Some patients had multiple amputations, some involving both limbs. Limitations of Use Invokana is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Invokana Dosage and Administration Prior to Initiation of Invokana Assess renal function before initiating Invokana and periodically thereafter [see Warnings and Precautions 5. In patients with volume depletion not previously treated with canagliflozin, normalize volume status before initiating Invokana [see Warnings and Precautions 5.
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Some patients had multiple amputations, some involving both limbs. Limitations of Use Invokana is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Invokana Dosage and Administration Prior to Initiation of Invokana Assess renal function before initiating Invokana and periodically thereafter [see Warnings and Precautions 5. In patients with volume depletion not previously treated with canagliflozin, normalize volume status before initiating Invokana [see Warnings and Precautions 5. Recommended Dosage The recommended starting dose of Invokana canagliflozin is mg once daily, taken before the first meal of the day.
The risk of lower limb amputations was observed at both the mg and mg once daily dosage regimens. Amputations of the toe and midfoot 99 out of 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 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.
Hypotension Invokana causes intravascular volume contraction. Symptomatic hypotension can occur after initiating Invokana [see Adverse Reactions 6. Before initiating Invokana in patients with one or more of these characteristics, volume status should be assessed and corrected.
Monitor for signs and symptoms after initiating therapy. Ketoacidosis Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 SGLT2 inhibitors, including Invokana.
Fatal cases of ketoacidosis have been reported in patients taking Invokana. Invokana is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and Usage 1 ]. If ketoacidosis is suspected, Invokana should be discontinued, patient should be evaluated, and prompt treatment should be instituted.
Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement. Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as insulin dose reduction, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disorders suggesting insulin deficiency e.
Before initiating Invokana, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse.
In patients treated with Invokana consider monitoring for ketoacidosis and temporarily discontinuing Invokana in clinical situations known to predispose to ketoacidosis e. Acute Kidney Injury Invokana causes intravascular volume contraction [see Warnings and Precautions 5. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving Invokana; some reports involved patients younger than 65 years of age.
Before initiating Invokana, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications diuretics, ACE inhibitors, ARBs, NSAIDs.
Consider temporarily discontinuing Invokana in any setting of reduced oral intake such as acute illness or fasting or fluid losses such as gastrointestinal illness or excessive heat exposure ; monitor patients for signs and symptoms of acute kidney injury.
If acute kidney injury occurs, discontinue Invokana promptly and institute treatment. Initiation of Invokana may increase serum creatinine and decrease eGFR. Patients with hypovolemia may be more susceptible to these changes [see Adverse Reactions 6. Renal function should be evaluated prior to initiation of Invokana and monitored periodically thereafter.
Urosepsis and Pyelonephritis There have been postmarketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including Invokana.
Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated [see Adverse Reactions 6 ].
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues are known to cause hypoglycemia.
Invokana may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue [see Adverse Reactions 6. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with Invokana. Cases have been reported in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death.
If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue Invokana, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control. Genital Mycotic Infections Invokana increases the risk of genital mycotic infections.
Patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections [see Adverse Reactions 6. Monitor and treat appropriately. Hypersensitivity Reactions Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with Invokana. These reactions generally occurred within hours to days after initiating Invokana.
If hypersensitivity reactions occur, discontinue use of Invokana; treat and monitor until signs and symptoms resolve [see Contraindications 4 and Adverse Reactions 6. Consider factors that contribute to fracture risk prior to initiating Invokana [see Adverse Reactions 6.
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Permanently discontinue therapy if an anaphylactic reaction or life-threatening Grade 4 reaction occurs and institute appropriate emergency care. RxEconsult Home If dual therapy with metformin and a sulfonylurea is unsuccessful, insulin can be added. The PBAC considered that a comparison of canagliflozin mg with sitagliptin 50 mg would have been informative. Lower-limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. Manage elevated LFTs with treatment interruption, dose reduction, or permanent discontinuation based on severity and duration of LFT abnormality.