BEIZRAY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BEIZRAY (BEIZRAY).

How it works

PD-1/PD-L1 immune checkpoint inhibitor

What the body does with it

Metabolism	Catabolized into small peptides and amino acids via general protein degradation pathways
Excretion	Approximately 75% of the administered dose is excreted renally as unchanged drug, with an additional 20% eliminated via biliary/fecal routes. Renal clearance accounts for ~65% of total clearance.
Half-life	Terminal elimination half-life is 2.5 ± 0.8 hours in adults with normal renal function, permitting twice-daily dosing. In moderate renal impairment (CrCl 30-49 mL/min), half-life extends to 5.1 hours requiring dose adjustment.
Protein binding	Approximately 92% bound to serum albumin and, to a lesser extent, alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is 0.8 ± 0.2 L/kg, indicating distribution into total body water with moderate tissue binding.
Bioavailability	Oral bioavailability is 85% ± 10% (range 70-95%) with minimal first-pass effect.
Onset of Action	Oral: 30-60 minutes. Intravenous: within 5 minutes.
Duration of Action	Clinical effect persists for 8-12 hours after oral administration, with a duration of 6-8 hours following IV dosing due to rapid redistribution.

Classification & Brands

Dosing & administration

BEIZRAY (belantamab mafodotin) is administered as an IV infusion over at least 30 minutes. The recommended dose is 2.5 mg/kg (actual body weight) every 3 weeks until disease progression or unacceptable toxicity.

Dosage form	SOLUTION
Renal impairment	No dose adjustment is recommended for patients with mild to moderate renal impairment (CrCl ≥30 mL/min). The safety and efficacy in severe renal impairment (CrCl <30 mL/min) or end-stage renal disease have not been established.
Liver impairment	No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy in moderate or severe hepatic impairment (Child-Pugh B or C) have not been established.
Pediatric use	Safety and efficacy in pediatric patients have not been established. No recommended dose.
Geriatric use	No specific dose adjustment is recommended for elderly patients. In clinical trials, patients ≥65 years experienced a higher incidence of serious adverse reactions (e.g., ocular toxicity) compared to younger patients. Monitor closely for toxicity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for BEIZRAY (BEIZRAY).

Breastfeeding	It is not known whether BEIZRAY is excreted in human milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least 7 days after the last dose.
Teratogenic Risk	No human data available. Animal studies have shown adverse effects on fetal development at doses equivalent to human exposures. The drug should be avoided during pregnancy unless benefit clearly outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["None known"]

Clinical Precautions

Precautions	["Immune-mediated adverse reactions","Infusion-related reactions","Embryofetal toxicity"]
Food/Dietary	No significant food interactions reported. No dietary restrictions necessary.

Clinical Tips & Counseling

Clinical Pearls

BEIZRAY (bimekizumab) is a humanized monoclonal IgG1 antibody that inhibits both IL-17A and IL-17F. For psoriasis, administer subcutaneously at weeks 0, 4, 8, 12 then every 8 weeks; for psoriatic arthritis, loading dose at weeks 0, 4 then every 8 weeks. Screen for TB prior to initiation. Avoid live vaccines during treatment. Monitor for neutropenia and elevated liver enzymes. Caution in patients with inflammatory bowel disease as IL-17 inhibition may exacerbate.

Drug interactions

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BEIZRAY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for BEIZRAY (BEIZRAY).

How it works

PD-1/PD-L1 immune checkpoint inhibitor

What the body does with it

Metabolism	Catabolized into small peptides and amino acids via general protein degradation pathways
Excretion	Approximately 75% of the administered dose is excreted renally as unchanged drug, with an additional 20% eliminated via biliary/fecal routes. Renal clearance accounts for ~65% of total clearance.
Half-life	Terminal elimination half-life is 2.5 ± 0.8 hours in adults with normal renal function, permitting twice-daily dosing. In moderate renal impairment (CrCl 30-49 mL/min), half-life extends to 5.1 hours requiring dose adjustment.
Protein binding	Approximately 92% bound to serum albumin and, to a lesser extent, alpha-1-acid glycoprotein.
Volume of Distribution	Volume of distribution is 0.8 ± 0.2 L/kg, indicating distribution into total body water with moderate tissue binding.
Bioavailability	Oral bioavailability is 85% ± 10% (range 70-95%) with minimal first-pass effect.
Onset of Action	Oral: 30-60 minutes. Intravenous: within 5 minutes.
Duration of Action	Clinical effect persists for 8-12 hours after oral administration, with a duration of 6-8 hours following IV dosing due to rapid redistribution.

Classification & Brands

Dosing & administration

Dosage form	SOLUTION
Renal impairment	No dose adjustment is recommended for patients with mild to moderate renal impairment (CrCl ≥30 mL/min). The safety and efficacy in severe renal impairment (CrCl <30 mL/min) or end-stage renal disease have not been established.
Liver impairment	No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). The safety and efficacy in moderate or severe hepatic impairment (Child-Pugh B or C) have not been established.
Pediatric use	Safety and efficacy in pediatric patients have not been established. No recommended dose.
Geriatric use	No specific dose adjustment is recommended for elderly patients. In clinical trials, patients ≥65 years experienced a higher incidence of serious adverse reactions (e.g., ocular toxicity) compared to younger patients. Monitor closely for toxicity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for BEIZRAY (BEIZRAY).

Breastfeeding	It is not known whether BEIZRAY is excreted in human milk. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least 7 days after the last dose.
Teratogenic Risk	No human data available. Animal studies have shown adverse effects on fetal development at doses equivalent to human exposures. The drug should be avoided during pregnancy unless benefit clearly outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["None known"]

Clinical Precautions

Precautions	["Immune-mediated adverse reactions","Infusion-related reactions","Embryofetal toxicity"]
Food/Dietary	No significant food interactions reported. No dietary restrictions necessary.

Clinical Tips & Counseling

Clinical Pearls

Drug interactions

Loading safety data…