Glyxera

To improve glycemic control in adults w/ type 2 DM as monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance; as dual oral therapy in combination w/ metformin when diet & exercise plus metformin alone do not provide adequate glycemic control, w/ sulfonylurea when diet & exercise plus maximal tolerated dose of a sulfonylurea alone do not provide adequate glycemic control & when metformin is inappropriate due to contraindications or intolerance, or w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (ie, thiazolidinedione) when use of PPARγ agonist is appropriate & when diet & exercise plus PPARγ agonist alone do not provide adequate glycemic control; as triple oral therapy in combination w/ sulfonylurea & metformin when diet & exercise plus dual therapy w/ these medicinal products do not provide adequate glycemic control or w/ PPARγ agonist & metformin when use of PPARγ agonist is appropriate & when diet & exercise plus dual therapy w/ these medicinal products do not provide adequate glycemic control. As add-on to insulin (w/ or w/o metformin) when diet & exercise plus stable dose of insulin do not provide adequate glycemic control.

100 mg once daily. Moderate renal impairment (GFR ≥30-<45 mL/min) 50 mg once daily. Severe renal impairment (GFR ≥15-<30 mL/min) or ESRD (GFR <15 mL/min) requiring hemodialysis or peritoneal dialysis 25 mg once daily, may be administered w/o regard to timing of dialysis.

May be taken with or without food.

Hypersensitivity.

Not to be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Discontinue if hypersensitivity reaction is suspected; assess other potential causes for the event, & initiate alternative treatment for diabetes. Discontinue treatment & other potentially suspect medicinal products if pancreatitis is suspected; do not restart treatment if acute pancreatitis is confirmed. Caution in patients w/ history of pancreatitis. Hypoglycemia when used in combination w/ insulin or sulfonylurea. Discontinue if bullous pemphigoid is suspected. Assess renal function prior to initiation of therapy & periodically thereafter. Reported dizziness & somnolence when driving or using machines; alert patients to the risk of hypoglycemia when used in combination w/ sulfonylurea or w/ insulin. Severe hepatic impairment. Not to be used during pregnancy & lactation. Safety & efficacy have not yet been established in childn & adolescents <18 yr.

Pancreatitis & hypersensitivity reactions. Hypoglycemia; headache.

Potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) could alter pharmacokinetics of sitagliptin in patients w/ severe renal impairment or ESRD. OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid. Small effect on plasma digoxin conc; monitor patients at risk of digoxin toxicity. Sitagliptin may be a mild inhibitor of P-gp in vivo.

Antidiabetic Agents

A10BH01 - sitagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Rx