DEERFIELD, Ill., June 21 Takeda Pharmaceuticals North America, Inc. announced today that ACTOplus metŪ XR, an extended-release version of the combination medication ACTOplus metŪ (pioglitazone HCl and metformin HCl), is now available in United States (U.S.) pharmacies for the treatment of type 2 diabetes as an adjunct to diet and exercise. This once-daily prescription medication, available in two commonly used dosages of pioglitazone and metformin XR - 15 mg/1000 mg and 30 mg/1000 mg tablets - is the first and only oral antidiabetic fixed-dose combination medication with the extended-release formulation of metformin.
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ACTOplus met XR combines ACTOSŪ (pioglitazone HCL) and metformin, two widely used diabetes medications with established safety profiles, in a single tablet. ACTOS directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces, and metformin acts primarily by reducing the amount of glucose produced in the liver. These medications work in combination, along with diet and exercise, to help patients with type 2 diabetes improve glycemic control.
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Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999. ACTOS has been an effective and appropriate treatment for people living with type 2 diabetes, and has been prescribed for more than 10 million patients to date.
Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Watson Laboratories, a subsidiary of Watson Pharmaceuticals, Inc. and licensed to Takeda Pharmaceutical Company Limited.
ACTOplus metŪ (pioglitazone HCl and metformin HCl) and ACTOplus metŪ XR (pioglitazone HCl and extended-release metformin HCl) Indications and Usage
ACTOplus met and ACTOplus met XR are prescription medications used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
Important Safety Information
ACTOplus met and ACTOplus met XR are not for everyone. Certain patients with heart failure should not start taking ACTOplus met or ACTOplus met XR. ACTOplus met and ACTOplus met XR can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.
Metformin, one of the medicines in ACTOplus met and ACTOplus met XR, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly. ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis. ACTOplus met and ACTOplus met XR should not be taken by people who drink excessive amounts of alcohol. Patients should talk to their doctor if they are going to have an X-ray procedure using injectable dye.
ACTOplus met and ACTOplus met XR are not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.
ACTOplus met and ACTOplus met XR may cause low blood sugar. Lightheadedness, shakiness, dizziness, or hunger may indicate low blood sugar. Patients who experience low blood sugar should talk to their doctor.
Some people taking ACTOplus met and ACTOplus met XR may experience flulike symptoms, mild to moderate swelling of legs and ankles, anemia, and weight gain.
If a patient is of childbearing age, they should talk to their doctor before taking ACTOplus met or ACTOplus met XR, as it could increase their chance of becoming pregnant. A patient should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
A patient should not take ACTOplus met or ACTOplus met XR if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOplus met or ACTOplus met XR and periodically thereafter. A patient should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.
Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult their doctor immediately. Some patients have experienced visual changes while taking ACTOplus met and ACTOplus met XR. Some people, particularly women, are at higher risk of having bone fractures while taking pioglitazone. Other side effects may include cold-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, sinus infection, and anemia.
Individuals are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For Complete Prescribing Information, including warnings about heart failure and lactic acidosis and Medication Guide, please visit www.ACTOS.com.
About ACTOSŪ (pioglitazone HCL) Indications and Usage
ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.
Important Safety Information
ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.
A patient should not take ACTOS if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOS and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.
If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.
ACTOS may cause low blood sugar when taken in combination with insulin or other oral antidiabetic drugs. Lightheadedness, shakiness, dizziness, or hunger, may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them. Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult with their doctor immediately. Some patients have experienced visual changes while taking ACTOS. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.
Individuals are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For Complete Prescribing Information, including warnings about heart failure and Medication Guide, please visit www.ACTOS.com.
Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
SOURCE Takeda Pharmaceuticals North America, Inc.
