Generic Name and Formulations:
Alogliptin, metformin (as HCl); 12.5mg/500mg, 12.5mg/1000mg; tabs.

Company:
Takeda Pharmaceuticals North America, Inc

Indications for KAZANO:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and metformin is appropriate. Limitations of use: not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Adult Dose for KAZANO:
Individualize. Swallow whole; do not split tabs. Take twice daily with food; increase dose gradually to reduce GI effects. Max 25mg alogliptin/2000mg metformin per day.

Children's Dose for KAZANO:
Not established.

Pharmacological Class:
Dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.

Contraindications:
Renal impairment (Scr ≥1.5mg/dL [men], ≥1.4mg/dL [women] or abnormal CrCl). Metabolic acidosis. Diabetic ketoacidosis.

Warnings/Precautions:
Confirm normal renal function before starting; monitor (esp. in elderly). Discontinue if lactic acidosis, ketoacidosis, renal impairment, shock, acute MI, acute CHF, hypoxemia, dehydration, sepsis, pancreatitis, or hypersensitivity reactions occur. Temporarily suspend during surgery; may restart when oral intake is resumed and renal function normalized. History of angioedema with other DPP-4 inhibitors. Obtain LFTs before starting therapy. Avoid if clinical or lab evidence of hepatic disease. Monitor hematology (esp. serum Vit. B12 in susceptible patients). Elderly, debilitated, malnourished, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Concomitant intravascular iodinated contrast agents (suspend during and for 48hrs after procedure). Pregnancy (Cat. B). Nursing mothers.

Interactions:
Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinine, quinidine, ranitidine, triamterene, trimethoprim, vancomycin), cimetidine: may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Caution with concomitant topiramate, or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); may induce metabolic acidosis. Diuretics, steroids, estrogens, oral contraceptives, phenothiazines, phenytoin, thyroid products, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid, others that may cause hyperglycemia. Concomitant sulfonylurea or insulin: may need lower dose of sulfonylurea or insulin to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.

Adverse Reactions:
Upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, UTI.

How Supplied:
Tabs—60, 180, 500