Leukemias, lymphomas, and other hematologic cancers:
Indications for: TECVAYLI
In adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Adult Dosage:
Give by SC inj into abdomen (preferred inj site), or alternatively at other sites (eg, thigh). If multiple injections are required, separate by at least 2cm apart. Premedicate with dexamethasone, diphenhydramine, and APAP approx. 1–3hrs prior to each dose of the step-up dosing schedule; also may be needed for subsequent doses in certain patients (see full labeling). Consider initiation of antiviral prophylaxis for herpes zoster. Step-up dosing schedule: 0.06mg/kg on Day 1, 0.3mg/kg on Day 4, 1.5mg/kg on Day 7, followed by 1.5mg/kg once weekly thereafter until disease progression or unacceptable toxicity. Restarting therapy after dose delay, dose modifications for adverse reactions, others: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Cytokine release syndrome (CRS). Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).
TECVAYLI Warnings/Precautions:
Risk of CRS, neurologic toxicity, including ICANS; should be hospitalized for 48hrs after administration of all doses of the step-up dosing schedule. Monitor for neurologic toxicity during treatment. Evaluate immediately and provide supportive care at 1st sign of CRS or neurologic toxicity. Infections (may be serious); monitor. Monitor immunoglobulin levels, CBCs, liver enzymes, bilirubin at baseline and periodically during treatment; provide supportive care and treat appropriately. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 5 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).
TECVAYLI Classification:
BCMA-directed CD3 T-cell engager.
TECVAYLI Interactions:
Concomitant CYP substrate drugs where minimal concentration changes may lead to serious adverse reactions; monitor and adjust dose as needed.
Adverse Reactions:
Pyrexia, CRS, musculoskeletal pain, inj site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, diarrhea, Grade 3/4 lab abnormalities (decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, decreased platelets); hepatotoxicity, neutropenia, pneumonia, sepsis, COVID-19, physical health deterioration, acute kidney injury, hypersensitivity reactions.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
