View source for Talquetamab-tgvs

{{DrugProjectFormSinglePage
|authorTag=[[User:Muhammad Waleed|Muhammad Waleed, M.B.B.S.]] [mailto:muhammad_waleed@ymail.com]
|genericName=Talquetamab-tgvs
|aOrAn=a
|drugClass=bispecific GPRC5D-directed CD3 T-cell engager
|indicationType=treatment
|indication=TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
|hasBlackBoxWarning=Yes
|adverseReactions=Cytokine Release Syndrome, Neurologic Toxicity (including ICANS), Oral Toxicity and Weight Loss, Infections, Cytopenias, Skin Toxicity, and Hepatotoxicity
|blackBoxWarningTitle=Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.
|blackBoxWarningBody=Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY. Initiate TALVEY treatment with step-up dosing to reduce the risk of CRS. Withhold TALVEY until CRS resolves or permanently discontinue based on severity. 
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur in patients receiving TALVEY. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold or permanently discontinue TALVEY based on severity. 
TALVEY is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).
|fdaLIADAdult=TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

The TALVEY dosing schedule involves a step-up dosing regimen followed by a weekly maintenance dose. The step-up dosing schedule begins on Day 1 with a dose of 0.01 mg/kg of the medication based on the actual body weight of the patient. On Day 4, the dose is increased to 0.06 mg/kg, and on Day 7, the first treatment dose is administered at a dose of 0.4 mg/kg.

After the initial step-up dosing phase, the weekly dosing schedule begins. Starting one week after the first treatment dose, subsequent treatment doses are given weekly thereafter. Each weekly dose is 0.4 mg/kg based on the patient's actual body weight. It's important to note that the interval between weekly doses should be at least 6 days to allow for resolution of adverse reactions, and doses may be administered between 2 to 4 days after the previous dose or up to 7 days after the previous dose.
|fdaLIADPed=Not indicated for pediatric patients.
|contraindications=Talvey is contraindicated in patients with a known hypersensitivity to talquetamab-tgvs or any of its excipients.
|warnings=Cytokine Release Syndrome (CRS): Monitor for signs and symptoms of CRS and manage according to severity.
Neurologic Toxicity: Monitor for neurologic symptoms, including ICANS.
Infections: Monitor for infections and treat promptly.
Cytopenias: Monitor complete blood counts regularly.
Hepatotoxicity: Monitor liver function tests.
|clinicalTrials=CRS
Neurologic toxicity (including ICANS)
Infections
Cytopenias (anemia, neutropenia, thrombocytopenia)
Gastrointestinal symptoms (nausea, diarrhea)
Skin toxicity
|drugInteractions=Talvey may interact with other immunosuppressive agents and increase the risk of infections.
|useInPregnancyFDA=Talvey may cause fetal harm. Women of childbearing potential should use effective contraception
|useInNursing=Breastfeeding is not recommended during treatment and for some time after the last dose.
|useInGeri=No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
|useInRenalImpair=No dose adjustment is required for renal impairment.
|useInHepaticImpair=No dose adjustment is required for hepatic impairment.
|administration=Subcutaneous injection with a step-up dosing regimen followed by weekly maintenance doses.
|monitoring=Close monitoring for CRS, neurologic toxicity, and infections is required. Regular blood counts and liver function tests should be performed.
|mechAction=Talvey (talquetamab-tgvs) is a bispecific T-cell engager that binds to CD3 on T-cells and GPRC5D on multiple myeloma cells, leading to T-cell-mediated cytotoxicity against the myeloma cells.
|PK=Subcutaneous administration leads to systemic absorption.The volume of distribution and protein binding specifics should be reviewed in detailed pharmacokinetic studies.Primarily metabolized through protein catabolism.The exact half-life and clearance should be verified from pharmacokinetic data.
|clinicalStudies=Clinical trials have shown efficacy in patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Detailed results from these trials are available in the prescribing information.
}}