Carvykti
Carvykti (ciltacabtagene autoleucel) is an immunotherapy used to treat multiple myeloma. Carvykti (ciltacabtagene autoleucel) is known as a chimeric antigen receptor (CAR) T-cell therapy, or CAR-T therapy. This treatment involves taking T-cells from your own body, programming them to better find cancer cells, and then infusing them back to your body so they can fight cancer. While Carvykti (ciltacabtagene autoleucel) is given as a one-time infusion, the entire process (including preparation and recovery) can take over a month. Treatment might lead to serious side effects such as cytokine release syndrome (CRS) and nervous system problems.
What is Carvykti (ciltacabtagene autoleucel)?
What is Carvykti (ciltacabtagene autoleucel) used for?
- Advanced multiple myeloma in adults (after trying at least one prior anticancer treatment)
How Carvykti (ciltacabtagene autoleucel) works
Your immune system can not only help fight off infections, but certain immune cells (T-cells) can also fight cancer. Sometimes, cancer cells try to hide from the T-cells. So in order for T-cells to work best to fight cancer, they need to tell the difference between healthy and cancer cells.
Carvykti (ciltacabtagene autoleucel) is a type of immunotherapy, also called CAR-T therapy. During treatment, your T-cells are removed from your body and sent to a lab. There, they’re programmed specifically to find and attack the multiple myeloma cancer cells in your body. Once ready, the T-cells are infused back into your body to destroy cancer cells.
Drug facts
More on Carvykti (ciltacabtagene autoleucel) essentials
Side effects of Carvykti (ciltacabtagene autoleucel)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Lower blood cell counts (up to 99%)
- Fever (96%)
- Cytokine release syndrome (95%)
- Low immunoglobulins levels (94%)
- Low blood pressure (51%)
- Muscle pain (48%)
- Tiredness (47%)
- Infections (41%)
- Diarrhea (33%)
- Chills (33%)
- Nausea (31%)
Less Common Side Effects
- Lower appetite
- Headache
- Fast heartbeat
- Dizziness
- Swelling
- Blood clotting problems
Carvykti (ciltacabtagene autoleucel) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, dizziness, chills, low blood pressure, fast heartbeat, headache, tiredness
- Serious nervous system problems: headache, confusion, changes in personality, depression, difficulty speaking, difficulty writing, weakness in the arms and legs, tingling in the hands and feet, tremor, slower movement, seizures
- Serious infections: fever, body aches, fast heartbeat, chills
- Bleeding (from low platelets): nosebleeds, blood in urine, blood in stool, unexplained bruising
The following Carvykti (ciltacabtagene autoleucel) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, shuffling walk
- Numbness or weakness of the face, uneven smile
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Severe back pain, numbness or weakness of the hands, arms, legs, or feet, loss of coordination, loss of bowel or bladder control
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Loss of appetite
- Muscle pain
- Nausea
Pros and cons of Carvykti (ciltacabtagene autoleucel)
Pros
- Works in a more targeted way than traditional chemotherapy
- Recommended treatment for certain people with multiple myeloma
- Option for people who've tried 4 previous therapies
Cons
- Can cause a serious reaction called cytokine release syndrome (CRS)
- Treatment requires a multi-step process that takes over a month
- Not available as a generic medication
Pharmacist tips for Carvykti (ciltacabtagene autoleucel)
- It's best to avoid driving or doing activities that needs a lot of focus and attention for at least 2 months after you receive Carvykti (ciltacabtagene autoleucel). This is because Carvykti (ciltacabtagene autoleucel) can cause some serious side effects after the infusion, including dizziness and coordination problems. Please work with your caregiver, family, or friends to plan transportation to and from appointments, as well as for help at home during this time.
- Your oncology team needs to closely monitor you for several weeks after you receive Carvykti (ciltacabtagene autoleucel) because treatment can lead to serious side effects. You'll need to stay close by the treatment center where you received Carvykti (ciltacabtagene autoleucel) for at least 4 weeks after your treatment. If needed, ask your healthcare team about how to plan for your stay and recommended places for lodging.
- Let your oncology team know right away if you notice symptoms of cytokine release syndrome (CRS), such as chills, fever, tiredness, and trouble breathing. These can happen days after you receive Carvykti (ciltacabtagene autoleucel). If you have CRS, your care team will need to give you medical attention right away to prevent life-threatening complications.
- Because Carvykti (ciltacabtagene autoleucel) treatment can weaken your immune system, you’re at risk for developing serious infections, even months after your treatment. You can help prevent infection by washing your hands often, avoiding crowds, and washing raw fruits and vegetables thoroughly before eating them.
- If you develop a temperature of 100.4 Fahrenheit or higher, seek medical help right away. This means you have a fever. A fever with Carvykti (ciltacabtagene autoleucel) can be serious, because it can mean you have an infection or it can be an early sign of cytokine release syndrome (CRS).
- It's unclear how live vaccines might affect Carvykti (ciltacabtagene autoleucel) treatment. To be safe, you should avoid getting any live vaccines within 6 weeks of the start of chemotherapy (lymphodepletion). Also, avoid live vaccines until after your immune system has recovered from Carvykti (ciltacabtagene autoleucel). Your oncology team will let you know when it’s safe for you to receive live vaccines.
Common questions about Carvykti (ciltacabtagene autoleucel)
Chimeric antigen T-cell therapy, or CAR-T therapy, is a type of immunotherapy used to treat cancer. This treatment uses cells from your own immune system, called T-cells, to attack and kill cancer cells. After collecting T-cells from your blood, a special lab programs the T-cells to attack proteins found on the outside of your cancer cells. Then you’ll take an infusion of the T-cells back into your body, where they can then attack the cancer cells. There are several types of CAR-T therapy, and each one programs T-cells to target proteins specific to the type of cancer you have. Carvykti (ciltacabtagene autoleucel) is programmed to attack a specific protein found on multiple myeloma cells.
Part of the complete Carvykti (ciltacabtagene autoleucel) treatment includes taking three days of chemotherapy before you take the T-cell infusion. This is called lymphodepleting chemotherapy, or lymphodepletion. Usually, the chemotherapy medications used for lymphodepleting chemotherapy are cyclophosphamide and fludarabine. Lymphodepletion helps prepare your body for the Carvykti (ciltacabtagene autoleucel) infusion by making sure the other immune cells in your body don’t attack or remove the Carvykti (ciltacabtagene autoleucel) cells before they can do their job. This helps make sure the Carvykti (ciltacabtagene autoleucel) cells will work better to fight and kill cancer cells.
The Risk Evaluation and Mitigation Strategy (REMS) program is a medication safety program created by the FDA for certain medications that can cause serious side effects. The REMS program gives specific instructions on how to minimize or manage serious side effects of the medications. Carvykti (ciltacabtagene autoleucel) is part of the REMS program because it can cause cytokine release syndrome (CRS) and neurotoxicity, which can be life-threatening. As part of Carvykti (ciltacabtagene autoleucel) REMS, you can only receive treatment at certified hospitals or clinics, and your oncology team needs to complete training on how to recognize and treat these side effects. Make sure to carry the Carvykti Patient Wallet Card with you at all times and get medical help right away if you notice symptoms of CRS or neurotoxicity, including fever, muscle pain, numbness in the hands and feet, and trouble with memory or movement.
Yes, Carvykti (ciltacabtagene autoleucel) can cause cytokine release syndrome (CRS), which is a serious immune reaction to the medication. This reaction happens when small immune proteins called cytokines overreact to the Carvykti (ciltacabtagene autoleucel) infusion and cause problems in your body. Symptoms of CRS can include fever, trouble breathing, tiredness, and low blood pressure. Typically, symptoms appear about a week after Carvykti (ciltacabtagene autoleucel) infusion and usually lasts for 4 days. Rarely, symptoms can last for several months. Because CRS can be life-threatening, your oncology team will ask you to stay close by the treatment center where you received Carvykti (ciltacabtagene autoleucel) for about a month after the infusion. This is so that they can monitor you regularly for symptoms of CRS and other serious side effects, and if needed, give you treatment as quickly as possible.
Yes, Carvykti (ciltacabtagene autoleucel) can cause nervous system problems, also known as neurotoxicities. These problems can include numbness in tingling in your fingers and toes, unusual muscle movement, difficulty speaking and writing, and confusion. Nervous system problems can also include a life-threatening condition called immune effector cell-associated neurotoxicity syndrome (ICANS). These problems can happen within days or weeks after the Carvykti (ciltacabtagene autoleucel) infusion. After your Carvykti (ciltacabtagene autoleucel) infusion, your oncology team will ask you to stay nearby the treatment center so they can monitor you closely for signs and symptoms of nervous system problems. It’s important for family members and caregivers to be aware of symptoms, in case you experience confusion or difficulty speaking.
Carvykti (ciltacabtagene autoleucel) can cause nausea, but it’s usually mild. Some people might feel nauseous from the lymphodepletion chemotherapy needed before the Carvykti (ciltacabtagene autoleucel) infusion. If appropriate, your oncologist might recommend you to take antiemetic medications, such as ondansetron (Zofran) or prochlorperazine (Compazine), to ease your symptoms. Let your oncology team know if you feel nauseous in the days after you've received the Carvykti (ciltacabtagene autoleucel) infusion. Sometimes nausea can be a symptom of CRS, which is a serious side effect that needs immediate medical attention.
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Risks and warnings for Carvykti (ciltacabtagene autoleucel)
Carvykti (ciltacabtagene autoleucel) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome
Cytokine release syndrome (CRS) is a potentially life-threatening immune reaction that the body can have to the Carvykti (ciltacabtagene autoleucel) infusion. In clinical studies, CRS typically occurred 7 days after the infusion and symptoms lasted about 4 days. Symptoms of CRS can include fever, tiredness, chills, and trouble breathing. Rarely, people can also develop other serious immune-related reactions, such as hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS). These complications can cause organ damage and are life-threatening.
Your oncologist will monitor you for symptoms for several weeks after your infusion. If you develop symptoms of CRS, get medical help right away. Typically, you’ll need to go to the hospital for treatment with corticosteroids and a medication called Actemra (tocilizumab) to manage it.
Nervous system problems (neurotoxicities)
Carvykti (ciltacabtagene autoleucel) can cause nervous system problems, such as feeling confused, trouble speaking, and poor balance. Symptoms typically appear within the first few weeks of the Carvykti (ciltacabtagene autoleucel) infusion and can last for several weeks (sometimes longer). Though not as common, some people have reported delayed symptoms of parkinsonism, such as difficulty controlling muscles, difficulty writing, and tremors. These symptoms can appear several months after the Carvykti (ciltacabtagene autoleucel) infusion and last for months to years.
Sometimes, Carvykti (ciltacabtagene autoleucel) can cause immune effector cell-associated neurotoxicity syndrome (ICANS) or Guillain-Barre Syndrome (GBS), which can be life-threatening. Your oncology team will monitor you for symptoms of nervous system problems closely after you receive Carvykti (ciltacabtagene autoleucel). You’ll need to stay close to the treatment center for at least a month after your infusion so you can get regular check ups and receive medical attention if needed.
REMS program
Because Carvykti (ciltacabtagene autoleucel) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems including immune effector-cell associated neurotoxicity syndrome (ICANS), it's only available through a special program called Risk Evaluation and Mitigation Strategy (REMS). This program requires your oncologist to complete special training to prescribe Carvykti (ciltacabtagene autoleucel). Additionally, the healthcare facility where you receive treatment must keep certain medications used to manage side effects, such as Actemra (tocilizumab), available in case you need it.
Lower blood cell counts
Carvykti (ciltacabtagene autoleucel) treatment, including the lymphodepleting chemotherapy before T-cell infusion, can lower blood cell counts in your body. This might last longer than 2 months after the Carvykti (ciltacabtagene autoleucel) infusion. Having lower blood cell counts puts you at higher risk for infections, bleeding, and anemia.
Your oncology team will closely monitor your blood cell counts after Carvykti (ciltacabtagene autoleucel) treatment. If your levels are low, they might recommend red blood cell or platelet transfusions, or a medication called growth factor that can prompt white blood cell growth. Make sure you go to all lab appointments so that your care team recommends so that they can keep a close eye on your blood cell counts.
Serious infections
People who received Carvykti (ciltacabtagene autoleucel) have developed serious and life-threatening infections, including bacterial, viral, and fungal infections. Carvykti (ciltacabtagene autoleucel) can cause your white blood cell (WBC) levels to drop, which can raise your risk for getting sick. People who had hepatitis B in the past might have a new infection (hepatitis B reactivation) after starting Carvykti (ciltacabtagene autoleucel). Your oncology team will monitor your WBC levels with lab tests, and they might prescribe medications, such as antibiotics or antivirals, to help protect you from serious infections.
You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your oncologist right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your healthcare team right away if you have any signs or symptoms of infection such as fever, body aches, and chills.
Risk of new cancers
Though not common, some people who received Carvykti (ciltacabtagene autoleucel) in clinical trials have developed new cancers, including blood cancers such as myelodysplastic syndrome (MDS). Some of these cancers appeared over a year after their Carvykti (ciltacabtagene autoleucel) infusions. Your oncology team will monitor you for new cancers regularly after Carvykti (ciltacabtagene autoleucel) treatment. Ask your care team if you’re concerned about the risk of cancers from Carvykti (ciltacabtagene autoleucel).
Risk of early death
In clinical studies, there were more early deaths in the Carvykti (ciltacabtagene autoleucel) group than in the group that didn’t receive Carvykti (ciltacabtagene autoleucel). Some of the deaths occurred before Carvykti (ciltacabtagene autoleucel) infusion and were caused by progression of the cancer. Some deaths occurred after Carvykti (ciltacabtagene autoleucel) infusion and majority of those were caused by side effects from Carvykti (ciltacabtagene autoleucel) , such as infection. Talk with your healthcare team if you’re concerned about the risks of Carvykti (ciltacabtagene autoleucel) treatment.
Low immunoglobulins
Some people taking Carvykti (ciltacabtagene autoleucel) experienced low immunoglobulin levels. Immunoglobulins are proteins that are an important part of your immune system, and help fight infection. When your immunoglobulins are low, this raises your risk for getting sick.
Your oncology team will monitor your immunoglobulin levels. If they’re too low, you might need to take a medication called intravenous immunoglobulin (IVIG) to replace immunoglobulins in your body.
Allergic reaction
Rarely, people experienced allergic reactions after their Carvykti (ciltacabtagene autoleucel) infusion. Reactions are typically mild and include symptoms such as flushing, warmth, fast heartbeat, wheezing, and an uncomfortable feeling in your chest. This reaction might be due to a preservative called dimethyl sulfoxide (DMSO), a preservative that’s part of the medication. If you have any symptoms of an allergic reaction during your infusion, tell your nurse right away.
Risks driving or using machines
Carvykti (ciltacabtagene autoleucel) treatment might cause nervous system changes that can include tiredness, confusion, and seizures. Don’t drive or participate in activities that would be dangerous if you couldn’t focus for 2 months after treatment. Talk with your oncology team and caregivers so that you have a plan in place to help you with transportation to appointments, chores at home, and emotional support, before you start Carvykti (ciltacabtagene autoleucel).
Carvykti (ciltacabtagene autoleucel) dosage
Typical dosage for Carvykti (ciltacabtagene autoleucel)
Carvykti (ciltacabtagene autoleucel) is usually given at a qualified treatment center or in a hospital setting. The treatment process takes several stages:
- Blood collection: Your immune cells are collected from your body. Your T cells are separated, while the rest of your immune cells are infused back into your body. This process takes 3 to 6 hours.
- Making Carvykti: Your T-cells are sent to a lab and made into Carvykti that’s specific for you. This step takes about a month.
- Pre-treatment with chemotherapy: To prepare your body to receive Carvykti, your oncologist will prescribe 3 days of chemotherapy, typically cyclophosphamide and fludarabine.
- Receiving Carvykti: Two to four days after the last dose of chemotherapy, your oncologist will infuse Carvykti into the vein as a one-time infusion over 30 to 60 minutes.
After treatment, you’ll need to stay at or near the qualified treatment center for at least 4 weeks so your oncologist can monitor your recovery and check for side effects.
What are alternatives to Carvykti (ciltacabtagene autoleucel)?
