Janumet

Initial therapy in type 2 DM to improve glycemic control when diet & exercise do not provide adequate glycemic control. As an adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM inadequately controlled on metformin or sitagliptin alone or in patients already being treated w/ the combination of sitagliptin & metformin. As part of triple combination therapy w/ a sulfonylurea as an adjunct to diet & exercise in adults w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: Metformin, sitagliptin or sulfonylurea; as add-on to insulin as an adjunct to diet & exercise to improve glycemic control in patients inadequately controlled w/ insulin & metformin alone.

Individualized dosage w/ a max daily dose of sitagliptin 100 mg & metformin 2,000 mg. Patient inadequately controlled w/ diet & exercise alone Starting dose: 50 mg/500 mg bd. May be titrated up to 50 mg/1,000 mg bd. Patient inadequately controlled on metformin monotherapy Starting dose: Sitagliptin 50 mg bd + metformin already taken. Patient inadequately controlled on sitagliptin monotherapy Starting dose: 50 mg/500 mg bd. May be titrated up to 50 mg/1,000 mg bd. Patient switching from sitagliptin co-administered w/ metformin Initiate w/ dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following antihyperglycemic agents: sitagliptin, metformin, sulfonylurea or w/ insulin & metformin Starting dose: Sitagliptin 50 mg bd + metformin dose based on glycemic control level. Gradual dose escalation to reduce GI effects associated w/ metformin. Patients currently on or initiating sulfonylurea or insulin therapy may require lower sulfonylurea or insulin doses to reduce the risk of hypoglycemia.

Should be taken with food.

Hypersensitivity. History of serious hypersensitivity to Janumet or sitagliptin eg, anaphylaxis or angioedema. Acute or chronic metabolic acidosis including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

Discontinue use if hypersensitivity reaction (including anaphylaxis, angioedema & exfoliative skin conditions including SJS) is suspected, assess for other potential causes & institute alternative diabetes treatment. Not to be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Not recommended in patients w/ (eGFR ≥30 & <45 mL/min/1.73 m²). Rarely, lactic acidosis may occur; discontinue use if acidosis is suspected & immediately hospitalize patient. Promptly discontinue if pancreatitis is suspected, for possible acute, fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Patient w/ history of pancreatitis. Measure vit B₁₂ levels at 2-3 yr intervals in patients predisposed to developing subnormal vit B₁₂ levels. Excessive acute or chronic alcohol intake. Temporarily suspend therapy prior to surgical procedure until resumption of oral intake & acceptable renal function. Promptly evaluate patients previously controlled on Janumet who develop lab abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis. Possible risk of hypoglycemia in combination w/ insulin or a sulfonylurea. Concomitant medications affecting renal function of or may result in significant hemodynamic change or may interfere w/ metformin disposition eg, cationic drugs that are eliminated by renal tubular secretion. Temporarily discontinue at the time of or prior to the procedure in patients w/ eGFR ≥30 to <60 mL/min/1.73 m²), history of hepatic impairment, alcoholism, or heart failure who will be administered w/ intra-arterial iodinated contrast, & w/hold for 48 hr subsequent to the procedure & reinstitute after renal function has been re-evaluated to be acceptable. Promptly discontinue in the event of CV collapse from whatever cause, acute CHF or MI & other conditions characterized by hypoxemia. W/hold treatment & temporarily administer insulin when patient is exposed to stress eg, fever, trauma, infection, or surgery due to potential temporary loss of glycemic control. Discontinue use if bullous pemphigoid is suspected; development of blisters or erosions while on treatment should be reported by the patient. Possible severe & disabling arthralgia. Avoid in patients w/ clinical or lab evidence of hepatic disease. Regular monitoring of renal function before initiation & at least annually thereafter; assess renal function more frequently in patients whom development of renal dysfunction is anticipated, particularly in the elderly patients, & discontinue if evidence of renal impairment is present. Pregnancy & lactation. Childn <18 yr. Elderly ≥65 yr.

Diarrhea, URTI, headache, nausea, vomiting, abdominal pain; hypoglycemia. Sitagliptin: Nasopharyngitis. Metformin HCl: Flatulence, indigestion, asthenia.

May increase lactic acidosis risk in concomitant use w/ topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide or dichlorphenamide). May increase systemic exposure of metformin & risk for lactic acidosis in concomitant use w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin [eg, organic cationic transporter-2/multidrug & toxin extrusion inhibitors (eg, ranolazine, vandetanib, dolutegravir & cimetidine)]. May produce hyperglycemia w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers & INH.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

POM