What are the precautions for Imdelltra (Tarlatamab-dlle)?

In clinical studies of Imdelltra (Tarlatamab-dlle), warnings and precautions such as cytokine release syndrome , neurotoxicity (includingICANS), cytopenias, infection, hepatotoxicity, allergy, and embryo-fetotoxicity have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Cytokine release syndrome (CRS): Including serious or life-threatening reactions; In clinical studies, mostCRS events occurred after the first dose. Clinical signs and symptoms include fever, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurotoxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).

Take Imdelltra in the recommended ascending doses Take Imdelltra before and after your Cycle 1 imdeltra infusion to reduce the risk of CRS. Make sure the patient is adequately hydrated before using Imdelltra. During treatment, monitor patients closely for signs and symptoms of CRS. At the first sign of CRS, stop the infusion immediately, assess the patient for hospitalization, and institute supportive care based on severity.

2. Neurotoxicity: Including immune effector cell-associated neurotoxic syndrome (ICANS);The most common neurotoxicity is headache, peripheral neuropathy, dizziness, insomnia, myasthenia, delirium, syncope and neurotoxicity. Clinical signs and symptoms of ICANS may include, but are not limited to, confusion, decreased level of consciousness, disorientation, drowsiness, and mental retardation.

Patients receiving Imdelltraare at risk for neurological adverse reactions andICANS, resulting in a decreased level of consciousness. Patients are advised not to drive and engage in hazardous occupations or activities, such as operating heavy or potentially hazardous machinery, until they develop any neurological symptoms. During treatment, monitor patients closely for signs and symptoms of neurotoxicity and ICANS. As soon as symptoms of ICANS occur, the patient is evaluated immediately and supportive care is provided based on severity.

3. Cytopenia: including neutropenia, thrombocytopenia and anemia. Monitor patients for signs and symptoms of cytopenias. AcceptingPerform a complete blood count before treatment with Imdelltra, before each dose, and as clinically indicated.

4. Infections: May include life-threatening and fatal infections. The most common infections are COVID-19 (during the epidemic), urinary tract infections, pneumonia, respiratory infections and candida infections. Monitor patients for signs and symptoms of infection before and during treatment with Imdelltra and administer treatment as clinically indicated.

5. Hepatotoxicity: In clinical studies, patients may experience an increase in aspartate aminotransferase (AST), an increase in alanine aminotransferase (ALT) , an increase in bilirubin, etc. Increased liver enzymes may be accompanied by or without CRS. Monitor liver enzymes and bilirubin prior to treatment with Imdelltra, before each dose, and as clinically indicated.

6. Allergy: Can cause severe allergic reactions; clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of allergy during treatment with Imdelltra and manage as clinically indicated.

7. Embryonic -Fetal Toxicity: Based on its mechanism of action, Imdelltra may cause harm to the fetus when used by pregnant women. Inform patients of the potential risks to the fetus. Advise females of childbearing potential to use effective contraception during treatment and for 2 months after the last dose.