Tarlatamab (Tarlatamab) Chinese instruction manual: indications, usage and dosage, adverse reactions, precautions

Tarlatamab, developed by Amgen of the United States, is a first-of-its-kind bispecific antibody drug targeting delta-like ligand 3 (DLL3) and CD3. It can simultaneously bind to DLL3 expressed on the surface of tumor cells and CD3 on the surface of T cells, thereby activating T cells to kill tumors. The drug was approved by the U.S. FDA on May 16, 2024, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

Tarlatamab (Tarlatamab) Indications

Tarlatamab (Tarlatamab) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during 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 dependent on verification and description of clinical benefit in confirmatory trials.

Tarlatamab usage and dosage

1. Incremental dosing

(1) Day 1 of cycle 1: Tarlatamab dose is ‌1mg‌ and needs to be monitored for 22 to 24 hours. It is recommended to stay in a medical institution for a total of 48 hours (including 1 hour after the start of infusion), and be accompanied by nursing staff during this period.

(2) Day 8 of cycle 1: The dose of talatumumab is increased to ‌10mg‌, and the monitoring requirements are the same as above.

(3) Day 15 of Cycle 1: The dose of talatumumab is maintained at ‌10mg‌, and observation is carried out for 6 to 8 hours after infusion.

2. Subsequent cycles ‌

(1) Day 1 and day 15 of cycle 2: The dose of talatumumab is ‌10mg‌, and the patient is observed for 6 to 8 hours after infusion.

(2) Days 1 and 15 of cycles 3 and 4: The dose of talatumumab is maintained at ‌10mg‌, and the observation time after infusion is shortened to 3 to 4 hours.

(3) Cycle 5 and subsequent infusion days 1 and 15: The dose of talatumumab is still ‌10 mg‌, and the observation time after infusion is further shortened to 2 hours.

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Adverse reactions of Tarlatamab

1. Common adverse reactions (≥20%)

Common adverse reactions of Tarlatamab are cytokine release syndrome, fatigue, fever, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.

2. Common grade 3 or 4 laboratory abnormalities (≥2%)

Tarlatamab (Tarlatamab) common ones are lymphopenia, decreased sodium, increased uric acid, decreased total neutrophil count, decreased hemoglobin, increased activated partial thromboplastin time, decreased potassium, increased aspartate aminotransferase, decreased leukocytes, decreased platelets, and increased alanine aminotransferase.

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Tarlatamab precautions

1. Cytokine release syndrome

Tarlatamab may cause cytokine release syndrome (CRS), including severe or life-threatening reactions. Monitor patients closely for signs and symptoms of CRS during treatment with talatumumab. Once signs of CRS appear, stop the infusion immediately, evaluate the patient for hospitalization, and initiate supportive care depending on the severity. Withhold or permanently discontinue talatumumab based on severity. If signs or symptoms of CRS occur, patients are advised to seek medical attention.

2. Nervous system toxicity

Talatumumab can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxic syndrome. Monitor patients closely for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of immune effector cell-associated neurotoxic syndrome, patients are immediately evaluated and supportive care is provided based on severity. Withhold talatumumab or permanently discontinue based on severity.

3. Cytopenia

Talatuzumab can cause cytopenias, including neutropenia, thrombocytopenia and anemia. Monitor patients for signs and symptoms of cytopenias. Perform a complete blood count prior to treatment with talatumumab, before each dose, and as clinically indicated. Depending on the severity of cytopenias, the drug may be temporarily or permanently discontinued.

4. Infection

Talatuzumab can cause serious infections, including life-threatening and fatal infections. Monitor patients for signs and symptoms of infection before and during treatment with talatumumab and treat as clinically indicated. Withhold or permanently discontinue medication based on severity.

5. Hepatotoxicity

Talatuzumab can cause hepatotoxicity. Monitor liver enzymes and bilirubin prior to treatment with talatumumab, before each dose, and as clinically indicated. Withhold talatumumab or permanently discontinue based on severity.

6. Hypersensitivity reaction

Talatuzumab can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity reactions during treatment with talatumumab and manage as clinically indicated. Discontinue or consider permanently discontinuing treatment based on severity.

7. Embryo-fetal toxicity

Talatuzumab may cause harm to the fetus when administered to pregnant women. Inform the patient of the potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment with talatumumab and for 2 months after the last dose.