Carvykti is a brand-name injectable suspension that’s prescribed for multiple myeloma. Carvykti contains the active ingredient ciltacabtagene autoleucel and belongs to the CAR T-cell therapy drug class.
Carvykti is Food and Drug Administration (FDA) approved to treat multiple myeloma in adults in certain situations. For this use, the cancer must be refractory or relapsed after treatment with at least one other therapy in the past.
Drug details
You’ll find key information about Carvykti below.
- Drug class: chimeric antigen receptor (CAR) T-cell therapy
- Drug form: suspension given as an intravenous (IV) infusion
- Generic or biosimilar available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2022
Carvykti has boxed warnings about certain serious side effects. A boxed warning is the most serious warning from the FDA. For details, see the “Carvykti precautions” section below.
Carvykti is available only as a brand-name medication. It’s a biologic drug that contains the active ingredient ciltacabtagene autoleucel. Carvykti is not currently available in biosimilar form.
Biologics are made using parts of living cells, while traditional drugs are made using chemicals. Traditional drugs have generic forms that are exact copies of the active drug in the brand-name form. However, biologics have biosimilars because they cannot be copied exactly.
Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug.
The Carvykti dosage your doctor prescribes will depend on the severity of your condition and your body weight in kilograms (kg). For reference, 1 kg is about 2.2 pounds (lb).
The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.
Drug form
Carvykti is a type of drug called CAR T-cell therapy. It’s made from T cells (a type of white blood cell) that are collected from your blood and modified in a laboratory to form a suspension.
For a more detailed explanation, visit the manufacturer’s website.
Dosage for multiple myeloma
Carvykti is prescribed to treat multiple myeloma in adults in certain situations. To learn when doctors prescribe Carvykti, see the “Carvykti uses” section below.
Carvykti is given as a one-time treatment. Your doctor will use your body weight to calculate the dose of Carvykti you need. Talk with your doctor if you have questions about what your specific dose will be.
How it’s given
Your doctor or another healthcare professional will administer Carvykti as an IV infusion. An IV infusion is an injection into a vein that’s given over a period of time. The infusion is typically given over 30 to 60 minutes.
Carvykti may cause serious side effects.* For this reason, the drug is only given in a treatment center that’s certified by the Carvykti risk evaluation and mitigation strategy (REMS) program. The Carvykti REMS program helps ensure your doctor understands how to give Carvykti and manage serious side effects that may occur.
After you receive Carvykti, you’ll likely stay in the treatment center where you received the drug for at least 10 days. You’ll continue staying near the treatment center for at least 4 weeks after receiving the infusion. This allows your doctor to watch closely for serious side effects.
If you have other questions about receiving Carvykti, talk with your doctor.
* Carvykti has boxed warnings for certain serious side effects. This is the most serious warning from the FDA. To learn more, see the “Carvykti precautions” section below.
About taking Carvykti
Below you’ll find information about key dosage issues.
- When to receive: You’ll receive one infusion of Carvykti. Your doctor will advise you on when to receive it.
- If you miss a dose: If you miss the appointment for your Carvykti infusion, call the treatment center right away to reschedule.
- Length of use: Carvykti is not meant to be used as a long-term treatment. It’s given as a one-time infusion.
- Length of time to work: Carvykti starts working right after your infusion. Because of how the drug works, you likely won’t feel it working in your body. Your doctor will monitor your condition to check whether Carvytki is working.
Carvykti can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Carvykti. These lists do not include all possible side effects.
For more information about the possible side effects of Carvykti, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Carvykti, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Carvykti. To learn about other mild side effects, talk with your doctor or pharmacist, or view Carvykti’s prescribing information.
Mild side effects of Carvykti can include:
- cough
- diarrhea or constipation
- dizziness
- edema (swelling, usually in your hands or feet)
- fast heart rate
- fatigue
- fever or chills
- headache
- loss of appetite
- low blood pressure
- mild infection, such as upper respiratory infection
- musculoskeletal pain
- nausea or vomiting
- shortness of breath
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Carvykti aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- low levels of immunoglobulin (a type of protein), which may include symptoms such as:
- bone pain
- fatigue
- weight loss
- serious infections such as pneumonia, which may include symptoms such as:
- cough
- fatigue
- fever or chills
- risk of cytokine release syndrome*
- risk of neurologic toxicity*
- risk of certain life threatening immune system conditions*
- risk of low blood cell counts*
- risk of certain other blood cancers*
* Carvykti has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Carvykti precautions” section below.
ALLERGIC REACTIONFor some people, Carvykti can cause an allergic reaction.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Carvykti, your doctor may recommend taking a different medication instead.
The Food and Drug Administration (FDA) approves prescription drugs such as Carvykti to treat certain conditions.
Carvykti for multiple myeloma
Carvykti is FDA approved to treat multiple myeloma in adults in certain situations. Multiple myeloma is a type of cancer that affects plasma cells. These are genetically modified T cells that help your immune system fight infection. (T cells are a specific type of white blood cells.)
For this use, the cancer must be refractory or relapsed. “Refractory” means the cancer did not respond to past treatments. “Relapsed” means the cancer came back after past treatments.
Specifically, Carvykti is used after the following multiple myeloma treatments have not worked:
- lenalidomide (Revlimid)
- immunomodulators, such as pomalidomide (Pomalyst)
- proteasome inhibitors, such as bortezomib (Velcade)
To learn more about multiple myeloma, visit our cancer hub.
Carvykti and children
Carvykti is not FDA approved for use in children. It’s not known for certain whether the drug is safe or effective for children.
Carvykti is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions with these substances in the drug’s prescribing information.
However, the drug may interact with certain lab tests or vaccines. See below to learn more.
Before receiving Carvykti, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
Interactions with lab tests and vaccines
Below is a list of lab tests and vaccines that can interact with Carvykti. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Lab tests that may interact with Carvykti | • certain HIV tests, such as HIV RNA tests |
---|---|
Vaccines that may interact with Carvykti | • live vaccines, such as the chickenpox vaccine (Varivax) or the measles, mumps, and rubella (MMR) vaccine |
As with all medications, the cost of Carvykti can vary. The actual price you’ll pay depends on your insurance plan and your location.
Financial and insurance assistance: If you need financial support to pay for Carvykti, or if you need help understanding your insurance coverage, help is available.
A program called MyCARVIKTI Patient Support Program is available for Carvykti. For more information and to find out if you’re eligible for support, call 800-559-7875 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Biosimilar version: Carvykti is a biologic drug that is not available in a biosimilar form. Biologics are made using parts of living cells, while traditional drugs are made using chemicals. Traditional drugs have generic forms that are exact copies of the active drug in the brand-name form. However, biologics have biosimilars because they cannot be copied exactly.
Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug. And they may cost less than brand-name drugs.
To learn more about saving money on prescriptions, check out this article.
Other drugs that can treat multiple myeloma are available. For example, another CAR T-cell therapy called Abecma (idecabtagene vicleucel) is approved for this use. (Carvytki is also a CAR T-cell therapy.)
Some drugs may be a better fit for you than others. If you’re interested in finding an alternative to Carvykti, talk with your doctor. They can tell you about how Carvytki compares with Abecma or other medications that treat multiple myeloma.
If you can become pregnant, consider the following information about pregnancy and breastfeeding.
Carvykti and pregnancy
It’s not known whether Carvykti should be used during pregnancy. To be safe, your doctor may advise you not to receive the drug while pregnant.
If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication. Your doctor will have you take a pregnancy test prior to treatment, and may also suggest birth control options to use before receiving Carvykti.
Carvykti and breastfeeding
It’s not known whether Carvykti should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this medication.
This drug comes with several precautions.
FDA warnings
This drug has boxed warnings for certain serious side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Risk of cytokine release syndrome: Carvykti may cause cytokine release syndrome (CRS). This condition results in the release of certain proteins into your blood, which can make your immune system overactive.
Mild CRS was common in clinical trials of Carvykti. With mild CRS, you may have symptoms such as dizziness, headache, or fatigue.
Severe CRS was less common in these trials. However, it can be life threatening for some people. With severe CRS, you may have signs and symptoms such as:
- low levels of oxygen in your body
- low blood pressure
- high levels of liver enzymes, which may be a sign of liver damage
Due to this risk, Carvytki is only given in a treatment center that’s certified by the Carvykti risk evaluation and mitigation strategy (REMS) program. The Carvykti REMS program helps ensure your doctor understands how to give Carvykti and manage serious side effects that may occur.
After you receive Carvykti, you’ll likely stay in the treatment center where you received the drug for at least 10 days. You’ll continue staying near the treatment center for at least 4 weeks after receiving the infusion. This allows your doctor to watch closely for CRS and other serious side effects of the drug.
If you have symptoms of CRS after receiving your Carvykti infusion, tell your doctor right away. They’ll give you treatments for this condition.
Risk of neurological toxicity: Carvytki may cause neurological toxicity. This means the drug may cause damage to your nervous system, which includes the brain and spinal cord.
Mild neurological toxicity, such as peripheral neuropathy, was common in clinical trials of Carvykti. Severe neurological toxicity was less common in these trials. This includes serious and possibly life threatening conditions such as:
- damage to cranial nerves
- encephalopathy (brain damage)
- Guillain-Barré syndrome
- immune effector cell-associated neurotoxicity syndrome (ICANS)
- Parkinsonism
Neurological toxicity may lead to confusion, slowed movements, or loss of consciousness. Other possible symptoms include seizures, difficulty speaking, or numbness in your face, arms, or legs.
Due to this risk, Carvytki is only given in a treatment center that’s certified by the Carvytki REMS program. (For details about this program, see “Risk of cytokine release syndrome” just above.)
In addition, you’ll likely stay in the treatment center for at least 10 days after your infusion. And you’ll continue staying near the treatment center for at least 4 weeks. This allows your doctor to closely monitor you for neurological toxicity and other serious side effects from the drug.
It’s important to avoid any activities that require alertness, such as driving, for at least 8 weeks after receiving your Carvytki infusion. This is because neurological toxicity can affect memory and coordination. If you have symptoms of neurological toxicity, you should avoid these activities until your doctor advises you that it’s safe to resume them.
Tell your doctor immediately if you have symptoms of neurological toxicity after the Carvytki infusion. They’ll treat your symptoms right away.
Risk of certain life threatening immune system conditions: Carvytki may cause certain life threatening immune system conditions. These overlapping conditions are called hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS).
HLH and MAS were rare in clinical trials of Carvykti. Symptoms of HLH/MAS may include:
- difficulty breathing
- high levels of ferritin (a protein that stores iron in your blood cells)
- low blood pressure
- blood clotting or bleeding more easily than usual
- organ damage, which may affect the kidneys, lungs, and other organs
Your doctor will watch for signs of HLH/MAS after your Carvykti treatment. They’ll recommend what to do if these conditions develop.
Risk of low blood cell counts: Carvytki may increase the risk of low blood cell counts. With this side effect, you may have low levels of platelets, red blood cells, or certain white blood cells called lymphocytes and neutrophils. These low blood cell counts may be long lasting or keep coming back.
Low blood cell counts were common in clinical trials of Carvykti. Symptoms can vary depending on the specific blood cell affected but may include:
Your doctor will likely check your blood cell levels after your Carvykti infusion. They’ll recommend what to do if you have low blood cell counts.
Risk of certain other blood cancers: Carvytki may increase the risk of certain other blood cancers. Examples include myelodysplastic syndrome and T-cell lymphoma.
Other blood cancers were rare in clinical trials of Carvykti. Such cancers can develop within a few weeks after your Carvykti infusion and may be life threatening.
Symptoms of other blood cancers may include:
- fatigue
- fever
- night sweats
- weight loss
Your doctor will watch for signs of other cancers after your Carvykti treatment. They’ll recommend what to do if a new cancer develops.
Other precautions
Before receiving Carvykti, discuss your health history with your doctor. Carvykti may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- current or past infection, including hepatitis B
- current or past problems with your nervous system, such as seizures
- conditions involving inflammation
- liver, kidney, heart, or lung problems
- previous allergic reaction to Carvykti or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Carvykti, see the “Carvykti side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.