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 considered canagliflozin and dapagliflozin similar but noted they have different safety profiles. Ketoacidosis usually occurs in patients with type 1 diabetes.

Some patients had multiple amputations, some involving both limbs. Diet and exercise are the first steps in managing the disease, followed by the addition of drug therapy with metformin.

In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. The submission assumed that canagliflozin would predominantly substitute for the growing gliptin market. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Since Invokana is a relatively new medicine, lower cost generics for this drug will not be available for many more years.

The submission assumed that the PBS listing of canagliflozin will not increase the current market.

Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported with the use of tenofovir prodrugs. The submission did not include additional costs for adverse events. Low blood sugar is not common with normal doses of Invokana. Please refer to the full Prescribing Information or a complete list of adverse drug reactions.

Appropriate diagnostic testing should be considered, e. In Trial ETSAR, the incidence of drug-induced liver injury defined as concurrent elevation in ALT or AST of more than three times the upper limit of normal, alkaline phosphatase less than two times the upper limit of normal, and total bilirubin at least two times the upper limit of normal was 1.

Monotherapy — When diet and exercise alone do not provide invokna glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. The SGLT-2 inhibitor drugswhich come as oral tablets, are sold as individual agents and in combination with other diabetes drugs.

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

The submission claimed that canagliflozin mg treatment resulted in a statistically significant larger reduction in mean HbA1c from baseline compared with sitagliptin. Median time to the first occurrence of Grade 3 or 4 neutropenia was 16 days range: Metformin Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or when used concomitantly with other glucose-lowering agents such as sulfonylureas or insulin or ethanol.

Published trial for Canagliflozin Hermansen, K et al. The sponsor claimed that most infections are self-diagnosed or diagnosed on clinical history, and therefore require no investigational diagnostic tests.

Indication and Important Safety Information | Janssen CarePath

The PBAC considered that the results of the indirect analyses were difficult to interpret due to the small number of patients, reduced power of the indirect comparison and the resulting wide confidence intervals, and differences in the common comparator arms of the trials.

Last updated on Apr 9, Serious urinary tract infections Ivnokana have occurred with this class of medications; contact your doctor if you have any symptoms of a UTI, such as:.

If neurological compromise is noted, urgent treatment is necessary. In invkkana, a roughly 2-fold increased risk of lower limb amputations was seen with canagliflozin. Accessed April 8, at http: I Missed Pii Dose of Invokana. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease COPD.

Indication and Important Safety Information

Medications for the treatment of hypersensitivity reactions should be available. Invokana is taken by mouth, and it comes in milligram mg and mg tablets.

Most invokanq plans will also cover the cost of Invokana. The published trials presented in the submission are shown in the following table: Economic Analysis The submission presented a cost-minimisation analysis, based on non-inferiority claim of canagliflozin mg to sitagliptin mg for mean reduction in HbA1c from baseline. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

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Manage reactions according to signs and symptoms. There are oral medications used first-line to control blood sugar, and may even help you…. The median onset was day A lower dose of insulin or insulin secretagogue may be required.

Invokana Insights: 10 Drug-Specific Facts You Should Know

These drugs are hypoglycemics drugs used to lower blood sugar in patients with type 2 diabetes. Severe acute exacerbations of hepatitis B e.

The PBAC considered also that prescribing of canagliflozin outside the proposed PBS restriction may be driven by its effects on weight loss, as well as the observed high utilisation of sitagliptin the main comparator outside its PBS listing. The PBAC therefore considered that canagliflozin was non-inferior to sitagliptin with respect to efficacy. 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.

Increased bleeding in hemophiliacs has been reported in patients receiving protease inhibitors. Interference with Determination of Complete Response — Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis SPE and immunofixation IFE assays used for the clinical monitoring of endogenous M-protein.

Worried you’ll need insulin? Serious infections and fatal outcomes have been reported in such patients. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. New Drug Approved for Type 2 Diabetes. Other Warnings with Canagliflozin. These hematomas may result in long-term or permanent paralysis. The date and level of the qualifying HbA1c must be documented in the patient’s medical records at the time of treatment with a sodium glucose co-transporter-2 inhibitor, a gliptin, a glitazone or a glucagon-like peptide-1 is initiated.