Tarlatamab

Tarlatamab is used to treat adults with extensive stage small cell lung cancer (ES-SCLC), when the cancer has progressed while on or after platinum-based chemotherapy.

Tarlatamab may also be used for reasons not mentioned in this medication guide.

Tarlatamab is given as an infusion into a vein by a healthcare provider. You will receive the infusion only on certain days during your first 28-day cycle and then will continue receiving it once every 2 weeks.

This medicine must be given slowly over 60 minutes.

You will need to be well hydrated before receiving tarlatamab. Ask your doctor if you need to drink extra fluids before your infusion.

Your doctor will need to check your progress regularly.

You will be monitored during and after your infusion for signs of an allergic reaction or other serious side effects.

You may be given other medications to treat or prevent certain side effects.

You will need frequent medical tests and your cancer treatments may be delayed or stopped based on the results.

After each of your first two infusions of tarlatamab, you must stay within one hour of the clinic or hospital for 48 hours and make sure you have a caregiver with you during this time. You will be monitored for a shorter time following later infusions. Your doctor will tell you how long you need to stay for monitoring.

Tarlatamab can lead to serious side effects, such as cytokine release syndrome (CRS) and neurologic issues. CRS and neurologic issues can be severe, life-threatening, or may result in death. Some side effects might require additional treatments, and your cancer treatment could be delayed or stopped.

Call your doctor immediately or seek emergency medical help if you experience: fever, chills, severe tiredness, a fast heartbeat, shortness of breath, nausea or vomiting, headache, dizziness, confusion, muscle weakness, numbness or tingling, problems with walking or balance, trouble speaking, memory loss, personality changes, shaking, unusual sleepiness, fainting, seizures, unusual bleeding, or any other new or serious side effect.

Tell your doctor if you have or have ever had:

• an allergic reaction to tarlatamab; or
• an active or chronic infection.

May harm an unborn baby. You will need to take a pregnancy test before starting this treatment. Use effective birth control while using tarlatamab and for at least 2 months after your last dose. Tell your doctor if you become pregnant or think you may be pregnant.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tarlatamab may cause serious side effects. Call your doctor right away if you have:

• low blood cell counts—fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection—sore throat, body aches, loss of appetite;
• liver problems—stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• signs and symptoms of nervous system disorders—headache; numbness or tingling in arms, legs, hands, or feet; dizziness, confusion, or disorientation; problems with balance, coordination, or muscle movement; sleepiness or sleeping problems; or seizures.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of tarlatamab may include:

• constipation, nausea;
• unpleasant or metallic taste in your mouth;
• muscle or bone pain;
• tiredness;
• abnormal blood tests;
• fever; or
• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Small Cell Lung Cancer:

Step-up Dosing Schedule to be administered as an intravenous infusion over one hour:Cycle 1:-Day 1: Step-up dose 1 mg IV-Day 8: 10 mg IV-Day 15: 10 mg IVCycle 2:-Day 1 and 15: 10 mg IVCycles 3 and 4-Day 1 and 15: 10 mg IVCycle 5 and subsequent infusions: 10 mg IVDuration of therapy: After step-up dosing schedule, administration is every 2 weeks until disease progression or unacceptable toxicity.Comments:-Should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactionsUse: Adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy

Call your doctor for guidance if you miss an appointment for your tarlatamab infusion.

An overdose of this product is not likely to happen. However, if an overdose does occur in a medical setting, it will be treated promptly.

Do not drive or engage in dangerous activities until you understand how tarlatamab will affect you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Other drugs may affect tarlatamab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.