Imdelltra

Pronunciation: im-del-trah
Generic name: tarlatamab-dlle
Dosage form: injection for IV administration

Medically reviewed by Carmen Pope, BPharm. Last updated on May 24, 2024.

What is Imdelltra?

Imdelltra (tarlatamab) is an injectable new cancer medication that may be used to treat adults with small cell lung cancer, extensive-stage (ES-SCLC) who have already received chemotherapy that contains platinum but it did not work or is no longer working.

Imdelltra (tarlatamab-dlle) is a bispecific T-cell engager with two arms that bind to different targets. One arm binds to DLL3 expressed on the surface of cells, including tumor cells, and the other binds to CD3 expressed on the surface of T-cells. This brings T-cells and tumor cells closer together. Imdelltra works by activating the immune system at the site of the cancer.

Imdelltra was approved on 16 May 2024 under the accelerated approval designation. Continued approval may be contingent upon continued benefits seen in clinical trials.

Imdelltra side effects

Imdelltra may cause serious side effects, including cytokine release syndrome (CRS), low blood cell counts (cytopenias), infections, liver toxicity, hypersensitivity reactions, neurological problems, and may be harmful to an unborn baby (see warnings below).

The most common side effects of Imdelltra affecting 20% or more people include:

Cytokine release syndrome
Fatigue and tiredness
Fever
A bad or metallic taste in your mouth
Decreased appetite
Muscle and bone pain
Constipation
Nausea.

The most common severe abnormal lab test results with Imdelltra include decreased white blood cells, decreased sodium, increased uric acid, decreased red blood cells, increased blood clotting time, decreased potassium, increased liver enzymes, and decreased platelets.

These are not all of the possible side effects of Imdelltra. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Imdelltra may cause serious side effects, including:

Cytokine Release Syndrome (CRS). CRS is common during Imdelltra treatment 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:

Fever of 100.4°F (38°C) or higher
Low blood pressure
Tiredness
Fast heartbeat or dizziness
Headache
Shortness of breath or trouble breathing
Nausea and vomiting
Confusion, restlessness, or feeling anxious
Problems with balance and movement, such as trouble walking
Heart, liver, or kidney problems
Unusual bleeding or bleeding that lasts a long time.

Low blood cell counts (cytopenias). Decreased blood cell counts are common with Imdelltra and can also be severe and may include:

Low white blood cell counts (neutropenia) which can increase your risk for infection.
Low red blood cell counts (anemia) which can cause tiredness and shortness of breath.
Low platelet counts (thrombocytopenia) which can cause bruising or bleeding problems.

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. Tell your healthcare provider right away if you develop any signs or symptoms of infection, such as:

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
Loss of appetite
Pain in your right upper stomach area (abdomen)
Dark urine
Yellowing of your skin or the white part of your eyes.

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 such as:

Shortness of breath or trouble breathing
Pain or tightness in your chest and back
Wheezing
Coughing
Feeling lightheaded or dizzy
Rash.

Neurologic problems, that can be serious or life-threatening. These 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:

Trouble speaking, memory loss, or personality changes
Confusion, feeling disoriented, slow thinking, or not being able to think clearly
Seizures
Problems with walking, loss of balance, or coordination
Weakness or numbness of your arms or legs
Shaking (tremors)
Headache
Numbness or tingling of your hands or feet
Trouble sleeping
Fainting or loss of consciousness
Feeling like you have no energy.

May cause harm to an unborn baby.

It is not known if Imdelltra is safe and effective in children.

Your healthcare provider will do bloodwork before you start and during treatment with Imdelltra and monitor you for signs or symptoms of these serious side effects during treatment and may temporarily or completely stop treatment if you develop certain serious side effects.

Before taking

Before receiving Imdelltra, tell your healthcare provider about all of your medical conditions, including if you:

have an infection or signs of an infection
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Imdelltra may harm your unborn baby. For females who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Imdelltra and you should use an effective form of birth control (contraception) during treatment, and for 2 months after your last dose.

Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment.

Breastfeeding

It is not known if Imdelltra passes into your breast milk. Do not breastfeed during treatment with Imdelltra and for 2 months after the last dose.

How is Imdelltra administered?

Imdelltra is administered by a healthcare provider in a clinic or hospital.

It is administered by intravenous (IV) infusion through a needle placed in a vein.
The infusion will take about 1 hour.

Your Imdelltra treatment schedule is divided into cycles that are usually 28 days (4 weeks) long.

Your healthcare provider will decide how many treatment cycles you will receive.
Due to the risk of CRS, you will receive Imdelltra on a “step-up dosing schedule”:
This means you will receive a smaller dose of Imdelltra on Day 1 of your first treatment cycle (Cycle 1).
You will receive the full treatment dose on Day 8 and Day 15 of Cycle 1.
You will receive the full treatment dose 1 time every 2 weeks after Day 15 of Cycle 1.
If your dose of Imdelltra is delayed for any reason, you may need to repeat the “step-up dosing schedule”.

Before receiving your Day 1 and Day 8 doses of Cycle 1, you will be given a medicine to help reduce your risk of CRS. This will be given into your vein by intravenous (IV) infusion.

You will also receive IV fluids after each of your Cycle 1 doses of Imdelltra (on Day 1, Day 8, and Day 15). Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

Due to the risk of CRS and neurologic problems, you will receive the following monitoring during treatment

For Day 1 and Day 8 of Cycle 1 doses, your healthcare provider will monitor you for 22 to 24 hours from the start of the Imdelltra infusion in an appropriate healthcare setting that can manage these side effects.
- You should stay within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the Imdelltra infusion after your Day 1 and Day 8 of Cycle 1 doses and be accompanied by a caregiver.
For Day 15 of Cycle 1 and Cycle 2 doses, your healthcare provider will watch you for 6 to 8 hours after the Imdelltra infusion.
For Cycle 3 and Cycle 4 doses, your healthcare provider will watch you for 3 to 4 hours after the Imdelltra infusion.
For Cycle 5 and later doses, your healthcare provider will watch you for 2 hours after the Imdelltra infusion.

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.

Your healthcare provider may temporarily stop or completely stop your treatment with Imdelltra if you develop CRS, neurologic problems, or any other severe side effects.

What should I avoid while receiving Imdelltra?

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.

What other drugs will affect Imdelltra?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Specific drug interactions are not listed in the product information for Imdelltra but other medications that have similar side effects, for example, cause CRS, low blood cell counts, liver problems, affect the immune system, or cause neurological problems, may potentially interact.

Talk to your healthcare provider about interactions with Imdelltra.

Storage

Store Imdelltra and the IV Solution Stabilizer (IVSS) vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until the time of use. Do not freeze.

May be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect it from light.

Imdelltra ingredients

Active ingredients: tarlatamab-dlle

Inactive ingredients: glutamic acid, polysorbate 80, sucrose, and sodium hydroxide.

Inactive ingredients of IV solution stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for Injection.

Available in 1mg and 10mg vials that require reconstitution and further dilution.