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Important Safety Information
  • Alogliptin is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
  • Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Alogliptin.
  • 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, 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 and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin if liver injury is confirmed and no alternative etiology can be found.
  • 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.
  • 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 or any other anti-diabetic drug.
  • 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%).

Patients taking Alogliptin 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.

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

Indication

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

Please see Full Prescribing Information, including Medication Guide for Alogliptin.


©2016 Perrigo Company, plc

Important Safety Information

WARNING: CONGESTIVE HEART FAILURE

  • 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.
  • Alogliptin and Pioglitazone is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin or pioglitazone, such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
  • Do not initiate in patients with NYHA Class III or IV heart failure.
  • 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.
  • Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Alogliptin and Pioglitazone.
  • Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly discontinue 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 and Pioglitazone and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin and Pioglitazone if liver injury is confirmed and no alternative etiology can be found. Use with caution in patients with liver disease.
  • 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.
  • 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 and Pioglitazone.
  • 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.
  • 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 and Pioglitazone or any other anti-diabetic drug.
  • Most common adverse reactions (4% of patients treated with co-administration of alogliptin and pioglitazone) were nasopharyngitis (4.9%), back pain (4.2%), and upper respiratory tract infection (4.1%).
  • Use with CYP2C8 strong inhibitors (e.g., gemfibrozil) will, or inducers (e.g., rifampin) may, require dose adjustment.

Patients taking Alogliptin and Pioglitazone 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.

Indication

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

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


©2016 Perrigo Company, plc

Important Safety Information

WARNING: LACTIC ACIDOSIS

  • 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 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.
  • Alogliptin and Metformin HCl is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin or metformin, such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.
  • 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.
  • Acute pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Alogliptin and Metformin HCl.
  • Hypersensitivity: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with alogliptin such as anaphylaxis, angioedema and severe cutaneous adverse reactions. In such cases, promptly discontinue Alogliptin and Metformin HCl, 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 and Metformin HCl and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Alogliptin and Metformin HCl if liver injury is confirmed and no alternative etiology can be found. Alogliptin and Metformin HCl should generally be avoided in patients with hepatic impairment.
  • Vitamin B12 deficiency: Metformin may lower Vitamin B12 levels. Monitor hematologic parameters annually.
  • 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 and Metformin HCl.
  • 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 and Metformin HCl or any other anti-diabetic drug.
  • Most common adverse reactions (4% of patients treated with co-administration 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%).
  • Cationic drugs eliminated by renal tubular secretion should be used with caution if taken with Alogliptin and Metformin HCl.

Patients taking Alogliptin and Metformin HCl 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.

Indication

Alogliptin and Metformin HCl is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Alogliptin and Metformin HCl is not for treatment of type 1 diabetes or diabetic ketoacidosis.

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


©2016 Perrigo Company, plc

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