(ciltacabtagene autoleucel)
Carvykti is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Carvykti is a personalized immunotherapy delivered as a onetime infusion, manufactured using the patient’s own white blood cells (T-cells) that have been genetically modified.
How Carvykti works Carvykti recognizes and binds to BCMA, a protein that is nearly universally expressed on myeloma cells, leading to the death of BCMA-expressing cells. Your own T cells are genetically modified to recognize and attack BCMA on the surface of your myeloma cells, thereby eliminating the myeloma cells.
How Carvykti is given The treatment process with Carvykti generally takes 2 to 3 months and is comprised of the following five steps: 1. Leukapheresis – Your blood is drawn, then passed through a machine that separates it into its individual components. The white blood cells are collected, and the remaining blood components are then immediately re-infused back into your bloodstream. This process may take 3 to 6 hours. 2. Modification of T cells – Your white blood cells are sent to a laboratory where your T cells are separated out, then genetically modified to make Carvykti. Making your Carvykti CAR T cells takes approximately 4 to 5 weeks. 3. Pre-infusion chemotherapy – While your Carvykti is being made, you may receive chemotherapy to treat your myeloma. Then, for the 3 days prior to your infusion of Carvykti, your doctor will give you chemotherapy to help prepare your body to receive the infusion of the genetically modified T cells. 4. Infusion of Carvykti – You may be given medicines to prevent or lessen a possible allergic reaction to Carvykti and to reduce fever. You will then receive your one-time infusion of Carvykti T cells through an intravenous catheter (tube). The infusion takes approximately 30 to 60 minutes. After the infusion, the genetically modified T cells will begin to seek out your myeloma cells and attack them.
5. Monitoring – Your doctor will monitor you for at least 10 days to observe that your treatment is working, and to check for any signs or symptoms of side effects. Blood tests will track your progress. You must stay close to the center where you receive your treatment for at least 4 weeks, and make a plan with your doctor for long-term follow-up.
Important safety information
Carvykti may cause side effects that are severe or life-threatening. Immediately contact your doctor or get emergency help if you experience any of the following: ¡ fever of 100.4°F/38°C or higher, ¡ chills or shivering, ¡ fast or irregular heartbeat, ¡ difficulty breathing, shortness of breath, ¡ very low blood pressure, ¡ dizziness or lightheadedness, ¡ effects on your nervous system, which may be subtle and can occur weeks after your infusion of Carvykti. The most common side effects that occurred in more than 20% of myeloma patients who received Carvykti are fever, cytokine release syndrome (CRS), hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, pathogenunspecified infections, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common laboratory side effects that occurred in 50% or more of myeloma patients who received Carvykti include thrombocytopenia, neutropenia, anemia, aminotransferase (enzyme) elevation, and hypoalbuminemia. Having Carvykti in your blood may cause a false-positive human immunodeficiency virus (HIV) test result by some commercial tests, even when you may be HIV-negative.
Support The MyCARVYKTI™ Patient Support Program helps patients who meet eligibility requirements, and their caregivers, receive assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at a certified treatment center. Call 1.800.559.7875. Visit myeloma.org to learn more about Carvykti as well as other myeloma therapies. As always, the IMF urges you to discuss all medical issues with your doctor, and to contact the IMF with your myeloma questions and concerns.
International Myeloma Foundation
4400 Coldwater Canyon Ave., Ste 300 – Studio City, CA 91604 USA 1.818.487.7455 1.800.452.CURE myeloma.org
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