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For Healthcare Professionals Only

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.

The INVOKANA SmPCs are available at:

Please click the following product name to access the full SmPC
INVOKANA 100 mg and 300 mg film-coated tablets

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. 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.
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: 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, haematocrit increased.
Uncommon: dehydration, postural dizziness, syncope, hypotension, orthostatic hypotension, rash, urticaria, bone fracture, renal failure (mainly in the context of volume depletion).
Other side effects: angioedema, diabetic ketoacidosis, anaphylactic reaction.

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:

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
Invokana 100 mg film-coated tablets 30 tablets EU/1/13/884/002 £39.20
Invokana 300 mg film-coated tablets 30 tablets EU/1/13/884/006 £39.20

MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Prescribing information last revised: June 2016.

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 Limited on 01494 567447 or at dsafety@its.jnj.com.