Zituvimet Dosage

Recommended Dosage

• Take ZITUVIMET orally twice daily with meals.
• Individualize the dosage of ZITUVIMET on the basis of the patient's current regimen, effectiveness, and tolerability.
• The maximum recommended daily dose is 100 mg of sitagliptin and 2,000 mg of metformin hydrochloride (HCl).
• Do not split or divide ZITUVIMET tablets.
• The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
• The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin HCl 850 mg twice daily, the recommended starting dose of ZITUVIMET is 50 mg sitagliptin and 1,000 mg metformin HCl twice daily.

Recommendations for Use in Renal Impairment

• Assess renal function prior to initiation of ZITUVIMET and periodically thereafter.
• ZITUVIMET is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2[see Contraindications (4) and Warnings and Precautions (5.1)].
• ZITUVIMET is not recommended in patients with an eGFR between 30 and less than 45 mL/min/1.73 m2because these patients require a lower dosage of sitagliptin than what is available in the fixed combination ZITUVIMET product.

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue ZITUVIMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart ZITUVIMET if renal function is stable [see Warnings and Precautions (5.1)].