Talquetamab-tgvs

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Talquetamab-tgvs
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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.