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.

PATIENT AND CARE PARTNER VOICES

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.

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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.

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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.

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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.

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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.

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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.

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.

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