PHYRAGO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PHYRAGO (PHYRAGO).

How it works

PHYRAGO is a monoclonal antibody that targets and neutralizes the activity of a specific inflammatory cytokine, thereby inhibiting downstream signaling pathways involved in immune-mediated inflammation.

What the body does with it

Metabolism	Metabolized via proteolysis; primarily eliminated through the reticuloendothelial system and endothelial cells.
Excretion	Primarily hepatic metabolism; renal excretion of unchanged drug accounts for <5% of dose; fecal elimination of metabolites accounts for ~90%.
Half-life	Terminal elimination half-life is 6–8 hours in adults; may be prolonged in hepatic impairment (up to 15 hours).
Protein binding	99% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15–0.3 L/kg (low, indicating minimal tissue distribution).
Bioavailability	Oral: 40–60% (first-pass effect); Intravenous: 100%.
Onset of Action	Oral: 30–60 minutes; Intravenous: immediate (within 5 minutes).
Duration of Action	Oral: 8–12 hours; Intravenous: 4–6 hours (dose-dependent).

Classification & Brands

Dosing & administration

200 mg orally twice daily with food.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: no adjustment. GFR 15-29 mL/min: reduce to 200 mg once daily. GFR <15 mL/min or dialysis: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce to 200 mg once daily. Child-Pugh C: contraindicated.
Pediatric use	Weight <30 kg: 5 mg/kg orally twice daily (max 200 mg/dose). Weight ≥30 kg: 200 mg orally twice daily.
Geriatric use	No dose adjustment required; monitor renal function and adjust per renal criteria.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PHYRAGO (PHYRAGO).

Breastfeeding	No data on M/P ratio. Due to potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for 2 weeks after last dose.
Teratogenic Risk	PHYRAGO is contraindicated in pregnancy. First trimester exposure carries high risk of major congenital malformations (cardiac, CNS). Second and third trimester exposure associated with fetal growth restriction, oligohydramnios, and neonatal renal impairment.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of serious infections, including tuberculosis, invasive fungal infections, and other opportunistic infections, which may lead to hospitalization or death.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to any component of PHYRAGO.","Active, serious infections including sepsis and opportunistic infections.","Moderate to severe heart failure (NYHA class III/IV) due to increased risk of adverse outcomes."]

Clinical Precautions

Precautions

["Risk of serious infections; screen for latent tuberculosis prior to initiation.","Hypersensitivity reactions including anaphylaxis.","Hepatotoxicity; monitor liver enzymes regularly.","Demyelinating disorders; discontinue if new onset or exacerbation.","Live vaccines should not be administered during therapy."]

Clinical Tips & Counseling

Drug interactions

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PHYRAGO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for PHYRAGO (PHYRAGO).

How it works

What the body does with it

Metabolism	Metabolized via proteolysis; primarily eliminated through the reticuloendothelial system and endothelial cells.
Excretion	Primarily hepatic metabolism; renal excretion of unchanged drug accounts for <5% of dose; fecal elimination of metabolites accounts for ~90%.
Half-life	Terminal elimination half-life is 6–8 hours in adults; may be prolonged in hepatic impairment (up to 15 hours).
Protein binding	99% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.15–0.3 L/kg (low, indicating minimal tissue distribution).
Bioavailability	Oral: 40–60% (first-pass effect); Intravenous: 100%.
Onset of Action	Oral: 30–60 minutes; Intravenous: immediate (within 5 minutes).
Duration of Action	Oral: 8–12 hours; Intravenous: 4–6 hours (dose-dependent).

Classification & Brands

Dosing & administration

200 mg orally twice daily with food.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: no adjustment. GFR 15-29 mL/min: reduce to 200 mg once daily. GFR <15 mL/min or dialysis: not recommended.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce to 200 mg once daily. Child-Pugh C: contraindicated.
Pediatric use	Weight <30 kg: 5 mg/kg orally twice daily (max 200 mg/dose). Weight ≥30 kg: 200 mg orally twice daily.
Geriatric use	No dose adjustment required; monitor renal function and adjust per renal criteria.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for PHYRAGO (PHYRAGO).

Breastfeeding	No data on M/P ratio. Due to potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for 2 weeks after last dose.
Teratogenic Risk	PHYRAGO is contraindicated in pregnancy. First trimester exposure carries high risk of major congenital malformations (cardiac, CNS). Second and third trimester exposure associated with fetal growth restriction, oligohydramnios, and neonatal renal impairment.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of serious infections, including tuberculosis, invasive fungal infections, and other opportunistic infections, which may lead to hospitalization or death.