QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(十六)
elfinavir, ritonavir, saquinavir, and telithromycin).
Intervention Do not coadminister QTERNMET XR with strong cytochrome P450 3A4/5inhibitors [see DOSAGE AND ADMINISTRATION (2.3) and CLINICALPHARMACOLOGY (12.3)].
Carbonic Anhydrase Inhibitors
Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide,acetazolamide, or dichlorphenamide) frequently causes a decrease in serum
bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis.Intervention Concomitant use of these drugs with QTERNMET XR may increase the risk
for lactic acidosis. Consider more frequent monitoring of these patients.
Drugs that Reduce Metformin Clearance
Clinical Impact Concomitant use of drugs that interfere with common renal tubular transportsystems involved in the renal elimination of metformin (e.g., organic cationictransporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors suchas ranolazine, vandetanib, dolutegravir, and cimetidine) could increasesystemic exposure to metformin and may increase the risk for lactic acidosis[see CLINICAL PHARMACOLOGY (12.3)].
Intervention Consider the benefits and risks of concomitant use.
Alcohol
Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism.
Intervention Warn patients against excessive alcohol intake while receiving QTERNMET
XR.
Insulin Secretagogues or Insulin
Clinical Impact Dapagliflozin, and saxagliptin can individually increase the risk ofhypoglycemia when combined with insulin or an insulin secretagogue.
Hypoglycemia does not occur in patients receiving metformin alone under
Table 4: Clinically Relevant Interactions Affecting Drugs Coadministered with
QTERNMET XR
usual circumstances of use but could occur during concomitant use with otherglucose-lowering agents (such as sulfonylureas and insulin).
Intervention A lower dose of insulin or insulin secretagogue may be required to reduce therisk of hypoglycemia when these agents are used in combination with
QTERNMET XR.
Drugs Affecting Glycemic Control
Clinical Impact Some medications can predispose to hyperglycemia and may lead to loss ofglycemic control. These medications include the thiazides and other diuretics,
corticosteroids, phenothiazines, thyroid products, estrogens, oralcontraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channelblockers, and isoniazid.
Intervention When such drugs are administered to a patient or withdrawn from a patientreceiving QTERNMET XR, the patient should be closely observed for loss ofblood glucose control or hypoglycemia.
Positive Urine Glucose Test
Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positiveurine glucose tests.
Intervention Monitoring glycemic control with urine glucose tests is not recommended inpatients taking SGLT2 inhibitors. Use alternative methods to monitor
glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control inpatients taking SGLT2 inhibitors.
Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Usealternative methods to monitor glycemic control.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal data showing adverse renal effects, from dapaglifloz |
