INVOKANA

INVOKANA- canagliflozin tablet, film coated
Cardinal Health

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 in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2) ] .

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 m2. 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 Warnings and Precautions (5.2) ] .

In patients with volume depletion, correct this condition before initiating INVOKANA [see Warnings and Precautions (5.2) , Use in Specific Populations (8.5 , 8.6) ] .

2.2 Recommended Dosage

See Table 1 for dosage recommendations based on estimated glomerular filtration rate (eGFR).

Table 1: Recommended Dosage
estimated glomerular filtration rate eGFR (mL/min/1.73 m2) Recommended Dosage

eGFR 60 or greater

100 mg orally once daily, taken before the first meal of the day. Dose can be increased to 300 mg once daily for additional glycemic control.

eGFR 30 to less than 60

100 mg once daily.

eGFR less than 30

Initiation is not recommended, however patients with albuminuria greater than 300 mg/day may continue 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), Use in Specific Populations (8.6)].

On dialysis

Contraindicated [see Contraindications (4)].

2.3 Concomitant Use with UDP-Glucuronosyl Transferase (UGT) Enzyme Inducers

Patients with eGFR 60 mL/min/1.73 m2 or greater

If an inducer of UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) is co-administered with INVOKANA, increase the dose to 200 mg (taken as two 100 mg tablets) once daily in patients currently tolerating INVOKANA 100 mg. The dose may be increased to 300 mg once daily in patients currently tolerating INVOKANA 200 mg and who require additional glycemic control [see Drug Interactions (7.1) ] .

Patients with eGFR less than 60 mL/min/1.73 m2

If an inducer of UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir) is co-administered with INVOKANA, increase the dose to 200 mg (taken as two 100 mg tablets) once daily in patients currently tolerating INVOKANA 100 mg. Consider adding another antihyperglycemic agent in patients who require additional glycemic control.

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

Serious hypersensitivity reaction to INVOKANA, such as anaphylaxis or angioedema [see Warnings and Precautions (5.8) and Adverse Reactions (6.1, 6.2)].
Patients on dialysis [see Use in Specific Populations (8.6) ] .

5 WARNINGS AND PRECAUTIONS

5.1 Lower Limb Amputation

An increased risk of lower limb amputations associated with INVOKANA use versus placebo was observed in CANVAS (5.9 vs 2.8 events per 1000 patient-years) and CANVAS-R (7.5 vs 4.2 events per 1000 patient-years), two randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular disease or were at risk for cardiovascular disease. The risk of lower limb amputations was observed at both the 100 mg and 300 mg once daily dosage regimens. The amputation data for CANVAS and CANVAS-R are shown in Tables 3 and 4, respectively [see Adverse Reactions (6.1) ].

Amputations of the toe and midfoot (99 out of 140 patients with amputations receiving INVOKANA in the two trials) were the most frequent; however, amputations involving the leg, below and above the knee, were also observed (41 out of 140 patients with amputations receiving INVOKANA in the two trials). Some patients had multiple amputations, some involving both lower limbs.

Lower limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.

Before initiating INVOKANA, consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients receiving INVOKANA for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue INVOKANA if these complications occur.

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