TECVAYLI Dosage & Rx Info | Uses, Side Effects

Tecvayli Generic Name & Formulations

Legal Class

General Description

Teclistamab-cqyv 30mg/3mL, 153mg/1.7mL; per vial; soln for SC inj; preservative-free.

Pharmacological Class

BCMA-directed CD3 T-cell engager.

How Supplied

Single-dose vial—1

Manufacturer

Janssen Biotech, Inc.

Generic Availability

Mechanism of Action

Teclistamab-cqyv is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.

Tecvayli Indications

Indications

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.

Tecvayli Dosage and Administration

Adult

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

Not established.

Tecvayli Contraindications

Not Applicable

Tecvayli Boxed Warnings

Boxed Warning

Cytokine release syndrome (CRS). Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).

Tecvayli Warnings/Precautions

Warnings/Precautions

Must be administered by a qualified healthcare professional. Have appropriate medical support available. Risk for CRS, neurologic toxicity (including ICANS). Initiate Tecvayli therapy with step-up dosing schedule and premedicate to reduce the risk of CRS. Monitor and evaluate immediately if CRS (may need hospitalization) or neurologic toxicity (including ICANS) occurs; manage according to guidelines, and provide supportive care; withhold or discontinue based on severity (see full labeling). 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).

REMS

YES

Tecvayli Pharmacokinetics

Absorption

The mean bioavailability of teclistamab-cqyv was 72% when administered subcutaneously.

Tecvayli Interactions

Interactions

Concomitant CYP substrate drugs where minimal concentration changes may lead to serious adverse reactions; monitor and adjust dose as needed.

Tecvayli Adverse Reactions

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.

Tecvayli Clinical Trials

See Literature

Tecvayli Note