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Tecvayli (teclistamab-cqyv)
teclistamab
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 reactions occurred in 72% of patients; initiate tx according to step-up dosing schedule and administer premeds to decr. CRS risk; monitor patients x48h in hospital after each dose of step-up dosing schedule for CRS signs/symptoms, including fever, hypoxia, chills, hypotension, sinus tachycardia, headache, elevated transaminases; provide supportive care as needed; withhold tx until signs/symptoms resolve or permanently D/C, based on severity
Neurological Toxicities
including immune effector cell-associated neurotoxicity syndrome (ICANS) and serious, life-threatening, or fatal reactions occurred in 57% 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 = teclistamab-cqyv
- [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
- [monotherapy]
- Dose: 0.06 mg/kg/dose SC x1 on day 1 (1st step-up dose), then 0.3 mg/kg/dose SC x1 on day 4 (2nd step-up dose), then 1.5 mg/kg/dose SC x1 on day 7 (1st tx dose) as part of step-up dosing schedule, then 1.5 mg/kg/dose SC qwk starting 1wk after 1st tx dose; Info: for patients refractory to at least 4 prior tx, including an anti-CD38 agent, a proteasome inhibitor, and an immunomodulatory agent; may give 2nd step-up dose 2-4 days or up to 7 days after 1st step-up dose; may give 1st tx dose 2-4 days or up to 7 days after 2nd step-up dose; may decr. frequency of tx dose to q2wk if complete response or better achieved and maintained for at least 6mo
- [combo with daratumumab/hyaluronidase]
- Dose: 0.06 mg/kg/dose SC x1 on day 1 at least 20h after daratumumab/hyaluronidase dose (1st step-up dose), then 0.3 mg/kg/dose SC x1 on day 3 (2nd step-up dose), then 1.5 mg/kg/dose SC x1 on day 7 (1st tx dose) as part of step-up dosing schedule, then 1.5 mg/kg/dose SC qwk x7wk starting 1wk after 1st tx dose, then 3 mg/kg/dose SC q2wk x16wk starting wk 9, then 3 mg/kg/dose SC q4wk starting wk 25; Info: for patients refractory to at least 1 prior tx, including a proteasome inhibitor and an immunomodulatory agent; may give 2nd step-up dose 2-4 days or up to 7 days after 1st step-up dose; may give 1st tx dose 2-4 days or up to 7 days after 2nd step-up dose; give 1st tx dose at least 3h after daratumumab/hyaluronidase dose and subsequent tx doses at least 15min after daratumumab/hyaluronidase dose
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1.1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x 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 x5mo after D/C
- caution: patients of childbearing potential
- caution: herpes zoster history
Drug Interactions .
Overview
teclistamab
bispecific T cell engager
- immunomodulatory effects
- lowers seizure threshold
- myelosuppressive oncologic agent
- peripheral neuropathy
- caution advised with narrow therapeutic index drugs, especially during teclistamab initiation/titration and up to 7 days after first full tx dose or during/after CRS; teclistamab may incr. cytokine release leading to suppression of metabolic enzymes, causing incr. drug levels, risk of adverse effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- fever
- hypoxia
- hypotension
- tachycardia
- ALT or AST elevated
- neurotoxicity, severe
- immune effector cell-associated neurotoxicity syndrome
- motor dysfunction
- sensory neuropathy
- encephalopathy
- seizures
- Guillain-Barre syndrome
- hepatic failure
- hepatotoxicity
- infection, severe
- opportunistic infection
- neutropenia
- febrile neutropenia
- HBV reactivation
- CMV reactivation
- herpes zoster (shingles) reactivation
- HSV reactivation
- PML
- hypersensitivity reaction, severe
- acute kidney injury
- sepsis
- pneumonia
- sudden death (combo tx)
- MI (combo tx)
- enterovirus myocarditis (combo tx)
- hemophagocytic lymphohistiocytosis (combo tx)
Common Reactions
- fever
- cytokine release syndrome
- musculoskeletal pain
- injection site reaction
- fatigue
- URI
- pneumonia
- headache
- nausea
- vomiting
- diarrhea
- constipation
- hypotension
- hypoxia
- rigors
- pain
- motor dysfunction
- arrhythmia
- sensory neuropathy
- cough
- edema
- encephalopathy
- hemorrhage
- HTN
- hypogammaglobulinemia
- UTI
- appetite decr.
- weight decr.
- dyspnea
- insomnia
- dizziness
- acute kidney injury
- lymphocytes decr.
- neutrophils decr.
- Plt decr.
- albumin decr.
- Hgb decr.
- alk phos incr.
- phosphate decr.
- GGT incr.
- sodium decr.
- ALT incr.
- AST incr.
- potassium decr.
- calcium decr.
- lipase incr.
- amylase incr.
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; hepatic panel at baseline, then as clinically indicated; CBC with diff, IgG levels, signs/symptoms of infection at baseline, then periodically during tx; signs/symptoms of cytokine release syndrome, neurological toxicities, including ICANS, x48h in hospital after each injection within step-up dosing schedule and as clinically indicated
Look/Sound-Alike Drug Names
Tecvayli confused with: Talvey
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm, including embryo-fetal death and hypogammaglobulinemia, 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 x5mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x5mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for teclistamab: other; CYP450: unknown
Excretion: for teclistamab: unknown; Half-life: 7-33 days
Subclass: Immunotherapy, BCMA Inhibitors ; Immunotherapy, Bispecific CD3 T-Cell Engagers
Mechanism of Action
for teclistamab: binds to B-cell maturation antigen (BCMA) 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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