Tarlatamab-dlle Injection

Tarlatamab-dlle injection should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

Tarlatamab-dlle injection may cause a serious, life-threatening reaction known as cytokine release syndrome (CRS) that may occur during and following infusion of this medication. Tell your doctor if you have ever had a reaction to tarlatamab-dlle or any other medication. You will receive certain medications to help prevent an allergic reaction before you receive each dose of tarlatamab-dlle. If you experience any of the following symptoms during or after receiving tarlatamab-dlle, tell your doctor immediately: fever, tiredness, weakness, dizziness, headache, nausea, vomiting, chills, rash, swelling of the face, wheezing, or difficulty breathing. If you experience a severe reaction, your doctor will stop your infusion and treat the symptoms of the reaction.

Tarlatamab-dlle injection may also cause serious, life-threatening central nervous system reactions. Tell your doctor if you have or have ever had seizures, confusion, loss of balance, or trouble speaking. If you experience any of the following symptoms, tell your doctor immediately: seizures, uncontrollable shaking of a part of the body, difficulty speaking, slurred speech, loss of consciousness, difficulty falling asleep or staying asleep, headache, confusion, or loss of balance.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tarlatamab-dlle and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of using tarlatamab-dlle injection.

Tarlatamab-dlle is used for treatment of advanced small cell lung cancer (SCLC) that has progressed on or after other treatments. Tarlatamab-dlle is in a class of medications called bispecific T-cell engager antibodies. It works by slowing or stopping the growth of cancer cells in your body.

Tarlatamab-dlle comes as a powder to be mixed with a liquid and to be given intravenously (into a vein) by a doctor or a nurse at a hospital or medical clinic. Tarlatamab-dlle will be given every 7 days for 3 doses and then every 2 weeks.

Your doctor may need to delay your treatment, change your dose, or stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with tarlatamab-dlle injection.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving tarlatamab-dlle,

• tell your doctor and pharmacist if you are allergic to tarlatamab-dlle, any other medications, or any of the ingredients in tarlatamab-dlle injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have an infection or if you have or have ever had an infection that keeps coming back. Also, tell your doctor if you have ever had radiation therapy to the brain or have received chemotherapy or have or have ever had liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you receive this medication. You should not become pregnant during your treatment with tarlatamab-dlle and for at least 2 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using tarlatamab-dlle, call your doctor. Tarlatamab-dlle may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed while receiving tarlatamab-dlle and for at least 2 months after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving tarlatamab-dlle.
• do not have any vaccinations without talking to your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Tarlatamab-dlle may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• reduced appetite
• nausea
• constipation
• muscle pain
• shortness of breath
• cough
• bad or metallic taste in the mouth

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• shortness of breath, trouble breathing, rash, wheezing
• tiredness, loss of appetite, pain in the upper, right-side of the stomach, dark urine, yellowing of skin or whites of eyes
• fever, cough, chest pain, shortness of breath, tiredness, sore throat, pain during urination, feeling unwell

Tarlatamab-dlle may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to tarlatamab-dlle.

If you miss a scheduled appointment for a tarlatamab-dlle dose, call your doctor or clinic right away to reschedule.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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