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References Prescribing information and adverse events reporting

Uncontrolled blood sugar
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INVOKANA (canagliflozin) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.1

INVOKANA® (canagliflozin) 100 mg & 300 mg film-coated tablets.

PRESCRIBING INFORMATION. Republic of Ireland

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATIONS: The treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes.

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. For oral use, swallow whole. 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; no dose adjustment. Severe; not studied, not recommended.

CONTRAINDICATIONS: Hypersensitivity to active substance or any excipient.

SPECIAL WARNINGS & PRECAUTIONS: Not for use in type 1 diabetes. Renal impairment: eGFR < 60 mL/min/1.73 m2: higher incidence of adverse reactions associated with volume depletion particularly with 300 mg dose; more events of elevated potassium; greater increases in serum creatinine and blood urea nitrogen (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 (e.g. known cardiovascular disease, eGFR < 60 mL/min/1.73 m2, anti-hypertensive therapy with history of hypotension, on diuretics or elderly). Not recommended with loop diuretics or in volume depleted patients. Monitor volume status and serum electrolytes. Haematocrit: careful monitoring if already elevated. Genital mycotic infections: risk in male and female patients, particularly in those with a history of GMI. Lower limb amputation: Consider risk factors before initiating. Monitor patients with a higher risk of amputation events. Counsel on routine preventative foot care and adequate hydration. Consider discontinuing Invokana when events preceding amputation occur (e.g. lower-extremity skin ulcer, infection, osteomyelitis or gangrene). Urine laboratory assessment: glucose in urine due to mechanism of action. Lactose intolerance: do not use in patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Diabetic ketoacidosis (DKA): rare DKA cases reported, including life-threatening and atypical presentation cases. Where DKA is suspected or diagnosed, discontinue Invokana treatment immediately. Interrupt treatment in patients who are undergoing major surgical procedures or have acute serious medical illnesses. Consider risk factors for development of DKA before initiating Invokana treatment.

SIDE EFFECTS: Very common (≥1/10): hypoglycaemia in combination with insulin or sulphonylurea, vulvovaginal candidiasis. Common (≥1/100 to <1/10): constipation, thirst, nausea, polyuria or pollakiuria, urinary tract infection (including pyelonephritis and urosepsis), balanitis or balanoposthitis, dyslipidemia, haematocrit increased. Uncommon (<1/100) but potentially serious: anaphylactic reaction, diabetic ketoacidosis, syncope, hypotension, orthostatic hypotension, urticaria, angioedema, bone fracture, renal failure (mainly in the context of volume depletion), lower limb amputations (mainly of the toe and midfoot, incidence rate of 0.63 per 100 subject-years, vs 0.34 for placebo). Refer to SmPC for details and 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 (e.g. 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 (e.g. rosuvastatin and some anti-cancer agents).

LEGAL CATEGORY: POM.

PACK SIZES & MARKETING AUTHORISATION NUMBER(S): Invokana 100 mg film-coated tablets: 30 tablets; EU/1/13/884/002. Invokana 300 mg film-coated tablets: 30 tablets; EU/1/13/884/006.

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. ® INVOKANA is a registered trade mark of Janssen-Cilag International NV and is used under licence. © 2017 Napp Pharmaceuticals Limited

FURTHER INFORMATION IS AVAILABLE FROM: Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18. For medical information enquiries, please contact info@mundipharma.ie.

Adverse events should be reported to: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Adverse events should also be reported to Mundipharma Pharmaceuticals Limited on drugsafetyireland@mundipharma.ie or by phone on 01 2063800 (1800 991830 outside office hours)

UK/INV-18203

Date of Preparation September 2018