Pronunciation:

tar-LAT-ue-mab - dlle

Brand Names:

• Imdelltra

Dosage Forms:

• Powder for Solution

Warnings:

Cytokine Release Syndrome and Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity SyndromeCytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving tarlatamab-dlle. Initiate treatment with tarlatamab-dlle using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold tarlatamab-dlle until CRS resolves or permanently discontinue based on severity.Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving tarlatamab-dlle. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold tarlatamab-dlle until ICANS resolves or permanently discontinue based on severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tarlatamab

Uses of This Medicine:

Tarlatamab-dlle injection is used to treat extensive stage small cell lung cancer (ES-SCLC) that has spread throughout the lung or to other parts of the body in patients who have received other cancer medicines (eg, platinum) that did not work well.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tarlatamab-dlle injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tarlatamab-dlle injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 1 hour. Your treatment schedule is divided into cycles that are usually 28 days long.

You will receive this medicine on a "step-up dosing schedule." This means you will receive a smaller dose on Day 1 of your first treatment cycle. Then, you will receive the full treatment dose on Day 8 and Day 15 of Cycle 1. You will receive your full dose every 2 weeks after Day 15 of Cycle 1.

Your doctor will ask you to stay in a medical facility during treatment with this medicine:

• For 22 to 24 hours on Day 1 and Day 8 of Cycle 1 doses.
• For 6 to 8 hours on Day 15 of Cycle 1 and Cycle 2 doses.
• For 3 to 4 hours on Cycle 3 and Cycle 4 doses.
• For 2 hours on Cycle 5 and later doses.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your may also receive extra fluids and other medicines (eg, steroid medicine) within 1 hour before or immediately after starting treatment with this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, confusion, double vision, drowsiness, restlessness, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious infections. Avoid being near people who are sick or have infections. Wash your hands often. Check with your doctor right away if you have a fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing or swallowing.

This medicine may cause dizziness, confusion, sleepiness, or tremors. Do not drive or do anything else that could be dangerous during treatment with this medicine until you know how this medicine affects you.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bladder pain

blood in the stools

bloody or cloudy urine

blurred vision

bruising

burning, numbness, tingling, or painful sensations

chest pain, discomfort, or tightness

confusion

cough

coughing or vomiting blood

diarrhea

difficult, burning, o painful urination

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fever or chills

frequent urge to urinate

headache

lower back or side pain

muscle or body pain

nausea

new loss of taste or smell

pale skin

sneezing

sore throat

stuffy or runny nose

sweating

swelling of the face, fingers, feet, or lower legs

trembling and shaking of the hands

trouble breathing

trouble sleeping

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weakness in the arms, hands, legs, or feet

weight gain

Less common

Coma

confusion as to time, place, or person

decreased urine output

ear congestion

hallucinations

holding false beliefs that cannot be changed by fact

increased thirst

loss of voice

muscle cramps

seizures

unusual excitement, nervousness, or restlessness

Rare

Anxiety

blue lips, fingernails, or skin

Incidence not known

Black, tarry stools

bleeding gums

dark urine

loss of appetite

pinpoint red spots on the skin

stomach pain, severe

trouble swallowing

ulcers, sores, or white spots in the mouth

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Arm or leg pain

back pain

bone pain

change in taste

constipation

difficulty in moving

joint pain or swelling

muscle aches, cramps, or stiffness

neck pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.