[AMGEN SPONSORED]: Dialog between HCP-Patient and Caregiver
Barbara's ES-SCLC has stopped responding to treatment. See Barbara and her daughter discuss next steps with Barbara's doctor.
Transcript
NARRATOR: Barbara has extensive stage small cell lung cancer and has been undergoing treatment with chemotherapy
containing platinum. Her recent scans show that her cancer is not responding to treatment.
Barbara and her daughter are disappointed that the chemotherapy is not working.
They are meeting with the oncologist to discuss what this means for Barbara's treatment journey.
DOCTOR: I know that receiving news about your cancer not responding to treatment can be overwhelming and may make you feel uncertain about the future.
That's completely understandable. I'm just-- I'm tired. I don't know if I have the energy for another round.
Mom, I know you're exhausted. I understand. We don't have to make any decisions right now,
but maybe hearing our options will help us figure out our next step. Let me ask you this.
What's most important to you right now in terms of your care? I'm not sure.
I don't know what to hope for at this point. I just wish something more could be done.
I'd like to share information about a treatment option, IMDELLTRA, also known as tarlatamab.
NARRATOR: What is IMDELLTRA or 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 the 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. What is the most important information I should know about IMDELLTRA?
IMDELLTRA can cause side effects that can be severe, life-threatening, or cause death, including Cytokine Release Syndrome, CRS.
CRS is common during treatment with IMDELLTRA and can be severe, life-threatening, or cause death.
Tell your health care provider or get medical help right away if you develop any signs or symptoms of CRS,
including fever of 100.4 degrees Fahrenheit or 38 degrees Celsius 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;
blood clots or unusual bleeding or bleeding that lasts a long time.
Important safety information continued. 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 one 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 one time every two 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
day 1 and day 8 doses. Your health 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 severe, life-threatening, or cause death. Neurologic problems may happen days or weeks
after you receive IMDELLTRA. Your health care provider may refer you to a health care provider who specializes
in neurologic problems. Tell your health care provider right away if you develop any signs or symptoms of neurologic problems,
including changes in taste; headache; numbness or tingling of your hands or feet;
dizziness; trouble sleeping; muscle weakness or numbness of arms or legs; problems with walking or loss
of balance or coordination; trouble speaking, memory loss, or personality changes; confusion,
feeling disoriented, slow thinking, or not being able to think clearly; fainting or loss of consciousness;
seizures, shaking, or tremors; sleepiness; feeling like you have no energy.
Important safety information continued. 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 health care provider will monitor you for 22 to 24 hours from the start of the IMDELLTRA infusion
in a health care setting that can manage these side effects. You should remain within one hour of a health care 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 health care provider will watch you for six to eight hours after the infusion. For cycle 3 and cycle 4 doses, your health care provider
will watch you for three to four hours after the IMDELLTRA infusion. For cycle 5 and later doses, your health care provider
will watch you for two hours after the IMDELLTRA infusion. Your health care provider will monitor you for signs and symptoms of CRS and neurologic problems
during treatment with IMDELLTRA 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 health care provider may temporarily stop or completely
stop your treatment with IMDELLTRA if you develop CRS or neurologic problems. Please see additional important safety information
at the end of this video and full prescribing information, including boxed warnings and medication guide on imdelltra.com.
IMDELLTRA is a type of targeted immunotherapy called a T cell engager, and it's approved by the FDA for adults with extensive stage
small cell lung cancer who have received treatment with chemotherapy that contains platinum and it did not work or is no longer working.
Extensive stage is cancer that has spread throughout the lung or to other parts of the body. How is it different from what my mom has been through already?
IMDELLTRA is not chemotherapy. It uses your body's own immune system to target and help fight small cell lung cancer
cells by recognizing specific molecules on their surface. It's interesting that it helps the immune system find
and destroy small cell lung cancer cells. But tell me more.
How's it given? Would I need to go into the hospital? So IMDELLTRA is given as an intravenous infusion
by your doctor, which means the medicine goes into your body through a needle, placed in a vein for an hour
each time in a hospital or clinic setting. To reduce the risk of Cytokine Release Syndrome, or CRS, which
is common during treatment with IMDELLTRA, you will receive treatment using a step-up dosing schedule, which
means we will start with a smaller dose and carefully monitor how you respond on day 1 of your first treatment cycle.
Then you'll receive the full treatment dose on day 8 and day 15 of cycle 1.
After that, you will receive additional doses one time every two weeks until your disease progresses
or you are unable to tolerate the side effects. So infusions every other week?
Yes, after the dose is on days 1, 8, and 15 of cycle 1, you will receive infusions every other week.
To help reduce your risk of CRS, before receiving the first two doses of IMDELLTRA, you'll be given a medicine, also
by intravenous infusion. For future doses, I will decide if more medicines are needed.
Your IMDELLTRA treatment schedule is divided into cycles that are usually 28 days or four weeks long.
As your doctor, I will decide how many treatment cycles you will need to receive. When you say monitor, does that mean
I'll be staying in the hospital for a long time? Well, it depends on your response to IMDELLTRA.
Due to the risk of CRS and neurologic problems, I will monitor you during your treatment with IMDELLTRA.
For the first two doses, we will monitor you for 22 to 24 hours from the start of the infusion in a health care setting.
We will need you and your caregiver-- your daughter, in this case-- to stay within one hour of our care center for 48 hours after each of the first two doses.
For the next three doses, the IMDELLTRA infusions on day 15 of cycle 1 and days 1 and 15 of cycle 2,
we will watch you for six to eight hours after each infusion. And for the four infusions after that, the infusions in cycle 3
and cycle 4, we will watch you for three to four hours after each infusion. Oh, I see.
We will monitor you for side effects and treat you as needed. Once we get to cycle 5 and for subsequent doses,
we will watch you for two hours after each infusion. So you will always receive some monitoring after infusion.
OK, and just to be sure I understand, because I live over an hour away, after those first two
doses where you want us to stay close to the care center for 48 hours, for any subsequent doses, I
would be able to go home after the infusion and monitoring time are completed? That's right.
If our monitoring of your signs and symptoms indicates that it is appropriate to do so, you will be able to go home.
Before she leaves the hospital, we'll inform you both on the signs and symptoms of CRS and neurologic problems that may occur with IMDELLTRA.
I'm glad your daughter is here with you because she will play an important role in your treatment with IMDELLTRA.
So would my mom have a long stay in the hospital? We would need to see how she responds to the first two doses.
Before she leaves the hospital, we'll inform you both on the signs and symptoms of CRS and neurologic problems that may occur with IMDELLTRA.
I'd be interested in moving forward, but I need to understand more about side effects and treatment
logistics. I don't like the idea of my daughter having to constantly look after me.
It's OK, Mom. We'll handle this together. I agree, though.
We need to know what's involved. That's fair. IMDELLTRA can cause side effects that
can be serious, life-threatening, or cause death, including CRS and neurologic problems.
We will monitor for 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. And I may temporarily stop or completely
stop your treatment with IMDELLTRA if you develop CRS or neurologic problems.
OK. DOCTOR: Other side effects may include low blood cell counts, infections, liver problems, allergic reactions, tiredness,
fever, a bad or metallic taste in your mouth, decreased appetite, constipation, nausea, headache, anemia,
and muscle or bone pain. Still, these are not all the possible side effects of IMDELLTRA.
After the first two doses, before you are discharged, we'd inform you both of the signs and symptoms of CRS and neurologic problems to watch for and provide you
with a wallet card that has our direct contact information in case you have any questions.
This sounds like a lot to coordinate. I'm worried about being a burden, especially to my daughter.
Mom, I want to help. Will there be someone to help guide us through everything? Yes.
If you begin treatment with IMDELLTRA, there are patient navigators, individuals who aren't members of your care team
but can help guide you through the treatment logistics and can connect you with support groups where you can engage with other patients and caregivers.
What would my role be? How can I best support my mom? Your support is invaluable. We'll provide educational materials and direct access
to the care team. You're not expected to be a medical expert. Just be the loving daughter you already are,
and support your mom in her treatment journey. Who knows what the future holds. But I'm ready to try IMDELLTRA.
That's great. I'll get you connected with the resources you need. I think IMDELLTRA could be a good option for you.
NARRATOR: What is IMDELLTRA or 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 the 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. What is the most important information I should know about IMDELLTRA?
IMDELLTRA can cause side effects that can be severe, life-threatening, or cause death, including Cytokine Release Syndrome, CRS.
CRS is common during treatment with IMDELLTRA and can be severe, life-threatening, or cause death.
Tell your health care provider or get medical help right away if you develop any signs or symptoms of CRS,
including fever of 100.4 degrees Fahrenheit or 38 degrees Celsius 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;
blood clots or unusual bleeding or bleeding that lasts a long time.
Important safety information continued. 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 one 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 one time every two 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
day 1 and day 8 doses. Your health 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 severe, life-threatening, or cause death. Neurologic problems may happen days or weeks
after you receive IMDELLTRA. Your health care provider may refer you to a health care provider who specializes
in neurologic problems. Tell your health care provider right away if you develop any signs or symptoms of neurologic problems,
including changes in taste; headache; numbness or tingling of your hands or feet;
dizziness; trouble sleeping; muscle weakness or numbness of arms or legs; problems with walking or loss
of balance or coordination; trouble speaking, memory loss, or personality changes; confusion,
feeling disoriented, slow thinking, or not being able to think clearly; fainting or loss of consciousness;
seizures, shaking, or tremors; sleepiness; feeling like you have no energy.
Important safety information continued. 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 health care provider will monitor you for 22 to 24 hours from the start of the IMDELLTRA infusion
in a health care setting that can manage these side effects. You should remain within one hour of a health care 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 health care provider will watch you for six to eight hours after the infusion. For cycle 3 and cycle 4 doses, your health care provider
will watch you for three to four hours after the IMDELLTRA infusion. For cycle 5 and later doses, your health care provider
will watch you for two hours after the IMDELLTRA infusion. Your health care provider will monitor you for signs and symptoms of CRS and neurologic problems
during treatment with IMDELLTRA 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 health care provider may temporarily stop or completely
stop your treatment with IMDELLTRA if you develop CRS or neurologic problems.
Important safety information continued. Before receiving IMDELLTRA, tell your health 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 health care 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 two months after the last dose of IMDELLTRA. Tell your health 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 two months after the last dose of IMDELLTRA. Tell your health care 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.
Important safety information continued. What are the possible side effects of IMDELLTRA?
IMDELLTRA can cause serious side effects, including low white blood cell counts, cytopenia.
Decreased blood cell counts can be severe and may include the following-- low types of 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 cause death. Your health care provider will check you for signs and symptoms of infection
before and during treatment with IMDELLTRA. Tell your health care provider right away if you develop any signs or symptoms of infection
during treatment with IMDELLTRA, including fever of 100.4 degrees Fahrenheit or 38 degrees Celsius
or higher, painful rash, cough, sore throat or runny nose, chest pain, pain during urination, tiredness, feeling
weak or generally unwell, shortness of breath, yeast infections in the mouth or other areas.
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 health care provider right away
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.
Important safety information continued. IMDELLTRA can cause serious side effects, including-- continued--
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 health care provider will do blood work before you start
and during treatment with IMDELLTRA. Your health care 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, decreased
appetite, a bad or metallic taste in your mouth, fever, muscle or bone pain, constipation, nausea.
These are not all the possible side effects of IMDELLTRA. Call your health care 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 boxed warnings and medication guide on imdelltra.com.
lung cancer
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