ARE YOU ELIGIBLE FOR CARVYKTI^®?

If you have not been prescribed CARVYKTI^® yet, you can use this simple tool to find out if you may be eligible for treatment. Answer the questions below to find out if you may be eligible.

Consider the lines of treatment you (or the person you care for) have received to treat multiple myeloma. Has the most recent treatment not worked or stopped working?

How many lines of treatments have you already received?
(This includes treatments such as proteasome inhibitors, immunomodulatory agents, or anti-CD38 antibodies.)

1 line

2 lines

3 lines

4 or more lines

Which of the following types of treatment have you already received?
(Check all that apply)

You may be a candidate for treatment with CARVYKTI^®.
Talk to your doctor about CARVYKTI^® and whether it's right for you.

There may still be treatment options available that may help control your multiple myeloma before it's time for you and your doctor to consider CARVYKTI^®. If your disease returns following 4 or more kinds of treatments, including at least 1 proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody, talk to your doctor to see if CARVYKTI^® is an option for you.

At this time, you (or the person you care for) are not a candidate for CARVYKTI^®. Please continue consulting with your doctor to learn more about keeping multiple myeloma under control.

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THE CARVYKTI^® TREATMENT PROCESS

CARVYKTI^® (ciltacabtagene autoleucel) is an individualized treatment that is prescribed and infused at a Certified Treatment Center. Your primary oncologist will help you set up a consultation at a Certified Treatment Center, which will determine your eligibility and provide your treatment with CARVYKTI^®. You'll still remain in contact and may keep your scheduled appointments with your primary oncologist, who will continue to be involved in your care throughout this process and especially when you return home for longer-term monitoring and follow-up care.

Therapy with CARVYKTI^® is a 5-step process that generally takes about 2 to 3 months to complete.*

STEP 1 CELL COLLECTION 3 TO 6 HOURS

STEP 1: 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 to 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.

Between cell collection and pre-infusion treatment, your doctor may prescribe additional therapy to treat your multiple myeloma, often called bridging therapy.^†

STEP 2 GENETICALLY MODIFYING YOUR T CELLS ~4 TO 5 WEEKS*

STEP 2: GENETICALLY MODIFYING YOUR T CELLS

~4 TO 5 WEEKS*

Your white blood cells are 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.^†

STEP 3 PRE-INFUSION TREATMENT 3 DAYS

STEP 3: PRE-INFUSION TREATMENT

3 DAYS

A few days before your CARVYKTI^® infusion, you’ll receive chemotherapy infusions with cyclophosphamide and fludarabine. These infusions will help prepare your body for the 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.

STEP 4 ONE-TIME CARVYKTI^® INFUSION ~30 TO 60 MINUTES

STEP 4: ONE-TIME CARVYKTI^® INFUSION

~30 TO 60 MINUTES

About a month after your initial cell collection, and 2 to 4 days after lymphodepleting chemotherapy, you’ll be given your CARVYKTI^® through a one-time intravenous infusion that takes approximately 30 to 60 minutes. Your healthcare providers will guide you through what your infusion day will be like.

STEP 5 MONITORING 4 WEEKS AND BEYOND

STEP 5: MONITORING

4 WEEKS AND BEYOND

After your infusion of CARVYKTI^®, your healthcare providers at the CARVYKTI^® Certified Treatment Center will closely monitor you daily for 10 days following infusion for any signs and 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 providers know if you're not feeling well. Do not drive, or operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you receive CARVYKTI^®. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects as discussed by your healthcare provider.

BCMA=B cell maturation antigen; CAR-T=chimeric antigen receptor T cell.

*Timing and outcomes of manufacturing may vary.

^†73/97 patients in the CARTITUDE-1 study received bridging therapy.

DOWNLOAD A GUIDE ON MONITORING POTENTIAL CARVYKTI® SIDE EFFECTS WITH THE HELP OF YOUR HEALTHCARE TEAM

DISCOVER SUPPORT TOOLS FOR YOUR JOURNEY

video_thumbnail_exploring_the_carvykti_treatment_process

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EXPLORE THE CARVYKTI^® TREATMENT PROCESS

Watch this immersive video that guides patients and caregivers through what to expect at each stage of the CARVYKTI^® journey.

SEE HOW YOUR CARVYKTI^® CAR-T CELLS ARE MADE

View video transcript

PLANNING FOR TREATMENT WITH CARVYKTI^®

Traveling away from home for medical care can be financially and logistically challenging. Support is available for eligible patients and their caregivers.

The MyCARVYKTI^® Patient Support Program

The MyCARVYKTI^® Patient Support Program, sponsored by Janssen Biotech, Inc., and Legend Biotech, is designed to help eligible patients prescribed CARVYKTI^® and their caregivers with support during treatment.

Patients who meet financial and other eligibility requirements, and their caregivers, may receive:

Assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at the CARVYKTI^® Certified Treatment Center

Support from MyCARVYKTI^® Patient Support Specialists, who are available to help guide eligible patients through the enrollment process and assist with program benefits

Learn more about MyCARVYKTI^® and find out if you're eligible 1-800-559-7875

Monday to Friday, 8:00 AM to 8:00 PM Eastern Time

FIND ADDITIONAL SUPPORT

TIPS FOR TREATMENT

Have someone like a friend or caregiver go with you to appointments.

A support system can make your treatment experience seem less overwhelming.

Plan your travel and lodging to stay near your CARVYKTI^® Certified Treatment Center

Your heathcare providers will monitor you closely for 4 weeks after you receive CARVYKTI^® to watch for side effects.

Wear loose, comfortable clothing.

Your doctor will need access to a vein to place the needle and catheter in your arm.

Bring a book, music, or something to do.

Leukapheresis takes 3 to 6 hours and may need to be repeated. The CARVYKTI^® infusion can take up to an hour. You may want activities during the monitoring period after infusion, too.

Have someone like a friend or caregiver go with you to appointments.

A support system can make your treatment experience seem less overwhelming.

Plan your travel and lodging to stay near your Certified Treatment Center

Your heathcare team will monitor you closely for 4 weeks after you receive CARVYKTI^® to watch for side effects.

Wear loose, comfortable clothing.

Your doctor will need access to a vein to place the needle and catheter in your arm.

Bring a book, music, or something to do.

Leukapheresis takes 3 to 6 hours and may need to be repeated. The CARVYKTI^® infusion can take up to an hour. You may want activities during the monitoring period after infusion, too.

CAREGIVER TIPS

Your role in supporting the person you care for—the encouragement, emotional support, and practical assistance you provide—makes you an important part of the treatment experience.

You may need to help the person you care for with:

Monitoring for signs and symptoms of side effects and communicating them to healthcare providers
Scheduling appointments
Providing transportation to appointments and keeping them company
Helping communicate with the healthcare providers (for example, providing medical and insurance information, asking questions)
Responsibilities at home
Emotional support and having someone to talk with
Managing their schedule and letting visitors know if they feel up to seeing them

You don't have to manage this alone. Support is available to help you along the way, and you may want to identify friends or family who can help you as well.

What is the most important information I should know about CARVYKTI^®?

CARVYKTI^® may cause side effects that are severe or life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:

fever (100.4°F/38°C or higher)
chills or shaking chills
fast or irregular heartbeat
difficulty breathing
very low blood pressure
dizziness/lightheadedness
effects on your nervous system, some of which can occur days or weeks after you receive the infusion, and may initially be subtle such as:
- feeling confused, less alert, or disoriented, having difficulty speaking or slurred speech, having difficulty reading, writing, and understanding words, memory loss
- loss of coordination affecting movement and balance, slower movements, changes in handwriting
- personality changes including a reduced ability to express emotions, being less talkative, disinterest in activities, and reduced facial expression
- tingling, numbness, and pain of hands and feet, difficulty walking, leg and/or arm weakness, and difficulty breathing
- facial numbness, difficulty moving muscles of face and eyes

It is important that you tell your healthcare providers that you have received CARVYKTI^® and to show them your CARVYKTI^® Patient Wallet Card. Your healthcare providers may give you other medicines to treat your side effects.

Before you receive CARVYKTI^® tell your healthcare provider about all your medical conditions, including if you have:

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.

How will I receive CARVYKTI^®?

CARVYKTI^® is made from your own white blood cells, so your blood will be collected by a process called ‘leukapheresis’ (loo-kah-fur-ee-sis). The procedure can take 3 to 6 hours and may need to be repeated.
Your white blood cells are sent to a manufacturing center to make CARVYKTI^®. It takes about 4-5 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
While CARVYKTI^® is being made, you may get other medicines to treat the multiple myeloma. This is so that your multiple myeloma does not get worse.

Before you get CARVYKTI^®, your healthcare provider will give you chemotherapy for 3 days to prepare your body.

30 to 60 minutes before you are given CARVYKTI^®, you may be given other medicines. These may include:

medicines for an allergic reaction (antihistamines)
medicines for fever (such as acetaminophen)

When your CARVYKTI^® is ready, your healthcare provider will give CARVYKTI^® to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of CARVYKTI^® will be given in one infusion bag. The infusion usually takes approximately 30-60 minutes.

After getting CARVYKTI^®, you will be monitored at the certified healthcare facility where you received your treatment for at least 10 days after the infusion.

What should I avoid after receiving CARVYKTI^®?

Do not drive, or operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get CARVYKTI^®. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects as discussed by your healthcare provider.
You must not be given certain vaccines called live vaccines for some time before and after CARVYKTI^® treatment. Talk to your healthcare provider if you need to have any vaccinations.
Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of CARVYKTI^®?

The most common side effects of CARVYKTI^® include:

fever (100.4°F/38°C or higher), chills
dizziness or light-headedness
headache, muscle or joint pain, feeling very tired
altered mental state, confusion
infections
low levels of antibodies (immunoglobulins) in the blood
cough, being short of breath
diarrhea, nausea, decreased appetite, constipation
fast or irregular heartbeat
problems with blood clotting

In a study comparing CARVYKTI^® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI^® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI^® and after treatment with CARVYKTI^®. The reasons for death were progression of multiple myeloma and side effects of the treatment.

CARVYKTI^® can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms after receiving CARVYKTI^®.

CARVYKTI^® can increase the risk of life-threatening infections including COVID-19 that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

CARVYKTI^® can cause various neurologic side effects, some of which may be severe or fatal. Symptoms include but are not limited to confusion, disorientation, loss of consciousness, seizures, difficulty speaking, reading or writing, tremor, slower movements, changes in personality, depression, tingling and numbness of hands and feet, leg and arm weakness, and facial numbness.

CARVYKTI^® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]), which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.

CARVYKTI^® may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

Having CARVYKTI^® in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.

These are not all the possible side effects of CARVYKTI^®. Call your healthcare provider if you have any side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI^®.

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ARE YOU ELIGIBLE FOR CARVYKTI®?

THE CARVYKTI® TREATMENT PROCESS