Product Description.:
12.5/1000, 322M
tablet , film-coated , yellow , oblong oblong
Debossed
NESINA (alogliptin)
KAZANO (alogliptin and metformin HCl)
OSENI (alogliptin and pioglitazone)
Each of these products:
Can be used in appropriate type 2 diabetes patients, in adjunct to diet and exercise,
in multiple clinical settings to improve blood glucose control and help lower A1C2,7,10
Individual results may vary.
The portfolio of products:
Includes fixed-dose combinations of agents with complementary and distinct mechanisms of action
Allows you to individualize a treatment plan for the management of type 2 diabetes1
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Join the Takeda Diabetes HCP program to request samples* of NESINA, KAZANO, and OSENI. As a member, you?ll have exclusive access to content and resources. You will also be kept informed about Takeda?s powerful portfolio of treatments for type 2 diabetes.
*Only healthcare professionals who are able to write prescriptions may receive samples. A valid state license number is required.
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Important Safety Information for NESINA, KAZANO, and OSENI
WARNING: CONGESTIVE HEART FAILURE?for OSENI
Thiazolidinediones, including pioglitazone, which is a component of OSENI, cause or exacerbate congestive heart failure in some patients.
After initiation of OSENI, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI must be considered.
OSENI is not recommended in patients with symptomatic heart failure.
Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.
WARNING: LACTIC ACIDOSIS?for KAZANO
Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
If acidosis is suspected, KAZANO should be discontinued and the patient hospitalized immediately.
NESINA, KAZANO, and OSENI are contraindicated in patients with a history of serious hypersensitivity reaction to any of the components of these products, such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
KAZANO is contraindicated in patients with renal impairment (e.g., serum creatinine levels .5 mg/dL for men, .4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
KAZANO is contraindicated in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.
Do not initiate OSENI in patients with established NYHA Class III or IV heart failure.
Warnings and Precautions?for KAZANO
Lactic acidosis: Warn against excessive alcohol intake. KAZANO is not recommended in hepatic impairment and is contraindicated in renal impairment. Ensure normal renal function before initiating and at least annually thereafter. Temporarily discontinue in patients undergoing radiologic studies with intravascular iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Lactic acidosis due to metformin accumulation during therapy is fatal in approximately 50% of cases. The risk increases in patients with renal impairment, congestive heart failure requiring drug treatment, and with increasing age.
Vitamin B12 deficiency: Metformin may lower Vitamin B12 levels. Monitor hematologic parameters annually.
Warnings and Precautions?for OSENI
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 I and II may increase risk. Monitor patients for signs and symptoms.
Edema: Dose-related edema may occur. Use with caution in patients with edema.
Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health.
Bladder cancer: Data suggest an increased risk of bladder cancer in pioglitazone users. Data also suggest that the risk increases
