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Saxagliptin/Metformin

    Brands

    DEA Class; Rx

    Common Brand Names; Kombiglyze XR

    • Antidiabetics, Biguanides/Dipeptyl Peptidase-IV Inhibitors

    Oral combination of a biguanide (metformin) and a dipeptidy-peptidase-4 (DPP-4) inhibitor (saxagliptin)
    Used in adults for the treatment of type 2 diabetes mellitus
    Per boxed warning the risk of lactic acidosis due to metformin requires care in prescribing and monitoring

    Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with sitagliptin or metformin and have inadequate glycemic control on sitagliptin or metformin alone

    Individualize starting dose based on patient’s current regimen

    For the treatment of type 2 diabetes mellitus in combination with diet and exercise.

    History of serious hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

    Severe renal disease: eGFR <30 ml/min/1.73 m²

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

    Diarrhea (9.6%)

    Nausea/vomiting (6.5%)

    Headache (6.5%)

    Hypoglycemia, saxagliptin (1.6%)

    Rash

    Lymphopenia

    Saxagliptin

    • Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
    • Pancreatitis
    • Severe and disabling arthralgia
    • Bullous pemphigoid
    • Rhabdomyolysis

    Metformin

    • Cholestatic, hepatocellular, and mixed hepatocellular liver injury

    Gradual increase of metformin dose may reduce GI side effects

    Metformin may decrease serum vitamin B12 concentration

    Do not exceed saxagliptin 2.5 mg/day when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)

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

    Inactive tablet ingredients (ie, ghost tablet) may be eliminated in the feces as a soft, hydrated mass

    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)

    Caution with history of angioedema

    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 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

    Adults

    2000 mg/day PO metformin; 5 mg/day PO saxagliptin.

    Geriatric

    2000 mg/day PO metformin; 5 mg/day PO saxagliptin.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Saxagliptin/metformin

    tablet, extended-release

    • 5mg/500mg
    • 2.5mg/1000mg
    • 5mg/1000mg