Tarlatamab-dlle
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[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.
Condition Name: (Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.)
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Overview
Tarlatamab-dlle is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager that is FDA approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include *fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, decreased potassium, increased aspartate aminotransferase, decreased white blood cells, decreased platelets, and increased alanine aminotransferase..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Tarlatamab-dlle FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tarlatamab-dlle in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tarlatamab-dlle in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tarlatamab-dlle FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tarlatamab-dlle in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tarlatamab-dlle in pediatric patients.
Contraindications
There is limited information regarding Tarlatamab-dlle Contraindications in the drug label.
Warnings
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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.
Condition Name: (Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.)
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There is limited information regarding Tarlatamab-dlle Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tarlatamab-dlle Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tarlatamab-dlle Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tarlatamab-dlle Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tarlatamab-dlle in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tarlatamab-dlle in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tarlatamab-dlle during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tarlatamab-dlle in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Tarlatamab-dlle in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tarlatamab-dlle in geriatric settings.
Gender
There is no FDA guidance on the use of Tarlatamab-dlle with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tarlatamab-dlle with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tarlatamab-dlle in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tarlatamab-dlle in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tarlatamab-dlle in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tarlatamab-dlle in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Tarlatamab-dlle Administration in the drug label.
Monitoring
There is limited information regarding Tarlatamab-dlle Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Tarlatamab-dlle and IV administrations.
Overdosage
There is limited information regarding Tarlatamab-dlle 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 Tarlatamab-dlle Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Tarlatamab-dlle Mechanism of Action in the drug label.
Structure
There is limited information regarding Tarlatamab-dlle Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tarlatamab-dlle Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Tarlatamab-dlle Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Tarlatamab-dlle Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tarlatamab-dlle Clinical Studies in the drug label.
How Supplied
There is limited information regarding Tarlatamab-dlle How Supplied in the drug label.
Storage
There is limited information regarding Tarlatamab-dlle 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 Tarlatamab-dlle Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tarlatamab-dlle interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tarlatamab-dlle Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tarlatamab-dlle 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.