Qtern(saxagliptin/dapagliflozin)tablets
QTERN Rx
Generic Name and Formulations:
Dapagliflozin 10mg, saxagliptin 5mg; tabs.
Company:
AstraZeneca Pharmaceuticals
Select therapeutic use: Diabetes
Indications for QTERN:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis. Only use in patients who tolerate dapagliflozin 10mg.
Adult:
Swallow whole. Take 10mg/5mg once daily in the AM. Renal impairment: do not initiate if eGFR <60mL/min/1.73m2; discontinue if eGFR falls persistently <60mL/min/1.73m2.
Children:
<18yrs: not established.
Contraindications:
Moderate-to-severe renal impairment (eGFR <45mL/min/1.73m2), ESRD, or 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, eva luate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). eva luate renal function prior to starting and monitor periodically thereafter; more frequently if eGFR <60mL/min/1.73m2. 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 known risk factors for heart failure; monitor for signs/symptoms; eva luate 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. 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.
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 result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.
Adverse Reactions:
Upper RTIs, UTIs, 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.
Generic Availability:
NO
How Supplied:
Tabs—30, 90, 500 |
