Patient Website | CARVYKTI® (ciltacabtagene autoleucel)

Learn About Carvykti^®

Learn about the CARVYKTI^® treatment process

PATIENT AND CARE PARTNER VOICES

01:00:03:00 - 01:00:32:06

NARRATOR

This video is about a patient treated with CARVYKTI® (ciltacabtagene autoleucel). Individual results may vary. Please see the full Important Safety Information at the end of this video and the full Prescribing Information and Medication Guide at CARVYKTI.com. Discuss any questions you have with your doctor. What is CARVYKTI® (ciltacabtagene autoleucel)?

CARVYKTI® is a treatment used for adult patients who have cancer of the bone marrow

01:00:32:10 - 01:00:55:16

called multiple myeloma. It is used when at least found other kinds of treatment have not worked or have 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 side effects that are severe or life-threatening and can lead to death.

01:00:55:18 - 01:01:28:12

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,

01:01:28:17 - 01:02:06:13

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

01:02:06:15 - 01:02:34:20

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.

01:02:34:21 - 01:03:08:06

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. 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.

01:03:08:07 - 01:03:38:05

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.

01:03:38:07 - 01:04:10:06

And I looked at him and I said, What is that? I’ve never heard of it. And I felt kind of silly. 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 100 people who had been living with multiple myeloma, many for some time.

01:04:10:09 - 01:04:44:10

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. 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 I was doing.

01:04:44:10 - 01:05:17:06

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 18 months later, my multiple myeloma relapsed. And so from then I had been through differing chemotherapies.

01:05:17:06 - 01:05:38:11

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.

01:05:38:12 - 01:06:07:17

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.

01:06:07:19 - 01:06:40:19

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.

01:06:40:21 - 01:07:06:22

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 or end the process. And you need to be prepared for that.

01:07:06:22 - 01:07:42:20

And you need to have a caregiver who is prepared for that. 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.

01:07:43:01 - 01:08:11:22

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. To all the people who have worked on Carvykti,

01:08:12:00 - 01:08:35:19

please keep doing what you’re doing. There are many more multiple myeloma patients out there who need this.

“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

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01:00:03:00 - 01:00:34:04

NARRATOR

CARVYKTI® is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma.

01:00:34:06 - 01:01:01:07

It is used when at least found other kinds of treatment have not worked or have 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 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:

01:01:01:09 - 01:02:00:22

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

01:02:00:22 - 01:02:35:00

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.

01:02:35:02 - 01:03:00:18

TONY

My name is Tony. I’m here to share my story and journey multiple myeloma with you folks. I noticed that my back ached, but then it just seemed to get intense with bringing me to tears and taking my breath away. One of the providers decided to start doing more in-depth tests of blood work and found as far as that there was some irregularities with my blood.

01:03:00:20 - 01:03:13:14

And then did more studies when I went to the oncology facility here in Rapid City. And that’s when the further test developed that the diagnosis of multiple myeloma.

01:03:13:16 - 01:03:28:19

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.

01:03:28:20 - 01:03:51:12

TONY

My treatment journey started to, of course, almost immediately after my diagnosis. I remember as far as going through and doing what they call infusion, I don’t know what infusion was to save my life. 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.

01:03:51:12 - 01:04:06:06

And 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.

01:04:06:08 - 01:04:31:22

MARY

I knew that he had gone through different chemo options, that they 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.

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I knew that it was the next best treatment option for Tony.

01:04:36:10 - 01:04:57:13

TONY

Yes, I was fortunate. It was a Carvykti and coming to this program, the short term versions of it, where people were able to take the treatment and not have to go so much through infusions and elimination of some of the drugs and the medication, and gave me a little bit of hope that there was more to go about that there was another page to be turned.

01:04:57:15 - 01:05:15:08

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 have been fortunate to have a person like my wife Mary, be involved and being able to bounce off things off of her.

01:05:15:08 - 01:05:53:20

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 the in between the daily check ups.

01:05:53:21 - 01:06:06:02

TONY

Going through the process of Carvykti, that one step is a little bit more independence. My life since Carvykti has been phenomenal as far as there’s less poking and prodding.

01:06:06:04 - 01:06:16:18

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.

01:06:16:18 - 01:06:43:08

TONY

For each day. Waking up is a new chapter good or bad or indifferent. That is just another thing, a slate to be praying it. But it’s about the hope. It’s about breathing another day. It’s about hugging kids, loved ones. But the thing is, is trusting the process and overcoming the fear. But just to go through and be able to trust what’s going on.

01:06:43:08 - 01:07:09:13

And at the end, writers 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 Carvykti, knowing that there was something else available out there to go on to another chapter, provide so much more hope.

“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

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01:00:03:00 - 01:00:34:04

NARRATOR

CARVYKTI® is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma.

01:00:34:06 - 01:01:01:07

Call your healthcare provider or get emergency help right away if you get any of the following:

01:01:01:09 - 01:02:00:22

01:02:00:22 - 01:02:35:00

01:02:35:03 - 01:03:00:05

MARY

My name is Mary. I’m from Rapid City, South Dakota, and wanted to participate today to share our experience with Carvykti. Being Tony’s partner in 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.

01:03:00:07 - 01:03:19:13

TONY

My treatment journey started to, of course, almost immediately after my diagnosis. Having support, any type of support is great, but having an immediate family available is a blessing. With Mary, she seems to always give 99% or 100% all the time.

01:03:19:15 - 01:03:40:19

MARY

It is 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. Gather. I was the note taker. I was the task doer. There are so many appointments to go to. There are so many things that have to be done and so much to to do.

01:03:40:19 - 01:04:02:11

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.

01:04:02:13 - 01:04:05:20

And the doctor said, you need to cancel your trip.

01:04:05:22 - 01:04:46:13

TONY

I had to be in Rochester, I believe, within a week to not find somebody to go with transportation, lodging, even meals. Everything that came about so was with Mary, my wife, that very fortunate that her work place 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 to with my son, my oldest son spent a week with me in Rochester when I started two tests.

01:04:46:15 - 01:05:22:11

MARY

01:05:22:15 - 01:05:46:01

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.

01:05:46:02 - 01:06:11:16

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. 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 to say yes.

01:06:11:18 - 01:06:33:15

TONY

My wife, Mary, a phenomenal lady. In fact, I hope when I grow up I can be like her. And to 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.

01:06:33:17 - 01:06:46:04

MARY

Carvykti, gave us hope. And we’re really thankful for that.

“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

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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-kuh-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^® Certified 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

4 WEEKS AND BEYOND

After your infusion of CARVYKTI^® (ciltacabtagene autoleucel), your healthcare provider at the CARVYKTI^® Certified Treatment Center will closely monitor you daily for 10 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 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. After this 4-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 provider know if you’re not feeling well. Refrain from driving or hazardous activities for at least 8 weeks following treatment with CARVYKTI^®.

IMPORTANT SAFETY INFORMATION

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.

^† BCMA=B-cell maturation antigen, CAR-T=chimeric antigen receptor-T cell.

* Timing and outcomes of manufacturing may vary.

^†208/208 patients in the CARTITUDE-4 study received bridging therapy.

SEE DETAILED TREATMENT PROCESS

DON'T WAIT TO FIND OUT IF CARVYKTI^® MAY BE RIGHT FOR YOU

CARVYKTI^® is an infusion of your own T cells, genetically modified to fight multiple myeloma

“I needed to be my own advocate…”

“CARVYKTI^® gave us hope and we're really thankful for that.”

“I encourage you to educate yourself with your team.”

DON'T WAIT TO FIND OUT IF CARVYKTI® MAY BE RIGHT FOR YOU

CARVYKTI® is an infusion of your own T cells, genetically modified to fight multiple myeloma

View video transcript

“I needed to be my own advocate…”

View video transcript

“CARVYKTI® gave us hope and we're really thankful for that.”

View video transcript

“I encourage you to educate yourself with your team.”

DON'T WAIT TO FIND OUT IF CARVYKTI^® MAY BE RIGHT FOR YOU

CARVYKTI^® is an infusion of your own T cells, genetically modified to fight multiple myeloma

“CARVYKTI^® gave us hope and we're really thankful for that.”