ZITUVIMET (sitagliptin and metformin HCl) tablets for oral use contain sitagliptin and metformin HCl. Sitagliptin Sitagliptin is an orally-active inhibitor of DPP-4 enzyme. Sitagliptin is present in ZITUVIMET tablets in the form of sitagliptin free base. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3 (trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine with an empirical formula of C 16 H 15 F 6 N 5 O and a molecular weight of ...

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ZITUVIMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET has not been studied in patients with a history of pancreatitis. ZITUVIMET is indicated as an adjunct to diet and exercise to improve glycemic control i...

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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 HCl. 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...

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Severe renal impairment: (eGFR below 30 mL/min/1.73 m 2 ) ( 4) Metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to ZITUVIMET, sitagliptin, or metformin, such as anaphylaxis or angioedema. ZITUVIMET is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) . Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to sitagliptin, metformin, or any of the e...

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In the event of overdose with ZITUVIMET, consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures dictated by the patient's clinical status. Per clinical judgement, consider removal of unabsorbed material from the gastrointestinal tract, and clinical monitoring (including obtaining an ECG). Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was ...

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Lactic Acidosis: See boxed warning . Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue ZITUVIMET. Heart Failure : Has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIMET in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. Acute Renal Failure: Has been rep...

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Table 4 presents clinically significant drug interactions with ZITUVIMET: Table 4: Clinically Significant Drug Interactions with ZITUVIMET Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with ZITUVIMET may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate,...

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Available data with ZITUVIMET and sitagliptin use in pregnant women are not sufficient to inform a ZITUVIMET-associated or sitagliptin-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 . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy . No adverse developmental effects were observed when sitaglipt...

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