Version July 2025
Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving tarlatamab. Initiate treatment with tarlatamab using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold tarlatamab 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 tarlatamab. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold tarlatamab until ICANS resolves or permanently discontinue based on severity.
Dosage guidance:
Safety: Administer according to the recommended step-up dosing schedule to reduce the incidence and severity of cytokine release syndrome (CRS). For cycle 1, administer recommended concomitant medications before/after cycle 1 infusions to reduce the risk of CRS. Tarlatamab should only be administered in a facility with appropriate medical support and by providers experienced in managing severe reactions such as CRS and neurotoxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS). Monitor patients in an appropriate health care setting during infusion and for 22 to 24 hours after the cycle 1 day 1 and cycle 1 day 8 infusions; patients should remain within 1 hour of an appropriate facility and be accompanied by a caregiver for a total of 48 hours from the beginning of the cycle 1 day 1 and cycle 1 day 8 infusions. Ensure patients are well hydrated prior to each tarlatamab dose.
Small cell lung cancer, extensive stage : IV:
|
Dosing schedule |
Day |
Tarlatamab dosea, c |
|---|---|---|
|
a Each cycle is 28 days in length. After step-up dosing schedule, continue until disease progression or unacceptable toxicity. If tarlatamab therapy is delayed, follow recommendations for restarting tarlatamab after dose delays. | ||
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b Administer recommended concomitant medications before/after each tarlatamab cycle 1 infusion. | ||
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c Ahn 2023, manufacturer's labeling. | ||
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Step-up dosing schedule cycle 1a, b |
Day 1 |
1 mgb |
|
Day 8 |
10 mgb | |
|
Day 15 |
10 mgb | |
|
Cycle 2 and beyonda |
Day 1 and 15 |
10 mg |
|
Treatment day |
Medication and dose |
|---|---|
|
Cycle 1, days 1 and 8 |
Dexamethasone 8 mg IV (or equivalent) within 1 hour prior to tarlatamab administration |
|
Cycle 1, days 1, 8, and 15 |
Normal saline 1 L IV over 4 to 5 hours immediately after completion of tarlatamab infusion |
|
Last tarlatamab dose administered |
Duration of delay from the last tarlatamab dose administered |
Action |
|---|---|---|
|
a Administer recommended concomitant medications before/after each tarlatamab cycle 1 infusion and monitor accordingly. | ||
|
Tarlatamab 1 mg on cycle 1, day 1 |
≤2 weeks (≤14 days) |
Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
|
>2 weeks (>14 days) |
Administer tarlatamab 1 mg (step-up dose). If tolerated, increase to 10 mg one week later. Then resume with the planned dosage schedule. | |
|
Tarlatamab 10 mg on cycle 1, day 8 |
≤3 weeks (≤21 days) |
Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
|
>3 weeks (>21 days) |
Administer tarlatamab 1 mg (step-up dose). If tolerated, increase to 10 mg one week later. Then resume with the planned dosage schedule. | |
|
Tarlatamab 10 mg on cycle 1, day 15 and subsequent cycles every 2 weeks thereafter |
≤4 weeks (≤28 days) |
Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
|
>4 weeks (>28 days) |
Administer tarlatamab 1 mg (step-up dose). If tolerated, increase to 10 mg one week later. Then resume with the planned dosage schedule. | |
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in tarlatamab pharmacokinetics were observed based on an eGFR 30 to <90 mL/minute.
eGFR 15 to 29 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (effects on tarlatamab pharmacokinetics are unknown).
End-stage kidney disease (eGFR <15 mL/minute): There are no dosage adjustments provided in the manufacturer's labeling (effects on tarlatamab pharmacokinetics are unknown).
Hepatic impairment prior to treatment initiation:
Mild impairment (total bilirubin ≤ ULN and AST > ULN): There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant difference in tarlatamab pharmacokinetics was observed based on mild hepatic impairment.
Moderate to severe impairment (total bilirubin >1.5 times ULN with any AST): There are no dosage adjustments provided in the manufacturer's labeling (effects on tarlatamab pharmacokinetics are unknown).
Acute hepatotoxicity during treatment:
Grade 3 ALT, AST, or bilirubin elevation: Withhold tarlatamab until improves to ≤ grade 1. Utilize recommendations on restarting tarlatamab following a dose delay.
Grade 4 ALT, AST, or bilirubin elevation: Permanently discontinue tarlatamab.
AST or ALT >3 times ULN with total bilirubin >2 times ULN in the absence of alternative causes: Permanently discontinue tarlatamab.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: The dosing in the approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).
No dose reductions for tarlatamab are recommended. Tarlatamab dose delays may be necessary to manage toxicities and may require repeat step-up dosing when restarting tarlatamab after a dose delay.
Cytokine release syndrome: If cytokine release syndrome (CRS) is suspected or at the first sign of CRS, immediately interrupt tarlatamab, evaluate for hospitalization, and based on severity institute supportive care until resolved; manage according to the table below and per clinical practice guidelines. Supportive therapy for CRS may include intensive care for severe or life-threatening CRS. Consider laboratory testing to monitor for disseminated intravascular coagulation, hematology parameters, as well as pulmonary, cardiac, kidney, and hepatic function. Evaluate and treat other causes of fever, hypoxia, and hypotension.
|
CRS gradea |
Symptoms |
Actions |
|---|---|---|
|
a Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS. | ||
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b Utilize recommendations on restarting tarlatamab after a dose delay. | ||
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c Taper corticosteroids per standard of care/institutional guidelines. | ||
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d Tocilizumab dose is 8 mg/kg (maximum dose: 800 mg) IV over 1 hour, if not responsive to IV fluids or increasing supplemental oxygen, may repeat every 8 hours as needed for a maximum of 3 tocilizumab doses per 24 hours or 4 total tocilizumab doses (Ahn 2023). | ||
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e CRS = cytokine release syndrome. | ||
|
Grade 1 |
Symptoms require symptomatic treatment only (temperature ≥38°C [100.4°F] without hypotension or hypoxia). |
Withhold tarlatamab until event resolves, then resume at the next scheduled doseb. Administer symptomatic treatment (eg, acetaminophen) for fever. |
|
Grade 2 |
Symptoms require and respond to moderate intervention (temperature ≥38°C [100.4°F], hypotension responsive to fluids not requiring vasopressors, hypoxia requiring low flow nasal cannula or blow-by). |
Withhold tarlatamab until event resolves, then resume at the next scheduled doseb. Recommend hospitalization for a minimum of 24 hours with cardiac telemetry and pulse oximetry. Administer symptomatic treatment (eg, acetaminophen) for fever. Administer supplemental oxygen and IV fluids when indicated. Consider dexamethasone 8 mg IV (or equivalent)c. Consider tocilizumab 8 mg/kg IV (maximum dose: 800 mg) (or equivalent)d. When resuming treatment at the next planned dose, monitor from the start of the tarlatamab infusion for 22 to 24 hours in an appropriate health care setting. |
|
Grade 3 |
Severe symptoms defined as temperature ≥38°C (100.4°F) with hemodynamic instability requiring a vasopressor with or without vasopressin or worsening hypoxia or respiratory distress requiring high flow nasal cannula (oxygen >6 L/minute) or face mask. |
Withhold tarlatamab until event resolves, then resume at the next scheduled doseb. In addition to grade 2 management:
When resuming treatment at the next planned dose, monitor from the start of the tarlatamab infusion for 22 to 24 hours in an appropriate health care setting. For recurrent grade 3 CRS: Permanently discontinue tarlatamab. |
|
Grade 4 |
Life-threatening symptoms defined as temperature ≥38°C (100.4°F) with hemodynamic instability requiring multiple vasopressors (excluding vasopressin) or worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure. |
Permanently discontinue tarlatamab. ICU care. Manage as per grade 3 treatment. Tocilizumabd 8 mg/kg IV (maximum dose: 800 mg) (or equivalent) is recommended. |
Neurologic toxicity: Interrupt tarlatamab and immediately evaluate at the first sign of neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS), and consider neurology evaluation. Rule out other causes of neurologic signs/symptoms. Provide supportive therapy, which may include intensive care for severe or life-threatening neurologic toxicities (including ICANS). Manage according to the table below and per clinical practice or institutional guidelines.
|
ICANS grade |
Severity |
Actions |
|---|---|---|
|
a Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS. | ||
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b If patient is arousable and able to perform ICE assessment:
If unarousable and unable to perform ICE assessment (grade 4 ICANS = 0 points) | ||
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c Utilize recommendations on restarting tarlatamab after a dose delay. | ||
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d Taper corticosteroids per standard of care/institutional guidelines. | ||
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e ICANS = immune effector cell–associated neurotoxicity syndrome; ICE = immune effector cell–associated encephalopathy. | ||
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f Ahn 2023. | ||
|
Grade 1a |
ICE score 7 to 9b with no depressed level of consciousness |
Withhold tarlatamab until ICANS resolves, then resume at the next scheduled dosec. Manage with supportive care. |
|
Grade 2a |
ICE score 3 to 6b and/or mild somnolence awakening to voice |
Withhold tarlatamab until ICANS resolves, then resume at the next scheduled dosec. Manage with supportive care. Administer dexamethasone 10 mg IV (or equivalent), may repeat every 6 hoursd or methylprednisolone 1 mg/kg IV every 12 hoursd if symptoms worsen. Monitor neurologic symptoms and consider consultation with neurology and other specialists for further evaluation and management. Monitor for 22 to 24 hours following the next tarlatamab dose. |
|
Grade 3a |
ICE score 0 to 2b and/or depressed level of consciousness (awakens only to tactile stimulus) and/or any clinical seizure focal or generalized that resolves rapidly, or nonconvulsive seizures on EEG that resolve with intervention and/or focal or local edema on neuroimaging |
Withhold tarlatamab until ICANS resolves, then resume at the next scheduled dosec. If there is no improvement to ≤ grade 1 within 7 days or grade 3 toxicity reoccurs within 7 days of reinitiation, permanently discontinue tarlatamab. Intensive monitoring (eg, ICU care) is recommended. Consider mechanical ventilation for airway protection. Dexamethasone 10 mg IV every 6 hoursd (or equivalent) or methylprednisolone 1 mg/kg IV every 12 hoursd. Consider repeat neuroimaging (CT or MRI) every 2 to 3 days if patient has persistent ≥ grade 3 neurotoxicity. Monitor for 22 to 24 hours following the next tarlatamab dose. For recurrent grade 3 CRS: Permanently discontinue tarlatamab. |
|
Grade 4a |
ICE score 0b (unarousable and unable to perform ICE) and/or stupor or coma and/or life-threatening prolonged seizure (>5 minutes) or repetitive clinical or electrical seizures without return to baseline in between and/or diffuse cerebral edema on neuroimaging, decerebrate or decorticate posturing or papilledema, cranial nerve VI palsy, or Cushing triad |
Permanently discontinue tarlatamab. ICU care. Consider mechanical ventilation for airway protection. Administer high-dose corticosteroids (eg, methylprednisolone 1 g IV once daily for 3 days, followed by rapid taper)d, f. Consider repeat neuroimaging (CT or MRI) every 2 to 3 days if patient has persistent ≥ grade 3 neurotoxicity. Treat convulsive status epilepticus per institutional guidelines. |
Other adverse reactions:
|
Adverse reaction |
Severity |
Action |
|---|---|---|
|
a Utilize recommendations on restarting tarlatamab after a dose delay. | ||
|
b G-CSF = granulocyte colony stimulating factor. | ||
|
Hematologic toxicity |
Neutropenia, grade 3 or 4 |
Withhold tarlatamab until recovery to ≤ grade 2a. Consider administration of G-CSFb. If recovery to ≤ grade 2 does not occur within 3 weeks, permanently discontinue tarlatamab. |
|
Neutropenia, grade 4, recurrent |
Permanently discontinue tarlatamab. | |
|
Febrile neutropenia |
Withhold tarlatamab until neutrophils recover to ≤ grade 2 and fever resolvesa. | |
|
Hemoglobin <8 g/dL |
Withhold tarlatamab until hemoglobin ≥8 g/dLa. | |
|
Thrombocytopenia, grade 3 or 4 |
Withhold tarlatamab until platelets recover to ≤ grade 2 and there is no evidence of bleedinga. If recovery to ≤ grade 2 does not occur within 3 weeks, permanently discontinue tarlatamab. | |
|
Thrombocytopenia, grade 4, recurrent |
Permanently discontinue tarlatamab. | |
|
Hypersensitivity |
Any |
Based on the severity, withhold tarlatamab or consider permanent tarlatamab discontinuation. Manage as clinically indicated. |
|
Infections |
All grades |
Manage as clinically indicated. Withhold tarlatamab in the step-up phase until infection resolves a. |
|
Grade 3 |
Withhold tarlatamab during the treatment phase until infection improves to ≤ grade 1a. | |
|
Grade 4 |
Permanently discontinue tarlatamab. | |
|
Other adverse reactions |
Grade 3 or 4 |
Withhold tarlatamab until recovery to ≤ grade 1 or baselinea. Consider permanently discontinuing tarlatamab if adverse reaction does not resolve within 28 days. Consider permanently discontinuing tarlatamab for grade 4 events. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Endocrine & metabolic: Decreased serum magnesium (33%), decreased serum potassium (50%), decreased serum sodium (68%), increased serum sodium (26%)
Gastrointestinal: Constipation (30%), decreased appetite (34%), dysgeusia (36%), nausea (22%; grades 3/4: 2%)
Hematologic & oncologic: Anemia 27%; grades 3/4: 6%), decreased neutrophils (12%; grades 3/4: 6%), decreased platelet count (33%; grades 3/4: 3%), lymphocytopenia (84%; grades 3/4: 57%)
Hepatic: Increased serum alanine aminotransferase (42%), increased serum alkaline phosphatase (22%), increased serum aspartate aminotransferase (44%), increased serum bilirubin (15%)
Hypersensitivity: Cytokine release syndrome (55%)
Infection: Infection (41%; including candidiasis [3%], opportunistic infection, pneumonia [9%], respiratory tract infection [3%], urinary tract infection [10%])
Nervous system: Fatigue (51%; including asthenia), neurotoxicity (47%; including delirium [2%], dizziness [7%], headache [14%], immune effector cell-associated neurotoxicity syndrome [ICANS: 9%], insomnia [6%], myasthenia [4%], peripheral neuropathy [7%], syncope [2%])
Neuromuscular & skeletal: Musculoskeletal pain (30%)
Renal: Increased serum creatinine (29%)
Respiratory: Cough (17%), dyspnea (17%)
Miscellaneous: Fever (36%)
1% to 10%:
Endocrine & metabolic: Increased uric acid (grades 3/4: 10%)
Hematologic & oncologic: Prolonged partial thromboplastin time (grades 3/4: 5%)
<1%: Hematologic & oncologic: Febrile neutropenia
Frequency not defined:
Cardiovascular: Pulmonary embolism
Endocrine & metabolic: Respiratory acidosis
Hematologic & oncologic: Tumor lysis syndrome
Respiratory: Aspiration pneumonia, respiratory failure
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to tarlatamab or any component of the formulation.
Concerns related to adverse effects:
• Cytokine release syndrome: Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur with tarlatamab. CRS occurred in over half of tarlatamab-treated patients, including grades 1 and 2, and rare grade 3 and 4 CRS events. Recurrent CRS occurred in nearly one-fourth of patients (including grades 1 and 2 recurrent CRS). Most CRS events (43%) occurred after the first dose; 29% of CRS cases occurred after the second dose, and some cases occurred after the third dose or later. Grade 2 and higher CRS typically occurred after the day 1 dose but have also occurred after the days 8 and 15 infusions in a small percentage of patients. The median time to CRS onset (all grades) from the most recent tarlatamab dose was 13.5 hours (range: 1 to 268 hours). The median time to onset for ≥ grade 2 CRS (from the most recent dose) was 14.6 hours (range: 2 to 566 hours). Clinical signs/symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening CRS complications may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, kidney and/or hepatic failure, and disseminated intravascular coagulation. To reduce the risk of CRS, the recommended step-up dose should be followed, and concomitant medications administered before and after cycle 1 infusions. Administer in an appropriate health care facility equipped to monitor/manage CRS. Counsel patients to seek medical attention if signs/symptoms of CRS occur.
• Cytopenias: Tarlatamab may cause cytopenias (including neutropenia, thrombocytopenia, and anemia). Thrombocytopenia occurred in one-third of tarlatamab patients, with grade 3 or 4 thrombocytopenia occurring in a small percentage of patients. The median time to onset for grade 3 or 4 thrombocytopenia was 50 days (range: 3 to 420 days). Neutropenia, including grade 3 or 4 neutropenia, has been reported. The median time to onset for grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213 days). Febrile neutropenia occurred rarely with tarlatamab. Anemia (decreased hemoglobin) occurred in over half of tarlatamab-treated patients, including some grade 3 or 4 events.
• Hepatotoxicity: Tarlatamab may cause hepatotoxicity. In the pooled safety population, elevated ALT and/or AST commonly occurred; grade 3 or 4 ALT and/or elevations each occurred in a small percentage of patients. Elevated bilirubin levels were also reported, including some grade 3 or 4 bilirubin elevations. Transaminase elevations may occur with or without concurrent CRS.
• Hypersensitivity: Tarlatamab may cause severe hypersensitivity reactions. Clinical hypersensitivity signs/symptoms may include (but are not limited to) rash and bronchospasm.
• Infection: Tarlatamab may cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections (including opportunistic infections) were observed in under half of tarlatamab-treated patients. Grade 3 or 4 infections have been reported. The most frequent infections were COVID-19 (mostly reported during the COVID-19 pandemic), urinary tract infection, pneumonia, respiratory tract infection, and Candida infection.
• Neurotoxicity: Neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur with tarlatamab. Neurologic toxicity (including ICANS) occurred in almost half of tarlatamab-treated patients, including some grade 3 events. The most frequent neurologic toxicities included headache, peripheral neuropathy, dizziness, insomnia, muscular weakness, delirium, syncope, and neurotoxicity. Most patients experienced ICANS following cycle 2 day 1. Grade 2 or higher ICANS was observed following days 1, 8, and 15 infusions in a small number of patients. The median time to onset of ICANS (from the first tarlatamab dose) was 29.5 days (range: 1 to 154 days). ICANS can occur several weeks following tarlatamab administration. The median time to resolution of ICANS was 33 days (range: 1 to 93 days). The onset of ICANS can be concurrent with CRS, following CRS resolution, or in the absence of CRS. Recurrent ICANS occurred in a small number of patients. Clinical signs and symptoms of ICANS may include (but are not limited to) confusion, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia. Tarlatamab increases the risk of neurologic adverse reactions and ICANS, resulting in depressed level of consciousness. Patients experiencing neurologic symptoms should refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Ref). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Ref). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Imdelltra: Tarlatamab-dlle 1 mg (1 ea); Tarlatamab-dlle 10 mg (1 ea) [contains polysorbate 80]
No
Solution (reconstituted) (Imdelltra Intravenous)
1 mg (per each): $1,800.00
10 mg (per each): $18,000.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Imdelltra: Tarlatamab-dlle 1 mg (1 ea); Tarlatamab-dlle 10 mg (1 ea) [contains polysorbate 80]
Tarlatamab is available through specialty distributors. Information regarding distribution is available from the manufacturer at https://www.imdelltrahcp.com/-/media/Themes/Amgen/imdelltrahcp-com/imdelltrahcp-com/documents/Access_Reimbursement_Guide.pdf.
IV: Infuse over 1 hour (at 250 mL/hour) at a constant flow rate using an infusion pump (the pump should be programmable, lockable, nonelastomeric, and have an alarm). The IV catheter for administration of concomitant medications may be used to administer tarlatamab. Flush catheter with NS over 3 to 5 minutes to ensure patency. IV line and catheter materials composed of polyolefin, PVC, and polyurethane have been shown to be compatible with tarlatamab at the specified administration conditions. The use of closed system transfer devices is not recommended (may result in potentially incorrect doses and compatibility testing has not been performed).
Monitor during and after infusion. Administer in a health care facility with appropriate medical support to manage severe reactions such as cytokine release syndrome and neurotoxicity, including immune effector cell–associated neurotoxicity syndrome.
Small cell lung cancer, extensive stage: Treatment of extensive stage small cell lung cancer in adults with disease progression on or after platinum-based chemotherapy.
Tarlatamab may be confused with amivantamab, belantamab mafadotin, elranatamab, epcoritamab, glofitamab, tafasitamab, talquetamab, tebentafusp, teclistamab, tislelizumab, tisotumab vedotin, zanidatamab.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Tarlatamab may increase serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Verify pregnancy status prior to initiating treatment in patients who could become pregnant.
Patients who could become pregnant should use effective contraception during therapy and for 2 months after the last dose of tarlatamab.
Animal reproduction studies have not been conducted. Based on the mechanism of action, in utero exposure to tarlatamab may compromise pregnancy maintenance.
It is not known if tarlatamab is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during treatment and for 2 months after the last dose of tarlatamab.
CBC with differential (prior to treatment, prior to each dose, and as clinically indicated); liver enzymes and bilirubin (prior to treatment, prior to each dose, and as clinically indicated). Verify pregnancy status prior to treatment (in patients who could become pregnant).
Monitor patients in an appropriate health care setting during infusion for all doses. Monitor for 22 to 24 hours after the cycle 1, days 1 and 8 infusions; patients should remain within 1 hour of an appropriate facility and be accompanied by a caregiver for a total of 48 hours from the beginning of each cycle 1, days 1 and 8 infusions. Following the cycle 1, day 15 infusion and cycle 2, days 1 and 15 infusions, observe patients for 6 to 8 hours after tarlatamab infusion. For the cycles 3 and 4, days 1 and 15 infusions, monitor for 3 to 4 hours after tarlatamab infusion and for cycle 5 and beyond, monitor for 2 hours after tarlatamab infusion. If ≥ grade 2 cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), or neurotoxicity develops, extended monitoring is necessary. Monitor patients who experience ≥ grade 2 CRS with continuous cardiac telemetry and pulse oximetry; severe or life-threatening CRS requires intensive monitoring (eg, ICU).
Monitor for CRS (signs/symptoms of CRS may include fever, hypoxia, chills, hypotension, tachycardia, headache, and elevated transaminases) and signs/symptoms of neurologic toxicity (including ICANS). Consider laboratory testing to monitor for disseminated intravascular coagulation, hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function. Monitor for signs/symptoms of cytopenias, hypersensitivity, and/or infections (prior to and during treatment).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up (Ref).
Tarlatamab is a bispecific T-cell engager (BiTE) therapy that directs T cells to cancer cells expressing delta-like ligand 3 (DLL3), independent of major histocompatibility complex (MHC) class I. DLL3 is a protein that inhibits Notch signaling and is usually localized intracellularly in normal cells but is abnormally expressed on the surface of small cell lung cancer cells, rendering it an ideal target in small cell lung cancer (Ref). Tarlatamab consist of 2 single-chain variable fragment (scFv) binding domains, joined by a flexible peptide linker, one which binds to the DDL3 antigen on the surface of cells including tumor cells and the other to CD3 on T-cells leading to T-cell activation, release of inflammatory cytokines, and lysis of DLL3 expressing cells (Ref).
Distribution: Vdss: 8.6 L.
Metabolism: Tarlatamab is expected to be metabolized via catabolic pathways into small peptides.
Half-life elimination: 11.2 days (range: 4.3 to 26.5 days).
Excretion: Clearance: 0.65 L/day.
