Onglyza (saxagliptin).

Qtern helps blood sugar control by targeting 2 different pathways- the liver and the kidneys. It may even help you lose weight.

What dosage and strength will Qtern be available in?

Qtern will be available as a fixed-dose combination 10mg/5mg tablet.

What side effects are associated with Qtern?

The most common side effects include:

When will Qtern be available?

Qtern was approved by the FDA on February 28th, 2017, but does not have an anticipated release date at this time. You can register for ongoing news, information, and updates related to Qtern here.

As of July 2016, Qtern was approved in all 28 European Union countries, including iceland, Liechtenstein and Norway and has been approved in the UK since January 2017.

For more information on Qtern, see the press announcement from the manufacturer AstraZeneca here.

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