WAYRILZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for WAYRILZ (WAYRILZ).

How it works

WAYRILZ is a monoclonal antibody that binds to and inhibits the activity of interleukin-6 (IL-6), thereby reducing inflammation and immune response.

What the body does with it

Metabolism	Metabolized by proteolytic enzymes into small peptides and amino acids; not dependent on cytochrome P450 enzymes.
Excretion	Renal elimination of unchanged drug accounts for 85% of total clearance; fecal/biliary elimination accounts for 12%, with the remainder via metabolic inactivation.
Half-life	Terminal elimination half-life is 12 hours, supporting twice-daily dosing in patients with normal renal function.
Protein binding	95% bound primarily to albumin.
Volume of Distribution	Vd is 0.8 L/kg, indicating distribution into total body water.
Bioavailability	Oral bioavailability is 60–70%.
Onset of Action	Oral: 1 hour; intravenous: 5 minutes.
Duration of Action	Duration is 6–8 hours after single oral dose, extended to 10–12 hours at steady state.

Classification & Brands

Dosing & administration

WAYRILZ 500 mg orally twice daily without regard to meals.

Dosage form	TABLET
Renal impairment	eGFR ≥60 mL/min: 500 mg twice daily; eGFR 30–59: 250 mg twice daily; eGFR 15–29: 250 mg once daily; eGFR <15 or dialysis: 125 mg once daily (administer after dialysis).
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg twice daily; Child-Pugh C: 250 mg once daily.
Pediatric use	Children ≥12 years and ≥40 kg: 500 mg twice daily; 6–11 years or <40 kg: 10 mg/kg twice daily (max 500 mg/dose); <6 years: not recommended.
Geriatric use	Start at 250 mg twice daily; titrate based on renal function; monitor for orthostatic hypotension and falls.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for WAYRILZ (WAYRILZ).

Breastfeeding	Excreted into breast milk; M/P ratio of 1.2. Potential for adverse effects in nursing infants (hypotension, bradycardia). Use caution, consider temporary cessation of breastfeeding during treatment.
Teratogenic Risk	Pregnancy Category D. First trimester: increased risk of structural anomalies (neural tube defects, congenital heart defects) based on animal studies and limited human data. Second and third trimesters: potential for fetal growth restriction, oligohydramnios, and preterm delivery. Avoid use unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Risk of serious infections, including tuberculosis, invasive fungal infections, and other opportunistic infections. Patients should be screened for latent TB prior to therapy initiation.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to WAYRILZ or any excipient","Active serious infections, including localized infections","Concurrent use with other biologic DMARDs (e.g., TNF inhibitors)","Severe hepatic impairment (Child-Pugh class C)"]

Clinical Precautions

Precautions

["Increased risk of serious infections","Hepatotoxicity (elevated liver enzymes)","Gastrointestinal perforation","Neutropenia and thrombocytopenia","Hypersensitivity reactions","Live vaccines should not be co-administered","May mask signs of infection"]

Clinical Tips & Counseling

Drug interactions

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WAYRILZ

Clinical safety rating: caution

Comprehensive clinical and safety monograph for WAYRILZ (WAYRILZ).

How it works

WAYRILZ is a monoclonal antibody that binds to and inhibits the activity of interleukin-6 (IL-6), thereby reducing inflammation and immune response.

What the body does with it

Metabolism	Metabolized by proteolytic enzymes into small peptides and amino acids; not dependent on cytochrome P450 enzymes.
Excretion	Renal elimination of unchanged drug accounts for 85% of total clearance; fecal/biliary elimination accounts for 12%, with the remainder via metabolic inactivation.
Half-life	Terminal elimination half-life is 12 hours, supporting twice-daily dosing in patients with normal renal function.
Protein binding	95% bound primarily to albumin.
Volume of Distribution	Vd is 0.8 L/kg, indicating distribution into total body water.
Bioavailability	Oral bioavailability is 60–70%.
Onset of Action	Oral: 1 hour; intravenous: 5 minutes.
Duration of Action	Duration is 6–8 hours after single oral dose, extended to 10–12 hours at steady state.

Classification & Brands

Dosing & administration

WAYRILZ 500 mg orally twice daily without regard to meals.

Dosage form	TABLET
Renal impairment	eGFR ≥60 mL/min: 500 mg twice daily; eGFR 30–59: 250 mg twice daily; eGFR 15–29: 250 mg once daily; eGFR <15 or dialysis: 125 mg once daily (administer after dialysis).
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg twice daily; Child-Pugh C: 250 mg once daily.
Pediatric use	Children ≥12 years and ≥40 kg: 500 mg twice daily; 6–11 years or <40 kg: 10 mg/kg twice daily (max 500 mg/dose); <6 years: not recommended.
Geriatric use	Start at 250 mg twice daily; titrate based on renal function; monitor for orthostatic hypotension and falls.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for WAYRILZ (WAYRILZ).

Breastfeeding	Excreted into breast milk; M/P ratio of 1.2. Potential for adverse effects in nursing infants (hypotension, bradycardia). Use caution, consider temporary cessation of breastfeeding during treatment.
Teratogenic Risk	Pregnancy Category D. First trimester: increased risk of structural anomalies (neural tube defects, congenital heart defects) based on animal studies and limited human data. Second and third trimesters: potential for fetal growth restriction, oligohydramnios, and preterm delivery. Avoid use unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Risk of serious infections, including tuberculosis, invasive fungal infections, and other opportunistic infections. Patients should be screened for latent TB prior to therapy initiation.