FORZINITY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FORZINITY (FORZINITY).

How it works

FORZINITY (sodium-glucose cotransporter-2 inhibitor) inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A9 and UGT2B7; minor metabolism via CYP3A4.
Excretion	Primarily renal excretion (60-70% as unchanged drug) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-18 hours; clinically significant for once-daily dosing in most patients.
Protein binding	85-90% bound to albumin.
Volume of Distribution	0.5-0.8 L/kg; indicates distribution into total body water, not extensive tissue binding.
Bioavailability	Oral: 60-70% (first-pass metabolism).
Onset of Action	Oral: 2-4 hours; intravenous: 15-30 minutes.
Duration of Action	24-36 hours; allows once-daily dosing; extended duration supports consistent therapeutic effect.

Classification & Brands

Dosing & administration

1.5 mg/kg intravenously every 4 weeks. For patients with body weight >100 kg, a fixed dose of 150 mg is recommended.

Dosage form	SOLUTION
Renal impairment	No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). For severe renal impairment (eGFR <30 mL/min/1.73 m²) or on dialysis, administer 1.5 mg/kg intravenously every 6 weeks.
Liver impairment	No dose adjustment required for mild hepatic impairment (Child-Pugh A). For moderate to severe hepatic impairment (Child-Pugh B or C), reduce dose to 1 mg/kg intravenously every 4 weeks.
Pediatric use	For children aged 2-12 years: 2 mg/kg intravenously every 4 weeks, maximum dose 100 mg. For adolescents >12 years: same as adult dosing.
Geriatric use	No specific dose adjustment required based on age alone. Monitor renal function and consider age-related decline in creatinine clearance.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FORZINITY (FORZINITY).

Breastfeeding	FORZINITY is contraindicated during breastfeeding due to potential for serious adverse reactions in nursing infants. The M/P ratio is unknown; however, the drug is lipophilic and likely excreted in human milk. Discontinue drug or breastfeeding.
Teratogenic Risk	FORZINITY is contraindicated in pregnancy. Based on animal studies and mechanism of action, there is a high risk of teratogenicity. First trimester exposure may cause major congenital malformations. Second and third trimester exposure may cause fetal renal impairment and oligohydramnios. Effective contraception must be used during treatment and for 1 month after cessation.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to FORZINITY or any excipient","Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or dialysis"]

Clinical Precautions

Precautions

["Ketoacidosis: May occur with euglycemia; assess for acidosis if symptoms present.","Lower limb amputation: Increased risk, especially in patients with prior amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers.","Hypotension: Risk is increased in patients with impaired renal function, elderly, or on diuretics.","Acute kidney injury: Not recommended in patients with eGFR <30 mL/min/1.73 m2.","Urosepsis and pyelonephritis: Urinary tract infections may become serious.","Hypoglycemia: Concomitant use with insulin or insulin secretagogues may increase risk.","Genital mycotic infections: Increased risk, especially in patients with history of infections."]

Clinical Tips & Counseling

Drug interactions

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FORZINITY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for FORZINITY (FORZINITY).

How it works

FORZINITY (sodium-glucose cotransporter-2 inhibitor) inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion.

What the body does with it

Metabolism	Primarily metabolized via glucuronidation by UGT1A9 and UGT2B7; minor metabolism via CYP3A4.
Excretion	Primarily renal excretion (60-70% as unchanged drug) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-18 hours; clinically significant for once-daily dosing in most patients.
Protein binding	85-90% bound to albumin.
Volume of Distribution	0.5-0.8 L/kg; indicates distribution into total body water, not extensive tissue binding.
Bioavailability	Oral: 60-70% (first-pass metabolism).
Onset of Action	Oral: 2-4 hours; intravenous: 15-30 minutes.
Duration of Action	24-36 hours; allows once-daily dosing; extended duration supports consistent therapeutic effect.

Classification & Brands

Dosing & administration

1.5 mg/kg intravenously every 4 weeks. For patients with body weight >100 kg, a fixed dose of 150 mg is recommended.

Dosage form	SOLUTION
Renal impairment	No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). For severe renal impairment (eGFR <30 mL/min/1.73 m²) or on dialysis, administer 1.5 mg/kg intravenously every 6 weeks.
Liver impairment	No dose adjustment required for mild hepatic impairment (Child-Pugh A). For moderate to severe hepatic impairment (Child-Pugh B or C), reduce dose to 1 mg/kg intravenously every 4 weeks.
Pediatric use	For children aged 2-12 years: 2 mg/kg intravenously every 4 weeks, maximum dose 100 mg. For adolescents >12 years: same as adult dosing.
Geriatric use	No specific dose adjustment required based on age alone. Monitor renal function and consider age-related decline in creatinine clearance.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for FORZINITY (FORZINITY).

Breastfeeding	FORZINITY is contraindicated during breastfeeding due to potential for serious adverse reactions in nursing infants. The M/P ratio is unknown; however, the drug is lipophilic and likely excreted in human milk. Discontinue drug or breastfeeding.
Teratogenic Risk	FORZINITY is contraindicated in pregnancy. Based on animal studies and mechanism of action, there is a high risk of teratogenicity. First trimester exposure may cause major congenital malformations. Second and third trimester exposure may cause fetal renal impairment and oligohydramnios. Effective contraception must be used during treatment and for 1 month after cessation.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to FORZINITY or any excipient","Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or dialysis"]