Indications for INVOKANA:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). To reduce the risk of major cardiovascular (CV) events (eg, CV death, nonfatal MI and stroke) in adults with T2DM and established CV disease. To reduce the risk of end-stage kidney disease, doubling of serum creatinine, CV death, and hospitalization for heart failure in adults with T2DM and diabetic nephropathy with albuminuria >300mg/day.
Limitations of Use:
Not for treating type 1 diabetes or diabetic ketoacidosis.
Take before first meal of the day. eGFR ≥60mL/min/1.73m2: initially 100mg once daily; may increase to 300mg once daily for additional glycemic control. eGFR 45–<60mL/min/1.73m2 or eGFR 30–<45mL/min/1.73m2 with albuminuria >300mg/day: 100mg once daily. Patients already initiated on therapy who meet criterion of eGFR <30mL/min/1.73m2 with albuminuria >300mg/day: may be continued at 100mg once daily. Concomitant UGT inducers (eGFR ≥60mL/min/1.73m2): increase to 200mg once daily in patients currently tolerating 100mg, may increase to 300mg once daily in those tolerating 200mg and require additional glycemic control; (eGFR <60mL/min/1.73m2): increase to 200mg once daily in patients currently tolerating 100mg, consider adding another antihyperglycemics if require additional glycemic control.
<18yrs: not established.
Severe renal impairment (eGFR <30mL/min/1.732) in patients being treated for glycemic control. Dialysis.
Lower limb amputation.
Increased risk of lower limb amputations; monitor for infection, new pain or tenderness, sores or ulcers in lower limbs, and discontinue if occur. Consider risk factors for amputation (eg, prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers) before initiation. Correct volume depletion before starting therapy. Monitor for symptomatic hypotension in renal impairment, elderly, low systolic BP, concomitant diuretics or drugs that interfere with the RAA system (eg, ACEIs, ARBs). 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). Consider temporarily discontinuing prior to scheduled surgery (for 3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). 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. Discontinue if hypersensitivity reactions occur; monitor until resolved. Consider bone fracture risks before initiation. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Monitor for genital mycotic infections, UTIs; treat if needed. Severe hepatic impairment: not recommended. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Antagonized by UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir): see Adults. Concomitant digoxin: monitor. Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Female genital mycotic infections, UTIs (may be serious), increased urination; lower limb amputation, hypotension, ketoacidosis (may be fatal), acute kidney injury, hypoglycemia, bone fractures, urosepsis, pyelonephritis; rare: Fournier's gangrene.
Tabs—30, 90, 500