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Welcome to the CAR-T Patient Journey Experience, a guide for patients and
caregivers brought to you by Janssen Biotech Inc. and Legend Biotech. The
developers of CARVYKTI® (ciltacabtagene autoleucel). What is
CARVYKTI® (ciltacabtagene autoleucel)? CARVYKTI® is a treatment
used for adult patients who have cancer of the bone marrow, called
multiple myeloma.
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It is used when at least one other treatment has not worked or has stopped
working. CARVYKTI® is a medicine made from your own white blood cells,
which have been changed (genetically modified) to recognize and attack
your multiple myeloma cells. CARVYKTI® may cause serious side effects,
which may be fatal or life-threatening, including the risk of cytokine
release syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity
Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, Hemophagocytic
Lymphohistiocytosis/Macrophage Activation Syndrome,
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prolonged and or recurrent cytopenias, and secondary hematological
malignancies. Because of the risk of CRS and neurologic toxicities,
CARVYKTI® is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS), called the CARVYKTI® REMS.
Please see the Important Safety Information in this video and the full
Prescribing Information and Medication Guide at CARVYKTI.com. Hello, my
name is Tina and I'm here to provide an overview of what to expect during
your CAR-T therapy.
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This experience will also provide some useful information to your
caregiver on their role throughout the treatment journey. As you may know,
CAR-T stands for Chimeric Antigen Receptor-T Cell. Over the next few
minutes, I will explain in detail the five steps of CAR-T therapy. These
include collecting your white blood cells, changing or genetically
modifying your T cells, pre-infusion treatment, receiving your one-time
CARVYKTI® infusion, and undergoing post-infusion monitoring for side
effects. In CAR-T therapy,
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your white blood cells are collected, and then your T cells are isolated
and modified by a manufacturing facility to change them into your CAR-T
cells. While they're being genetically modified, you may undergo what's
called bridging therapy, which I'll explain a little later. After being
modified, the cells are reintroduced to your body where they are
programmed to recognize a protein present on the surface of multiple
myeloma cells, as well as some other immune cells.
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Remember your healthcare team is here for you and ready to answer any
questions you may have about your specific CAR-T treatment. Let's begin.
We're going to be here for a little while. Rest, relax. Rachel's going to
take care of you. I'll check in this afternoon to see how you do. And you
can go ahead and take a seat here on this bed.
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Yes, go right ahead… The first step in CAR-T therapy is cell collection or
leukapheresis. Your cells will be collected in a leukapheresis room with
the assistance of a leukapheresis nurse. Your blood will be drawn into a
machine that separates the white and red blood cells. Collect some of the
white blood cells, including T cells, and returns the rest of the blood
into your body.
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This process may take 3 to 6 hours and may need to be repeated. After you
complete the cell collection process you may be treated with medicines,
sometimes referred to as bridging therapy, to control your multiple
myeloma. So the disease does not worsen while your CAR-T cells are being
manufactured. Bridging therapies are anti-cancer treatments that are
intended to reduce the number of cancer cells in your body.
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These treatments may take place at home or at a treatment center. Your
healthcare team will let you know if bridging therapy is necessary for
you. Once your white blood cells have been extracted, they are frozen and
sent to a manufacturing site. There, the T cells are separated and
customized into your ciltacabtagene autoleucel CAR-T cells.
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This is done by genetically modifying your T cells to be able to recognize
B cell maturation antigens (BCMA) on the surface of multiple myeloma
cells. Your CARVYKTI® CAR- T cells are then frozen and sent back to
your CARVYKTI® certified treatment center. This process typically
takes around 4 to 5 weeks, but timing and outcomes of manufacturing may
vary. Your healthcare team will provide a more specific time frame for you
the closer you get to your infusion date.
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Remember, your healthcare team is there to help every step of the way, so
you and your caregivers should never hesitate to ask questions. Once your
cells have been manufactured, it's time to begin preparing for your
CARVYKTI® infusion. A few days before your infusion, you'll receive
low-dose chemotherapy infusions with cyclophosphamide and fludarabine.
These infusions will help prepare your body for the CAR-T infusion.
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Each of these infusions will be given to you once a day for three days.
These infusions are given to help clear out some of your white blood cells
to make the necessary space in your immune system for CARVYKTI®. This
is also known as lympho-depleting chemotherapy. Your healthcare team will
guide you through this chemotherapy infusion process. It is important for
you and your caregiver to communicate regularly with your healthcare
provider regarding how you are feeling and any symptoms you think you are
experiencing.
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Mr. Glover, how are you today? We got your CAR-T therapy back… The day has
come usually about 4 to 5 weeks after your initial cell collection and 2
to 4 days after your last low dose chemotherapy. You will be ready for
your CARVYKTI® infusion. Your healthcare team will let you know what
to expect and guide you through the process.
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Your T cells have been genetically modified at the manufacturing facility,
and will now be returned to your body to fight the multiple myeloma cancer
cells. 30 to 60 minutes before you were given your CAR-T infusion, you may
be given other medicines. These may include medicines for an allergic
reaction, antihistamines and medicines for fever, such as acetaminophen.
Your healthcare provider will give you CARVYKTI® through a one-time
intravenous infusion that takes approximately 30 to 60 minutes.
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It is helpful to be well-hydrated and have eaten some food before
arriving. It is required that you be accompanied by a caregiver to help
throughout this infusion day. After your infusion of CARVYKTI®, you
will be monitored for side effects. Your healthcare team should provide
you with a detailed plan which will be tailored to your needs. In some
cases, this will be in collaboration with your primary oncologist.
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Caregivers serve as another set of eyes and ears for your healthcare
teams. They should be observant and keep the contact information of the
healthcare team members handy to be able to alert them quickly if they
think you are having symptoms of a side effect. And there we are, you are
all done. After your infusion of CARVYKTI®, your healthcare providers
at the CARVYKTI® Certified Treatment Center will closely monitor you
daily for ten days following infusion for any signs and symptoms of a
reaction to treatment.
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You should plan to stay close to the location where you received your
treatment for at least four weeks. Your healthcare provider will check to
see that your treatment is working, and help you with any side effects
that may occur. You may be hospitalized if you develop serious side
effects until your side effects are under control, and it is safe for you
to leave the hospital, your healthcare provider will want to do blood
tests to follow your progress.
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It is important that you have your blood tested. If you miss an
appointment, call your healthcare provider as soon as possible to
reschedule. After this four week monitoring period, your healthcare
provider will continue to provide care and partner with you to create a
plan for long-term monitoring and regular follow-ups. Let your healthcare
providers know if you're not feeling well.
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Refrain from driving or hazardous activities for at least eight weeks
following treatment with CARVYKTI®. You must not be given certain
vaccines, called live vaccines, for some time before and after
CARVYKTI® treatment. Talk to your healthcare provider if you need to
have any vaccinations. Do not donate blood, organs, tissues or cells for
transplantation. CARVYKTI® may cause side effects that are severe or
life-threatening and can lead to death.
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Call your healthcare provider or get emergency help right away if you get
any of the following. Fever (100.4°F, 38°C or higher). Chills or shaking
chills. Fast or irregular heartbeat. Difficulty breathing. Very low blood
pressure. Dizziness/Lightheadedness. Effects on your nervous system, some
of which can occur days or weeks after you receive the infusion and may
initially be subtle, such as: feeling confused, less alert or disoriented,
having difficulty speaking or slurred speech, having difficulty reading,
writing and understanding words, memory loss.
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Loss of coordination affecting movement and balance, slower movements,
changes in handwriting. Personality changes including a reduced ability to
express emotions, being less talkative. disinterest in activities and
reduced facial expression. Tingling, numbness and pain of hands and feet,
difficulty walking, leg and or arm weakness and difficulty breathing.
Facial numbness, difficulty moving muscles of face and eyes.
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It is important that you tell your healthcare providers that you have
received CARVYKTI®, and to show them your CARVYKTI® Patient Wallet
Card. Your healthcare providers may give you other medicines to treat your
side effects. CARVYKTI® can cause a very common side effect called
cytokine release syndrome or CRS, which can be severe or fatal. Symptoms
of CRS include fever, difficulty breathing, dizziness or lightheadedness,
nausea, headache, fast heartbeat, low blood pressure, or fatigue.
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Tell your healthcare provider right away if you develop fever or any of
these other symptoms after receiving CARVYKTI®. CARVYKTI® can
cause various neurologic side effects, some of which may be severe or
fatal. Signs or symptoms associated with neurologic toxicity, some of
which may occur days or weeks following the infusion, may include, but are
not limited to: confusion, disorientation, loss of consciousness,
seizures, difficulty speaking, reading or writing.
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tremor, slower movements, changes in personality, depression, tingling and
numbness of hands and feet, leg and arm, weakness and facial numbness. The
most common side effects of CARVYKTI® include fever (100.4°F, 38°C or
higher), chills. Dizziness or lightheadedness. Headache, muscle or joint
pain, feeling very tired. Altered mental state, confusion. Infections. Low
levels of antibodies, (immunoglobulins) in the blood. Cough, being short
of breath. Diarrhea, nausea, decreased appetite, constipation. Fast or
irregular heartbeat, and problems with blood clotting.
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Other possible side effects CARVYKTI® can increase the risk of
life-threatening infections, including COVID-19 that may lead to death.
Tell your healthcare provider right away if you develop fever, chills, or
any signs or symptoms of an infection. CARVYKTI® can lower one or more
types of your blood cells: red blood cells, white blood cells or platelets
(cells that help blood to clot), which may make you feel weak or tired or
increase your risk of severe infection or bleeding that may lead to death.
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After treatment, your healthcare provider will test your blood to check
for this. Tell your healthcare provider right away if you get fever,
chills, or any signs or symptoms of an infection, are feeling tired, or
have bruising or bleeding. Having CARVYKTI® in your blood may cause
some commercial human immunodeficiency virus HIV tests to incorrectly give
you an HIV positive result,
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even though you may be HIV negative. These are not all the possible side
effects of CARVYKTI®. Tell your healthcare providers if you experience
any side effects. Your caregiver plays a key role in helping you identify
and communicate about any symptoms that may suggest you are having a side
effect, which you should report to your healthcare team as soon as
possible.
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They may ask you to undergo certain tests to identify particular side
effects, because of CRS and neurologic toxicities. Capacity is available
only through a restricted program under a Risk Evaluation and Mitigation
Strategy, (REMS), called the CARVYKTI® REMS. For more information
about the CARVYKTI® REMS program, visit CARVYKTIREMS.com
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We hope this experience has given you a better idea of what to expect
during your CARVYKTI® journey. Your healthcare team at the Certified
Treatment Center will provide you with the specific course of your care
and will be able to answer any questions you have concerning this
treatment. For more information and to discover other resources for
patients and caregivers, visit CARVYKTI.com
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IMPORTANT SAFETY INFORMATION.
What is the most important information I should know about CARVYKTI?
CARVYKTI® may cause side effects that are severe or life-threatening and
can lead to death. Call your healthcare provider or get emergency help
right away if you get any of the following:
- fever (100.4°F/38°C or higher)
- chills or shaking chills
- fast or irregular heartbeat
- difficulty breathing
- very low blood pressure
- dizziness/lightheadedness
effects on your nervous system, some of which can occur days or weeks
after you receive the infusion, and may initially be subtle such as:
feeling confused, less alert, or disoriented, having difficulty
speaking or slurred speech, having difficulty reading, writing, and
understanding words, memory loss
loss of coordination affecting movement and balance, slower movements,
changes in handwriting
personality changes including a reduced ability to express emotions,
being less talkative, disinterest in activities, and reduced facial
expression
tingling, numbness, and pain of hands and feet, difficulty walking,
leg and/or arm weakness, and difficulty breathing
- facial numbness, difficulty moving muscles of face and eyes
It is important that you tell your healthcare providers that you have
received CARVYKTI® and to show them your CARVYKTI® Patient Wallet Card.
Your healthcare providers may give you other medicines to treat your side
effects.
Before you receive CARVYKTI® tell your healthcare provider about all your
medical conditions, including if you have:
Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
How will I receive CARVYKTI?
CARVYKTI® is made from your own white blood cells, so your blood will
be collected by a process called ‘leukapheresis’ (loo-kah-fur-ee-sis).
The procedure can take 3 to 6 hours and may need to be repeated.
Your white blood cells are sent to a manufacturing center to make
CARVYKTI®. It takes about 4-5 weeks from the time your cells are
received at the manufacturing site and are available to be shipped back
to your healthcare provider, but the time may vary.
While CARVYKTI® is being made, you may get other medicines to treat
the multiple myeloma. This is so that your multiple myeloma does not get
worse.
Before you get CARVYKTI®, your healthcare provider will give you
chemotherapy for 3 days to prepare your body.
30 to 60 minutes before you are given CARVYKTI®, you may be given other
medicines. These may include:
- medicines for an allergic reaction (antihistamines)
- medicines for fever (such as acetaminophen)
When your CARVYKTI® is ready, your healthcare provider will give CARVYKTI®
to you through a catheter (tube) placed into your vein (intravenous
infusion). Your dose of CARVYKTI® will be given in one infusion bag. The
infusion usually takes approximately 30-60 minutes.
After getting CARVYKTI®, you will be monitored at the certified healthcare
facility where you received your treatment for at least 10 days after the
infusion.
You should plan to stay close to the location where you received your
treatment for at least 4 weeks. Your healthcare provider will check to see
that your treatment is working and help you with any side effects that may
occur. You may be hospitalized if you develop serious side effects until
your side effects are under control and it is safe for you to leave the
hospital.
Your healthcare provider will want to do blood tests to follow your
progress. It is important that you have your blood tested. If you miss an
appointment, call your healthcare provider as soon as possible to
reschedule.
What should I avoid after receiving CARVYKTI®?
Do not drive, or operate heavy machinery, or do other activities that
could be dangerous if you are not mentally alert, for at least 8 weeks
after you get CARVYKTI®. This is because the treatment can cause memory
and coordination problems, sleepiness, confusion, dizziness, seizures,
or other neurologic side effects as discussed by your healthcare
provider.
You must not be given certain vaccines called live vaccines for some
time before and after CARVYKTI® treatment. Talk to your healthcare
provider if you need to have any vaccinations.
Do not donate blood, organs, tissues, or cells for transplantation.
What are the possible or reasonably likely side effects of CARVYKTI®?
The most common side effects of CARVYKTI® include:
- fever (100.4°F/38°C or higher), chills
- dizziness or light-headedness
- headache, muscle or joint pain, feeling very tired
- altered mental state, confusion
- infections
- low levels of antibodies (immunoglobulins) in the blood
- cough, being short of breath
- diarrhea, nausea, decreased appetite, constipation
- fast or irregular heartbeat
- problems with blood clotting
In a study comparing CARVYKTI® to standard therapy, there was a higher
rate of death in the first 10 months in the CARVYKTI® arm (14%) compared
to the standard therapy arm (12%). The increased rate of deaths occurred
before receiving CARVYKTI® and after treatment with CARVYKTI®. The reasons
for death were progression of multiple myeloma and side effects of the
treatment.
CARVYKTI® can cause a very common side effect called cytokine release
syndrome or CRS, which can be severe or fatal. Symptoms of CRS include
fever, difficulty breathing, dizziness or lightheadedness, nausea,
headache, fast heartbeat, low blood pressure, or fatigue. Tell your
healthcare provider right away if you develop fever or any of these other
symptoms after receiving CARVYKTI®.
CARVYKTI® can increase the risk of life-threatening infections including
COVID-19 that may lead to death. Tell your healthcare provider right away
if you develop fever, chills, or any signs or symptoms of an infection.
CARVYKTI® can cause various neurologic side effects, some of which may be
severe or fatal. Symptoms include but are not limited to confusion,
disorientation, loss of consciousness, seizures, difficulty speaking,
reading or writing, tremor, slower movements, changes in personality,
depression, tingling and numbness of hands and feet, leg and arm weakness,
and facial numbness.
CARVYKTI® can lower one or more types of your blood cells (red blood
cells, white blood cells, or platelets [cells that help blood to clot]),
which may make you feel weak or tired, or increase your risk of severe
infection or bleeding that may lead to death. After treatment, your
healthcare provider will test your blood to check for this. Tell your
healthcare provider right away if you get a fever, chills, or any signs or
symptoms of an infection, are feeling tired, or have bruising or bleeding.
CARVYKTI® may increase your risk of getting cancers including certain
types of blood cancers. Your healthcare provider should monitor you for
this.
Having CARVYKTI® in your blood may cause some commercial Human
Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive
result even though you may be HIV-negative.
These are not all the possible side effects of CARVYKTI®. Call your
healthcare provider if you have any side effects. You may report side
effects to FDA at 1-800-FDA-1088.
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Please read full Prescribing Information, including Boxed Warning for
CARVYKTI®.
