Uses
What is Imdelltra used for?
Imdelltra is used to treat a certain type of lung cancer called extensive stage small-cell lung cancer (ES-SCLC). Extensive small-cell lung cancer is a cancer that has spread throughout the lungs and to other parts of the body.
Imdelltra may also be used for other conditions as determined by your healthcare provider.
How does Imdelltra work (mechanism of action)?
DLL3 is a protein found in small-cell lung cancer cells. Imdelltra works by activating a type of white blood cell in your body (T-cells) to attack your DLL3 cancer cells.
How is Imdelltra supplied (dosage forms)?
Imdelltra is available in a 1 mg or 10 mg vial that is diluted and injected into a blood vessel.
How should I store Imdelltra?
Imdelltra is given by a healthcare provider in a hospital or clinic.
Side Effects
What are the most common side effects of Imdelltra?
The most common side effects of Imdelltra are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- A condition that causes your immune system to go into overdrive (cytokine release syndrome) (see below)
- Tiredness
- Fever
- Change in how things taste
- Decreased appetite
- Muscle or bone pain
- Constipation
- Low levels of red blood cells (anemia)
- Nausea
- Increase in uric acid
- Changes in levels of certain types of blood cells and electrolytes
- Changes in liver function tests
There may be other side effects of Imdelltra that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Imdelltra?
While less common, the most serious side effects of Imdelltra are described below, along with what to do if they happen.
Severe Allergic Reactions. Imdelltra may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems, wheezing, or coughing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Pain or tightness in your chest and back
Cytokine Release Syndrome. Imdelltra can cause a condition called cytokine release syndrome (CRS), which is when your immune system becomes overactive and causes inflammation all over your body. You may be more at risk of experiencing cytokine release syndrome when you first start receiving Imdelltra. You may receive a smaller dose of Imdelltra when you first start treatment and may be given other medicines and fluids to manage your symptoms. Call your healthcare provider right away if you experience any of the following signs or symptoms of cytokine release syndrome.
- Fever
- Dizziness, feeling lightheaded, or fainting (which can be caused by low blood pressure)
- Tiredness
- Fast heartbeat
- Headache
- Trouble breathing or shortness of breath
- Nausea
- Vomiting
- Confusion, anxiety, or restlessness
- Trouble with balance and movement
- Heart, liver, or kidney problems
- Unusual bleeding or bleeding that lasts a long time
Neurological Problems. Imdelltra can cause neurological problems including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) that can happen days or weeks after you receive treatment. Your healthcare provider may refer you to another healthcare provider that specializes in neurological problems. Call your healthcare provider right away if you experience any of the following signs or symptoms of neurological problems.
- Trouble speaking, memory loss, or personality changes
- Confusion, feeling disorientated, slow thinking, or not being able to think clearly
- Seizures
- Problems with walking or loss of balance/coordination
- Tingling, numbness, or weakness in your arms, hands, legs, or feet
- Tremors or shaking
- Headache
- Numbness or tingling of your hands or feet
- Trouble sleeping
- Fainting or losing consciousness
- Tiredness
Blood Disorders. Imdelltra can cause blood disorders, such as low red blood cell levels (anemia), low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). Your healthcare provider will do bloodwork before and during treatment with Imdelltra. Get help right away if you have any of the following symptoms of blood disorders.
- Fever
- Shortness of breath
- Pale or yellowish skin
- Easy bruising or bleeding
- Frequent infection
- Unusual weakness or tiredness
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Headache
- Fast or abnormal heartbeat
Infection. Imdelltra can increase the risk of infections, including serious infections. Your healthcare provider will check for signs and symptoms of an infection before and during treatment with Imdelltra. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
- Chest pain
- Tiredness
- Painful rash
- Sore throat
Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Imdelltra. Your healthcare provider will monitor your liver function before and during treatment with Imdelltra. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Warnings & Precautions
Who should not use Imdelltra?
Allergies to Ingredients. People who are allergic to any of the following should not use Imdelltra.
- Imdelltra
- Tarlatamab-dlle
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Imdelltra.
What should I know about Imdelltra before using it?
Imdelltra can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination during treatment with Imdelltra if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair your consciousness until your signs and symptoms go away.
Your healthcare provider will decide how many treatment cycles of Imdelltra you will receive. Each treatment cycle is usually 28 days (4 weeks).
Your healthcare provider will discuss with you how they would like to monitor you and how long they would like to monitor you after you have received Imdelltra. When you first receive Imdelltra (Cycle 1), your healthcare provider may recommend you stay within 1 hour of either a hospital or clinic with a caregiver in case you experience any side effects. This is because your risk of cytokine release syndrome and neurological problems may be the highest when you first start receiving Imdelltra.
Drink plenty of water to stay hydrated before receiving your dose of Imdelltra.
What should I tell my healthcare provider before using Imdelltra?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Imdelltra is right for you.
In particular, make sure that you discuss any of the following.
Infection. Tell your healthcare provider if you have an infection or signs of an infection (see Serious Side Effects for more information). Imdelltra may cause serious infections.
Pregnancy. Imdelltra may cause harm to an unborn baby. Use effective forms of contraception (birth control, condoms, etc.) while you are receiving Imdelltra and 2 months after your last dose of Imdelltra. Your healthcare provider may do a pregnancy test before you start treatment with Imdelltra. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, contact your healthcare provider.
Breastfeeding. It is not known if Imdelltra passes into breast milk. Do not breastfeed during your treatment with Imdelltra and for 2 months after your last dose of Imdelltra. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Imdelltra?
For more information about Imdelltra, you can visit the manufacturer’s website at https://www.amgen.com/ or call them at 800-772-6436.
Interactions
Does Imdelltra interact with foods or drinks?
There are no known interactions between Imdelltra and foods or drinks.
It is unknown if drinking alcohol will affect Imdelltra. The risk of dizziness, confusion, and sleepiness may be increased if you drink alcohol while using Imdelltra.
Does Imdelltra interact with other medicines (drug interactions)?
There are no known interactions between Imdelltra and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Imdelltra?
If you or someone else has used too much Imdelltra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Imdelltra?
Imdelltra is given by a healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving Imdelltra as scheduled.