INVOKANA 300 mg/1
canagliflozin · TABLET, FILM COATED · Janssen Pharmaceuticals, Inc.
Canagliflozin is a prescription tablet used to help manage type 2 diabetes by helping your kidneys remove excess sugar through urine. It may also be used to reduce the risk of heart and kidney problems in patients with type 2 diabetes.
Key Facts
- Brand Name
- INVOKANA
- Generic Name
- canagliflozin
- NDC Code (Product)
50458-141- Manufacturer
- Janssen Pharmaceuticals, Inc.
- Strength
- 300 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA204042
- Marketing Start
- 03/29/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease ( 1 ) To reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria ( 1 ). Lim…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess renal function before initiating and as clinically indicated ( 2.1 ) The recommended starting dose is 100 mg once daily, taken before the first meal of the day ( 2.2 ) Dose can be increased to 300 mg once daily in patients tolerating 100 mg once daily who have an eGFR of 60 mL/min/1.73 m 2 or greater and require additional glycemic control ( 2.2 ) Dose adjustment for patients with renal impairment may be required ( 2.3 ) See full prescribing information for INVOKANA dosage modifications due to drug interactions ( 2.4 ) Withhold INVOKANA at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting ( 2.5 ). 2.1 Prior to Initiation of INVOKANA Assess renal function before initiating INVOKANA and as clinically indicated [see Dosage and Administration (2.3) and Warnings and Precautions (5.3) ] . In patients with volume depletion, correct this condition before initiating INVOKANA [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5 , 8.6) ] . 2.2 Recommended Dosage and Administration The recommended dosage of INVOKANA is 100 mg orally once daily, taken before the first meal of the day. For addi…
Contraindications
4 CONTRAINDICATIONS INVOKANA is contraindicated in patients with a serious hypersensitivity reaction to INVOKANA, such as anaphylaxis or angioedema [see Warnings and Precautions (5.8) and Adverse Reactions (6.1 , 6.2) ] . Serious hypersensitivity reaction to INVOKANA ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 7: Clinically Significant Drug Interactions with INVOKANA UGT Enzyme Inducers Clinical Impact: UGT enzyme inducers decrease canagliflozin exposure which may reduce the effectiveness of INVOKANA. Intervention: For patients with eGFR 60 mL/min/1.73 m 2 or greater, if an inducer of UGTs is administered with INVOKANA, increase the dosage to 200 mg daily in patients currently tolerating INVOKANA 100 mg daily. The total daily dosage may be increased to 300 mg daily in patients currently tolerating INVOKANA 200 mg daily who require additional glycemic control. For patients with eGFR less than 60 mL/min/1.73 m 2 , if an inducer of UGTs is administered with INVOKANA, increase the dosage to 200 mg daily in patients currently tolerating INVOKANA 100 mg daily. Consider adding another antihyperglycemic agent in patients who require additional glycemic control [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) ] . Examples: Rifampin, phenytoin, phenobarbital, ritonavir Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when INVOKANA is used concomitantly with insulin secretagogues (e.g., sulfonylurea) or insulin. I…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Lower Limb Amputation [see Warnings and Precautions (5.2) ] Volume Depletion [see Warnings and Precautions (5.3) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.5) ] Necrotizing Fasciitis of the Perineum (Fournier's gangrene) [see Warnings and Precautions (5.6) ] Genital Mycotic Infections [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Bone Fracture [see Warnings and Precautions (5.9) ] Most common adverse reactions (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ) 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. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, a…
Frequently Asked Questions
What is INVOKANA used for?
Canagliflozin is a prescription tablet used to help manage type 2 diabetes by helping your kidneys remove excess sugar through urine. It may also be used to reduce the risk of heart and kidney problems in patients with type 2 diabetes.
Is INVOKANA a controlled substance?
INVOKANA is not classified as a controlled substance by the DEA.
What is the generic name for INVOKANA?
The generic name for INVOKANA is canagliflozin. There are 7 other brand versions of canagliflozin.
What is the NDC code for INVOKANA 300 mg/1?
The NDC (National Drug Code) for INVOKANA 300 mg/1 is 50458-141, listed by Janssen Pharmaceuticals, Inc..