Diabetes:

Indications for QTERN:

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:

Swallow whole. Take in the AM. Not currently treated with dapagliflozin: initially 5mg/5mg once daily; if tolerated and need additional glycemic control, may increase to 10mg/5mg once daily.

Children:

<18yrs: not established.

Contraindications:

Moderate to severe renal impairment (eGFR <45mL/min/1.73m2), ESRD, or on dialysis.

Warnings/Precautions:

Correct volume depletion and assess for volume contraction before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, or on loop diuretics). Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Evaluate renal function prior to starting and monitor periodically thereafter. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Consider risks/benefits in patients with higher risk factors of heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Monitor for genital mycotic infections, UTIs, increases in LDL-C; treat as appropriate. Active bladder cancer: not recommended. Prior history of bladder cancer: consider benefits/risks. History of angioedema to other DPP-4 inhibitors. Severe hepatic impairment. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.

Pharmacologic Class:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.

Interactions:

Concomitant strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin): not recommended. Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Greater potential for volume depletion with concomitant diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Upper RTI, UTI, dyslipidemia, headache, diarrhea, back pain, arthralgia; increases in LDL-C, genital mycotic infections (esp. females), hypersensitivity reactions, pancreatitis, heart failure, hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, bladder cancer, possible severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.

Generic Availability:

NO

How Supplied:

Tabs—30, 90, 500

Pricing for QTERN

5mg/5mg tablet (Qty: 30)
Appx. price $496
GoodRx