Key takeaways
- Imdelltra (tarlatamab-dlle) is an immunotherapy drug used to treat extensive-stage small cell lung cancer (SCLC) after platinum-based chemotherapy has stopped working. It works by attaching to both immune system cells and cancer cells to help fight the cancer.
- The drug is given as an intravenous (IV) infusion using a step-up dosing schedule. You’ll be monitored closely at a facility for 22 to 24 hours after the first 2 doses.
- Imdelltra carries boxed warnings for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), both potentially life threatening conditions. Common side effects include fatigue, fever, loss of appetite, constipation, and nausea.
Imdelltra (tarlatamab-dlle) is a type of immunotherapy drug used to treat extensive-stage small-cell lung cancer in certain situations. It’s given as an IV infusion by a healthcare professional.
Imdelltra is a biologic medication. A biologic is made from parts of living organisms. Imdelltra isn’t available in a biosimilar form. Like generic drugs, biosimilars tend to be cheaper than biologics.
Imdelltra is used to treat extensive stage small cell lung cancer (SCLC) in certain adults.
SCLC is a type of lung cancer that grows and spreads quickly. “Extensive” means the cancer has spread through your lungs and to other areas of your body, including nearby lymph nodes. It may cause symptoms such as cough, chest pain, and difficulty breathing.
Imdelltra is used after platinum-based chemotherapy drugs have not worked or have stopped working. Examples of these chemotherapy drugs include cisplatin and carboplatin.
Imdelltra is a type of immunotherapy drug that works by attaching to both immune system cells and cancer cells. This helps activate immune system cells to fight cancer cells.
Like most drugs, Imdelltra may cause mild to serious side effects. Mild side effects that have been reported frequently include:
- fatigue
- fever
- loss of appetite
- a metallic or bitter taste in your mouth
- constipation
- musculoskeletal pain
- nausea
- shortness of breath
- cough
Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Imdelltra can occur, but they aren’t common.
They include:
- Low blood cell counts (cytopenias): This includes low white blood cells (which increase your risk of infections), low red blood cells (which cause tiredness), and low platelets (which can cause bleeding or bruising).
- Serious infections: Imdelltra can cause serious, life threatening infections such as pneumonia or urinary tract infections.
- Liver problems (hepatotoxicity): This is indicated by elevated liver enzymes and bilirubin levels.
- Electrolyte imbalances: You may experience low levels of electrolytes such as potassium and sodium, or high levels of uric acid. High uric acid levels can lead to kidney stones or gout.
- Severe allergic reaction: Symptoms of a severe allergic reaction can include a rash, wheezing, shortness of breath, or tightness in your chest.
- Boxed warnings: Risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which is nervous system damage.
If you think you’re having a medical emergency, you should call 911 or your local emergency number.
Your doctor will recommend the dosage of Imdelltra that’s right for you.
Imdelltra is available in two strengths: 1 milligram (mg) and 10 mg.
It’s given as an intravenous (IV) infusion (an injection into your vein over time) by your doctor or another healthcare professional. Each infusion lasts about 1 hour.
Recommended dosages
To lower the risk of side effects, your doctor will use a “step-up” dosing schedule for your first treatment cycle:
- First dose: 1 mg
- Second dose: 10 mg given 1 week after the first dose
- Third dose: 10 mg given 1 week after the second dose
After the first three doses, you’ll continue receiving one 10-mg infusion of Imdelltra every 2 weeks.
Monitoring after your infusions
Because of the boxed warnings for severe side effects, you will receive your doses in a hospital, clinic, or infusion center.
After your first two doses (days 1 and 8), you will be closely monitored by healthcare professionals at the facility for 22 to 24 hours.
After you leave the facility, you must stay within 1 hour of a hospital or clinic for a total of 48 hours following the start of those infusions, and you must have a caregiver with you. Your doctor will give you steroid medications and IV fluids before and after your first two doses to help reduce side effects.
For later doses, you will still need to be monitored at the facility for 2 to 8 hours after the infusion
If you miss an appointment for an Imdelltra infusion, call your doctor’s office as soon as possible to reschedule. If your dose is delayed for too long, your doctor may need to restart the step-up dosing schedule
Imdelltra is typically used as a long-term treatment. You’ll likely receive it as long as the cancer does not progress and the drug’s side effects are manageable.
Imdelltra begins to work after you receive your first infusion. But you likely won’t feel the drug working in your body. Your doctor will order tests throughout your treatment to check whether Imdelltra is working.
Below is important information you should consider before receiving Imdelltra.
Interactions
Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works.
Imdelltra causes a release of cytokines in your body, which might temporarily affect how your body processes other medications for up to 14 days after a reaction.
Tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take, as well as vitamins and supplements.
Pregnancy and breastfeeding
Imdelltra is not safe to receive during pregnancy because it can harm a fetus.
If you can become pregnant, your doctor may have you take a pregnancy test before you receive Imdelltra infusions. If you are able to become pregnant, you should use birth control throughout your treatment and for 2 months after your final dose.
It’s not known whether Imdelltra passes into breast milk. Because of the potential for serious side effects, you should not breastfeed during your treatment and for 2 months after your last dose.
Imdelltra has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.
Boxed warnings for Imdelltra include:
Risk of cytokine release syndrome (CRS)
Imdelltra may cause CRS, a condition where the drug causes a rapid release of proteins into your blood, resulting in a dangerous, overactive immune system.
CRS is common and usually occurs shortly after your first few doses.
Mild symptoms include fever, fatigue, fast heart rate, and headache. Severe CRS can be life threatening and cause a dangerous drop in blood pressure, breathing problems, bleeding, or liver and kidney failure.
To lower your risk of CRS, your doctor may give you a corticosteroid drug with your Imdelltra infusion.
Risk of nervous system damage
Imdelltra treatment may cause serious neurologic problems, including a life-threatening condition called ICANS. Symptoms can happen days or weeks after treatment and include:
- confusion
- memory loss
- extreme sleepiness
- dizziness
- trouble speaking
- weakness in the arms or legs
- seizures
Because of these risks, your doctor will temporarily stop or completely discontinue Imdelltra if you develop symptoms of CRS or ICANS.
Do not drive, operate heavy machinery, or perform dangerous activities if you experience neurological symptoms like dizziness or confusion.
Whether you have health insurance or not, cost may be a factor when you’re considering Imdelltra. What you’ll pay depends on several factors, including your treatment plan.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. A program called Amgen SupportPlus may also be available.
Other drugs are available that can treat your condition. If you’d like to explore an alternative to Imdelltra, talk with your doctor. They can tell you about other medications that might work well for you.
Examples of other drugs used to treat SCLC include:
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Imdelltrais an immunotherapy drug used to treat adults with extensive-stage SCLC that has progressed after platinum-based chemotherapy.
It is administered by IV infusion, with a step-up dosing schedule to help reduce the risk of severe immune reactions.
Imdelltra carries serious boxed warnings for potentially life threatening conditions: CRS and ICANS. For this reason, doctors will monitor you closely during treatment.
Disclaimer: While Healthline strives for factual, comprehensive, and current information, this article is not a substitute for a licensed healthcare professional’s expertise. Always consult a doctor before taking or discontinuing any medication. Drug information is subject to change and may not cover all uses, directions, precautions, warnings, interactions, reactions, or adverse effects. The lack of a warning does not guarantee a drug’s safety, effectiveness, or appropriateness for all patients or specific uses. Learn more about our approach to content integrity.