What is IMDELLTRA™ (tarlatamab-dlle)? IMDELLTRA™ is a prescription medicine used to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which is cancer that has spread throughout lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or …READ MORE
IMDELLTRA™ is a prescription medicine used to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which is cancer that has spread throughout lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if IMDELLTRA™ is safe and effective in children.
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Based on 99 patients, of which 2 patients saw their tumor completely disappear, and 38 patients saw their tumor partially shrink by at least 30%.2,4,5
Important Considerations: The approval of IMDELLTRA™ in these patients is based on a study that measured the size of tumor shrinkage. Talk to your healthcare provider to see if IMDELLTRA™ is right for you.2,5
Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA™ and can also be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:
Neurologic Problems. IMDELLTRA™ can cause neurologic problems that can be serious or life-threatening. Neurologic problems may happen days or weeks after you receive IMDELLTRA™. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:
Due to the risk of CRS and neurologic problems, you will receive the following monitoring during treatment with IMDELLTRA™:
Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with IMDELLTRA™, as well as other side effects, and treat you as needed. You may be hospitalized if you develop signs or symptoms of CRS or neurologic problems during treatment with IMDELLTRA™. Your healthcare provider may temporarily stop or completely stop your treatment with IMDELLTRA™ if you develop CRS, neurologic problems, or any other side effects that are severe.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Do not drive, operate heavy or potentially dangerous machinery or do other dangerous activities, including work-related activities, during treatment with IMDELLTRA™ if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
Low white blood cell counts (cytopenia). Decreased blood cell counts are common with IMDELLTRA™ and can also be severe. IMDELLTRA™ may cause the following low blood cell counts:
Infections. IMDELLTRA™ can cause serious infections that can be life-threatening and may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with IMDELLTRA™. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with IMDELLTRA™, including: fever of 100.4°F (38°C) or higher; painful rash, cough, sore throat, chest pain, pain during urination, tiredness, feeling weak or generally unwell, shortness of breath.
Liver problems. IMDELLTRA™ can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any signs or symptoms of liver problems, including: tiredness, dark urine, loss of appetite, yellowing of your skin or the white part of your eyes, pain in your right upper stomach-area (abdomen).
Allergic reactions. IMDELLTRA™ can cause allergic reactions that can be severe. Go to the nearest emergency room or get medical help right away if you develop any signs or symptoms of a severe allergic reaction during treatment with IMDELLTRA™, including: shortness of breath or trouble breathing, coughing, pain or tightness in your chest and back, feeling lightheaded or dizzy, wheezing, rash.
Your healthcare provider will do bloodwork before you start and during treatment with IMDELLTRA™. Your healthcare provider will monitor you for signs or symptoms of these serious side effects during treatment and may temporarily or completely stop treatment with IMDELLTRA™ if you develop certain serious side effects.
The most common side effects of IMDELLTRA™ also include: tiredness, muscle or bone pain, fever, constipation, a bad or metallic taste in your mouth, nausea, decreased appetite.
These are not all the possible side effects of IMDELLTRA™.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see IMDELLTRA™ full Prescribing Information, including Medication Guide.
IMDELLTRA™ is a prescription medicine used to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which is cancer that has spread throughout lung or to other parts of the body, and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if IMDELLTRA™ is safe and effective in children.
Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA™ and can also be serious or life-