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Imdelltra
Tarlatamab‑dlle
$2505.00
1mg · 1 vial
BrandBranded medicine· By Amgen
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FDA boxed warningCytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
About Imdelltra
Overview
Imdelltra contains tarlatamab-dlle, a medicine called a bispecific T-cell engager. It is used to treat adults with extensive-stage small cell lung cancer that has progressed during or after platinum-based chemotherapy. It works by binding to DLL3 on cells, including cancer cells, and CD3 on immune cells called T cells, activating the T cells to destroy cells carrying DLL3.
What it treats
Extensive-stage small cell lung cancer (ES-SCLC) in adults whose disease has progressed during or after platinum-based chemotherapy.
Safety information
Side effects
Common side effects of Imdelltra include cytokine release syndrome (CRS), tiredness, reduced appetite, anemia (low red blood cells), changes in taste, fever, constipation, muscle and bone pain, and nausea. Contact your doctor promptly about serious side effects, including CRS, nervous system toxicity (including immune effector cell-associated neurotoxicity syndrome, or ICANS), low blood cell counts, infections, liver injury, and hypersensitivity reactions. CRS is both common and a serious risk. Severe blood test abnormalities can include low lymphocyte and neutrophil counts (types of white blood cells), low sodium, and high uric acid. Blood counts and liver tests need monitoring during treatment. Depending on the severity of side effects, your doctor may pause or permanently stop treatment.
FDA boxed warning
Cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
Before taking this medicine
The supplied FDA label lists no contraindications for Imdelltra. Warnings include low blood cell counts, infections, liver toxicity and hypersensitivity reactions. Blood counts, liver enzymes and bilirubin require monitoring during treatment, along with signs of infection or hypersensitivity. Treatment may need to be withheld or permanently stopped depending on severity. Imdelltra may harm an unborn baby. Women who could become pregnant should use effective contraception. Do not breastfeed during treatment.
Using Imdelltra
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label IMDELLTRA (AMG757) (TARLATAMAB-DLLE) KIT [AMGEN, INC] (DailyMed, retrieved 19 September 2026).
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