Recommendations for All Patients

• Healthcare providers should individualize the starting dose of KAZANO based on the patient's current regimen.
• KAZANO should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. Do not split tablets.
• Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 25 mg alogliptin and 2000 mg metformin hydrochloride (HCl).
• The following doses are available:

  12.5 mg alogliptin and 500 mg metformin HCl

  12.5 mg alogliptin and 1000 mg metformin HCl

Recommendations for Use in Renal Impairment

Assess renal function prior to initiation of KAZANO and periodically thereafter.

KAZANO is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1)].

KAZANO is not recommended in patients with an eGFR between 30 and 59 mL/min/1.73 m2 because these patients require a lower daily dosage of alogliptin than what is available in the fixed combination KAZANO product.

Kazano requires no dose adjustment in patients with an eGFR of 60 mL/min/1.73 m2 or greater.

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue KAZANO at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart KAZANO if renal function is stable [see Warnings and Precautions (5.1)].