Saxagliptin

DEA Class; Rx

Common Brand Names; Onglyza

Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

• Urinary tract infection (7%)
• Headache (7%)
• Hypersensitivity-related events (<4%; eg, urticaria, facial edema)
• Peripheral edema (<4%; increased incidence when coadministered with thiazolidinediones)
• Upper respiratory tract infection (3%)
• Gastroenteritis (2%)
• Hypoglycemia (1.6%)
• Increased creatinine phosphokinase
• Increased creatinine
• Idiopathic thrombocytopenic purpura rash
• Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
• Pancreatitis
• Severe and disabling arthralgia
• Bullous pemphigoid
• Rhabdomyolysis

Renal impairment

Decrease dose with strong CYP450 3A4/5 inhibitors

Coadministration with thiazolidinediones (eg, rosiglitazone, pioglitazone) increases risk for peripheral edema

Pancreatitis reported with saxagliptin; monitor for signs and symptoms and discontinue if pancreatitis suspected

Serious hypersensitivity reactions with saxagliptin reported (typically within the first 3 months of therapy)

History of angioedema

Coadministration with a sulfonylurea or with insulin may increase hypoglycemia; monitor closely and adjust sulfonylurea and/or insulin dose accordingly

Postmarketing cases of bullous pemphigoid requiring hospitalization reported with DPP-4 inhibitor use; patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor; inform patients to report development of blisters or erosions while on treatment; if bullous pemphigoid is suspected, discontinue therapy and refer patient to dermatologist for diagnosis and appropriate treatment

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

There are no clinical studies establishing conclusive evidence of macrovascular risk reduction with this therapy

Limited available data in pregnant women are not sufficient to determine 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