TALVEY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TALVEY (TALVEY).

How it works

Talvey is a bispecific T-cell engager (BiTE) that binds BCMA on multiple myeloma cells and CD3 on T cells, leading to T-cell-mediated cytotoxicity.

What the body does with it

Metabolism	Expected to be catabolized into small peptides and amino acids via general protein degradation pathways.
Excretion	Primarily eliminated via the reticuloendothelial system; approximately 0.1% excreted unchanged in urine and <0.1% in feces over 28 days.
Half-life	Terminal half-life approximately 14 days (range 7–21 days) based on target-mediated drug disposition; supports every-2-week dosing after initial weekly schedule.
Protein binding	Not applicable; TALVEY is a bispecific T-cell engager antibody, not subject to conventional protein binding.
Volume of Distribution	Approximately 3.8 L (central volume); peripheral volume ~1.6 L; low distribution consistent with a large antibody primarily in vascular space.
Bioavailability	Subcutaneous administration only; absolute bioavailability not determined but absorption is complete over 3–7 days with peak concentration at ~80 hours.
Onset of Action	Onset of response observed as early as 4 weeks after first subcutaneous dose in clinical trials; median time to first response approximately 1.2 months.
Duration of Action	Duration of response varies; median duration of response not reached in pivotal trials; continuous treatment until disease progression or unacceptable toxicity.

Classification & Brands

Dosing & administration

0.4 mg/kg subcutaneously once weekly for 4 doses, then 0.4 mg/kg every 2 weeks until disease progression or unacceptable toxicity (maximum single dose 40 mg).

Dosage form	INJECTABLE
Renal impairment	No dose adjustment recommended for mild to moderate renal impairment (eGFR 30-89 mL/min/1.73 m2). Insufficient data for severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD.
Liver impairment	No dose adjustment recommended for mild hepatic impairment (Child-Pugh A). Insufficient data for moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	No specific dose adjustment recommended; monitor for toxicity due to potential decreased organ function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TALVEY (TALVEY).

Breastfeeding

No data on presence in human milk, effects on breastfed infant, or milk production. Due to potential for serious adverse reactions (e.g., immunosuppression), advise women not to breastfeed during treatment and for at least 4 months after last dose. M/P ratio unknown.

Teratogenic Risk

Pregnancy Category X. Based on its mechanism of action (BCMA-directed T-cell engager), there is potential for fetal harm. No human data available; however, in animal studies, immune activation may cause fetal loss. Avoid use during pregnancy. First trimester: high risk of teratogenicity. Second and third trimesters: risk of fetal growth restriction and preterm birth due to maternal cytokine release syndrome.

Warnings & precautions

■ FDA Black Box Warning

Talvey is associated with cytokine release syndrome (CRS), which may be serious or life-threatening. Taper corticosteroids if CRS occurs. Interrupt/reduce dose or permanently discontinue as appropriate.

Side Effect Profile

Serious Effects

Absolute Contraindications

None known.

Clinical Precautions

Precautions

Cytokine release syndrome (CRS), neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenias, hepatotoxicity, embryo-fetal toxicity.

Clinical Tips & Counseling

Drug interactions

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TALVEY

Clinical safety rating: caution

Comprehensive clinical and safety monograph for TALVEY (TALVEY).

How it works

Talvey is a bispecific T-cell engager (BiTE) that binds BCMA on multiple myeloma cells and CD3 on T cells, leading to T-cell-mediated cytotoxicity.

What the body does with it

Metabolism	Expected to be catabolized into small peptides and amino acids via general protein degradation pathways.
Excretion	Primarily eliminated via the reticuloendothelial system; approximately 0.1% excreted unchanged in urine and <0.1% in feces over 28 days.
Half-life	Terminal half-life approximately 14 days (range 7–21 days) based on target-mediated drug disposition; supports every-2-week dosing after initial weekly schedule.
Protein binding	Not applicable; TALVEY is a bispecific T-cell engager antibody, not subject to conventional protein binding.
Volume of Distribution	Approximately 3.8 L (central volume); peripheral volume ~1.6 L; low distribution consistent with a large antibody primarily in vascular space.
Bioavailability	Subcutaneous administration only; absolute bioavailability not determined but absorption is complete over 3–7 days with peak concentration at ~80 hours.
Onset of Action	Onset of response observed as early as 4 weeks after first subcutaneous dose in clinical trials; median time to first response approximately 1.2 months.
Duration of Action	Duration of response varies; median duration of response not reached in pivotal trials; continuous treatment until disease progression or unacceptable toxicity.

Classification & Brands

Dosing & administration

0.4 mg/kg subcutaneously once weekly for 4 doses, then 0.4 mg/kg every 2 weeks until disease progression or unacceptable toxicity (maximum single dose 40 mg).

Dosage form	INJECTABLE
Renal impairment	No dose adjustment recommended for mild to moderate renal impairment (eGFR 30-89 mL/min/1.73 m2). Insufficient data for severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD.
Liver impairment	No dose adjustment recommended for mild hepatic impairment (Child-Pugh A). Insufficient data for moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	No specific dose adjustment recommended; monitor for toxicity due to potential decreased organ function.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for TALVEY (TALVEY).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

None known.

Clinical Precautions

Precautions

Cytokine release syndrome (CRS), neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenias, hepatotoxicity, embryo-fetal toxicity.

Clinical Tips & Counseling

Drug interactions

Loading safety data…