"The U.S. Food and Drug Administration today approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Type 2 diabetes is the most common form of the disease, affe"...
Limitation of Use
DOSAGE AND ADMINISTRATION
The recommended starting dose of INVOKANA (canagliflozin) is 100 mg once daily, taken before the first meal of the day. 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, the dose can be increased to 300 mg once daily [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY, and PATIENT INFORMATION].
Patients With Renal Impairment
No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m² or greater).
The dose of INVOKANA is limited to 100 mg once daily in patients with moderate renal impairment with an eGFR of 45 to less than 60 mL/min/1.73 m² .
INVOKANA should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m² .
Assessment of renal function is recommended prior to initiation of INVOKANA therapy and periodically thereafter. INVOKANA should be discontinued when eGFR is persistently less than 45 mL/min/1.73 m² [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
Concomitant Use With UDP-Glucuronosyl Transferase (UGT) Enzyme Inducers
If an inducer of UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) is co-administered with INVOKANA, consider increasing the dosage to 300 mg once daily in patients currently tolerating INVOKANA 100 mg once daily who have an eGFR of 60 mL/min/1.73 m² or greater and require additional glycemic control [see DRUG INTERACTIONS].
Consider another antihyperglycemic agent in patients with an eGFR of 45 to less than 60 mL/min/1.73 m² receiving concurrent therapy with a UGT inducer.
Dosage Forms And Strengths
- INVOKANA 100 mg tablets are yellow, capsule-shaped, film-coated tablets with “CFZ” on one side and “100” on the other side.
- INVOKANA 300 mg tablets are white, capsule-shaped, film-coated tablets with “CFZ” on one side and “300” on the other side.
INVOKANA (canagliflozin) tablets are available in the strengths and packages listed below:
100 mg tablets are yellow, capsule-shaped, film-coated tablets with “CFZ” on one side and “100” on the other side.
NDC 50458-140-30 Bottle of 30
NDC 50458-140-90 Bottle of 90
NDC 50458-140-50 Bottle of 500
NDC 50458-140-10 Blister package containing 100 tablets (10 blister cards containing10 tablets each)
300 mg tablets are white, capsule-shaped, film-coated tablets with “CFZ” on one side and “ 300” on the other side.
NDC 50458-141-30 Bottle of 30
NDC 50458-141-90 Bottle of 90
NDC 50458-141-50 Bottle of 500
NDC 50458-141-10 Blister package containing 100 tablets (10 blister cards containing 10 tablets each)
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).
Active ingredient made in Belgium.Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Manufactured by: Janssen Ortho, LLC Gurabo, PR 00778. Date of approval: March 2015
Last reviewed on RxList: 3/19/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Invokana Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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