Abbreviated Prescribing Information: Invokana (canagliflozin) 100mg & 300mg film-coated tablets.
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.
Presentation: Canagliflozin 100mg and canagliflozin 300mg, film-coated tablets.
Use: Adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: (1) as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or (2) in addition to other medicinal products for the treatment of diabetes. Dosage and administration: Oral administration. Recommended starting dose is 100mg once daily, preferably taken before the first meal of the day. Tablets should be swallowed whole. In patients needing tighter glycaemic control and tolerating canagliflozin 100mg once daily, dose can be increased to 300mg once daily if eGFR ≥ 60 mL/min/1.73 m2. [Refer to SmPC for dose adjustment according to eGFR]. Care when increasing dose in patients ≥ 75 years of age, patients with known cardiovascular disease (CVD), other patients for whom the initial canagliflozin-induced diuresis poses risk. Correcting volume depletion prior to initiation of canagliflozin is recommended. Consideration of a lower dose(s) of insulin/insulin secretagogue if using canagliflozin as an add-on therapy is recommended. Elderly: Renal function and risk of volume depletion should be taken into account. Paediatric population: The safety and efficacy of canagliflozin in children under 10 years of age have not yet been established. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and Precautions: [Refer to SmPC for more detail] Renal impairment: Limit dose to 100mg once daily in adult patients with eGFR < 60 mL/min/1.73 m2. Regardless of pre-treatment eGFR, adult patients on canagliflozin may experience an initial fall in eGFR that attenuates over time. Monitor renal function prior to and after initiating canagliflozin. Also monitor after initiating concomitant products that may reduce renal function. Canagliflozin should not be used in patients with type 1 diabetes mellitus. Patients at risk of volume depletion: Canagliflozin induces osmotic diuresis which may reduce intravascular volume and decrease blood pressure (BP). Caution should be exercised in patients for whom a canagliflozin-induced drop in BP could pose a risk. In children weighing < 50 kg, caution is advised when up-titrating to the 300 mg dose, since safety data are limited. Advise patients to report symptoms of volume depletion. Canagliflozin is not recommended for use in patients receiving loop diuretics or who are volume depleted. Diabetic ketoacidosis (DKA): Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors including in children less than 50 kg body weight. Presentation of DKA may be atypical. Risk of DKA appears to be higher in patients with moderately to severely decreased renal function who require insulin. Assess patients immediately if symptoms occur, regardless of blood glucose level. Where DKA is suspected/diagnosed, discontinue canagliflozin immediately. Treatment should be interrupted in patients who are hospitalised for acute serious medical illnesses and withheld for an appropriate period of days prior to major surgical procedures or acute serious medical illnesses associated with prolonged fasting. Monitoring of serum ketones is recommended in these patients. Consider alternative anti-hyperglycaemic therapy, including insulin.. Before initiating canagliflozin, consider factors in patient history that may predispose to DKA. DKA may be prolonged after discontinuation. Canagliflozin should not be used for treatment of patients with type 1 diabetes. Lower limb amputations: Before initiating canagliflozin, consider factors in patient history that may increase risk for amputation. Consider careful monitoring of patients with a higher risk for amputation, and counsel patients. Consider stopping canagliflozin in patients who develop events which may precede amputation. Necrotising fasciitis of the perineum: (Fournier’s gangrene): This rare but serious and potentially life-threatening event requires urgent surgical intervention and antibiotic treatment. Advise patients to seek medical attention if they experience a combination of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Urogenital infection or perineal abscess may precede necrotising fasciitis. If Fournier’s gangrene is suspected, discontinue canagliflozin and institute prompt treatment. Elevated haematocrit: Monitor haematocrit levels in patients with an already elevated haematocrit. Elderly: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function. Genital mycotic infections: Vulvovaginal candidiasis, and balanitis/balanoposthitis were reported in clinical studies. Urinary tract infections (UTIs): Complicated UTIs including pyelonephritis and urosepsis have been reported. Temporary interruption of canagliflozin should be considered. Cardiac failure: Experience in New York Heart Association (NYHA) class III is limited, with no experience in clinical studies with canagliflozin in NYHA class IV. Urine laboratory assessments: Patients taking canagliflozin will test positive for glucose in their urine. Lactose intolerance: Patients with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this product.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, lithium, 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).Pregnancy and lactation: Do not use canagliflozin during pregnancy or when breast-feeding. Discontinue canagliflozin when pregnancy is detected. Effect on fertility unknown. Effects on ability to drive and use machines: Canagliflozin has no or negligible influence on ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with insulin/insulin secretagogue, and to the elevated risk of adverse reactions related to volume depletion.Side-effects (SEs): Adverse reactions are based on the pooled analysis of placebo-controlled, clinical studies. Very Common (≥ 1/10): vulvovaginal candidiasis, hypoglycaemia in combination with insulin or sulphonylurea. Common (≥ 1/100, <1/10): balanitis or balanoposthitis, urinary tract infection (pyelonephritis and urosepsis have been reported post-marketing), constipation, thirst, nausea, polyuria or pollakiuria, dyslipidaemia, haematocrit increased. Uncommon (≥ 1/1,000 to < 1/100): dehydration, dizziness postural, syncope, hypotension, orthostatic hypotension, photosensitivity, rash, urticaria, bone fracture, renal failure (mainly in the context of volume depletion), blood creatinine increased, blood urea increased, blood potassium increased, blood phosphate increased, lower limb amputations (mainly of the toe and midfoot) especially in patients at high risk for heart disease. For less frequent side effects see SmPC.Pack size: 30 x 1 film-coated tablets. Legal category: POM.
Marketing Authorisation Holder: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium.
Marketing Authorisation Number: EU/1/13/884/001-004 (100mg) and EU/1/13/884/005-008 (300mg).
Marketed by: A. Menarini Pharmaceuticals Ireland Ltd. Further information is available on request from A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924 or may be found in the SmPC.Last updated: August 2025