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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The PBAC also noted that, overall, CV events did not differ between the two groups during the entire period of follow up. Consider discontinuation if these disorders develop. Other options include glucagon like peptide 1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and thiazolidinediones. Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including nonsteroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions.

Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

If appropriate, anti-hepatitis B therapy may be warranted. Accessed April 8, at http: Some patients had multiple amputations, some involving both limbs. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy innvokana does not increase these risks. The PBAC noted the small patient numbers in the Phase III studies with long term exposure to canagliflozin and considered that the long term safety is unclear.

Effects on Serum Creatinine: Amputations of the toe and midfoot were most invokanaa however, amputations involving the leg were also observed. 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. Invokana is usually added on to other diabetes treatmentssuch as metformin, sulfonylureas, or insulin, as an “adjunct”, when a patient no longer responds, or if the blood sugar level is too high at the outset.

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Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.

Invokana Insights: 10 Drug-Specific Facts You Should Know

The sponsor also claimed that such cases would be managed with over-the-counter treatments, and that therefore higher infection rates would not be associated with increased cost to government.

Usually, most patients will start at the mg dose, but your dose may go up.

The submission described canagliflozin mg as non-inferior in terms of comparative efficacy and safety versus dapagliflozin 10 mg. Since Invokana is a relatively new medicine, lower cost generics for this drug will not ;i available for many more years. It may be that another more affordable medication can be prescribed.

Efficacy and safety of invokqna dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Stop the infusion if the patient develops signs of anaphylaxis.

TGA eBS – Product and Consumer Medicine Information

Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone targeted agents. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Clinical P for the Proposed Therapy Type 2 diabetes is a metabolic disorder characterised by hyperglycaemia resulting from resistance to the action of insulin, insufficient insulin secretion or both.

The submission assumed that the PBS listing of canagliflozin will not increase the oi market. However, the Committee recommended the restriction wording be modified to better reflect current clinical practice in which patients whose diabetes cannot be successfully managed with a combination of metformin and a sulfonylurea, irrespective of reason, are moved to dual therapy with metformin or a sulfonylurea, and a sodium glucose transporter 2 inhibitor, a dipeptidyl peptidase 4 inhibitor gliptina thiazolidinedione glitazoneor a glucagon-like peptide All claims and other submissions to payers should be in compliance with jnvokana applicable requirements.

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Please refer to the full Prescribing Information for a complete list of adverse drug reactions. The submission did not make a claim regarding the mg dose of canagliflozin. View all slides as one page.

Manage elevated LFTs with treatment invokna, dose reduction, or permanent discontinuation based on severity and duration of LFT abnormality.

The submission claimed that canagliflozin mg is equi-effective to sitagliptin mg, based on doses are derived from fixed dose head to head trials and consistent with the product information PI for both drugs.

Exercise caution and monitor patients with heart failure.

Canagliflozin, tablet, 100 mg and 300 mg, Invokana® – July 2013

Stevens-Johnson syndrome was reported with darunavir coadministered with cobicistat in clinical trials at a rate of 0. The PBAC considered that this claim was adequately supported in terms of comparative effectiveness based on HbA1c change only, but did not consider the claim of comparative safety to be adequately supported.

In patients with chronic kidney disease, also assess serum phosphorus.