KAZANO® (alogliptin and metformin hcl) tablet,
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Drug: KAZANO (alogliptin and metformin HCl) tablets for oral
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(drug info link)
Initial U.S. Approval: 2013
WARNING: LACTIC ACIDOSIS
See full prescribing information for complete boxed warning
•Lactic acidosis 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
•Symptoms include 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, discontinue KAZANO and hospitalize the
INDICATIONS AND USAGE
KAZANO is a dipeptidyl-peptidase-4 (DPP-4) inhibitor and a biguanide
combination product indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitation of Use: Not for treatment of type 1 diabetes or
DOSAGE AND ADMINISTRATION
•Individualize the starting dose of KAZANO based on the patient's
•KAZANO should be taken twice daily with food.
•May adjust the dosing based on effectiveness and tolerability, while
not exceeding the maximum recommended daily dose of 25 mg alogliptin and
2000 mg metformin HCl.
DOSAGE FORMS AND STRENGTHS
Tablets: 12.5 mg alogliptin and 500 mg metformin HCl, 12.5 mg alogliptin
and 1000 mg metformin HCl. (3)
•Metabolic acidosis, including diabetic ketoacidosis.
•History of a serious hypersensitivity reaction to alogliptin or
metformin, components of KAZANO, such as anaphylaxis, angioedema or
severe cutaneous adverse reactions.
WARNINGS AND PRECAUTIONS
•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.
•Acute pancreatitis: There have been postmarketing
reports of acute pancreatitis. If pancreatitis is suspected, promptly
•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 KAZANO, assess for other
potential causes, institute appropriate monitoring and treatment, and
initiate alternative treatment for diabetes.
•Hepatic effects: Postmarketing reports of hepatic
failure, sometimes fatal. Causality cannot be excluded. If liver injury
is detected, promptly interrupt KAZANO and assess patient for probable
cause, then treat cause if possible, to resolution or stabilization. Do
not restart KAZANO if liver injury is confirmed and no alternative
etiology can be found.
•Temporarily discontinue in patients undergoing radiologic studies with
intravascular administration of iodinated contrast materials or any
surgical procedures necessitating restricted intake of food and fluids.
•Vitamin B12 deficiency: Metformin may lower Vitamin
B12 levels. Monitor hematologic parameters annually.
•Hypoglycemia: When used with an insulin secretagogue
(e.g., sulfonylurea) or with insulin, a lower dose of the insulin
secretagogue or insulin may be required to reduce the risk of
•Macrovascular outcomes: There have been no clinical
studies establishing conclusive evidence of macrovascular risk reduction
with KAZANO or any other antidiabetic drug.