Tarlatamab-dlle
Generic Name: tarlatamab-dlle
Brand Names:
Imdelltra (amg757)
11 DESCRIPTION Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary cells. It consists of 982 amino acids and has a molecular weight of approximately 105 kilodaltons.
Overview
11 DESCRIPTION Tarlatamab-dlle is a bispecific DLL3-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary cells. It consists of 982 amino acids and has a molecular weight of approximately 105 kilodaltons.
Uses
1 INDICATIONS AND USAGE IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administer as an intravenous infusion over 1 hour. ( 2.2 ) Administer IMDELLTRA according to the step - up dosing schedule in Table 1 to reduce the risk of cytokine release syndrome. ( 2.2 ) Administer concomitant medications as recommended. ( 2.3 ) Monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1) ] Neurologic Toxicity Including ICANS [see Warnings and Precautions (5.2) ] Cytopenias [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions (> 20%) were cytokine release syndrome, fatigue, decreased appetite, anemia, dysgeusia, pyrexia, constipation, musculoskeletal pain, and nausea.
Warnings
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. 5 WARNINGS AND PRECAUTIONS Cytopenias : Monitor complete blood counts prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity. ( 5.3 ) Infections : Monitor for signs and symptoms of infection; treat appropriately. Withhold or permanently discontinue based on severity. ( 5.4 ) Hepatotoxicity : Monitor liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. 4 CONTRAINDICATIONS None . None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier . Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance.
Storage
16.2 Storage and Handling Store IMDELLTRA and IV Solution Stabilizer (IVSS) vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. IMDELLTRA and IV Solution Stabilizer (IVSS) vials may be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect from light.
Frequently Asked Questions
What is Tarlatamab-dlle used for?▼
1 INDICATIONS AND USAGE IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy. ( 1 )
What are the side effects of Tarlatamab-dlle?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1) ] Neurologic Toxicity Including ICANS [see Warnings and Precautions (5.2) ] Cytopenias [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions (> 20%) were cytokine release syndrome, fatigue, decreased appetite, anemia, dysgeusia, pyrexia, constipation, musculoskeletal pain, and nausea.
Can I take Tarlatamab-dlle during pregnancy?▼
8.1 Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier . Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance.
What are the important warnings for Tarlatamab-dlle?▼
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. 5 WARNINGS AND PRECAUTIONS Cytopenias : Monitor complete blood counts prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity. ( 5.3 ) Infections : Monitor for signs and symptoms of infection; treat appropriately. Withhold or permanently discontinue based on severity. ( 5.4 ) Hepatotoxicity : Monitor liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. 4 CONTRAINDICATIONS None . None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.