INVOKANA® film-coated tablets PRESCRIBING INFORMATION ACTIVE INGREDIENT(S): Canagliflozin hemihydrate, equivalent to 100 mg or 300 mg canagliflozin. Please refer to Summary of Product Characteristics (SmPC) before prescribing. INDICATION(S): In adults with type 2 diabetes mellitus to improve glycaemic control as: monotherapy when diet and exercise alone do not provide adequate glycaemic control and use of metformin considered inappropriate; add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. DOSAGE & ADMINISTRATION: Adults: recommended starting dose: 100 mg once daily. In patients tolerating this dose and with eGFR ≥ 60 mL/min/1.73 m2


needing


tighter glycaemic control, dose can be increased to 300 mg once daily. Caution increasing dose in patients ≥ 75 years old, with known cardiovascular disease or for whom initial canagliflozin-induced diuresis is a risk. Correct volume depletion prior to initiation. When add-on, consider lower dose of insulin or insulin secretagogue to reduce risk of hypoglycaemia. Children: no data available. Elderly: consider renal function and risk of volume depletion. Renal impairment: not to be initiated with eGFR < 60 mL/min/1.73 m2


. If eGFR falls below this value


during treatment, adjust or maintain dose at 100 mg once daily. Discontinue if eGFR persistently < 45 mL/min/1.73 m2


. Not for use in end stage renal


disease or patients on dialysis. Hepatic impairment: mild or moderate hepatic impairment: no dose adjustment. Severe hepatic impairment: not studied, not recommended. CONTRAINDICATIONS: Hypersensitivity to active substance or any excipient. SPECIAL WARNINGS & PRECAUTIONS: Not for use in type 1 diabetes. Not to be used for treatment of diabetic ketoacidosis. Renal impairment: eGFR < 60 mL/min/1.73 m2


:


higher incidence of ADRs associated with volume depletion particularly with 300 mg dose; more events of elevated potassium; greater increases in serum creatinine and BUN; limit dose to 100 mg once daily and discontinue when eGFR < 45 mL/min/1.73 m2


100mg and 300mg efficacy


INVOKANA® and single price . Not


studied in severe renal impairment. Monitor renal function prior to initiation and at least annually. Volume depletion: caution in patients for whom a canagliflozin-induced drop in blood pressure is a risk (eg, known cardiovascular disease, eGFR < 60 mL/min/1.73 m2


,


anti-hypertensive therapy with history of hypotension, on diuretics or elderly people). Not recommended with loop diuretics or volume depleted patients. Monitor volume status and serum electrolytes. Elevated haematocrit: caution. Genital mycotic infections: risk in male and female patients, particularly in those with a history of GMI. Urine laboratory assessment: glucose in urine due to mechanism of action. Lactose intolerance: do not use in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. SIDE EFFECTS: Very common: hypoglycaemia in combination with insulin or sulphonylurea, vulvovaginal candidiasis. Common: constipation, thirst, nausea, polyuria or pollakiuria, urinary tract infection (including pyelonephritis and urosepsis), balanitis or balanoposthitis, dyslipidemia, hematocrit increased. Uncommon: dehydration, postural dizziness, syncope, hypotension, orthostatic hypotension, rash, urticaria, bone fracture, blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased. Other side effects: angioedema. Refer to SmPC for other side effects. PREGNANCY: No human data. Not recommended. LACTATION: Unknown if excreted in human milk. Should not be used during breast-feeding. INTERACTIONS: Diuretics: may increase risk of dehydration and hypotension. Insulin and insulin secretagogues: risk of hypoglycaemia; consider lower dose of insulin or insulin secretagogue. Effects of other medicines on Invokana: Enzyme inducers (eg, St. John’s wort, rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may decrease exposure of canagliflozin; monitor glycaemic control. Consider dose increase to 300 mg if administered with UGT enzyme inducer. Cholestyramine may reduce canagliflozin exposure; take canagliflozin at least 1 hour before or 4-6 hours after a bile acid sequestrant. Effects of Invokana on other medicines: Monitor patients on digoxin, other cardiac glycosides, dabigatran. Inhibition of Breast Cancer Resistance Protein cannot be excluded; possible increased exposure of drugs transported by BCRP (eg, rosuvastatin and some anti- cancer agents). Refer to SmPC for full details of interactions. LEGAL CATEGORY: POM PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS Invokana 100 mg film-coated tablets, EU/1/13/884/002, pack of 30 tablets: £39.20. Invokana 300 mg film-coated tablets, EU/1/13/884/006, pack of 30 tablets: £39.20. MARKETING AUTHORISATION HOLDER: Janssen- Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG UK. © Janssen-Cilag Ltd 2015


Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/ yellowcard. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.


Prescribing information last revised: August 2015. Date of preparation: September 2015 PHGB/VOK/0815/0018


flexibility at A * 1-3


INVOKANA® 100mg


» Comparable HbA1c reductions vs sitagliptin in dual therapy at 52 weeks**1 » Greater weight and blood pressure reductions vs sitagliptin in dual therapy at 52 weeks**†1


INVOKANA® 300mg » Greater HbA1c reductions vs sitagliptin in dual and triple therapy at 52 weeks‡1,2 » Greater weight and blood pressure reductions in dual and triple therapy at 52 weeks†‡1,2


OKANA® 100mg once-daily, who have an eGFR ≥60ml/min/1.73m2 glycaemic control, the dose can be increased to 300mg once-daily.


» Greater than 1% HbA1c reductions (11mmol/mol) in 4 clinical trials2,4-6 CONTINUE TO CHANGE THE CONVERSATION IN TYPE 2 DIABETES INV*The recommended starting dose of INVOKANA® is 100mg once-daily. In patients tolerating


and need tighter


†**As add on to metformin. INVOKANA® is not indicated for weight loss or the treatment of hypertension.


‡ As add on to metformin and add on to metformin and sulphonylurea.


All products have specific benefits and risks. Please see each product’s Summaries of Product Characteristics for full details (INVOKANA® Prescribing Information August 2015)


References: 1. Lavalle-González FJ et al. Diabetologia 2013; 56:2582-2592 2. Schernthaner G et al. Diabetes Care 2013; 36(9); 2508-2515. 3. INVOKANA® Prescribing Information August 2015 4. Stenlof K et al. Diabetes Obes Metab 2012; 15(4): 372-382 5. Forst T et al. Diabetes, Obesity and Metabolism 2014; 16: 467-477, 2014 6. Wilding JPH et al. Int J Clin Pract, 2013; 67(12): 1267-82


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