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SGLT2 Inhibitor Pregnancy: Contraindicated — animal data shows renal toxicity in late pregnancy; avoid throughout pregnancy and breastfeeding

Empagliflozin (Heart Failure / CKD)

Brand names: Jardiance

Adult dose

Dose: 10 mg once daily
Route: Oral
Frequency: Once daily (morning, with or without food)
Max: 10 mg/day for HF/CKD indications
HFrEF (EMPEROR-Reduced), HFpEF (EMPEROR-Preserved), CKD (EMPA-KIDNEY) — regardless of diabetes status; also T2DM with cardiovascular risk (EMPA-REG OUTCOME); same 10 mg dose across all indications

Paediatric dose

Dose: Not established for HF/CKD in paediatrics N/A/kg
Route: N/A
Frequency: N/A
Max: N/A
Not licensed for HF/CKD in paediatrics

Dose adjustments

Renal

For HF/CKD: use down to eGFR ≥20 (EMPA-KIDNEY); for T2DM glucose lowering: eGFR ≥45 only (reduced glycaemic efficacy below 45)

Hepatic

No dose adjustment required

Paediatric weight-based calculator

Not licensed for HF/CKD in paediatrics

Clinical pearls

  • EMPEROR-Reduced (Packer et al. NEJM 2020): empagliflozin reduced composite of CV death + HF hospitalisation by 25% in HFrEF vs placebo regardless of diabetes status — established SGLT2 inhibitors as a fourth pillar of HFrEF therapy alongside ACEi/ARNi, beta-blocker, and MRA
  • EMPEROR-Preserved (Anker et al. NEJM 2021): empagliflozin reduced HF hospitalisation in HFpEF (EF >40%) — first therapy to show benefit in HFpEF; expanded use across entire HF spectrum; EMPA-KIDNEY (NEJM 2023) showed benefit down to eGFR ≥20
  • Cardio-renal mechanism: SGLT2 inhibitors reduce glomerular hyperfiltration, decrease tubulo-glomerular feedback activation, lower pre/afterload via osmotic diuresis, reduce myocardial oxidative stress, and shift myocardial substrate towards ketone bodies — multiple complementary mechanisms explain broad cardio-renal benefits
  • Euglycaemic DKA: empagliflozin must be held at least 3 days before elective surgery or prolonged fasting — DKA can occur with NORMAL blood glucose (euglycaemic DKA); patients may not present with classic hyperglycaemia; test ketones if unwell on SGLT2 inhibitor
  • Sick day rules: counsel patients to hold empagliflozin when unwell, fasting, or dehydrated (MHRA sick day rules for SGLT2 inhibitors) — reduces DKA and AKI risk; resume when eating and drinking normally

Contraindications

  • eGFR <20 for HF/CKD (limited data)
  • Diabetic ketoacidosis (euglycaemic DKA risk — hold perioperatively)
  • Type 1 diabetes
  • Known hypersensitivity

Side effects

  • Genital mycotic infections (candidiasis)
  • UTIs
  • Euglycaemic DKA (rare but serious — hold before surgery/fasting)
  • Volume depletion (postural hypotension)
  • Fournier's gangrene (MHRA rare warning)
  • Polyuria

Interactions

  • Insulin/sulfonylureas — additive hypoglycaemia risk (reduce insulin/SU dose when adding)
  • Diuretics — additive volume depletion
  • Lithium — SGLT2 inhibitors increase lithium excretion — monitor

Monitoring

  • eGFR and electrolytes (at initiation, 4 weeks, then 3-6 monthly)
  • Blood pressure
  • Signs of DKA (ketones if unwell — even if glucose normal)
  • Genital hygiene advice
  • Weight and volume status

Reference: BNFc; BNF 90; EMPEROR-Reduced (Packer et al. NEJM 2020); EMPEROR-Preserved (Anker et al. NEJM 2021); EMPA-KIDNEY (NEJM 2023); NICE TA679; MHRA SPC Jardiance. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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