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saxagliptin (Rx)Brand and Other Names:Onglyza

 
 
 

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

saxagliptin and

No Results

     
     activity indicator 
    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

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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

            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 advice 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 category: B

            Lactation: Not known whether distributed in breast milk; caution advised

            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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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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