saxagliptin (Rx)

Brand and Other Names:Onglyza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
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Diabetes Mellitus Type 2

2.5-5 mg PO qDay

Dosage Modifications

Combination therapy: May need to reduce dosage of sulfonylurea or other insulin secretagogues when administered in combination

Coadministration with strong CYP450 3A4/5 inhibitors: Not to exceed 2.5 mg PO qDay

Renal impairment

  • CrCl ≥50 mL/min: No dose adjustment required
  • CrCl <50 mL/min: Not to exceed 2.5 mg PO qDay
  • ESRD requiring hemodialysis: Not to exceed 2.5 mg PO qDay administered postdialysis
  • ESRD requiring peritoneal dialysis: Not studied

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and saxagliptin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10% (selected)

            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%)

            Frequency Not Defined

            Increased creatinine phosphokinase

            Increased creatinine

            Idiopathic thrombocytopenic purpura rash

            Postmarketing reports

            Severe and disabling arthralgia

            Bullous pemphigoid

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            Warnings

            Contraindications

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

            Cautions

            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

            Congestive heart failure (CHF) risks

            • In the SAVOR-TIMI 53 trial (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) 16,492 patients with type 2 diabetes mellitus and a history of, or at risk of, cardiovascular events were randomized to saxagliptin or placebo
            • A higher incidence of hospitalization for CHF was observed in patients treated with saxagliptin compared with those treated with placebo (3.5% vs 2.8%; P=0.007); this increased risk was highest among patients with elevated levels of natriuretic peptides, previous heart failure, or chronic kidney disease
            • Circulation. 2014 Oct 28;130(18):1579-88
            • Observe patients for signs and symptoms of heart failure during therapy; inform patients of characteristic symptoms of heart failure and advise patients to immediately report them; if heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of therapy
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            Pregnancy & Lactation

            Pregnancy

            Limited available data in pregnant women are not sufficient to determine drug-associated risk for major birth defects and miscarriage; published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk

            No adverse developmental effects independent of maternal toxicity observed when saxagliptin and metformin were administered separately or in combination to pregnant rats and rabbits during period of organogenesis

            Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, pre- eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. also increases fetal risk for major malformations and macrosomia related morbidity

            Lactation

            There is no information regarding presence of metformin or alogliptin in human milk, effects on breastfed infant, or effects on milk production; limited published studies report that metformin is present in human milk; however, there is insufficient information to determine effects of metformin on breastfed infant and no available information on effects of metformin on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Dipeptidyl peptidase IV (DPP-4) inhibition that results in increased incretin hormones and enhanced glycemic control

            Absorption

            Peak plasma time: 2hr (saxagliptin); 4 hr (5-hyroxy saxagliptin)

            Distribution

            Vd: Negligible

            Metabolism

            Hepatic by CYP450 3A4/5 to active metabolite (50% potency of parent compound)

            Elimination

            Half-life (elimination): 2.5 hr (saxagliptin); 3.1 hr (5-hydroxy saxagliptin)

            Renal clearance: 7.2 L/hr

            Excretion: Urine (75%); feces (22%)

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            Administration

            Instructions

            May administer with or without food

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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Code Definition
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