CARVYKTI® (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. 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 IS DIFFERENT FROM OTHER
COMMONLY USED CANCER THERAPIES
Unlike chemotherapy and a stem cell transplant, CARVYKTI is made from your own white blood cells
and is designed to find and attack multiple myeloma. Talk with your doctor to find out if CARVYKTI is
the right treatment option for you.
Your body has its own defense system, called the immune system. It includes cells called T cells. These T cells monitor your body for signs of infection, disease, or cancer. However, sometimes cancer cells can hide from T cells or prevent them from being targeted.
CAR-T cell therapy is a way to boost your immune system's ability to fight cancer. It involves collecting your own T cells and changing them to create personalized CAR-T cells that can recognize and eliminate cancer cells. These CAR-T cells are then returned to your body through a single infusion. CARVYKTI CAR-T cells are designed to specifically target a protein called
BCMA, which is over-expressed on multiple myeloma cells. BCMA can be found on other cells too, such as plasma cells, but at lower levels.
Once back in your body, the CAR-T cells multiply. They create a large number of cells that seek out and eliminate cancer cells.
CAR-T=chimeric antigen receptor T-cell.
Learn more about
the science behind
CARVYKTI
Multiple myeloma is the third most common hematological malignancy in the United States.
It is characterized by the abnormal accumulation of immune cells, called plasma cells in the bone marrow, which produce excessive amounts of antibodies.
The cancerous plasma cells produce high numbers of a marker called B cell maturation antigen, or BCMA, which has been linked to the progression of multiple myeloma.
BCMA is a protein found on nearly all multiple myeloma cells as well as normal plasma cells.
BCMA is overexpressed on multiple myeloma cells compared with healthy plasma cells, making it a potential target for multiple myeloma therapy.
Chimeric antigen receptor T cell therapy, known as CAR T, is a cancer treatment in which specific immune cells, called T cells, are collected from the patient, changed, and returned to their body to recognize and fight cancer cells.
Carvicti is a personalized CAR T cell therapy used for adult patients with multiple myeloma who have received at least one other treatment and whose multiple myeloma has come back or has stopped responding to treatment.
Carvicti CAR T cells have a receptor on their surface designed to find and bind BCMA protein.
The binding triggers Carvicti to become activated and multiply.
This creates more cells that can seek out and destroy cancer cells.
After a one time infusion of Carvicti, the genetically modified CAR T cells multiplied in the patient's blood.
This increase in CAR T cells coincided with a reduction in multiple myeloma tumor burden.
What is Carvicti?
Siltacabdigine Autolusal.
Carvicti is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma.
It is used when at least one other treatment has not worked or has stopped working.
Carvicti is a medicine made from your own white blood cells which have been changed genetically modified to recognize and attack your multiple myeloma cells.
Important Safety information What is the most important information I should know about CARVICTI?
Carvicti 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° Fahrenheit, 38°C or higher chills or shaking.
Chills, Fast or irregular heartbeat, Difficulty breathing, Very low blood pressure, dizziness, Lightheadedness, Persistent or severe diarrhea.
Abdominal pain and weight loss 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, disinterested in activities, and reduced facial expression.
Tingling, numbness and pain of the 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 Carvicti and to show them your Carvicti Patient Wallet Card.
Your healthcare providers may give you other medicines to treat your side effects.
Before you receive CAR Victi, tell your healthcare provider about all your medical conditions, including if you have current or past neurologic problems such as seizures, stroke, new or worsening memory loss, lung or breathing problems, heart problems, liver problems, kidney problems, a recent or active infection, low blood counts.
Tell your health care provider about all the medicines you take, including prescription and over the counter medicines, vitamins and herbal supplements.
How will I receive Carvicti?
Carvicti is made from your own white blood cells, so your blood will be collected by a process called leukophoresis.
The procedure can take three to six hours and may need to be repeated.
Your white blood cells are sent to a manufacturing center to make Carvicti.
It takes about four to five 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 Carvicti is being made, you may get other medicines to treat the multiple myeloma.
This is so your multiple myeloma does not get worse.
Before you get Carvicti, your healthcare provider will give you chemotherapy for three days to prepare your body 30 to 60 minutes.
Before you are given Carvicti, you may be given other medicines.
These may include medicines for an allergic reaction, antihistamines, medicines for fever such as acetaminophen.
When your Carvicti is ready, your healthcare provider will give Carvicti to you through a catheter tube placed into your vein.
Intravenous infusion.
Your dose of Carvicti will be given in one infusion bag.
The infusion usually takes approximately 30 to 60 minutes.
After getting Carvicti, you will be monitored at the certified healthcare facility where you received your treatment for at least seven days after the infusion.
You should plan to stay close to the location where you received your treatment for at least two 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 Carvicti?
Avoid driving for at least two weeks after you get Carvicti.
You must not be given certain vaccines, called live vaccines, for some time before and after CAR victi 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 CAR Victi?
The most common side effects of CAR Victi include fever, 100.4° Fahrenheit, 38°C or higher, chills, dizziness, 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, problems with blood clotting.
In a study comparing Carvicti to standard therapy, there was a higher rate of death in the 1st 10 months in the CARVICTI arm 14% compared to the standard therapy arm 12%.
The increased rate of deaths occurred before receiving Carvicti and after treatment with Carvicti.
The reasons for death were progression of multiple myeloma and side effects of the treatment.
CARVICTI 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 Carvicti.
CARVICTI 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.
CARVICTI 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.
Carvicti 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.
Carvicti can cause serious gastrointestinal side effects, including severe or persistent diarrhea or ruptured bowel, which can be life threatening and may lead to death.
Tell your healthcare provider right away if you develop diarrhea, abdominal pain, weight loss, fever, chills, or any signs or symptoms of an infection.
CARVICTI may increase your risk of getting cancers, including certain types of blood cancers.
Your healthcare provider should monitor you for this.
Having Carvick D 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 Carvick D Call your healthcare provider if you have any side effects.
You may report side effects to FDA at 1800 FDA 1088.
Please read full prescribing information, including Boxed Warning for Carvicti.
Find out more about the .
Actor portrayal.
Tony and Mary
TELL THEIR
CARVYKTI STORYIndividual results may vary.
00:00:00:00 - 00:00:24:00
NARRATOR:
This video is about a patient treated with CARVYKTI (ciltacabtagene autoleucel). Individual results may vary. Please see the full Important Safety Information in this video and the full Prescribing Information and Medication Guide at CARVYKTI.com. Discuss any questions you have with your doctor.
00:00:24:00 - 00:00:50:00
What is CARVYKTI (ciltacabtagene autoleucel)? CARVYKTI is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. 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.
00:00:50:00 - 00:01:27:00
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, persistent or severe diarrhea, abdominal pain, and weight loss,
00:01:27:00 - 00:02:19:00
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, disinterested 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.
00:02:19:00 - 00:02:30:00
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.
00:02:47:00 - 00:03:25:00
TONY:
My name is Tony, I am here to share my story and journey of multiple myeloma with you folks. I noticed that my back ached, but then it just seemed to get intense. It would bring me to tears and take my breath away. One of the providers decided to start doing more in-depth tests, blood work, and found that, as far as that, there was irregularities with my blood and then did more studies when I went to the oncology facility here in Rapid City. And that's when the further tests developed at the diagnosis of multiple myeloma.
00:03:25:00 - 00:03:41:00
MARY:
It was very scary. It was a week before our son's graduation from high school. It was a lot to take in. We had a lot to learn. We had a lot to just absorb at that time. And he was given 3 to 6 months to live without treatment.
00:03:41:00 - 00:04:18:00
TONY:
My treatment journey started, of course, almost immediately after my diagnosis. I remember as far as going through and doing what they call infusion. I didn't know what infusion was to save my life, so I just knew I was getting poked a lot and spending days at the infusion center, getting as far as treatment and looking for taking a regimen of pills. First year was, seemed like I was in the hospital quite a bit, almost every other week. It felt being as far as being monitored so closely that any time I ran a temperature to go in, which seemed like it was more often than not.
00:04:18:00 - 00:04:48:00
MARY:
I knew that he had gone through different chemo options that had failed. He had gone through a stem cell treatment that had failed. Tony's cancer started progressing, we booked a trip to New York to see a Yankees game, which marked a bucket list off and the whole family was going to go. And two weeks after that, we got a call saying there was a slot open for CARVYKTI. And the doctor said, "you need to cancel your trip." I knew that it was the next best treatment option for Tony.
00:04:48:00 - 00:05:28:00
TONY:
Yes, I was fortunate it was CARVYKTI and coming to his program, the short term versions of it where people were able to take a treatment and not have to go so much through infusions and elimination of some of the drugs and the medication, it gave me a little bit of hope that there was more to go about, that there was another page to be turned. I had to be in Rochester, I believe, within a week. Having that rush of having to call, make arrangements and things running through my head and I've been fortunate to have a person like my wife, Mary, being involved and being able to bounce off things off her.
00:05:28:00 - 00:06:05:00
MARY:
My experience as Tony went through CARVYKTI was wondering what was going to happen next, a little bit, you know, knowing the side effects that could happen, and kind of waiting for them. You know, they count the days, right? You know, this day, if you're going to have a side effect, it could happen by this day. So you kind of sit with anticipation, and you're waiting, and you're going to the appointments, the daily check-ins. And you come back, and you do the vitals, you know, and keep track of those things in between the daily checkups.
00:06:05:00 - 00:06:18:00
TONY:
Going through the process of CARVYKTI, that one step is, a little bit more independent. My life since CARVYKTI has been phenomenal as far as there's less poking and prodding.
00:06:18:00 - 00:06:29:00
MARY:
CARVYKTI gave us hope, and we're really thankful for that. When Tony was first diagnosed, even with treatment at the time, with the options available, they said 3 to 5 years.
00:06:29:00 - 00:07:22:00
TONY:
Each day waking up is a new chapter, good or bad or indifferent, that it's just not a thing, a slate to be prayed at, but it's about the hope. It's about breathing another day. It's about hugging kids, loved ones. But the thing is trusting the process and overcoming the fear. But just to go through and be able to trust what's going on and that the providers know exactly, especially now that to realize, looking back, that there are certain things that have to happen in order for you to be eligible for certain programs, such as in CARVYKTI, knowing that there was something else available out there to go on to another chapter, provides so much more hope.
00:07:22:00 - 00:07:50:00
NARRATOR:
What is CARVYKTI (ciltacabtagene autoleucel)? CARVYKTI is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. 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.
00:07:50:00 - 00:08:25:00
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, persistent or severe diarrhea, abdominal pain, and weight loss.
00:08:25:00 - 00:09:15:00
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, disinterested 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.
00:09:15:00 - 00:09:27:00
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.
00:09:27:00 - 00:09:58:00
Before you receive CARVYKTI, tell your healthcare provider about all your medical conditions, including if you have: Current or past neurologic problems (such as seizures, stroke, new or worsening memory loss), Lung or breathing problems, Heart problems, Liver problems, Kidney problems, A recent or active infection, Low blood counts. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
00:09:58:00 - 00:10:25:00
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.
00:10:25:00 - 00:10:55:00
While CARVYKTI is being made, you may get other medicines to treat the multiple myeloma. This is so 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. Thirty 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).
00:10:55:00 - 00:11:13:00
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.
00:11:13:00 - 00:11:42:00
After getting CARVYKTI, you will be monitored at the certified healthcare facility where you received your treatment for at least 7 days after the infusion. You should plan to stay close to the location where you received your treatment for at least 2 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.
00:11:42:00 - 00:11:55:00
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.
00:11:55:00 - 00:12:20:00
What should I avoid after receiving CARVYKTI? Avoid driving for at least 2 weeks after you get 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.
00:12:20:00 - 00:13:00:00
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/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, problems with blood clotting.
00:13:00:00 - 00:13:24:00
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.
00:13:24:00 - 00:13:51:00
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.
00:13:51:00 - 00:14:06:00
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.
00:14:06:00 - 00:14:32:00
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.
00:14:32:00 - 00:15:03:00
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.
00:15:03:00 - 00:15:23:00
CARVYKTI can cause serious gastrointestinal side effects, including severe or persistent diarrhea or ruptured bowel, which can be life-threatening and may lead to death. Tell your healthcare provider right away if you develop diarrhea, abdominal pain, weight loss, fever, chills, or any signs or symptoms of an infection.
00:15:23:00 - 00:15:32:00
CARVYKTI may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.
00:15:32:00 - 00:15:45:00
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.
00:15:45:00 - 00:16:04:00
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. Please read full Prescribing Information, including Boxed Warning, for CARVYKTI.
Actor portrayal.