IMDELLTRA

/ Amgen

Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients
from the start of this medical product infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
After step-up dosing schedule, administer tarlatamab biweekly (every 2 weeks)
until disease progression or unacceptable toxicity.
See prescribing information for full details.

For the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Hypersensitivity to the active substance or to any of the excipients.

Cytokine Release Syndrome
This medical product can cause cytokine release syndrome (CRS) including serious or life-threatening reactions. 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 this medical product in an appropriate health care facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA.
Neurologic Toxicity Including ICANS
Tarlatamab can cause serious or life-threatening neurologic toxicity, including ICANS. 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.
Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of ICANS, immediately evaluate the patient and provide supportive therapy based on severity. Withhold this medical product or permanently discontinue based on severity.
Cytopenias
Tarlatamab can cause cytopenias including neutropenia, thrombocytopenia, and anemia.
Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with IMDELLTRA, before each dose, and as clinically indicated. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue.
Infections
Tarlatamab can cause serious infections, including life-threatening and fatal infections. infections including opportunistic infections. Grade 3 or 4 infections occurred in 13% of patients. The most frequent infections were COVID-19 (9%,
majority during the COVID-19 pandemic), urinary tract infection (10%), pneumonia (9%), respiratory tract infection (3.2%), and candida infection (3.2%). Monitor patients for signs and symptoms of infection prior to and during treatment with tarlatamab and treat as clinically indicated. Withhold or permanently discontinue this medical product based on severity.
Hepatotoxicity
Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA, before each dose, and as clinically indicated. Withhold this medical product or permanently discontinue based on severity.
Hypersensitivity
Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with tarlatamab and manage as clinically indicated. Withhold or consider permanent discontinuation of tarlatamab based on severity.
Embryo-Fetal Toxicity
Based on its mechanism of action, tarlatamab may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with tarlatamab and for 2 months after the last dose.
Effects on ability to drive and use machines
Patients receiving tarlatamab 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, in the event of any neurologic symptoms until they resolve.
See prescribing information for full details.

clinically significant adverse reactions:
Cytokine Release Syndrome (CRS), Neurologic Toxicity Including ICANS, cytopenias, Infections, hepatotoxicity, hypersensitivity.
See prescribing information for full details.

Please refer to the license holder for further details.

Fertility
Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area)
Pregnancy: Based on its mechanism of action, tarlatamab may cause fetal harm when administered to a pregnant woman. There are no available data on the use of tarlatamab in pregnant women to inform a drug-associated risk.
Lactation: There is insufficient information on the excretion of pegfilgrastim /metabolites in human milk, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.