Active Ingredient: Tarlatamab
Tarlatamab 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.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1 milligrams tarlatamab, one dose, over the duration of 7 days. Afterwards, intravenous, 10 milligrams tarlatamab, one dose, over the duration of 7 days. Afterwards, intravenous, 10 milligrams tarlatamab, once every 5 weeks.
Table 1. Recommended dosage and schedule of tarlatamab:
| Dosing Schedule | Day | Dose of tarlatamab | Administration Instructions | Recommended Monitoring |
|---|---|---|---|---|
| Step-up Dosing Schedule Cycle 1 | Day 1a | Step-up dosea 1 mg | Administer tarlatamab as a 1-hour intravenous infusion in an appropriate healthcare setting. | Monitor patients from the start of the tarlatamab 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 infusion with tarlatamab, accompanied by a caregiver. |
| Day 8a | 10 mga | |||
| Day 15 | 10 mg | Observe patients for 6-8 hours post tarlatamab infusionb. | ||
| Cycle 2 | Day 1 and 15 | 10 mg | Observe patients for 6-8 hours post tarlatamab infusionb. | |
| Cycles 3 and 4 | Day 1 and 15 | 10 mg | Observe patients for 3-4 hours post tarlatamab infusionb. | |
| Cycle 5 and subsequent infusions | Day 1 and 15 | 10 mg | Observe patients for 2 hours post tarlatamab infusionb. |
a Administer recommended concomitant medications before and after Cycle 1 tarlatamab infusions as described in Table 3.
b Extended monitoring in a healthcare setting is not required unless the patient experiences Grade ≥2 CRS, ICANS or neurological toxicity during prior treatments.
Note: see Table 3 for recommendation on restarting tarlatamab after dose delays.
Administer recommended concomitant medications for tarlatamab administration during Cycle 1 as presented in Table 2 to reduce the risk of cytokine release syndrome.
Table 2. Recommended concomitant medications for tarlatamab administration for Cycle 1:
| Treatment Day | Medication | Administration |
|---|---|---|
| Day 1 and Day 8 | Administer 8 mg of dexamethasone intravenously (or equivalent) | Within 1-hour prior to tarlatamab administration |
| Day 1, Day 8 and Day 15 | Administer 1 liter of normal saline intravenously over 4-5 hours | Immediately after completion of tarlatamab infusion |
If a dose of tarlatamab is delayed, restart therapy based on the recommendation as listed in Table 3 and resume the dosing schedule accordingly. Administer recommended concomitant medications as indicated in Table 2.
Table 3. Recommendations for restarting therapy with tarlatamab after dosage delay:
| Last Dose Administered | Time Since the Last Dose Administered | Actiona |
|---|---|---|
| 1 mg on Cycle 1 Day 1 | 2 weeks or less (≤14 days) | Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
| Greater than 2 weeks (>14 days) | Administer tarlatamab step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. | |
| 10 mg on Cycle 1 Day 8 | 3 weeks or less (≤21 days) | Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
| Greater than 3 weeks (>21 days) | Administer tarlatamab step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. | |
| 10 mg on Cycle 1 Day 15 and subsequent Cycles every 2 weeks thereafter | 4 weeks or less (≤28 days) | Administer tarlatamab 10 mg, then resume with the planned dosage schedule. |
| Greater than 4 weeks (>28 days) | Administer tarlatamab step-up dose 1 mg. If tolerated, increase to 10 mg 1 week later. Then resume with the planned dosage schedule. |
a Administer recommended concomitant medications before and after Cycle 1 tarlatamab infusions and monitor patients accordingly.
No dose reduction for tarlatamab is recommended.
Diagnose CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension.
If CRS is suspected, manage according to the recommendations. Monitor patients who experience Grade 2 or higher CRS (e.g., hypotension not responsive to fluids, or hypoxia requiring supplemental oxygen) with continuous cardiac telemetry and pulse oximetry.
For severe or life-threatening CRS, recommend administering tocilizumab or equivalent therapy and intensive monitoring (e.g., ICU) for supportive therapy. Perform laboratory testing to monitor for disseminated intravascular coagulation (DIC), hematology parameters, as well as pulmonary, cardiac, renal, and hepatic function.
Administer as an intravenous infusion over one hour.
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