Diabetes:

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 (ESKD), doubling of serum creatinine, CV death, and hospitalization for heart failure (HF) in adults with T2DM and diabetic nephropathy with albuminuria >300mg/day.

Limitations of Use:

Not recommended in patients with type 1 diabetes; may increase risk of diabetic ketoacidosis. Not recommended in adults with T2DM with an eGFR <30mL/min/1.73m2.

Adult Dosage:

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 30–<60mL/min/1.73m2: 100mg once daily. eGFR <30mL/min/1.73m2: do not initiate, however with albuminuria >300mg/day: may be continued at 100mg once daily (for reducing risk of ESKD, doubling of serum creatinine, CV death, and hospitalization for HF). 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 antihyperglycemic if require additional glycemic control.

Children Dosage:

<18yrs: not established.

INVOKANA Contraindications:

Patients on dialysis.

INVOKANA Warnings/Precautions:

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) prior to initiation. Assess renal function prior to starting and as clinically indicated. Prior to initiation, assess and correct volume status in those with renal impairment, elderly, or taking loop diuretics; monitor during therapy. 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). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Monitor for genital mycotic infections, UTIs (including urosepsis, pyelonephritis); treat if needed. Discontinue if hypersensitivity reactions occur; monitor until resolved. Consider bone fracture risks before initiation. Renal impairment. Severe hepatic impairment: not recommended. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

INVOKANA Classification:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

INVOKANA Interactions:

Antagonized by UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir): see Adult dose. Concomitant digoxin: monitor. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

Female genital mycotic infections, UTIs (may be serious), increased urination; lower limb amputation, hypotension, ketoacidosis (may be fatal), acute kidney injury, hypoglycemia, bone fractures; rare: Fournier's gangrene.

Generic Drug Availability:

NO

How Supplied:

Tabs—30, 90, 500