Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
IMDYLLTRA is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.
IMDYLLTRA treatment should be initiated under the direction of and supervised by physicians experienced in the use of cancer therapy. It should be administered in an appropriate healthcare facility. See table 2 for recommended concomitant medicinal products.
Patients should be monitored from the start of the infusion for 6 to 8 hours on day 1 and day 8. Additional monitoring and monitoring on subsequent infusions is at the discretion of the physician.
On day 1 and day 8, patients should be instructed to remain within proximity of an appropriate healthcare facility for 24 hours starting from each infusion, accompanied by a caregiver.
Both patients and caregivers should be informed on signs and symptoms of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) prior to discharge.
The recommended dosing schedule of IMDYLLTRA is an initial dose of 1 mg on day 1 followed by 10 mg on days 8, 15, and every 2 weeks thereafter as shown in table 1. Patients should be treated until disease progression or unacceptable toxicity.
Table 1. Recommended dosing schedule of IMDYLLTRA:
| Dose of IMDYLLTRA | |
| Day 1 | 1 mg |
| Day 8 | 10 mg |
| Day 15 and every 2 weeks thereafter | 10 mg |
Concomitant medicinal products for IMDYLLTRA administration should be administered as presented in table 2 to reduce the risk of cytokine release syndrome (see section 4.4).
Table 2. Concomitant medicinal products for day 1 and day 8:
| Treatment day | Medicinal products | Administration |
| Day 1 and day 8 | Administer 8 mg of dexamethasone intravenously (or equivalent) | Within 1 hour prior to IMDYLLTRA infusion |
| Intravenous administration of 1 litre of sodium chloride 9 mg/mL (0.9%) solution for injection is recommended per standard of care guidelines | Immediately after completion of IMDYLLTRA infusion |
If a dose of IMDYLLTRA is delayed, therapy should be restarted based on the recommendations listed in table 3, and the dosing schedule should be resumed accordingly. Recommended concomitant medicinal products should be administered as indicated in table 2.
Table 3. Recommendations for restarting therapy with IMDYLLTRA after dose delay:
| Last dose administered | Time since the last dose administered | Actiona |
| 1 mg on day 1 | 2 weeks or less (≤14 days) | Administer IMDYLLTRA 10 mg, then resume with the planned dosing schedule. |
| Greater than 2 weeks (>14 days) | Administer IMDYLLTRA 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosing schedule. | |
| 10 mg on day 8 | 3 weeks or less (≤21 days) | Administer IMDYLLTRA 10 mg, then resume with the planned dosing schedule. |
| Greater than 3 weeks (>21 days) | Administer IMDYLLTRA 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosing schedule. | |
| 10 mg on day 15 and every 2 weeks thereafter | 4 weeks or less (≤28 days) | Administer IMDYLLTRA 10 mg, then resume with the planned dosing schedule. |
| Greater than 4 weeks (>28 days) | Administer IMDYLLTRA 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosing schedule. |
a Administer recommended concomitant medicinal products before and after IMDYLLTRA infusions on day 1 and day 8 and monitor patients accordingly (see table 2).
No dose reduction for IMDYLLTRA is recommended.
See table 4 for recommended actions for the management of CRS, table 5 for recommended actions for the management of ICANS, and table 6 for the management of other adverse reactions.
CRS should be diagnosed based on clinical presentation (see section 4.4). Patients should be evaluated and treated for other causes of fever, hypoxia, and hypotension. If CRS is suspected, it should be managed according to the recommendations in table 4. Patients who experience grade 2 or higher CRS (e.g., hypotension not responsive to fluids, or hypoxia requiring supplemental oxygen) should be monitored for CRS signs and symptoms including fever, hypotension and hypoxia using pulse oximetry or cardiac telemetry as indicated. For severe or life-threatening CRS, anti-IL-6 therapy is recommended, for example, tocilizumab and admission in an intensive-care unit (ICU) for supportive therapy.
Table 4. Guidelines for grading, dose modification and management of cytokine release syndromea:
| CRS grade | Defining symptoms | IMDYLLTRA dose modification | Management |
| Grade 1 | Symptoms require symptomatic treatment only (e.g., fever ≥38°C without hypotension or hypoxia). | • Withhold IMDYLLTRA until event resolves, then resume IMDYLLTRA at the next scheduled doseb. | • Administer symptomatic antipyretic treatment (e.g., paracetamol) for fever. • Consider dexamethasonec (or equivalent) 4 mg to 10 mg orally or intravenously. |
| Grade 2 | Symptoms require and respond to moderate intervention. • Fever ≥38°C, • Hypotension responsive to fluids not requiring vasopressors, and/or • Hypoxia requiring low flow nasal cannula or blow-by. | • Withhold IMDYLLTRA until event resolves, then resume IMDYLLTRA at the next scheduled doseb. | • Hospitalisation with monitoring for fever, hypotension and hypoxia using pulse oximetry or, as indicated, cardiac telemetry, is recommended. • Administer symptomatic antipyretic treatment (e.g., paracetamol) for fever. • Administer supplemental oxygen and intravenous fluids when indicated. • Consider dexamethasonec (or equivalent) 8 mg orally or intravenously. • Consider tocilizumab (or equivalent). When resuming treatment at the next planned dose, monitor patients at the physician's discretion in an appropriate healthcare facilityb. |
| Grade 3 | Severe symptoms defined as temperature ≥38°C with: • Haemodynamic instability requiring a vasopressor (with or without vasopressin) and/or • Worsening hypoxia or respiratory distress requiring high flow nasal canula (>6 L/min oxygen) or face mask. | • Withhold IMDYLLTRA until the event resolves, then resume IMDYLLTRA at the next scheduled doseb. • For recurrent grade 3 events, permanently discontinue IMDYLLTRA. | In addition to grade 2 treatment: • Intensive monitoring, e.g., ICU care is recommended. • Administer dexamethasonec (or equivalent) 8 mg intravenously every 8 hours up to 3 doses. • Vasopressor support as needed. • High flow oxygen support as needed. • Tocilizumab (or equivalent) is recommended. • Prior to the next dose, administer concomitant medicinal products as recommended for day 1 and day 8 (see table 2). When resuming treatment at the next planned dose, monitor patients at the physician's discretion in an appropriate healthcare facilityb. |
| Grade 4 | Life-threatening symptoms defined as temperature ≥38°C with: • Haemodynamic instability requiring multiple vasopressors (excluding vasopressin) and/or • Worsening hypoxia or respiratory distress despite oxygen administration requiring positive pressure. | Permanently discontinue IMDYLLTRA. | • ICU care. • Per grade 3 treatment. |
a CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading (2019).
b See table 3 for recommendations on restarting IMDYLLTRA after dose delays.
c Taper steroids per standard of care guidelines.
ICU = Intensive Care Unit
Patients should be monitored for signs and symptoms of ICANS. Other causes of neurologic symptoms should be ruled out. Intensive care should be provided for severe or life-threatening neurologic toxicities. If ICANS is suspected, it should be managed according to the recommendations in table 5.
Table 5. Guidelines for grading, dose modification and management of immune effector cell-associated neurotoxicity syndromea:
| ICANS gradea | Defining symptoms | IMDYLLTRA dose modification | Management |
| Grade 1 | ICE score 7-9b with no depressed level of consciousness. | • Withhold IMDYLLTRA until ICANS resolves, then resume IMDYLLTRA at the next scheduled dosec. | • Supportive care. |
| Grade 2 | ICE score 3-6b and/or mild somnolence awaking to voice. | • Withhold IMDYLLTRA until ICANS resolves, then resume IMDYLLTRA at the next scheduled dosec. | • Supportive care. • Dexamethasoned (or equivalent) 8 mg to 10 mg orally or intravenously. • If symptoms worsen, repeat dexamethasone every 12 hours or methylprednisoloned (or equivalent) 1 mg/kg intravenously every 12 hours. • Monitor neurologic symptoms and consider consultation with neurologist and other specialists for further evaluation and management. • Monitor patients at the physician's discretion following the next dose of IMDYLLTRAc. |
| Grade 3 | ICE score 0-2b and/or depressed level of consciousness awakening only to tactile stimulus and/or any clinical seizure focal or generalised that resolves rapidly Or Nonconvulsive seizures on EEG that resolve with intervention and/or focal or local oedema seen on neuroimaging. | • Withhold IMDYLLTRA until the ICANS resolves, then resume IMDYLLTRA at the next scheduled dosec. • If there is no improvement to grade ≤1 within 7 days, permanently discontinue IMDYLLTRA. • For recurrent grade 3 events, permanently discontinue. | • Intensive monitoring, e.g., ICU care is recommended. • Consider mechanical ventilation for airway protection. Dexamethasoned (or equivalent) 10 mg intravenously every 6 hours or methylprednisoloned (or equivalent) 1 mg/kg intravenously every 12 hours. • Consider repeat neuroimaging (CT or MRI) every 2-3 days if patient has persistent grade ≥3 neurotoxicity. • Monitor patients at the physician's discretion following the next dose of IMDYLLTRAc. |
| Grade 4 | ICE score 0b (patient is 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 oedema on neuroimaging, decerebrate or decorticate posturing or papilloedema, cranial nerve VI palsy, or Cushing's triad. | • Permanently discontinue IMDYLLTRA. | • ICU care. • Consider mechanical ventilation for airway protection. • High-dose corticosteroids such as methylprednisoloned 1 000 mg/day in divided doses intravenously for 3 days. • Consider repeat neuroimaging (CT or MRI) every 2-3 days if patient has persistent grade ≥3 neurotoxicity. • Treat convulsive status epilepticus per institutional guidelines. |
a ICANS based on American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading (2019).
b If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital = 4 points); Naming (names 3 objects, e.g., point to clock, pen, button = 3 points); Following commands (e.g., "show me 2 fingers" or "close your eyes and stick out your tongue" = 1 point); Writing (ability to write a standard sentence = 1 point); and Attention (count backwards from 100 by ten = 1 point). If patient is unarousable and unable to perform ICE Assessment (grade 4 ICANS) = 0 points.
c See table 3 for recommendations on restarting IMDYLLTRA after dose delays.
d Taper steroids per standard of care guidelines.
CT = Computed Tomography; EEG = Electroencephalogram; ICU = Intensive Care Unit; MRI = Magnetic resonance imaging
Neutropenia and other adverse reactions should be managed in accordance with table 6.
Table 6. Recommended treatment interruptions of IMDYLLTRA for the management of other adverse reactionsa,b:
| Adverse reactions | Severitya | Dose modificationb |
| Neutropenia (see section 4.4) | Grades 1 and 2 | No treatment interruption needed. |
| Grade 3 | • Interrupt IMDYLLTRA for at least 3 days and until the event improves to grade ≤2, then resume IMDYLLTRA. Consider using granulocyte-colony stimulating factor (G-CSF). | |
| Grade 4 | • Interrupt IMDYLLTRA for at least 3 days and until the event improves to grade ≤2, then resume IMDYLLTRA. • If event lasts for >7 days or grade 4 event reoccurs, permanently discontinue IMDYLLTRA. Consider using granulocyte-colony stimulating factor (G-CSF). | |
| Hepatotoxicity (see section 4.4)c | Grade 3 Increased ALT or AST or bilirubin | • Withhold IMDYLLTRA until improved to grade ≤1. |
| Grade 4 Increased ALT or AST or bilirubin | • Permanently discontinue IMDYLLTRA. | |
| AST or ALT >3 × ULN with total bilirubin> 2 × ULN in the absence of alternative causes | • Permanently discontinue IMDYLLTRA. | |
| Other adverse reactions (see section 4.8) | Grade 3 or 4 | Withhold IMDYLLTRA until recovery to grade ≤1 or baseline. Consider permanently discontinuing if adverse reaction does not resolve within 28 days. • Consider permanent discontinuation for grade 4 events. |
a Severity based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
b See table 3 for recommendations on restarting IMDYLLTRA after dose delays.
c For patients with liver enzyme elevations at baseline, multiples of baseline values should be used for hepatotoxicity assessment.
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
No dose adjustment is necessary in elderly patients (≥65 years of age).
No dose adjustment is required in patients with mild hepatic impairment (see section 5.2). Limited data is available in patients with moderate hepatic impairment. IMDYLLTRA has not been studied in patients with severe hepatic impairment. No dose recommendations can be made for patients with moderate or severe hepatic impairment.
No dose adjustment is required in patients with mild or moderate renal impairment (see section 5.2). IMDYLLTRA has not been studied in patients with severe renal impairment. No dose recommendations can be made for patients with severe renal impairment to end-stage renal disease.
There is no relevant use of IMDYLLTRA in the paediatric population for the treatment of small cell lung cancer.
IMDYLLTRA is for intravenous use.
IMDYLLTRA is to be reconstituted and then further diluted prior to administration by intravenous infusion.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
The infusion line for premedication can be used for IMDYLLTRA. An infusion line flush should be conducted between administering concomitant medicinal products and IMDYLLTRA.
Administer the entire contents of IMDYLLTRA as an intravenous infusion over 1 hour at a constant flow rate using an infusion pump, see table 7. The pump should be programmable, lockable, non-elastomeric, and have an alarm.
The infusion line is primed with sodium chloride 9 mg/mL (0.9%) solution for injection OR final prepared IMDYLLTRA.
Upon completion of the IMDYLLTRA infusion, the intravenous infusion line should be flushed over 3-5 minutes using sodium chloride 9 mg/mL (0.9%) solution for injection.
Table 7. Tarlatamab administration information:
| Infusion duration for 250 mL intravenous preparation | Infusion rate (mL/hour) |
| 1 hour | 250 mL/hour |
Doses up to 100 mg every 2 weeks and 200 mg every 3 weeks have been evaluated in clinical trials. In the event of an overdose, the patient must be closely monitored for signs or symptoms of adverse reactions and should be treated symptomatically, and supportive measures instituted as required.
Unopened vial:
4 years.
Diluted solution for intravenous infusion (infusion bag):
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C to 8°C and 8 hours at 20°C to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the method of reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Store and transport refrigerated (2°C to 8°C).
Do not freeze.
Store in the original packaging in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
IMDYLLTRA consists of two packaging configurations. Each IMDYLLTRA pack contains 1 vial of powder for concentrate for solution for infusion and 2 vials of solution (stabiliser).
IMDYLLTRA 1 mg powder for concentrate and solution for solution for infusion:
IMDYLLTRA 10 mg powder for concentrate and solution for solution for infusion:
Strictly observe aseptic technique when preparing the solution for infusion since tarlatamab vials do not contain antimicrobial preservatives.
Table 10. Required amount of water for injections to reconstitute IMDYLLTRAa:
| IMDYLLTRA vial strength | Amount of water for injections needed to reconstitute IMDYLLTRA | Final concentration |
| 1 mg | 1.3 mL | 0.9 mg/mL |
| 10 mg | 4.4 mL | 2.4 mg/mL |
1. Transfer required amount of water for injections (refer to table 10) into the tarlatamab vial to provide a final tarlatamab concentration of 0.9 mg/mL (1 mg vial) or 2.4 mg/mL (10 mg vial). Direct the water along the walls of the IMDYLLTRA vial and not directly on the lyophilised powder.
2. Gently swirl contents. Do not shake.
3. Visually inspect that the solution is clear to slightly opalescent, colourless to slightly yellow. Do not use if solution is cloudy or has particulates.
Table 11. Preparation guide for 1-hour infusion:
| IMDYLLTRA vial strength | IMDYLLTRA dose | Volume of sodium chloride 9 mg/mL (0.9%) solution for injection to withdraw from infusion bag | Volume of solution (stabiliser) to add to infusion bag | Volume of reconstituted IMDYLLTRA to add to infusion bag |
| 1 mg | 1 mg | 14 mL | 13 mL | 1.1 mL |
| 10 mg | 10 mg | 17 mL | 13 mL | 4.2 mL |
Note: the final concentrations for the different strength vials are NOT the same following reconstitution.
1. Use an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
2. Withdraw the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the pre-filled infusion bag and discard (refer to table 11). Disregard any overfill in the infusion bag.
3. Add solution (stabiliser).
4. Add reconstituted IMDYLLTRA.
5. Remove the air from the infusion bag using an empty syringe to avoid foaming.
6. Prime infusion line with sodium chloride 9 mg/mL (0.9%) solution for injection or final prepared product from the infusion bag.
The storage time per section 6.3 includes total time permitted from point of reconstitution of first vial to the end of administration. After removal from refrigeration, allow the infusion bag to reach room temperature and complete administration of the diluted IMDYLLTRA infusion solution within the allowable room temperature storage time (including infusion time). If the prepared tarlatamab infusion bag is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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