Item info. These highlights do not include all the info. needed to use ACTOS safely and effectively. See full prescribing info. for ACTOS. ACTOS (pioglitazone) tablets for oral use Initial U.S. Approval: 1999 --INDICATIONS AND USAG ACTOS is thiazolidinedione and an agonist for peroxisome proliferator -activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to mprove glycemic control in adults with type diabetes mellitus in multiple clinical settings 4 Important Limitations of Use: Not for treatment of type diabetes or diabetic ketoacidosis. -DOSAGE AND ADMINISTR ATION ? Initiate ACTOS at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class or II heart failure. If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to maximum of 45 mg once daily. Obtain liver tests before starting ACTOS. If abnormal, use caution when treating with ACTOS, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on ACTOS is not recommended in patients without liver disease. - DOSAGE FORMS AND STRENGTHS Tablets: 15 mg, 30 mg, and 45 mg -- -CONTRAINDICATIONS -- ? Initiation in atients with established New York Heart Association (NYHA Class III or IV heart failure [see Boxed Warning] Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOS. -- -WARNINGS AND PRECAUT IONS - - Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class and II may increase risk. Monitor patients for signs and symptoms. Hypoglycemia: When used with insulin or an insulin secretagogue, lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. (5. 2) Hepatic effects: Postmarketing reports of hepatic failure, so metimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt ACTOS and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart ACTOS if liver injury is confirmed and no alternate etiology can be found. Bladder cancer: Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. The observational data further suggest that the risk inc reases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with prior history of bladder cancer (5. 4) Edema: Dose- related edema may occur. (5. 5) Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. (5. 6) Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes (5. 7) Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reducti on with ACTOS or any other antidiabetic drug. (5. 9) -- ADVERSE REACTIONS Most common adverse reactions ?5%) are upper respiratory tract infection, headache, sinusitis, myalgia, and pharyngitis. 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1- 877- 825- 3327 or FDA at 1- 800- FDA -1088 or www.fda.gov/medwatch -- --DRUG INTERACTIONS - Strong CYP2C8 inhibitors (e.g., gemfibrozil) increase pioglitazone concentrations Limit ACTOS dose to 15 mg daily (2.3, 7.1) CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone concentrations USE IN SPECIFIC POPU LATIONS -- Nursing mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother Pediatrics: Not recommended for use in pediatric patients See 17 for PATIENT COUNSELING info. and Medication Guide Revised: 11/2013
