ActoPlus met approved by the FDA for type 2 diabetes

FDA ( U.S. Food and Drug Administration ) has approved the New Drug Application ( NDA ) for ActoPlus met for the treatment of type 2 diabetes.

ActoPlus met combines Actos ( Pioglitazone ) and Metformin, two widely used diabetes medications, in a single tablet.

Actos directly targets insulin resistance, and Metformin acts primarily by reducing the amount of glucose produced by the liver.

ActoPlus met is available in two dosages of Pioglitazone/Metformin – 15 mg/500 mg and 15 mg/850 mg – both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of Pioglitazone 45 mg and Metformin 2,550 mg.

“ To reach target blood glucose levels, many people with type 2 diabetes will have to take a combination of therapies. In fact, within three years of being prescribed their first medication, approximately 50 percent of patients will need to add additional therapies to manage their condition,” said Ralph DeFronzo, at the University of Texas Health Science Center at San Antonio.
According to the American Diabetes Association, diabetes affects more than 18 million people, and type 2 diabetes is the most common form of the disease. Both Pioglitazone and Metformin are widely used medications in the treatment of type 2 diabetes and both have a known safety profile. Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease.

ActoPlus met is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Pioglitazone and Metformin or whose diabetes is not adequately controlled with Metformin or Pioglitazone alone.

A small number of people who have taken Metformin, a component of ActoPlus met, have developed a rare, serious condition called lactic acidosis.
Lactic acidosis, a buildup of lactic acid in the blood, can be fatal in about half the cases.
Because lactic acidosis occurs most frequently in people with kidney problems, ActoPlus met should not be used in people with kidney disease or in people 80 years of age and older whose kidneys do not work properly.

ActoPlus met should not be taken by people with metabolic acidosis, congestive heart failure requiring treatment, or with hypersensitivity to Pioglitazone, Metformin or any other component of ActoPlus met.

ActoPlus met should not be taken by people who drink excessive amounts of alcohol.
ActoPlus met should be discontinued in patients with severe infection or in patients undergoing x-ray studies using intravenous contrast dye.

Actos and ActoPlus met can cause fluid retention that may lead to or worsen heart failure.
The patients should talk to their doctor immediately if they experience rapid weight gain, fluid retention, or shortness of breath while taking either drug.
Actos or ActoPlus met is not recommended in moderate to severe heart failure.

Physicians should perform a blood test to check for liver problems before prescribing Actos or ActoPlus met and periodically thereafter.
The patients should not take Actos or ActoPlus met if they have active liver disease.

Actos or ActoPlus met should not be used in patients with type 1 diabetes.

Source: Takeda Pharmaceuticals North America, 2005