Introducing
Alogliptin

Nesina® Authorized Generic

Alogliptin and Metformin HCl

Kazano® Authorized Generic

Alogliptin and Pioglitazone

Oseni® Authorized Generic

To help manage type 2 diabetes in multiple patients.

For appropriate patients with type 2 diabetes in addition to diet and exercise.

Indication: Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone are not for treatment of type 1 diabetes or diabetic ketoacidosis.

Important Safety Information for Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone



WARNING: CONGESTIVE HEART FAILURE—for Alogliptin and Pioglitazone

  • Thiazolidinediones, including pioglitazone, which is a component of Alogliptin and Pioglitazone, cause or exacerbate congestive heart failure in some patients.
  • After initiation of Alogliptin and Pioglitazone, 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 Alogliptin and Pioglitazone must be considered.
  • Alogliptin and Pioglitazone is not recommended in patients with symptomatic heart failure.
  • Initiation of Alogliptin and Pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

WARNING: LACTIC ACIDOSIS—for Alogliptin and Metformin HCl

  • 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, Alogliptin and Metformin HCl should be discontinued and the patient hospitalized immediately.
  • Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone 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.
  • Alogliptin and Metformin HCl is contraindicated in patients with renal impairment (e.g., serum creatinine levels 1.5 mg/dL for men, 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
  • Alogliptin and Metformin HCl is contraindicated in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis.
  • Do not initiate Alogliptin and Pioglitazone in patients with established NYHA Class III or IV heart failure.

Warnings and Precautions—for Alogliptin and Metformin HCl

  • Lactic acidosis: Warn against excessive alcohol intake. Alogliptin and Metformin HCl 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 Alogliptin and Pioglitazone

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 with duration of use. Do not use Alogliptin and Pioglitazone in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria or urinary urgency as these may be due to bladder cancer.

Macular edema: Macular edema has been reported in some patients taking pioglitazone. Recommend regular eye exams. Instruct patients to report any visual changes promptly.

Ovulation: Therapy with pioglitazone may result in ovulation in some premenopausal anovulatory women.

Warnings and Precautions—for Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone

  • Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone.
  • Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin such as anaphylaxis, angioedema or severe cutaneous adverse reactions. In such cases, promptly discontinue Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. Use caution in a patient with a history of angioedema with another DPP-4i because it is unknown whether such patients will be predisposed to angioedema.
  • Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. Baseline liver test panel is recommended. If liver injury is detected, promptly interrupt Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone if liver injury is confirmed and no alternative etiology can be found. Use with caution in patients with hepatic impairment.
  • Hypoglycemia: Insulin and insulin secretagogues are known to cause hypoglycemia. A lower dose of the insulin or insulin secretagogue may be required to minimize the risk when used in combination with Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone.
  • Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
  • Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Alogliptin, Alogliptin and Metformin HCl, or Alogliptin and Pioglitazone, or any other anti-diabetic drug.

Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

Patients should not stop taking their medicine without first talking to their health care professionals.

Adverse Reactions

Most common adverse reactions (4% of patients treated with Alogliptin 25 mg and more frequently than in patients who received placebo) were nasopharyngitis (4.4%), headache (4.2%), and upper respiratory tract infection (4.2%).

Most common adverse reactions (4% of patients treated with coadministration of alogliptin and metformin) were upper respiratory tract infection (8.0%), nasopharyngitis (6.8%), diarrhea (5.5%), hypertension (5.5%), headache (5.3%), back pain (4.3%), and urinary tract infection (4.2%).

Most common adverse reactions (4% of patients treated with coadministration of alogliptin and pioglitazone) were nasopharyngitis (4.9%), back pain (4.2%), and upper respiratory tract infection (4.1%).

Drug Interactions

Use of Alogliptin and Pioglitazone with CYP2C8 strong inhibitors (e.g., gemfibrozil) will, or inducers (e.g., rifampin) may, require dose adjustment.

Cationic drugs eliminated by renal tubular secretion should be used with caution if taken with Alogliptin and Metformin HCl.

Indication

Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin, Alogliptin and Metformin HCl, and Alogliptin and Pioglitazone are not for treatment of type 1 diabetes or diabetic ketoacidosis.

Please see the full Prescribing Information, including Medication Guide, for Alogliptin.

Please see the full Prescribing Information, including Medication Guide, for Alogliptin and Metformin HCl.

Please see the full Prescribing Information, including Medication Guide, for Alogliptin and Pioglitazone.

Hide references

  1. American Diabetes Association. Standards of medical care in diabetes—2013. Diabetes Care. 2013;36:S11-S66.
  2. NESINA (alogliptin) Prescribing Information. Takeda Pharmaceuticals.
  3. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 008 Group. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract. 2009;63:46-55.
  4. DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012;97:1615-1622.
  5. Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drug-naïve patients with type 2 diabetes. Diabetes Care. 2010;33:2406-2408.
  6. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 010 Group. Efficacy and safety of dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care. 2008;31:2315-2317.
  7. KAZANO (alogliptin and metformin HCl) Prescribing Information. Takeda Pharmaceuticals.
  8. Pratley RE, Fleck P, Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naïve patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014;16(7):613—621.613—621
  9. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364-1379.
  10. OSENI (alogliptin and pioglitazone) Prescribing Information. Takeda Pharmaceuticals.
  11. Defronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773-795.
  12. Bajaj M, Suraamornkul S, Pratipanawatr T, et al. Pioglitazone reduces hepatic fat content and augments splanchnic glucose uptake in patients with type 2 diabetes. Diabetes. 2003;52:1364-1370.
  13. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, double-blind, active-controlled, parallel-group study. Diabetes Obes Metab. 2011;13:1088-1096.
  14. Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2009;25:2361-2371.
  15. Puddu A, Sanguineti R, Durante A, Viviani GL. Pioglitazone attenuates the detrimental effects of advanced glycation end-products in the pancreatic beta cell line HIT-T15. Regul Pept. 2012;177:79-84.
  16. Gastaldelli A, Miyazaki Y, Mahankali A, et al. The effect of pioglitazone on the liver: role of adiponectin. Diabetes Care. 2006;29:2275-2281.
  17. Nam S, Chesla C, Stotts NA, Kroon L, Janson SL. Barriers to diabetes management: patient and provider factors. Diabetes Res Clin Pract. 2011;93(1):1-9.
Show ↑

IMPORTANT SAFETY INFORMATION



WARNING: CONGESTIVE HEART FAILURE—for Alogliptin and Pioglitazone

  • Thiazolidinediones, including pioglitazone, which is a component of Alogliptin and Pioglitazone, cause or exacerbate congestive heart failure in some patients.
  • After initiation of Alogliptin and Pioglitazone, 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 Alogliptin and Pioglitazone must be considered.
  • Alogliptin and Pioglitazone is not recommended in patients with symptomatic heart failure.
  • Initiation of Alogliptin and Pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

WARNING: LACTIC ACIDOSIS—for Alogliptin and Metformin HCl

  • 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, Alogliptin and Metformin HCl should be discontinued and the patient hospitalized immediately.

©2016 Perrigo Company, plc. This site is intended for use by U.S. residents only.

NESINA, KAZANO, and OSENI are trademarks of Takeda Pharmaceutical Company Limited, registered with the U.S. Patent and Trademark Office.