Talquetamab-tgvs: Difference between revisions
(Created page with "{{DrugProjectFormSinglePage |authorTag=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...") |
(No difference)
|
Revision as of 20:38, 13 May 2024
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Muhammad Waleed, M.B.B.S. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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)
There is limited information regarding Talquetamab-tgvs FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Talquetamab-tgvs Contraindications in the drug label.
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). |
There is limited information regarding Talquetamab-tgvs Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Talquetamab-tgvs Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Talquetamab-tgvs Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Talquetamab-tgvs Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Talquetamab-tgvs in women who are pregnant.
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
There is no FDA guidance on the use of Talquetamab-tgvs in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Talquetamab-tgvs in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Talquetamab-tgvs in geriatric settings.
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
There is no FDA guidance on the use of Talquetamab-tgvs in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Talquetamab-tgvs in patients with 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
There is limited information regarding Talquetamab-tgvs Administration in the drug label.
Monitoring
There is limited information regarding Talquetamab-tgvs Monitoring in the drug label.
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
There is limited information regarding Talquetamab-tgvs Mechanism of Action in the drug label.
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
There is limited information regarding Talquetamab-tgvs Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Talquetamab-tgvs Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Talquetamab-tgvs Clinical Studies in the drug label.
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
{{#ask: Page Name::Talquetamab-tgvs |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Talquetamab-tgvs |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.