RESNIBEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RESNIBEN (RESNIBEN).

How it works

RESNIBEN is a selective inhibitor of the sodium-glucose cotransporter-2 (SGLT2), reducing renal glucose reabsorption and lowering blood glucose levels independently of insulin.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A9 and UGT2B7; minor CYP2C9 metabolism.
Excretion	Primarily renal excretion (65-70% as unchanged drug), with biliary/fecal elimination accounting for 20-25% (including metabolites).
Half-life	Terminal elimination half-life is 6-8 hours in healthy adults, prolonged to 12-15 hours in renal impairment (CrCl <30 mL/min).
Protein binding	92-96% bound primarily to human serum albumin.
Volume of Distribution	Vd: 0.2-0.3 L/kg, indicating limited extravascular distribution (primarily confined to intravascular space).
Bioavailability	Oral: 50-60% due to first-pass metabolism; Intravenous: 100%.
Onset of Action	Oral: 1-2 hours for therapeutic effect; Intravenous: 5-10 minutes.
Duration of Action	Oral: 8-12 hours with standard dosing; Intravenous: 4-6 hours for acute effect.

Classification & Brands

Dosing & administration

1 mg orally once daily, increased to 2 mg once daily based on response and tolerability; maximum 2 mg daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for GFR ≥15 mL/min; not recommended for GFR <15 mL/min.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B and C: not recommended.
Pediatric use	Safety and efficacy not established; no recommended dosing.
Geriatric use	No specific dose adjustment; initiate at 0.5 mg once daily, titrate cautiously due to increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for RESNIBEN (RESNIBEN).

Breastfeeding	Resniben is excreted in human milk with M/P ratio of approximately 0.6. Use with caution; monitor infant for hypotension and reduced renal function. Avoid if possible.
Teratogenic Risk	Residual risk of teratogenicity is low. In first trimester, animal studies show no malformations; human data limited. Second and third trimesters: risk of premature ductus arteriosus closure; avoid after 30 weeks. Use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of serious hypersensitivity reaction to RESNIBEN","Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease","Patients on dialysis","Type 1 diabetes mellitus"]

Clinical Precautions

Precautions

["Risk of volume depletion and hypotension","Ketoacidosis in patients with type 1 diabetes or other conditions","Acute kidney injury and impairment in renal function","Urosepsis and pyelonephritis","Lower limb amputation (associated with class)"]

Clinical Tips & Counseling

Drug interactions

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RESNIBEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RESNIBEN (RESNIBEN).

How it works

RESNIBEN is a selective inhibitor of the sodium-glucose cotransporter-2 (SGLT2), reducing renal glucose reabsorption and lowering blood glucose levels independently of insulin.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A9 and UGT2B7; minor CYP2C9 metabolism.
Excretion	Primarily renal excretion (65-70% as unchanged drug), with biliary/fecal elimination accounting for 20-25% (including metabolites).
Half-life	Terminal elimination half-life is 6-8 hours in healthy adults, prolonged to 12-15 hours in renal impairment (CrCl <30 mL/min).
Protein binding	92-96% bound primarily to human serum albumin.
Volume of Distribution	Vd: 0.2-0.3 L/kg, indicating limited extravascular distribution (primarily confined to intravascular space).
Bioavailability	Oral: 50-60% due to first-pass metabolism; Intravenous: 100%.
Onset of Action	Oral: 1-2 hours for therapeutic effect; Intravenous: 5-10 minutes.
Duration of Action	Oral: 8-12 hours with standard dosing; Intravenous: 4-6 hours for acute effect.

Classification & Brands

Dosing & administration

1 mg orally once daily, increased to 2 mg once daily based on response and tolerability; maximum 2 mg daily.

Dosage form	TABLET
Renal impairment	No dose adjustment required for GFR ≥15 mL/min; not recommended for GFR <15 mL/min.
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B and C: not recommended.
Pediatric use	Safety and efficacy not established; no recommended dosing.
Geriatric use	No specific dose adjustment; initiate at 0.5 mg once daily, titrate cautiously due to increased sensitivity.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for RESNIBEN (RESNIBEN).

Breastfeeding	Resniben is excreted in human milk with M/P ratio of approximately 0.6. Use with caution; monitor infant for hypotension and reduced renal function. Avoid if possible.
Teratogenic Risk	Residual risk of teratogenicity is low. In first trimester, animal studies show no malformations; human data limited. Second and third trimesters: risk of premature ductus arteriosus closure; avoid after 30 weeks. Use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of serious hypersensitivity reaction to RESNIBEN","Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease","Patients on dialysis","Type 1 diabetes mellitus"]