Talquetamab-tgvs
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Muhammad Waleed, M.B.B.S. [2]
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Black Box Warning
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Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.
See full prescribing information for complete Boxed Warning.
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). |
Overview
Talquetamab-tgvs is a bispecific GPRC5D-directed CD3 T-cell engager that is FDA approved for the treatment of 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.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Cytokine Release Syndrome, Neurologic Toxicity (including ICANS), Oral Toxicity and Weight Loss, Infections, Cytopenias, Skin Toxicity, and Hepatotoxicity.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Not indicated for pediatric patients.
Off-Label Use and Dosage (Pediatric)
Contraindications
Talvey is contraindicated in patients with a known hypersensitivity to talquetamab-tgvs or any of its excipients.
Warnings
|
Cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.
See full prescribing information for complete Boxed Warning.
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). |
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.
Adverse Reactions
Clinical Trials Experience
CRS Neurologic toxicity (including ICANS) Infections Cytopenias (anemia, neutropenia, thrombocytopenia) Gastrointestinal symptoms (nausea, diarrhea) Skin toxicity
Postmarketing Experience
There is limited information regarding Talquetamab-tgvs Postmarketing Experience in the drug label.
Drug Interactions
Talvey may interact with other immunosuppressive agents and increase the risk of infections.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Talvey may cause fetal harm. Women of childbearing potential should use effective contraception
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Talquetamab-tgvs in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Talquetamab-tgvs during labor and delivery.
Nursing Mothers
Breastfeeding is not recommended during treatment and for some time after the last dose.
Pediatric Use
There is no FDA guidance on the use of Talquetamab-tgvs in pediatric settings.
Geriatic Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients.
Gender
There is no FDA guidance on the use of Talquetamab-tgvs with respect to specific gender populations.
Race
There is no FDA guidance on the use of Talquetamab-tgvs with respect to specific racial populations.
Renal Impairment
No dose adjustment is required for renal impairment.
Hepatic Impairment
No dose adjustment is required for hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Talquetamab-tgvs in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Talquetamab-tgvs in patients who are immunocompromised.
Administration and Monitoring
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.
IV Compatibility
There is limited information regarding the compatibility of Talquetamab-tgvs and IV administrations.
Overdosage
There is limited information regarding Talquetamab-tgvs overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Talquetamab-tgvs Pharmacology in the drug label.
Mechanism of Action
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.
Structure
There is limited information regarding Talquetamab-tgvs Structure in the drug label.
Pharmacodynamics
There is limited information regarding Talquetamab-tgvs Pharmacodynamics in the drug label.
Pharmacokinetics
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.
Nonclinical Toxicology
There is limited information regarding Talquetamab-tgvs Nonclinical Toxicology in the drug label.
Clinical Studies
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.
How Supplied
There is limited information regarding Talquetamab-tgvs How Supplied in the drug label.
Storage
There is limited information regarding Talquetamab-tgvs Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Talquetamab-tgvs Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Talquetamab-tgvs interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Talquetamab-tgvs Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Talquetamab-tgvs Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.