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.
a chance at more time for the things that really count
In a clinical study, CARVYKTI® reduced the risk of disease progression or passing away by 59% compared with standard therapy.
Ask your doctor about CARVYKTI®, a personalized treatment for multiple myeloma (MM) after first relapse. Use this tool to help start the conversation.
Ask your doctor about CARVYKTI®, a personalized treatment for multiple myeloma (MM) after first relapse. Use this tool to help start the conversation.
CARVYKTI® is an infusion of your own T cells, genetically modified to fight multiple myeloma
CARVYKTI® is a kind of therapy called CAR-T—which stands for chimeric antigen receptor T-cell. T cells are a part of your immune system that fight against infection.
CARVYKTI® works by changing your own T cells to recognize and attack a target on the surface of multiple myeloma cells and certain other healthy cells after a single infusion. The entire process generally takes about 2 to 3 months.
Learn About Carvykti®
PATIENT AND CARE PARTNER VOICES
00:00:02:00 - 00:00:23:15
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
00:00:50:10 - 00:02:19:15
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 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.
00:02:19:20 - 00:02:37:00
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.
00:02:48:15 - 00:03:07:20
JULIA
My name is Julia. I have multiple myeloma. I am a retired nurse practitioner, I became a nurse practitioner at 54 years of age. I am the mother of five, It’s a blended family. I had two and my husband had three. I have 11 grandchildren.
00:03:10:20 - 00:03:57:00
I think everyone remembers the day they were told they had multiple myeloma. And how it came about is I’d been having some back pain. They found a tumor in my spine, and they said it was most likely malignant, which was terrifying. My doctor, my primary care doctor, arranged for me to go to the hospital and to have a biopsy of the tumor and a bone marrow biopsy as well. And then I remember he came into my hospital room, and he stood in the corner and said, so we’re pretty sure what you have is multiple myeloma. And I looked at him and I said, what is that? I’ve never heard of it, and I felt kind of silly.
00:03:59:15 - 00:04:45:10
One of the national organizations was going to have a patient care conference in Chicago, so I scheduled us to go to that conference. And honestly, that changed everything. I saw there a couple of hundred people who had been living with multiple myeloma, many for some time. And so, I was a lot more optimistic at that point but still didn’t know much. I did not have any chemotherapy for two years until my numbers began to go up. And by then I understood a lot about multiple myeloma, and I understood the need to begin chemotherapy.
00:04:49:15 - 00:05:47:20
During that time, I just continued my life as usual, you know, going to an oncologist locally every three months for blood test and to see how it was doing. And after two years, my numbers started to go up, and it was at that time we wanted to begin treatment, and my treatment was all guided by my myeloma specialist from Moffitt. My first difficult decision was stem cell transplant, I did that, I recovered, and then eighteen months later, my multiple myeloma relapsed. And so, from then I had been through differing chemotherapies and in each one of those, I had to decide whether or not I would continue. And it was recommended that I go to a place where Car-T was being done and do a consult with a Car-T specialist.
00:05:51:20 - 00:06:20:10
When my numbers continued to go up, I received a call from my Moffitt doctor, and he said, there is an opening for you at Mayo, and we think you should go there and have Car-T. And I made that decision with that information, along with my team of doctors, and my family, my husband, for support, particularly because he was my caregiver.
00:06:21:05 - 00:06:52:10
Part of your preparation for Car-T at the hospital where I went was to be completely informed about every step of the way. And so, I met with Car-T nurses who had a lot of experience besides the information; they answered every question I could possibly have. So, when I was looking at a decision for CARVYKTI, the idea that I could have a one-time infusion, I decided to go forward with that.
00:06:54:15 - 00:07:23:00
One of the things I learned during the process of treatment from the beginning of when I had multiple myeloma, is that one, I needed to be my own advocate, when you’re making a decision to go forward with CARVYKTI, you need to become knowledgeable about the drug and the process, and you need to be prepared for that, and you need to have a caregiver who’s prepared for that.
00:07:23:20 - 00:07:54:15
One of the things I think was most important in my myeloma journey was being part of a support group, and that support group gave me an avenue to learn more about everything, and I felt well informed. We all learn from each other. I think the support group was the most important avenue of knowledge in my myeloma journey.
00:07:56:10 - 00:08:22:15
I am a multiple myeloma group leader, that’s one of the things I did in order to give back. My advice to anyone who’s newly diagnosed with multiple myeloma is to seek out information. I tell everyone that they should join a support group, and I often say, just come to one meeting and then make your decision after that.
00:08:22:20 - 00:08:31:20
To all the people who have worked on CARVYKTI, please keep doing what you’re doing. There are many more multiple myeloma patients out there who need this.
00:08:50:00 - 00:09:16:00
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
00:09:16:15 - 00:10:29:15
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 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.
00:10:30:00 - 00:10:43:00
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.
00:10:43:15 - 00:11:16:15
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.
00:11:17:00 - 00:11:26:00
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
00:11:26:15 - 00:12:02:15
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 your multiple myeloma does not get worse.
00:12:03:00 - 00:12:40:15
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) 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.
00:12:41:00 - 00:13:23:00
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. 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.
00:13:23:15 - 00:13:47:15
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.
00:13:48:00 - 00:14:28:15
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
00:14:29:00 - 00:14:52:15
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.
00:14:53:00 - 00:15:20:00
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.
00:15:20:15 - 00:15:33:15
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.
00:15:34:00 - 00:16:00:00
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.
00:16:00:15 - 00:16:31:00
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.
00:16:31:15 - 00:16:51:15
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.
00:16:52:00 - 00:17:00:00
CARVYKTI may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.
00:17:00:15 - 00:17:13:15
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.
00:17:14:00 - 00:17:33:00
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.
“I needed to be my own advocate…”
Julia didn’t let her multiple myeloma define her. Hear her story of seeking out information, support, and treatment.
JULIA SHARES HER STORY
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.
“CARVYKTI® gave us hope and we're really thankful for that.”
Tony and his wife share their story about finding a multiple myeloma diagnosis and how he and his doctor decided CARVYKTI® was right for him.
TONY AND MARY SHARE THEIR JOURNEY
00:00:02:00 - 00:00:23:15
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
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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 persistent or severe diarrhea, abdominal pain, and weight loss,
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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,
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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.
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MARY:
My name is Mary. I’m from Rapid City, South Dakota, and I wanted to participate today to share our experience with CARVYKTI. Being Tony’s partner and hearing the diagnosis of multiple myeloma, it was very scary. It was a lot to take in, we had a lot to learn. We had a lot to just absorb at that time. Tony: My treatment journey started, of course, almost immediately after my diagnosis.
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TONY:
Having support, any type of support, is great, but having the immediate family available is a blessing. With Mary, she seems to always give 99% or 100% all the time. Mary: There’s definitely a wide range of emotions in the beginning, I think it took me a little while to feel some of those, though, to be honest with you. In the beginning, I was the master information gatherer, I was the note taker, I was the task doer. There are so many appointments to go to.
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MARY:
There’s so many things that have to be done and so much to do. I mean, there’s just the busyness, the busyness of learning, the medications, the busyness of getting used to this new life. 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.”
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TONY:
I had to be in Rochester, I believe, within a week to find somebody to go with transportation, lodging, even meals, everything that came about. So, I was with Mary, my wife, very fortunate that her workplace was phenomenal. They gave her the time that she needed. And within that short timeframe, that allowed her to not only transport me, but also to be with me and provide as a care provider, and also with my son, my oldest son spent a week with me in Rochester when I started the tests.
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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.
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MARY:
I’m really good at suggesting to other people to take care of themselves and to do things for themselves. I’m not as good at doing that for myself. When speaking to people who are looking at going through this process. I encourage you to educate yourself, educate yourself with your team. Educate yourself with the support that you have available to you. Be best friends with the social worker, they know a lot of resources available. They may have a caregiver support group available to you. Find one, join it. It does help.
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MARY:
Take care of yourself, use your family, use your friends. Let them help you. When they’re offering help, say yes, it’s okay. It’s okay to say yes. Tony: My wife, Mary, phenomenal lady. In fact, I hope when I grow up, I can be like her. And, as far as that I’m... I’m very blessed today. So I was fortunate with CARVYKTI and coming to this program. The thing I realize now and ever more is that I’m not alone. Only if I allow myself to be. Mary: CARVYKTI gave us hope, and we’re really thankful for that.
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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
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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,
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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,
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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 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.
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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.
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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.
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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)
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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 7 days after the infusion.
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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. 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.
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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 What are the possible or reasonably likely side effects of CARVYKTI?
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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
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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.
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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.
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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.
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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.
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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. 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.
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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.
“I encourage you to educate yourself with your team.”
Mary shares caregiving tips and her experience helping her partner Tony through his multiple myeloma diagnosis and treatment journey with CARVYKTI®.
CARING FOR A LOVED ONE
Carvykti®: A Personalized Medicine Delivered Through a One-Time Infusion
The CARVYKTI® treatment process, from cell collection through initial monitoring, generally takes about 2 to 3 months to complete.
CELL COLLECTION
~3 TO 6 HOURS
Some of your blood is drawn into a machine that separates the white and red blood cells, collects some of the white blood cells (including T cells), and returns the rest of the blood into your body. This process is called leukapheresis (loo-kah-fur-ee-sis). This process may take ~3 to 6 hours and may need to be repeated until the process is complete.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
GENETICALLY MODIFYING YOUR T cells
~4 TO 5 WEEKS
Your white blood cells are frozen and sent to a manufacturing site, where the T cells are separated out and customized into your CARVYKTI® CAR-T cells. This is done by genetically modifying your T cells to be able to recognize BCMA on the surface of multiple myeloma cells. Your CARVYKTI® CAR-T cells are then frozen and sent to your CARVYKTI® Activated Treatment Center.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
PRE-INFUSION TREATMENT
3 DAYS
A few days before your infusion of CARVYKTI® (ciltacabtagene autoleucel), you’ll receive low-dose chemotherapy infusions with cyclophosphamide and fludarabine. These infusions will help prepare your body for the CAR-T infusion. Each of these infusions will be given to you once a day for 3 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 lymphodepleting chemotherapy.
ONE-TIME CARVYKTI® INFUSION
~30 TO 60 MINUTES
About a month after your initial cell collection, and 2 to 4 days after your last low-dose chemotherapy, you’ll be given your CARVYKTI® through a one-time intravenous infusion that takes approximately 30 to 60 minutes. Your healthcare provider will guide you through what your infusion day will be like.
Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.†
MONITORING
2 WEEKS AND BEYOND
After your infusion of CARVYKTI®, your healthcare provider at the CARVYKTI® Activated Treatment Center will closely monitor you daily for 7 days following infusion for any signs or symptoms of a reaction to treatment.
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.
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. After this 2-week monitoring period, your healthcare providers 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. Refrain from driving or hazardous activities for at least 2 weeks following treatment with CARVYKTI®.
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. Talk to your doctor if you have any questions about your health condition or treatment.
*Timing and outcomes of manufacturing may vary.
†208/208 patients in the CARTITUDE-4 study received bridging therapy.
*Timing and outcomes of manufacturing may vary.
†208/208 patients in the CARTITUDE-4 study received bridging therapy.
