INVOKANA

INVOKANA- canagliflozin tablet, film coated
Janssen Pharmaceuticals, Inc.

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.

Limitations of Use

INVOKANA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)] .

INVOKANA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2. INVOKANA is likely to be ineffective in this setting based upon its mechanism of action.

2 DOSAGE AND ADMINISTRATION

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 additional glycemic control, the dosage of INVOKANA may be increased to the maximum recommended dosage of 300 mg once daily.

2.3 Recommended Dosage in Patients with Renal Impairment

Table 1 provides dosage recommendations for patients with renal impairment, based on estimated glomerular filtration rate (eGFR).

Table 1: Recommended Dosage in Patients with Renal Impairment
Estimated Glomerular Filtration Rate [eGFR (mL/min/1.73 m 2)] Recommended Dosage
eGFR 30 to less than 60 The maximum recommended dosage is100 mg orally once daily.
eGFR less than 30
  • Initiation is not recommended
  • Patients taking INVOKANA with albuminuria greater than 300 mg/day may continue INVOKANA 100 mg once daily to reduce the risk of ESKD, doubling of serum creatinine, CV death, and hospitalization for heart failure [see Indications and Usage (1)and Use in Specific Populations (8.6)].

2.4 Concomitant Use with UDP-Glucuronosyl transferase (UGT) Enzyme Inducers

When co-administering INVOKANA with an inducer of UGT (e.g., rifampin, phenytoin, phenobarbital, ritonavir), increase the dosage of INVOKANA based on renal function [see Drug Interactions (7)]:

  • In patients with eGFR 60 mL/min/1.73 m 2 or greater, increase the dosage to 200 mg orally once daily in patients currently tolerating INVOKANA 100 mg once daily. The maximum recommended dosage of INVOKANA is 300 mg once daily.
  • In patients with eGFR less than 60 mL/min/1.73 m 2 , increase to a maximum recommended dosage of 200 mg orally once daily in patients currently tolerating INVOKANA 100 mg once daily.

2.5 Temporary Interruption for Surgery

Withhold INVOKANA at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume INVOKANA when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1)and Clinical Pharmacology (12.2)].

3 DOSAGE FORMS AND STRENGTHS

  • INVOKANA 100 mg tablets are yellow, capsule-shaped, tablets with “CFZ” on one side and “100” on the other side.
  • INVOKANA 300 mg tablets are white, capsule-shaped, tablets with “CFZ” on one side and “300” on the other side.

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)] .

5 WARNINGS AND PRECAUTIONS

5.1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis

In patients with type 1 diabetes mellitus, INVOKANA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose transporter 2 (SGLT2) inhibitors compared to patients who received placebo; this risk may be greater with higher doses of INVOKANA. INVOKANA is not indicated for glycemic control in patients with type 1 diabetes mellitus.

Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including INVOKANA.

Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include acute febrile illness, reduced caloric intake, ketogenic diet, surgery, insulin dose reduction, volume depletion, and alcohol abuse.

Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL). Ketoacidosis and glucosuria may persist longer than typically expected. Urinary glucose excretion persists for 3 days after discontinuing INVOKANA [see Clinical Pharmacology (12.2)]; however, there have been postmarketing reports of ketoacidosis and glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors.

Consider ketone monitoring in patients at risk for ketoacidosis if indicated by the clinical situation. Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis. If ketoacidosis is suspected, discontinue INVOKANA, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting INVOKANA.

Withhold INVOKANA, if possible, in temporary clinical situations that could predispose patients to ketoacidosis. Resume INVOKANA when the patient is clinically stable and has resumed oral intake [see Dosage and Administration (2.5)] .

Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue INVOKANA and seek medical attention immediately if signs and symptoms occur.

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