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INDICATIONS

What is IMDELLTRA™ (tarlatamab-dlle)? IMDELLTRA™ is a prescription medicine used
to treat adults with extensive-stage small cell lung cancer (ES-SCLC), which is
cancer that has spread throughout lung or to other parts of the body, and who
have received treatment with chemotherapy that contains platinum, and it did not
work or …READ MORE

What is IMDELLTRA™ (tarlatamab-dlle)?

IMDELLTRA™ is a prescription medicine used to treat adults with extensive-stage
small cell lung cancer (ES-SCLC), which is cancer that has spread throughout
lung or to other parts of the body, and who have received treatment with
chemotherapy that contains platinum, and it did not work or is no longer
working.

It is not known if IMDELLTRA™ is safe and effective in children.

 * Important Safety Information
 * Indication
 * Full Prescribing Information
 * Medication Guide
 * For Healthcare Professionals

 * About Small Cell
   Lung Cancer
 * About
   IMDELLTRA™
   * How IMDELLTRA™ Works
   * Clinical Results
   * Side Effects
 * Starting
   IMDELLTRA™
 * Patient Support
   and Resources
   * Patient Support and Resources
   * Downloads and Support Groups
 * For Healthcare Professionals
 * Important Safety Information
 * Indication






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is not responsible for the content of the third party website and is not
adopting such content into this website.


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For adults with extensive-stage small cell lung cancer (ES-SCLC)
who have had prior platinum-based chemotherapy1


MOVE FORWARD WITH IMDELLTRA™

About
IMDELLTRA™Starting treatment
with IMDELLTRA™Patient support
and resources
In a study of 99 adult patients with ES-SCLC who had 2 or more prior treatments,


2 IN 5 PATIENTS (40%) RESPONDED TO IMDELLTRA™,2

which means their tumor shrank or disappeared.3

Based on 99 patients, of which 2 patients saw their tumor completely disappear,
and 38 patients saw their tumor partially shrink by at least 30%.2,4,5

Important Considerations: The approval of IMDELLTRA™ in these patients is based
on a study that measured the size of tumor shrinkage. Talk to your healthcare
provider to see if IMDELLTRA™ is right for you.2,5

Close

See less


IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT IMDELLTRA™?

IMDELLTRA™ MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA™
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

DUE TO THE RISK OF CRS, YOU WILL RECEIVE IMDELLTRA™ AS PER THE FOLLOWING
“STEP-UP DOSING SCHEDULE”:

 * The step-up dosing schedule is when you receive a smaller dose of IMDELLTRA™
   on Day 1 of your first treatment cycle (Cycle 1).
 * You will receive the full treatment dose of IMDELLTRA™ 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 of IMDELLTRA™, 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.

Neurologic Problems. IMDELLTRA™ can cause neurologic problems that can be
serious or life-threatening. Neurologic problems 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
 * seizure
 * problems with walking, or 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

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

 * 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
   remain 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
   observe 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 with IMDELLTRA™. Your
healthcare provider may temporarily stop or completely stop your treatment with
IMDELLTRA™ if you develop CRS, neurologic problems, or any other side effects
that are severe.

BEFORE RECEIVING IMDELLTRA™, TELL YOUR HEALTHCARE PROVIDER ABOUT ALL OF YOUR
MEDICAL CONDITIONS, INCLUDING IF YOU:

 * have an infection
 * are pregnant or plan to become pregnant. IMDELLTRA™ may harm your unborn
   baby.

 * FEMALES WHO ARE ABLE TO BECOME PREGNANT:

 * Your healthcare provider should do a pregnancy test before you start
   treatment with IMDELLTRA™.
 * You should use an effective form of birth control (contraception) during
   treatment with IMDELLTRA™, and for 2 months after the last dose of
   IMDELLTRA™.
 * Tell your healthcare provider right away if you become pregnant or think that
   you may be pregnant during treatment with IMDELLTRA™.
 * are breastfeeding or plan to breastfeed. 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 of IMDELLTRA™.

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

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 ARE THE POSSIBLE SIDE EFFECTS OF IMDELLTRA™?

IMDELLTRA™ MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Low white blood cell counts (cytopenia). Decreased blood cell counts are common
with IMDELLTRA™ and can also be severe. IMDELLTRA™ may cause the following low
blood cell counts:

 * low white blood cell counts (neutropenia). Low white blood cells can increase
   your risk for infection.
 * low red blood cell counts (anemia). Low red blood cells can cause tiredness
   and shortness of breath.
 * low platelet counts (thrombocytopenia). Low platelet counts 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 with IMDELLTRA™. Tell your
healthcare provider right away if you develop any signs or symptoms of infection
during treatment with IMDELLTRA™, including: 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, dark urine, loss of appetite, yellowing of your skin or
the white part of your eyes, pain in your right upper stomach-area (abdomen).

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 with
IMDELLTRA™, including: shortness of breath or trouble breathing, coughing, pain
or tightness in your chest and back, feeling lightheaded or dizzy, wheezing,
rash.

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

The most common side effects of IMDELLTRA™ also include: tiredness, muscle or
bone pain, fever, constipation, a bad or metallic taste in your mouth, nausea,
decreased appetite.

These are not all the possible side effects of IMDELLTRA™.

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

Please see IMDELLTRA™ full Prescribing Information, including Medication Guide.

WHAT IS IMDELLTRA™ (TARLATAMAB-DLLE)?

IMDELLTRA™ is a prescription medicine used to treat adults with extensive-stage
small cell lung cancer (ES-SCLC), which is cancer that has spread throughout
lung or to other parts of the body, and who have received treatment with
chemotherapy that contains platinum, and it did not work or is no longer
working.

It is not known if IMDELLTRA™ is safe and effective in children.


References: 1. IMDELLTRA™ (tarlatamab-dlle) medication guide, Amgen. 2.
IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 3. Delgado A, et
al. Am J Cancer Res. 2021;11:1121-1131. 4. National Cancer Institute. NCI
Dictionary of Cancer Terms.
https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 4,
2024. 5. Aykan NF, et al. World J Clin Oncol. 2020;11:53-73.

References: 1. National Cancer Institute. NCI Dictionary of Cancer Terms.
https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed April 4,
2024. 2. American Cancer Society. www.cancer.org. Accessed April 4, 2024. 3.
IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Einsele H, et al. Cancer. 2020;126:3192-3201.

References: 1. IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen. 2.
Delgado A, et al. Am J Cancer Res. 2021;11:1121-1131. 3. Eisenhauer EA, et al.
Eur J Cancer. 2009;45:228-247. 4. Aykan NF, et al. World J Clin Oncol.
2020;11:53-73.

References: 1. IMDELLTRA™ (tarlatamab-dlle) medication guide, Amgen. 2.
Shimabukuro-Vornhagen A, et al. J Immunother Cancer. 2018;6:56.

References: 1. IMDELLTRA™ (tarlatamab-dlle) medication guide, Amgen. 2.
IMDELLTRA™ (tarlatamab-dlle) prescribing information, Amgen.

See more




IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT IMDELLTRA™?

IMDELLTRA™ MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:

Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA™
and can also be serious or life-

ABOUT SMALL CELL LUNG CANCER
 * About Small Cell Lung Cancer

ABOUT IMDELLTRA™
 * How IMDELLTRA™ works
 * Clinical results
 * Side effects

STARTING IMDELLTRA™
 * Starting IMDELLTRA™

PATIENT SUPPORT AND
RESOURCES
 * Patient support and resources
 * Downloads and support groups

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