INVOKANA PI PDF
Learn about INVOKANA®, an SGLT2 inhibitor that helps lower blood sugar and risk of cardiovascular disease in adults. See full Prescribing & Safety Info. INVOKANA is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an INVOKANA mg once daily who have an eGFR of 60 mL/min/ m2. INVOKANA® is now the only oral diabetes treatment approved to in the INVOKANA® U.S. full Prescribing Information (PI).3 The PI also.
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Monitor patients for signs and symptoms of infection including osteomyelitisnew pain or tenderness, sores, or ulcers involving invokama lower limbs, and discontinue if these complications occur. Signs of low blood sugar include: Add-on combination therapy – Combination therapy with other anti-hyperglycaemic agents including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control 4.
Yeast infections in vagina or penis Urinary tract infections or frequent urgent need to urinate Thirst More serious side effects may include: PBAC agreed that uncertainty persisted regarding the cardiovascular safety profile of canagliflozin and noted that additional post-marketing studies commenced following the FDA recommendation of canagliflozin in March which include: Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
Supplementary indirect comparisons of canagliflozin mg with dapagliflozin 10 mg were also presented: Evidence of tissue necrosis can occur more than 1 week after the extravasation. Symptoms of infusion reactions consisted of back pain, invooana pain or discomfort, nausea and vomiting, flushing, erythema, and palpitations.
Indication and Important Safety Information
These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension, and resistant bradyarrhythmias have occurred with severe acidosis.
The most common Invokana side effects include:. If your blood sugar control is not adequate, your doctor may decide a higher Invokana dose is needed but only if your kidney function is good enough for the higher dose. New onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported in patients receiving protease inhibitors.
Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. The PBAC did not consider that the assumption of linear growth of the gliptin market was reasonable given the volatility of the diabetes market noted in the October and February DUSC reports.
The PBAC noted a substantially higher incidence of both male and female genital mycotic infections and osmotic diuresis related adverse events in the canagliflozin arms compared to sitagliptin. Your insurance may cover all or some of the cost of this medication. Hypersensitivity reactions, including anaphylactic reaction, hypersensitivity, and drug hypersensitivity have been reported in patients treated with siltuximab.
Canagliflozin is not PBS-subsidised for use in combination with metformin and a sulfonylurea triple oral therapyas monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor gliptinthiazolidinedione glitazone or a glucagon-like peptide Any other sodium glucose transport 2 inhibitors listed on the PBS for use in the third line setting should be required to join the same risk share.
The sponsor claimed that most infections are self-diagnosed or diagnosed on clinical history, and therefore require no investigational diagnostic tests.
Consider discontinuation if these disorders develop. Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving darunavir coadministered with ritonavir.
Invokana Insights: 10 Drug-Specific Facts You Should Know
The PBAC did not consider this claim to be reasonable, agreeing that infections could be more common in non-trial populations, and considered that the cost of managing infections related to treatment should be accounted for. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases.
What Do You Need to Know? It is very important you do not take two doses of Invokana at the same time, unless your doctor instructs you to do this. The submission did not anticipate any cost consequences with the PBS listing of canagliflozin, but did not account for any costs related to the management of adverse events.
Monotherapy — When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Perform appropriate tests, if indicated, to confirm AI.
Canagliflozin, tablet, 100 mg and 300 mg, Invokana® – July 2013
Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. In patients with chronic kidney disease, also assess serum phosphorus. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
Evaluate patients for fracture and fall risk.
The submission claimed that canagliflozin mg treatment resulted in a statistically significant larger reduction in mean HbA1c from baseline compared with sitagliptin. The submission did not include additional costs for adverse events. Accessed April 8, at https: Increases in LDL-cholesterol levels associated with canagliflozin were also noted. Like most other medicines, Invokana has important drug interactions you should be aware of. Li order to manage the risk of possible usage invokanaa the third line setting proposed by the sponsor, the PBAC recommended that a risk share arrangement should be put in place.
Control hypertension and correct hypokalemia before and during treatment. Cases of acute and chronic invokna have been reported with postmarketing TNF-blocker use. Severe acute exacerbations of hepatitis B e.