INVOKANA® (canagliflozin) is indicated:
INVOKANA® is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
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.
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.
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 for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if these complications occur.
UGT Enzyme Inducers: Co-administration with rifampin lowered INVOKANA® exposure, which may reduce the efficacy of INVOKANA®. For patients with eGFR ≥60 mL/min/1.73 m2, if an inducer of UGTs (eg, 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.
For patients with eGFR <60 mL/min/1.73 m2, if an inducer of UGTs 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.
Please read full Prescribing Information and Medication Guide for INVOKANA®.
cp-68813v5
INVOKANA® (canagliflozin) is indicated:
INVOKANA® is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
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.
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.
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 for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if these complications occur.
UGT Enzyme Inducers: Co-administration with rifampin lowered INVOKANA® exposure, which may reduce the efficacy of INVOKANA®. For patients with eGFR ≥60 mL/min/1.73 m2, if an inducer of UGTs (eg, 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.
For patients with eGFR <60 mL/min/1.73 m2, if an inducer of UGTs 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.
Please read full Prescribing Information and Medication Guide for INVOKANA®.
cp-68813v5