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Overview: Carvykti is used to treat a type of blood cancer. It is made using cells from your body and works by enhancing your immune system to find and attack cancer cells. Common side effects include fever, tiredness, low blood pressure, and nausea. Tell your health care provider or get help right away if you have a high fever, chills, shaking, a fast heartbeat, trouble breathing, confusion, or trouble moving or speaking.

Uses

What is Carvykti used for?

Carvykti (ciltacabtagene autoleucel) is commonly used to treat multiple myeloma, which is a type of blood cancer, in certain people. It is typically used after other treatments have not worked or stopped helping.

Carvykti may also be used for other conditions as determined by your health care provider.

How does Carvykti work (mechanism of action)?

Carvykti is a chimeric antigen receptor (CAR) T-cell therapy. It is a type of personalized medicine where white blood cells, called T cells, are taken from your body and altered in a lab. This makes the cells grow special proteins on them called CARs, which can enhance their ability to find and attack cancer cells. The new CAR T-cells are then put back into your body to treat your cancer.

How is Carvykti supplied (dosage forms)?

Brands and other names

  • Carvykti

Dosage forms and strengths

Carvykti is available in an injectable form that is given by a health care provider.

How should I store Carvykti?

Carvykti is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Carvykti?

The most common side effects of Carvykti are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Fever and chills
  • Cytokine release syndrome (see Overactive Immune Response below)
  • Low antibodies (see below)
  • Low blood pressure or dizziness
  • Muscle and bone pain
  • Infections (see below)
  • Tiredness
  • Cough
  • Diarrhea or constipation
  • Nausea, vomiting, loss of appetite
  • Encephalopathy (see Brain Problems below)
  • Headache
  • Fast heartbeat
  • Shortness of breath
  • Fluid retention
  • Blood disorders (see below)

There may be other side effects of Carvykti that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Carvykti?

While less common, the most serious side effects of Carvykti are described below, along with what to do if they happen.

Severe Allergic Reactions. Carvykti may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Overactive Immune Response. Carvykti can cause dangerous and life-threatening conditions called cytokine release syndrome (CRS) and hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS). Both occur when your immune system responds too much to medicines, cancer, or infection. Get emergency help if you have any of the following symptoms even several weeks after you use Carvykti.

  • Fever or chills
  • Fast or racing heart
  • Dizziness or feeling lightheaded
  • Bleeding
  • Trouble breathing
  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness

Nervous System Problems. Carvykti can cause brain and nerve problems, including a condition called immune effector cell-associated neurotoxicity syndrome (ICANS). Get emergency help if you have any of the following symptoms.

  • Confusion
  • Seizures
  • Balance problems
  • Trouble moving or talking 
  • Tremor

Infections. Carvykti can increase your risk of infections, including serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Fever of 100.4 F (38 C) or higher
  • Burning or stinging when you pee
  • Cough or coughing up blood 
  • Chills, sweating, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss

Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Carvykti may increase your risk of a latent microbe becoming active again, causing an infection. Before you start treatment with Carvykti, tell your health care provider if you have cytomegalovirus (CMV), hepatitis B, hepatitis C, or any other serious infections.

Blood Disorders. Carvykti can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low neutrophils (neutropenia), including febrile neutropenia, which can lead to dangerous infections. Keep all appointments to have your blood checked. Get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Low Antibodies. Carvykti may cause you to have low levels of certain types of antibodies, called immunoglobulins. Low immunoglobulin levels could increase your risk for infection. Keep all appointments to check your blood tests after getting this medicine.

Cancer. Carvykti can cause a new cancer to develop. Tell your health care provider about any new symptoms that you may get.

Warnings & Precautions

Who should not use Carvykti?

Allergies to Ingredients. People who are allergic to any of the following should not use Carvykti.

  • Carvykti
  • Ciltacabtagene autoleucel
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Carvykti.

What should I know about Carvykti before using it?

Carvykti is given by a health care provider in a hospital or clinic.

Carvykti is made using your own white blood cells, so it will take several weeks for the medicine to be ready. Talk to your health care provider about what to expect during the process.

Carvykti is given as a single dose. Your health care provider will give you certain medicines on a specific schedule before you receive Carvykti. Make sure to attend all appointments and take all medicines they give you as instructed.

Carvykti can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination for at least eight weeks after receiving Carvykti.

You should not donate blood, tissues, or organs after using Carvykti.

After using Carvykti, it is possible that blood tests will give you a false-positive test result for HIV. Tell every health care provider you see that you have received Carvykti.

In a study, a higher number of people who received Carvykti died in the first 10 months compared to people who did not receive Carvykti. Some of these deaths were caused by side effects of Carvykti and some were caused by their cancer getting worse. You and your health care provider will discuss the benefits and risks of Carvykti before starting this treatment.

What should I tell my health care provider before using Carvykti?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Carvykti is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Brain or nerve problems, such as seizures, stroke, or memory loss
  • Breathing or lung problems
  • Heart problems
  • Kidney or liver problems
  • Infection
  • HIV or any problem with your immune system
  • Low levels of blood cells

Vaccines. Talk to your health care provider about any vaccines that you may need. You should not receive certain vaccines within six weeks before starting the treatment process for Carvykti, during treatment, and until your immune system recovers after Carvykti. Tell your health care provider about any vaccines you have recently received or have scheduled.

Pregnancy. Do not use Carvykti if you are pregnant or think you may be pregnant. It is not known if Carvykti may cause harm to a fetus, but it may cause serious problems if it reaches the baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will likely give you a pregnancy test before you use Carvykti. If you or your partner can become pregnant, they may recommend using birth control during and after treatment. Talk to your health care provider if you would like to get pregnant after using this medicine.

Breastfeeding. It is not known if Carvykti passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Carvykti?

For more information about Carvykti, you can visit the manufacturer’s website at www.carvykti.com or call them at 800-526-7736.

Interactions

Does Carvykti interact with foods or drinks?

There are no known interactions between Carvykti and foods or drinks.

It is unknown if drinking alcohol will affect Carvykti, but heavy drinking can slow your immune response and make it harder for your body to fight infection and cancer.

Does Carvykti interact with other medicines (drug interactions)?

There are no known interactions between Carvykti and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Carvykti?

If you or someone else has used too much Carvykti, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Carvykti?

Carvykti is given by a health care provider in a hospital. Call them right away if you are going to miss your appointment for Carvykti or any of the other medicines you need before using Carvykti. 

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