INVOKANA™(canagliflozin) tablets

INVOKANA is supplied as film-coated tablets for oral administration, containing 102 and 306 mg of canagliflozin in each tablet strength, corresponding to 100 mg and 300 mg of canagliflozin (anhydrous), respectively.

Inactive ingredients of the core tablet are croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following excipients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/PEG, talc, and iron oxide yellow, E172 (100 mg tablet only).

Limitation of Use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis

Severe renal impairment, ESRD, or on dialysis

WARNINGS AND PRECAUTIONS

1. Hypotension: Before initiating INVOKANA, assess volume status and correct hypovolemia in patients with renal impairment, the elderly, in patients with low systolic blood pressure, or if on diuretics, ACEi, or ARB. Monitor for signs and symptoms during therapy
2. Impairment in Renal Function: Monitor renal function during therapy. More frequent monitoring is recommended in patients with eGFR below 60 mL/min/1.73 m²
3. Hyperkalemia: Monitor potassium levels in patients with impaired renal function and in patients predisposed to hyperkalemia
4. Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with INVOKANA
5. Genital mycotic infections: Monitor and treat if indicated
6. Hypersensitivity reactions: Discontinue INVOKANA and monitor until signs and symptoms resolve
7. Increased LDL-C: Monitor LDL-C and treat per standard of care

ADVERSE REACTIONS
Most common adverse reactions associated with INVOKANA (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination

To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS
UGT inducers (e.g., rifampin): Canagliflozin exposure is reduced. Consider increasing dose from 100 mg to 300 mg (2.3, 7.1)

Digoxin: Monitor digoxin levels.

USE IN SPECIFIC POPULATIONS

1. Pregnancy: No adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
2. Nursing mothers: Discontinue drug or nursing
3. Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume
4. Renal impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function
5. Hepatic impairment: Not recommended with severe hepatic impairment

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

The recommended starting dose is 100 mg once daily, taken before the first meal of the day.

Dose can be increased to 300 mg once daily in patients tolerating INVOKANA 100 mg once daily who have an eGFR of 60 mL/min/1.73 m² or greater and require additional glycemic control.

INVOKANA is limited to 100 mg once daily in patients who have an eGFR of 45 to less than 60 mL/min/1.73 m².

Assess renal function before initiating INVOKANA. Do not initiate INVOKANA if eGFR is below 45 mL/min/1.73 m².

Discontinue INVOKANA if eGFR falls below 45 mL/min/1.73 m².

Tablets: 100 mg, 300 mg

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

Manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778

Licensed from Mitsubishi Tanabe Pharma Corporation
Date of approval: March 2013
© 2013 Janssen Pharmaceuticals, Inc.