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Talvey (talquetamab-tgvs)
talquetamab
Black Box Warnings .
Appropriate Use
restricted distribution program (TECVAYLI and TALVEY REMS) due to cytokine release syndrome (CRS) and neurological toxicity risk; administer only at certified healthcare facility with trained healthcare providers to manage CRS and neurological toxicities; 1-855-810-8064 or www.TEC-TALREMS.com for more information
Cytokine Release Syndrome
including fatal or life-threatening reaction occurred in 76% of patients; initiate tx according to step-up dosing schedule to decr. CRS risk; monitor patients x48h in hospital after each dose of step-up dosing schedule; manifestations may include fever, hypotension, chills, hypoxia, headache, tachycardia; provide supportive care as needed; withhold tx until signs/symptoms resolve or permanently D/C, based on severity
Neurological Toxicities
serious, life-threatening, or fatal reaction, including immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 55% of patients; may occur concurrently with CRS, after CRS resolution, or in the absence of CRS; monitor patients x48h in hospital after each dose of step-up dosing schedule; provide supportive care as needed; withhold tx until signs/symptoms resolve or permanently D/C, based on severity
Adult Dosing .
Dosage forms: INJ
Restricted Distribution in US
- [1-855-810-8064 or www.TEC-TALREMS.com for more information]
Special Note
- [drug name clarification]
- Info: nonproprietary name = talquetamab-tgvs
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, prophylactic antimicrobials, and dosing including toxicity-related dose adjustments
multiple myeloma, relapsed or refractory
- [0.01 mg/kg/dose SC x1 on day 1, then 0.06 mg/kg/dose SC x1 on day 4, then 0.4 mg/kg/dose SC x1 on day 7 as part of step-up dosing schedule, then 0.4 mg/kg/dose SC qwk starting day 14]
- Alt: 0.01 mg/kg/dose SC x1 on day 1, then 0.06 mg/kg/dose SC x1 on day 4, then 0.4 mg/kg/dose SC x1 on day 7, then 0.8 mg/kg/dose SC x1 on day 10 as part of step-up dosing schedule, then 0.8 mg/kg/dose SC q2wk starting day 24; Info: for patients refractory to at least 4 prior tx, including an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-3x ULN or AST >ULN: no adjustment; bilirubin >3x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active (step-up dosing schedule use)
- avoid: breastfeeding during tx and x3mo after D/C
- caution: patients of childbearing potential
Drug Interactions .
Overview
talquetamab
bispecific T cell engager
- immunomodulatory effects
- myelosuppressive oncologic agent
- peripheral neuropathy
- caution advised with narrow therapeutic index drugs metabolized by CYP450 liver enzymes, especially at initiation and up to 14 days after 1st tx dose or during/after CRS; talquetamab may transiently increase cytokine release leading to suppression of CYP450 metabolic function, causing incr. levels of concomitant drugs, risk of adverse effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- hypoxia
- hypotension
- tachycardia
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- stomatitis
- infection, serious
- sepsis
- neutropenia
- thrombocytopenia
- skin reaction, severe
- hepatotoxicity
Common Reactions
- fever
- cytokine release syndrome
- dysgeusia
- nail disorder
- pain
- skin disorder
- rash
- fatigue
- weight loss
- xerostomia
- xerosis
- dysphagia
- infection
- diarrhea
- hypotension
- headache
- rigors
- pruritus
- appetite decr.
- stomatitis
- nausea
- cough
- constipation
- encephalopathy
- edema
- sensory neuropathy
- injection site reaction
- dyspnea
- tachycardia
- motor dysfunction
- hypoxia
- lymphocytes decr.
- Hgb decr.
- albumin decr.
- neutrophils decr.
- Plt decr.
- alk phos incr.
- phosphate decr.
- GGT incr.
- ALT or AST incr.
- potassium decr.
- sodium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; hepatic panel at baseline, then as clinically indicated; CBC with diff, signs/symptoms of infection, wt at baseline, then regularly during tx; signs/symptoms of cytokine release syndrome, neurological toxicities x48h in hospital after each injection within step-up dosing schedule and as clinically indicated
Look/Sound-Alike Drug Names
Talvey confused with: Tecvayli
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm, including abortion, based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x3mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x3mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for talquetamab: catabolism; CYP450: unknown
Excretion: for talquetamab: unknown; Half-life: 8.4 days
Subclass: Immunotherapy, Bispecific CD3 T-Cell Engagers ; Immunotherapy, GPRC5D Inhibitors
Mechanism of Action
for talquetamab: binds to G protein-coupled receptor class C group 5 member D (GPRC5D) on multiple myeloma cells, recruiting T-cells via the anti-CD3 domain, leading to T-cell activation, cytokine release, and direct lysis of tumor cells (bispecific T-cell engager)
Formulary .
No Formulary Selected
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