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For your appropriate adult patients with type 2 diabetes, in addition to diet and exercise

DOSING & ADMINISTRATION


CONVENIENT, ONCE-DAILY DOSING

Once-daily KOMBIGLYZE® XR (saxagliptin and metformin HCl extended-release) provides the maximum dose of saxagliptin (5 mg) combined with the lowest starting dose of metformin XR (500 mg).

KOMBIGLYZE XR once-daily dosing options

ONCE-DAILY DOSING

5 mg saxagliptin/ 500 mg metformin XR

5 mg saxagliptin/ 1000 mg metformin XR

2.5 mg saxagliptin/ 1000 mg metformin XR

5 mg saxagliptin and 2000 mg metformin XR*

*Can be taken as two 2.5/ 1000 mg tablets once daily.

Tablets shown are not actual size.

KOMBIGLYZE XR once-daily dosing options

ONCE-DAILY DOSING

5 mg saxagliptin/ 500 mg metformin XR

5 mg saxagliptin/ 1000 mg metformin XR

2.5 mg saxagliptin/ 1000 mg metformin XR

5 mg saxagliptin and 2000 mg metformin XR*

*Can be taken as two 2.5/ 1000 mg tablets once daily.

Tablets shown are not actual size.

MAXIMUM RECOMMENDED DOSE

5 mg saxagliptin and 2000 mg metformin XR

  • Tablets must be swallowed whole and never crushed, cut, or chewed1
  • Generally taken once daily with evening meal; gradually titrate dose to reduce gastrointestinal (GI) side effects associated with metformin1
  • Occasionally, the inactive ingredients of KOMBIGLYZE XR will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet1
  • Contraindicated in patients with renal impairment (eg, serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/dL for women, or abnormal creatinine clearance),  hypersensitivity to metformin hydrochloride, metabolic acidosis (including diabetic ketoacidosis), and history of a serious hypersensitivity reaction to KOMBIGLYZE XR or saxagliptin (eg, anaphylaxis, angioedema, or exfoliative skin conditions)1
  • Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials1
  • Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin exposure, limit KOMBIGLYZE XR to 2.5 mg/1000 mg once daily when coadministered with a strong CYP3A4/5 inhibitor (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin)

Recommended Starting Dose

  • For patients who need 5 mg of saxagliptin and who are not currently treated with metformin, the recommended starting dose of KOMBIGLYZE XR is 5 mg saxagliptin/500 mg metformin extended-release once daily1
  • Patients treated with metformin
    • The dose of KOMBIGLYZE XR should provide metformin at the dose already being taken, or the nearest therapeutically appropriate dose
    • Following a switch from metformin IR to metformin extended-release, glycemic control should be closely monitored and dosage adjustments made accordingly1
  • Patients who need 2.5 mg saxagliptin
    • May be treated with KOMBIGLYZE XR 2.5/1000 mg
    • If patients are metformin-naïve or require a higher dose of metformin, individual components should be used1

INDIVIDUALIZING TREATMENT FOR YOUR PATIENTS

Consider KOMBIGLYZE XR for patients who:

  • Need improved glycemic control
  • Could benefit from individualized therapy based on current regimen, effectiveness, and tolerability to both saxagliptin and metformin HCl
  • Do not have renal impairment

Drug Interactions

  • Limit the saxagliptin dose to 2.5 mg daily for patients also taking strong CYP3A4/5 inhibitors (eg, ketoconazole).
  • Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination; use with caution.