Generic Name and Formulations:
Alogliptin, metformin (as HCl); 12.5mg/500mg, 12.5mg/1000mg; tabs.
Takeda Pharmaceuticals USA, 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.
Individualize. Swallow whole. Take twice daily with food; increase dose gradually to reduce GI effects. Max 25mg alogliptin/2000mg metformin per day.
Renal impairment (Scr ≥1.5mg/dL [men], ≥1.4mg/dL [women] or abnormal CrCl). Metabolic acidosis. Diabetic ketoacidosis.
Confirm normal renal function before starting; monitor (esp. in elderly). Discontinue if lactic acidosis, renal impairment, shock, acute MI or CHF, hypoxemia, dehydration, sepsis, pancreatitis, serious hypersensitivity reactions, or severe joint pain is suspected or occurs. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Hepatic impairment: not recommended. Obtain LFTs before starting therapy. Temporarily suspend during surgery; may restart when oral intake is resumed and renal function normalized. Monitor hematology (esp. serum Vit. B12 in susceptible patients). Elderly, debilitated, malnourished, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. History of angioedema with other DPP-4 inhibitors. Concomitant intravascular iodinated contrast agents (suspend during and for 48hrs after procedure). Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy. Nursing mothers.
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 may cause hyperglycemia. May need lower dose of concomtant sulfonylurea or insulin to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.
Dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.
Upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, UTI; pancreatitis, heart failure, hypersensitivity reactions, hepatic failure, severe and disabling arthralgia; rare: lactic acidosis (may be fatal).
Tabs—60, 180, 500