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CKD Nephroprotection Pregnancy: There are no data from the use of canagliflozin in pregnant women and animal studies have shown reproductive toxicity — canagliflozin SHOULD NOT be used during pregnancy, and when pregnancy is detected treatment should be discontinued. Breast-feeding: it is unknown whether canagliflozin and/or its metabolites are excreted in human milk; animal data show excretion in milk and pharmacologically mediated effects in breast-feeding offspring, a risk to newborns/infants cannot be excluded, and canagliflozin should NOT be used during breast-feeding. Fertility: not studied in humans; no effects on fertility in animal studies.

Canagliflozin (CKD)

Brand names: Invokana

Canagliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor used here for its renoprotective role in diabetic chronic kidney disease, in addition to glucose lowering.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Diabetic kidney disease, as add-on to standard of care (e.g. ACE inhibitors or ARBs): canagliflozin 100 mg once daily
Route: Oral
Frequency: Once daily, preferably before the first meal of the day
Max: For the renal (diabetic kidney disease) indication the dose is 100 mg once daily. The highest dose in §4.2 is 300 mg once daily, which applies only to glycaemic control in patients tolerating 100 mg once daily who have an eGFR at least 60 mL/min/1.73 m2 or CrCl at least 60 mL/min
Source: UK SPC (eMC) for Invokana 100 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/8855/smpc). GLYCAEMIC-CONTROL REGIMEN in the same §4.2: recommended starting dose 100 mg once daily; in patients tolerating 100 mg once daily who have an eGFR at least 60 mL/min/1.73 m2 or CrCl at least 60 mL/min and need tighter glycaemic control the dose can be increased to 300 mg once daily. Because the glycaemic-lowering efficacy of canagliflozin is reduced in moderate renal impairment and likely absent in severe renal impairment, if further glycaemic control is needed the addition of other anti-hyperglycaemic agents should be considered. CARE should be taken when increasing the dose in patients aged 75 years and over, patients with known cardiovascular disease, or other patients for whom the initial canagliflozin-induced diuresis poses a risk. In patients with evidence of VOLUME DEPLETION, correcting this condition prior to initiation is recommended. When used as add-on therapy with insulin or an insulin secretagogue (e.g. a sulphonylurea), a lower dose of insulin or the secretagogue may be considered to reduce the risk of hypoglycaemia. ELDERLY: renal function and risk of volume depletion should be taken into account. HEPATIC: no dose adjustment for mild or moderate impairment; not studied in and not recommended for severe hepatic impairment. MONITORING (§4.4): renal function prior to initiation and at least annually thereafter, and prior to initiation of concomitant medicines that may reduce renal function and periodically thereafter; regardless of pretreatment eGFR, patients experience an initial fall in eGFR that thereafter attenuates over time. §4.4 also states canagliflozin should NOT be used in patients with type 1 diabetes mellitus. PAEDIATRIC (no per-kg dose is stated, so paedDose is null): no dose adjustment is required for the treatment of type 2 diabetes mellitus in children aged 10 years and older (i.e. the adult mg doses and the eGFR table apply); in children weighing less than 50 kg caution is advised when up-titrating to the 300 mg dose since safety data are limited; safety and effectiveness have not been established in children below 10 years of age. The US label adds that safety and effectiveness have NOT been established in paediatric patients for the renal/cardiovascular outcome indications. Verify any paediatric use against a children's formulary. METHOD: oral use, once a day, preferably before the first meal of the day; tablets should be swallowed whole. If a dose is missed it should be taken as soon as the patient remembers, but a double dose should not be taken on the same day. NOTE ON SOURCES: eMC §4.5 (interactions) was NOT captured in this bundle — the interaction entries below come from §7 of the US label (INVOKANA, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aad6a5e4-0449-44dd-8bb7-e9b17a1fbbc3, label date 2026-02-17) and are US labelling. §4.4 and §4.8 were truncated at the fetch limit.

Dose adjustments

Renal

§4.2 Table 1 (dose adjustment recommendations in adults and children aged 10 years and older), by eGFR (mL/min/1.73 m2) or CrCl (mL/min): eGFR at least 60 — initiate with 100 mg, and in patients tolerating 100 mg and requiring additional glycaemic control the dose can be increased to 300 mg. eGFR 30 to less than 60 — use 100 mg (if further glycaemic control is needed, consider adding other anti-hyperglycaemic agents). eGFR below 30, with urinary albumin/creatinine ratio above 300 mg/g — continue 100 mg for patients already taking Invokana, continuing until dialysis or renal transplantation; Invokana should NOT be initiated. §4.4 adds that in adults with eGFR below 60 mL/min/1.73 m2 or CrCl below 60 mL/min a higher incidence of volume-depletion adverse reactions was reported, particularly with the 300 mg dose, along with more events of elevated potassium and greater increases in serum creatinine and blood urea nitrogen — the dose should therefore be limited to 100 mg once daily in these patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Very common: vulvovaginal candidiasis
  • Common: balanitis or balanoposthitis; urinary tract infection (pyelonephritis and urosepsis have been reported post-marketing)
  • Rare: anaphylactic reaction
  • Not known: necrotising fasciitis of the perineum (Fournier's gangrene)
  • The §4.8 summary names the most commonly reported adverse reactions during treatment as hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria (urinary frequency); adverse reactions leading to discontinuation in at least 0.5% of canagliflozin-treated adults were vulvovaginal candidiasis (0.7% of female patients) and balanitis or balanoposthitis (0.5% of male patients). The §4.8 table was truncated at the fetch limit part-way through the 'metabolism and nutrition disorders' row, so this list is not complete

Interactions

  • US label §7: UGT enzyme inducers (e.g. rifampin, phenytoin, phenobarbital, ritonavir) decrease canagliflozin exposure and may reduce effectiveness — for patients with eGFR at least 60 mL/min/1.73 m2 increase the dosage to 200 mg daily in patients currently tolerating 100 mg daily (and up to 300 mg daily in patients tolerating 200 mg daily who require additional glycaemic control); for eGFR below 60 mL/min/1.73 m2 increase to a maximum of 200 mg daily in patients currently tolerating 100 mg daily, and consider adding another antihyperglycaemic agent if further glycaemic control is required. (This dose-escalation instruction is US labelling and is not stated in the UK §4.2 text retrieved.)
  • US label §7 and UK §4.2: insulin or insulin secretagogues (e.g. sulphonylurea) — increased risk of hypoglycaemia; concomitant use may require a lower dose of the insulin or secretagogue
  • US label §7: digoxin — canagliflozin increases digoxin exposure (the intervention text for this entry was truncated at the source-fetch limit; check the full label)
  • eMC §4.5 was not captured in the source bundle and must be checked on the SPC

Clinical monograph

How it works

It blocks SGLT2 in the proximal renal tubule, increasing urinary glucose and sodium excretion; the resulting tubuloglomerular feedback reduces intraglomerular pressure and slows nephropathy progression.

Prescribing in practice

  • Counsel on diabetic ketoacidosis, which can occur with near-normal blood glucose; withhold during acute illness, dehydration or before surgery (sick-day rules), and stop if ketoacidosis is suspected.
  • Canagliflozin specifically has been associated with an increased risk of lower-limb amputation and of fracture; assess foot health and review in patients at risk.
  • Volume depletion and genital mycotic and urinary infections are common; glucose-lowering efficacy falls at low eGFR though renal benefit persists down to defined thresholds in the SPC.

Monitoring

Monitor renal function, volume status and ketone awareness, and review foot health and fracture risk during treatment.

Counselling the patient

  • Stop the tablet and seek urgent advice if you feel very unwell with nausea, vomiting, deep breathing or abdominal pain.
  • Maintain good foot care and report any new foot ulcers, sores or infection.
  • Drink adequate fluids and watch for genital itching or thrush, which is treatable.

Evidence & guidelines

The CREDENCE trial showed canagliflozin reduced progression of kidney disease and cardiovascular events in patients with type 2 diabetes and diabetic nephropathy.

Reference: CREDENCE Trial (Perkovic et al. NEJM 2019); CANVAS Trial (Neal et al. NEJM 2017); MHRA DSU 2016 (Amputation); NICE TA775; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.