The only
SGLT2 inhibitor with a proven efficacy profile vs sitagliptin in dual AND triple
therapy1,2
SMC ACCEPTED FOR
RESTRICTED USE IN DUAL, TRIPLE & ADD ON
TO INSULIN THERAPY4
NICE RECOMMENDED
AS AN OPTION IN DUAL, TRIPLE & ADD ON TO INSULIN THERAPY3
NICE recommended (TA315)
Canagliflozin in dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes, only if:
- a sulphonylurea is contraindicated or not tolerated or - the person is at significant risk of hypoglycaemia or its consequences.
Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with:
- metformin and a sulphonylurea or - metformin and a thiazolidinedione.
INVOKANA® (canagliflozin) works in an insulin-independent way, inhibiting SGLT2 receptors in the kidneys to excrete excess blood glucose via the urine. INVOKANA® can improve glycaemic control in type 2 diabetes, providing HbA1c reductions in a once-daily pill, with the additional benefits of weight loss and blood pressure reductions.5
With two studies comparing INVOKANA®
with sitagliptin, one in dual therapy, one in triple therapy, these are results worth talking about.1,2 INVOKANA®
is not indicated for weight loss or the treatment of hypertension INVOKANA® film-coated tablets PRESCRIBING INFORMATION Weight change and systolic blood pressure change from baseline were prespecified secondary endpoints
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 studied in patients with 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. 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 hypoglycaemia in
glucose-galactose malabsorption. SIDE combination with
insulin or sulphonylurea,
EFFECTS: Very vulvovaginal
common: candidiasis.
Common: constipation, thirst, nausea, polyuria or pollakiuria, urinary tract infection, 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
AD 5
5. INVOKANA®
©Janssen-Cilag Ltd.
www.invokana.janssen.co.uk
PHGB/VOK/0114/0004b(4). Date of preparation: November 2014. change the conversation
increased. 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: £49.99. 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 2014. Prescribing information last revised: April 2014.
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.
This medicinal product is subject to additional monitoring and it is therefore important to report any suspect adverse reactions related to this medicinal product.
References: 1. Lavalle-Gonzalez FJ et al. Diabetologia 2013; 56: 2582 – 2592 2. Schernthaner G et al. Diabetes Care 2013; 36(9): 2508-2515 3. National Institute for Health and Clinical Excellence 2014. TA315. Available from:
http://guidance.nice.org.uk/TA315
4. Scottish Medicines Consortium 2014. Canagliflozin, 100mg and 300mg film-coated tablets (INVOKANA®
) SMC No (963/14) 100mg and 300mg Summaries of Product Characteristics. Available from
www.medicines.org.uk last accessed 15th October 2014
Canagliflozin in combination with insulin with or without other antidiabetic drugs is recommended as an option for treating type 2 diabetes.
SMC Accepted (SMC 963/14) · In dual therapy in combination with metformin · Triple Therapy in combination with metformin plus standard of care · Add-on to insulin therapy in combination with insulin plus standard of care
FAMILY OF DIABETES COMPANIES
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