Imdelltra (amg757)
Tarlatamab-dlle · Kit
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 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. ( 2.2 , 2.6 ) 2.1 Important Dosage and Administration Information Administer IMDELLTRA according to the step-up dose and schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome (CRS) [see Dosage and Administration (2.2) ] . Evaluate complete blood count, 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 if clinically indicated [see Warnings and Precautions (5.3 , 5.5) ] . Ensure patients are well hydrated prior to administration of IMDELLTRA [see Warnings and Precautions (5.1) ] . For Cycle 1, administer recommended concomitant medications in Table 3 before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions to reduce the risk of CRS reactions [see Dosage and Administration (2.3) ] . IMDELLTRA should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions, such as CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Warnings and Precautions (5.1 , 5.2) ] . Due to the risk of CRS and neurologic toxicity, including ICANS, 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 [see Dosage and Administration (2.5) and Warnings and Precautions (5.1 , 5.2) ] . Recommend patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Inform both the patient and the caregiver on the signs and symptoms of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) prior to discharge. 2.2 Recommended Dosage and Administration Administer IMDELLTRA as an intravenous infusion for one hour. The recommended step-up dose and schedule for IMDELLTRA is provided in Table 1. Administer step-up dose and schedule on Cycle 1 Day 1 to reduce the incidence and severity of CRS. After step-up dose and schedule on Cycle 1 Day 1, administer IMDELLTRA every 2 weeks until disease progression or unacceptable toxicity. Table 1. Recommended Dose and Schedule of IMDELLTRA Dosing Schedule Day Dose of IMDELLTRA Administration Instructions Recommended Monitoring Note: See Table 4 for recommendation on restarting IMDELLTRA after dose delays. Step-up Dose and Schedule Cycle 1 Day 1 Administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3. Step-up dose 1 mg Administer IMDELLTRA as a 1-hour intravenous infusion in an appropriate healthcare setting. 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 that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the IMDELLTRA infusion accompanied by a caregiver. Day 8 10 mg Day 15 10 mg Observe patients for 6-8 hours post IMDELLTRA infusion Extended monitoring in a healthcare setting is not required unless the patient experiences Grade ≥ 2 CRS, ICANS or neurological toxicity during prior treatments. See Tables 5 and 6 for monitoring recommendations. Cycle 2 Day 1 and 15 10 mg Observe patients for 6-8 hours post IMDELLTRA infusion . Cycles 3 and 4 Day 1 and 15 10 mg Observe patients for 3-4 hours post IMDELLTRA infusion . Cycle 5 and subsequent infusions Day 1 and 15 10 mg Observe patients for 2 hours post IMDELLTRA infusion . Administration The intravenous (IV) catheter for concomitant medications administration can be used to administer the IMDELLTRA infusion. To ensure patency, flush the IV catheter over 3 to 5 minutes using 0.9% Sodium Chloride for Injection. Administer the reconstituted and diluted IMDELLTRA as a 1-hour intravenous infusion at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm. Flush the IV-line upon completion of the IMDELLTRA infusion. Table 2 provides the infusion duration and rate. Table 2. IMDELLTRA Infusion Duration and Rate Infusion Duration for 250 mL IV Preparation Infusion Rate 1 hour 250 mL/hour 2.3 Recommended Concomitant Medications for IMDELLTRA Administration for Cycle 1 Day 1 and Cycle 1 Day 8 Administer recommended concomitant medications for IMDELLTRA during Cycle 1 Day 1 and Cycle 1 Day 8 as presented in Table 3 to reduce the risk of CRS [see Warnings and Precautions (5.1) ] . Table 3.
Dosage forms and strengths
For injection: 1 mg of white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 10 mg of white to slightly yellow lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 1 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution. ( 3 ) For injection: 10 mg of lyophilized powder in a single-dose vial for reconstitution and further dilution. ( 3 )
Contraindications
None . None. ( 4 )
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. Withhold or permanently discontinue based on severity. ( 5.5 ) Hypersensitivity : Monitor for signs and symptoms of hypersensitivity and treat accordingly. Withhold or permanently discontinue based on severity. ( 5.6 ) Embryo - Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.7 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome IMDELLTRA can cause cytokine release syndrome (CRS) including life-threatening or fatal reactions. In the pooled safety population [see Adverse Reactions (6.1) ] , CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3. Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA was 15 hours (range: start of infusion to 15 days). Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC). Administer IMDELLTRA following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA infusions as described in Table 3 to reduce the risk of CRS [see Dosage and Administration (2.3) ] . Administer IMDELLTRA in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA. At the first sign of CRS, immediately discontinue IMDELLTRA infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA based on severity [see Dosage and Administration (2.5) ] . Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur. 5.2 Neurologic Toxicity Including ICANS IMDELLTRA can cause life-threatening or fatal neurologic toxicity including ICANS. In the pooled safety population [see Adverse Reactions (6.1) ] , neurologic toxicity occurred in 65% of patients who received IMDELLTRA, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA- treated patients, including events with the preferred terms: ICANs (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS [see Adverse Reactions (6.1) ] . Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA. The median time to onset of ICANS from the first dose of IMDELLTRA was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days). The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Patients receiving IMDELLTRA are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve . Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA or permanently discontinue based on severity [see Dosage and Administration (2.5) ] .
Side effects
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. The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased sodium, decreased total neutrophils, and increased uric acid. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to intravenous IMDELLTRA, as a single agent, at the recommended dosage of IMDELLTRA 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year. The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%). The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%). Extensive Stage Small Cell Lung Cancer The safety of IMDELLTRA was evaluated in 252 patients in DeLLphi-304, a multicenter, randomized, open label trial in patients with extensive stage small cell lung cancer (ES- SCLC) with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody [see Clinical Studies (14.1) ]. Patients received IMDELLTRA (n=252) or investigator's choice or investigator's choice of topotecan [n=176], lurbinectedin [n=45] or amrubicin [n=23]. Among patients who received IMDELLTRA, 41% were exposed for 6 months or longer and 18% were exposed for greater than one year. The demographic characteristics of patients who received IMDELLTRA were: median age 64 years (range: 20 to 86); 71% male; 60% White, 38 % Asian, 0.8% Black or African American; and 4.8% were of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 52% of patients who received IMDELLTRA. Serious adverse reactions in >3% of patients included CRS (17%), pyrexia (6%), pneumonia (5%) and ICANS (3.6%). Fatal adverse reactions occurred in 8% of patients who received IMDELLTRA, including one fatal adverse reaction of ICANS (0.4%). Fatal adverse reactions occurring in more than one patient included pneumonia (1.6%), cardio-respiratory arrest (1.6%), and sepsis (0.8%). Permanent discontinuation of IMDELLTRA due to an adverse reaction occurred in 6% of patients. Adverse reactions which resulted in permanent discontinuation of IMDELLTRA in > 1% of patients included pneumonia (1.2%). Dosage interruptions of IMDELLTRA due to an adverse reaction occurred in 38% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included neutropenia (5%), fatigue (4.4%), pneumonia (4%), decreased appetite (2.8%), COVID-19 (2%). Table 13 summarizes adverse reactions observed in DeLLphi-304. Table 13. Adverse Reactions (≥ 15%) in Patients with SCLC Who Received IMDELLTRA in DeLLphi-304 Adverse Reaction IMDELLTRA Graded using CTCAE Version 4.0 and Version 5.0. (N = 252) Standard of Care (N = 244) Any Grade (%) Grade 3 or 4 (%) Any Grade (%) Grade 3 or 4 (%) Immune system disorders Cytokine release syndrome Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019. 56 1.2 1.2 0 General disorders and administration site conditions Fatigue Includes fatigue and asthenia 39 6 43 10 Pyrexia Includes body temperature increased, hyperthermia, pyrexia 29 1.2 11 1.2 Metabolism and nutrition disorders Decreased appetite 37 2 23 1.6 Gastrointestinal disorders Constipation 30 0.4 22 0 Nausea 25 0.4 32 0 Nervous system disorders Dysgeusia Includes ageusia, dysgeusia, hypogeusia 28 0 2.5 0 Headache Includes headache and tension headache 16 0 9 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain Includes arthralgia, back pain, bone pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, spinal pain 27 1.6 21 2.5 Respiratory, thoracic and mediastinal disorders Cough Includes cough and productive cough 17 0 17 0 Clinically relevant adverse reactions occurring in < 15% of patients who received IMDELLTRA were immune effector cell-associated neurotoxicity syndrome, neurotoxicity, tremor, seizure, ataxia, confusional state, delirium, dyspnea, encephalopathy and weight decreased. Table 14 summarizes laboratory abnormalities in DeLLphi-304. Table 14. Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients with SCLC in DeLLphi-304 Laboratory Abnormality IMDELLTRA The denominator used to calculate the rate varied for IMDELLTRA (Range: 229 to 250) and SOC (Range: 205 to 226) based on the number of patients with a baseline value and at least one post-treatment value.
Use in specific populations
Lactation : Advise not to breastfeed. ( 8.2 ) 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. Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of tarlatamab-dlle in human milk or the effects on the breastfed child or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to IMDELLTRA are unknown. Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with IMDELLTRA and for 2 months after the last dose. 8.3 Females and Males of Reproductive Potential IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiating IMDELLTRA. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose. 8.4 Pediatric Use The safety and effectiveness of IMDELLTRA have not been established in pediatric patients. 8.5 Geriatric Use Of the 473 patients with SCLC who received IMDELLTRA 10 mg as a single agent, 51% were 65 years of age or older and 11% were 75 years of age or older. No overall differences in IMDELLTRA pharmacokinetics, safety or efficacy were observed between older patients (≥ 65 years of age) and younger patients.
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. Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause maternal toxicity, embryo-fetal toxicity or teratogenicity.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of IMDELLTRA have not been established in pediatric patients.
Geriatric use
8.5 Geriatric Use Of the 473 patients with SCLC who received IMDELLTRA 10 mg as a single agent, 51% were 65 years of age or older and 11% were 75 years of age or older. No overall differences in IMDELLTRA pharmacokinetics, safety or efficacy were observed between older patients (≥ 65 years of age) and younger patients.
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. IMDELLTRA (tarlatamab-dlle) for injection is supplied as a sterile, preservative-free, white to slightly yellow, lyophilized powder in a single-dose vial for reconstitution and further dilution. Each 1 mg vial contains tarlatamab-dlle (1 mg), glutamic acid (0.72 mg), polysorbate 80 (0.04 mg), sucrose (37.1 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 1.3 mL of Sterile Water for Injection the resulting concentration is 0.9 mg/mL IMDELLTRA. Each 10 mg vial contains tarlatamab-dlle (10 mg), glutamic acid (3.7 mg), polysorbate 80 (0.2 mg), sucrose (194.4 mg), and sodium hydroxide to adjust pH to 4.2. After reconstitution with 4.4 mL of Sterile Water for Injection the resulting concentration is 2.4 mg/mL IMDELLTRA. IV Solution Stabilizer is supplied as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each vial of IV Solution Stabilizer contains citric acid monohydrate (36.75 mg), lysine hydrochloride (1598.8 mg), polysorbate 80 (7 mg), sodium hydroxide to adjust pH to 7.0, and water for injection.
Mechanism of action
12.1 Mechanism of Action Tarlatamab-dlle is a bispecific 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 causes T-cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells. Tarlatamab-dlle had anti-tumor activity in mouse models of SCLC.
How supplied
16.1 How Supplied IMDELLTRA (tarlatamab-dlle) for injection is a sterile, preservative-free, white to slightly yellow, lyophilized powder supplied as follows: 1 mg package (NDC 55513-059-01) contains 1 single-dose vial of 1 mg IMDELLTRA and 2 vials of 7 mL IV Solution Stabilizer. 10 mg package (NDC 55513-077-01) contains 1 single-dose vial of 10 mg IMDELLTRA and 2 vials of 7 mL IV Solution Stabilizer. 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.
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.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Cytokine Release Syndrome (CRS) Inform patients and their caregivers of the risk of CRS, and to immediately contact their healthcare provider for signs and symptoms associated with CRS including pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting [see Warnings and Precautions (5.1) ] . Advise patients that they should be monitored from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 doses in an appropriate healthcare setting [see Warnings and Precautions (5.1) ] . Advise patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. Neurologic Toxicity Including Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) Discuss the signs and symptoms associated with ICANS with patients and their caregivers. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of ICANS, such as encephalopathy, confusion, delirium, seizure, ataxia, weakness or numbness of arms and legs, tremor, and headache. Advise patients who experience neurologic toxicity or symptoms of ICANS to refrain from driving, operating heavy or potentially dangerous machinery, and engaging in hazardous occupations or activities during treatment with IMDELLTRA [see Warnings and Precautions (5.2) ] . Cytopenias Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia with patients and their caregivers [see Warnings and Precautions (5.3) ] . Inform patients that they will need to undergo lab tests to monitor blood counts. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of cytopenias. Infections Discuss the signs and symptoms of infections with patients and their caregivers. Advise patients of the risk of serious infections, and to immediately contact their healthcare provider for signs or symptoms of infections [see Warnings and Precautions (5.4) ] . Hepatotoxicity Discuss the signs and symptoms of hepatotoxicity and bilirubin with patients and their caregivers. Inform patients that they will need to undergo lab tests to monitor liver function. Advise patients to immediately contact their healthcare provider for signs and symptoms of liver dysfunction [see Warnings and Precautions (5.5) ] . Hypersensitivity Discuss the signs and symptoms of allergic reactions with patients and their caregivers. Advise patients to immediately seek medical attention for any signs and symptoms of severe reactions [see Warnings and Precautions (5.6) ] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA and for 2 months after the last dose [see Warnings and Precautions (5.7) , Use in Specific Populations (8.1 , 8.3) ] . Lactation Advise women not to breastfeed during treatment with IMDELLTRA and for 2 months after the last dose [see Use in Specific Populations (8.2) ] .
Label text from the FDA structured product label by Amgen, Inc (revised Jun 23, 2026). Long sections are shortened; the complete label is on DailyMed.
Imdelltra (amg757) NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 55513-059 | Kit | Amgen, Inc | BLA |
| 55513-077 | Kit | Amgen, Inc | BLA |
Frequently asked questions
What is Imdelltra (amg757) 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…
What are the side effects of Imdelltra (amg757)?
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) ]… See the full label for the complete list.
Who makes Imdelltra (amg757)?
Imdelltra (amg757) is listed by 1 labeler in the FDA NDC directory, including Amgen, Inc.