Carvykti

What is Carvykti?

Carvykti is used to treat multiple myeloma, a form of cancer in the bone marrow. Carvykti can be used by adults with multiple myeloma, which has returned or did not respond well to other treatments. Carvykti, an immunotherapy made from the patient's immune cells that have been genetically modified so they can find and kill cancerous cells, is used in adults with multiple myeloma.

Carvykti, a genetically modified autologous cell immunotherapy directed at B-cell maturity antigen (BCMA), is an alternative to standard T-cell immunotherapy.

Carvykti, also known as Car-T therapy, is an immunotherapy made with T cells taken from the patient. T-cells, which are part of your immune system and help fight bacteria and protect you against disease, attach to the proteins (antigens) on the surface cells they need to kill. On the surface of cancer cells, there are many B cell maturation (BCMA) antigens. Your T cells can't destroy cancer if they don't possess the correct receptors. Carvykti therapy involves adding a receptor gene to the patient's T cells. This receptor attaches itself to the BCMA found on cancer cells, allowing it to attack and destroy the cancer. The gene for the receptor is called chimeric receptor antigen, or CAR. Therefore, modified T cells are known as CAR T cells.

Carvykti was approved by the Food and Drug Administration on February 28, 2022. It is used to treat adults with relapsed and refractory myeloma after they have received four or more treatments, including a proasome inhibitor, an immunomodulatory drug, and a monoclonal anti-CD38 antibody.

Similar/related drugs

Abecma, Blenrep, Tecvayli, Xpovio, Kyprolis, Elrexfio, and Talvey

Side effects of Carvykti

Common Carvykti side effects

• Feeling confused, coughing, or having trouble breathing
• Headache, dizziness;
• Speech problems;
• Low blood cell count
• If you have any of the following symptoms, it is likely that you are infected with:
• Constipation; nausea; or
• You may experience pain in your muscles or joints.

Serious side effects

See also the Warnings section below. If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of your lips, face, throat, or tongue.

This medicine can cause a serious side effect called cytokine-release syndrome (CRS). If you experience any of the following symptoms, tell your carers immediately: fever; chills; trouble breathing; severe nausea; and and diarrheif CRS occurs, your carers have medications available to treat it quickly.

Call your doctor immediately if you:

• Depression, confusion, loss of consciousness, or seizures.
• If you experience tingling or numbness in your hands, feet, legs, arms, or facial nerves, then this is a sign of a neurological disorder.
• Low blood counts—fever and chills; tiredness; flu Mouth sores or skin sores Easy bruising. Unusual bleeding. Pale skin. Cold in the hands and feet. Feeling light-headed.

Other side effects may also occur.Call your physician if experiencing side effects; contact FDA by dialing 1-800-FDA-1088 and report these instances of adverse reaction.

Warnings

Carvykti can cause severe side effects, including those that are life-threatening or fatal. Patients have experienced cytokine release syndrome, including life-threatening or fatal reactions. Carvykti should not be used if you are suffering from an infection or inflammation. Tocilizumab, or tocilizumab combined with corticosteroids, should be used to treat severe or life-threatening cases of CRS.

Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred after treatment with this medication, including before or concurrently with the onset of CRS or CRS resolution. After treatment with this medication, you will be closely monitored for any neurologic reactions. You may need supportive care or corticosteroids.

Parkinsonism and Guillain-Barre Syndrome, as well as their associated complications that resulted in fatal or life-threatening effects, have been reported following treatment with this medication.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, have occurred after taking this medicine. HLH/MAS may occur in conjunction with CRS and neurologic toxicities.

Recurrent and/or prolonged cytopenias accompanied by bleeding, infection, and the need for stem cell transplantation to restore hematopoietic function occurred after treatment with Carvykti. Carvykti REMS. The medicine is only available through a restricted programme under Risk Evaluation and Mitigation Strategies (REMS).

Before you take this drug

Inform your physician of any of the following issues:

• Neurologic problems (such as stroke, seizures, and memory loss);
• Breathing problems
• Heart problems
• Liver or kidney disease
• Recent or active infection
• Low blood counts

Pregnancy

Carvykti should not be used by women who are pregnant or women with the potential to become pregnant who do not use contraception. Women who are pregnant should be informed that the foetus may be at risk. The treatment physician should discuss pregnancy after Carvykti.

This medicine will require women to undergo pregnancy testing. You will also need to use birth control during the treatment of this medicine to prevent pregnancy.Inform your physician immediately if you are pregnant, planning on becoming pregnant, or hoping to conceive in order to receive proper preconception advice and medical treatment.

Breastfeeding

Breastfeeding may not be possible while taking this medication. You should ask your doctor if there are any risks.

How to take Carvykti?

Carvykti can only be obtained in a hospital or clinic that is authorized and administered by trained professionals. Carvykti must be administered following an intravenous leukapheresis procedure (pronounced 'LOO-kuh-fuh-REE-sis").Leukapheresis involves the collection of blood through a catheter placed in a vein. The catheter is attached to a machine that separates the white blood cells and other blood components. The cells will then be sent to a lab, where they will be made into carvykti. This process takes 4 to 5 weeks.

Pre-treatment with chemotherapy is usually given 3 days prior to your Carvykti treatment. Before you start Carvykti, you will receive other medications that help prevent side effects and allergic reactions.

Your care provider will then inject the medication into your vein via an IV once your body is ready for treatment. After your injection, you will be closely monitored to ensure that there are no serious side effects or allergic reactions.

Blood tests will be required to ensure that the treatment is not causing any harmful effects. This medicine can increase your risk of developing other types of cancer. Discuss this matter with your physician. You may require cancer screening tests for the rest of your life.

Carvykti can cause false-positive results in a lab test for the human HIV virus. Inform any physician that treats you of your use of this medication. Plan to stay close to the hospital or clinic that you visited where you received your medicine for at least four weeks. You should not be so far from the hospital that it will take you more than two hours to return.

Details on dosage

Adult Recommended Dose Range (Multiple Myeloma): 0.5–1x106 CAR-positive viable T-cells per kg body weight, with a maximum of 1x108 viable CAR T-cells per single dose infusion.
Comments Only for autologous use. Only for intravenous use. Carvykti should be administered after cyclophosphamide or fludarabine, a regimen that depletes lymphocytes.
Premedicate using acetaminophen along with the antihistamine H1.

What should be avoided?

• For at least eight weeks following Carvykti, do not drive or operate heavy equipment or engage in other potentially dangerous activities if you're not mentally alert. The treatment may cause memory and coordination issues, sleepiness or confusion, dizziness, or seizures, as well as other neurologic side effects, which your healthcare provider will discuss.
• During the time between Carvykti treatments and before, you must avoid certain live vaccines.Consult with your physician if any vaccinations are needed.
• Don't donate organs, tissue, or cells to transplantation.

Interaction with other drug

Tell your doctor about all of the medications you are taking, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements. You may receive an incorrect HIV-positive result if you use Carvykti while taking some commercial HIV tests.