Version October 2024
Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving tarlatamab. Initiate treatment with tarlatamab using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold tarlatamab until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving tarlatamab. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold tarlatamab until ICANS resolves or permanently discontinue based on severity.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Endocrine & metabolic: Decreased serum magnesium (33%), decreased serum potassium (50%), decreased serum sodium (68%), increased serum sodium (26%)
Gastrointestinal: Constipation (30%), decreased appetite (34%), dysgeusia (36%), nausea (22%; grades 3/4: 2%)
Hematologic & oncologic: Anemia 27%; grades 3/4: 6%), decreased neutrophils (12%; grades 3/4: 6%), decreased platelet count (33%; grades 3/4: 3%), lymphocytopenia (84%; grades 3/4: 57%)
Hepatic: Increased serum alanine aminotransferase (42%), increased serum alkaline phosphatase (22%), increased serum aspartate aminotransferase (44%), increased serum bilirubin (15%)
Hypersensitivity: Cytokine release syndrome (55%)
Infection: Infection (41%; including candidiasis [3%], opportunistic infection, pneumonia [9%], respiratory tract infection [3%], urinary tract infection [10%])
Nervous system: Fatigue (51%; including asthenia), neurotoxicity (47%; including delirium [2%], dizziness [7%], headache [14%], immune effector cell-associated neurotoxicity syndrome [ICANS: 9%], insomnia [6%], myasthenia [4%], peripheral neuropathy [7%], syncope [2%])
Neuromuscular & skeletal: Musculoskeletal pain (30%)
Renal: Increased serum creatinine (29%)
Respiratory: Cough (17%), dyspnea (17%)
Miscellaneous: Fever (36%)
1% to 10%:
Endocrine & metabolic: Increased uric acid (grades 3/4: 10%)
Hematologic & oncologic: Prolonged partial thromboplastin time (grades 3/4: 5%)
<1%: Hematologic & oncologic: Febrile neutropenia
Frequency not defined:
Cardiovascular: Pulmonary embolism
Endocrine & metabolic: Respiratory acidosis
Hematologic & oncologic: Tumor lysis syndrome
Respiratory: Aspiration pneumonia, respiratory failure
There are no contraindications listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Imdelltra: Tarlatamab-dlle 1 mg (1 ea); Tarlatamab-dlle 10 mg (1 ea) [contains polysorbate 80]
No
Small cell lung cancer, extensive stage: Treatment of extensive stage small cell lung cancer in adults with disease progression on or after platinum-based chemotherapy.
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