INVOKANA PI PDF

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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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Serious urinary tract infections UTI have occurred with this class of medications; contact your doctor if you have any symptoms of a UTI, such as:. Drug-induced hepatitis and cases of liver injury, including some fatalities, have been reported.

TGA eBS – Product and Consumer Medicine Information

If you’ve had an allergic reaction in the past imvokana canagliflozin – such as a rash, hives, or swelling – you should also not invkkana Invokana. In patients with chronic kidney disease, also assess serum phosphorus.

Manage reactions according to signs and symptoms. The following was noted from the Phase III trials: Median time to complete resolution was 14 days range: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

The PBAC considered that this claim was adequately supported in invokaba of comparative effectiveness based on HbA1c change only, but did not consider the claim of comparative safety to be adequately supported. Canagliflozin was TGA registered on 12 September for treatment of adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, to improve glycaemic control as:. Aminotransferase elevations were not ihvokana prior to discovery of liver injury in many cases.

The third-party service providers, not Janssen, are responsible for the information invookana assistance provided under this program. 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 The FDA stated that patients who experience invoknaa or symptoms of ketoacidosis such as trouble breathing, nausea, vomiting, abdominal [stomach] pain, confusion, unusual fatigue or sleepiness should contact their doctor immediately to determine if they have ketoacidosis, as your drug treatment may need to be stopped.

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Onvokana submission also included a supplementary comparison with dapagliflozin, a pharmacological analogue of canagliflozin. In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population.

But if it is almost time for next dose, skip the missed dose and take Invokana at your regularly scheduled time. Accessed April 8, at http: Use ESAs only for anemia from myelosuppressive chemotherapy. The submission proposed that the place in therapy of canagliflozin invokama as an alternative treatment option, with a different mechanism of action, to the currently available oral antidiabetic agents.

Consider supportive care with transfusions. Unvokana and Dose Specifics. Each HCP and patient is responsible for verifying and confirming any information provided.

Indication and Important Safety Information | Janssen CarePath

Ip patients with antihistamines, antipyretics, and corticosteroids. How Effective Is Invokana? Mild-to-moderate rash was also reported and often occurred and resolved with continued dosing.

In ketoacidosis, your blood becomes acidic the pH is too low.

The most common Invokana side effects include:. RPLS is a neurological disorder, which is not caused by an infection or demyelination. Severe acute exacerbations of hepatitis B e. Serious bacterial, fungal, and viral infections, some requiring hospitalization, were reported. The PBAC noted that while the overall rates of adverse events associated with canagliflozin and sitagliptin treatment were similar, there was a higher rate of genital mycotic infections in canagliflozin treatment groups.

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.

The equi-effective doses are canagliflozin mg to sitagliptin mg. Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: Most medicare plans will also cover the cost of Invokana.

It is very important you do not take two doses of Invokana invokqna the same time, unless your doctor instructs you to do this. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Monitor patients for signs and symptoms of infection including osteomyelitisnew pain or tenderness, sores, or ulcers involving the lower limbs, and discontinue if these complications occur.

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The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents.

Frequently monitor patients during the entire infusion.

Indication and Important Safety Information

Authority required To be finalised. The PBAC noted with the listing of canagliflozin, the NOTE for the currently listed gliptins, glitazones including combination products and glucagon-like peptide-1 agents will need to be updated to include sodium glucose co-transporter 2 inhibitors. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis.

Also, the FDA warned that patients taking canaglifozin should notify their doctor right away if they notice any new pain, tenderness, sores, ulcers, or infections in their legs or feet. Although more often diagnosed in older women, osteoporosis can affect anyone but there are several lifestyle changes you can make to keep your bones in the best health possible.

Drug interactions should always be assessed whenever you start — or even stop — a medication. The submission did not include potential costs of renal function monitoring, as recommended in the FDA approved PI. Purpose of Application The submission requested an Authority required listing for treatment of patients with type 2 diabetes mellitus T2DM as dual oral combination therapy with metformin or a sulfonylurea.

If a strong CYP3A inhibitor for short-term use i. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. Monitor patients with neutropenia for signs of infection. Prompt hemodialysis is recommended. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Worried you’ll need insulin?

One case of reversible posterior leukoencephalopathy syndrome RPLS was observed in clinical studies of psoriasis and psoriatic arthritis. Canagliflozin was TGA registered on 12 September for treatment of adults with type 2 diabetes mellitus, as an adjunct to diet and exercise, to improve glycaemic control as: