Alogliptin/Metformin

DEA Class; Rx

Common Brand Names; Kazano

Renal impairment (ie, eGFR <30 ml/min/1.73 m²); renal impairment may also result from medical conditions (eg, shock, acute MI, septicemia)

Acute or chronic metabolic acidosis, including diabetic ketoacidosis; diabetic ketoacidosis should be treated with insulin

Hypersensitivity to alogliptin or metformin, including anaphylaxis, angioedema, or severe cutaneous adverse reactions including Stevens-Johnson syndrome

• Upper respiratory tract infection (8%)
• Nasopharyngitis (6.8%)
• Hypoglycemia (1.8-6.3%)
• Diarrhea (5.5%)
• Hypertension (5.5%)
• Headache (5.3%)
• Back pain (4.3%)
• Urinary tract infection (4.2%)
• Hypersensitivity (0.6%)
• Pancreatitis (0.2%)
• Severe and disabling arthralgia
• Anaphylaxis, angioedema, rash, urticaria
• Severe cutaneous adverse reactions, including Stevens-Johnson syndrome
• Hepatic enzyme elevations
• Fulminant hepatic failure
• Bullous pemphigoid
• Rhabdomyolysis
• Constipation
• Nausea
• Ileus
• Adverse Effects
• Renal and urinary disorders: Tubulointerstitial nephritis

Lactic acidosis (see Black Box Warnings)

Pancreatitis reported

Caution with sensitivity to another DPP-4 inhibitor or metformin; discontinue if serious hypersensitivity reaction suspected (see Contraindications)

Fatal and nonfatal hepatic failure reported; type 2 DM is also known to cause fatty liver disease and liver enzyme elevation; monitor carefully and interrupt alogliptin treatment if LFTs elevated, do not restart alogliptin without another explanation for the liver test abnormalities

Insulin and insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia; therefore, a lower dose of insulin of insulin secretagogue may be needed to minimize hypoglycemia risk

Coadministration with drugs that may affect renal function or metformin elimination

Temporarily withhold metformin for any surgical procedures that restrict fluid/food intake

Hypoxic conditions (eg, shock, acute CHF, acute MI) associated with lactic acidosis (see Black Box Warnings)

Alcohol potentiates metformin’s effect on lactate metabolism; avoid excessive alcohol intake

Metformin may decrease vitamin B12 levels

Hypoglycemia may occur with metformin if calorie intake is deficient

Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate

Limited available data in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

There is no information regarding presence of metformin or alogliptin in human milk, effects on breastfed infant, or effects on milk production

Alogliptin/metformin

tablet

• 12.5mg/500mg
• 12.5mg/1000mg