What is Carvykti and why is its demand outpacing supply?
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 part of your immune system that fight against infection. CARVYKTI changes 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 treatment process generally takes several months.
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 four 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
TREATMENT WITH CARVYKTIIS A 5-STEP PROCESS
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.
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.
3. PRE-INFUSION TREATMENT
3 DAYS
A few days before your CARVYKTI infusion, you’ll receive chemotherapy infusions to help prepare your body for the infusion.
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.
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.
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
- 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.
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.” 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.
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.
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 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
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.