Ciltacabtagene autoleucel

What is Ciltacabtagene autoleucel?

• Ciltacabtagene autoleucel (Carvykti) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy is a medication used to treat multiple myeloma.

What are the uses of this medicine?

• 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.

How does this medicine work?

• CARVYKTI is a BCMA-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient's own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.
• Upon intravenous administration back into the patient, ciltacabtagene autoleucel are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells.
• BCMA, a tumor-associated antigen (TAA) and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in plasma cell survival.
• BCMA is overexpressed on malignant plasma cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• HIV and the lentivirus used to make CARVYKTI have limited, short spans of identical genetic material (RNA).
• Having CARVYKTI in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.

Is this medicine FDA approved?

• Ciltacabtagene autoleucel was approved for medical use in the United States in February 2022, and in the European Union in May 2022.

How should this medicine be used?

Administer a lymphodepleting regimen of cyclophosphamide and fludarabine before infusion of CARVYKTI.

• Do NOT use a leukodepleting filter.
• Verify the patient's identity prior to infusion.
• Premedicate with acetaminophen and an H1-antihistamine.
• Avoid prophylactic use of systemic corticosteroids.
• Confirm availability of tocilizumab prior to infusion.

Recommended dosage:

• The recommended dose range is 0.5–1.0×106 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×108 CAR-positive viable T cells per single infusion.

Administration:

• CARVYKTI is made from your own white blood cells, so your blood will be collected by a process called 'leukapheresis' (loo-kah-fur-ee-sis).
• 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 (anti-histamines)
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a cell suspension for intravenous infusion.
• A single dose of CARVYKTI contains a cell suspension of 0.5–1.0×106 CAR-positive viable T cells per kg body weight in one infusion bag.

This medicine is available in fallowing brand namesː

• CARVYKTI

What side effects can this medication cause?

The most common side effects of this medicine include:

• fever (100.4°F/38°C or higher), chills
• dizziness or light-headedness
• 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 may cause side effects that are severe or life-threatening and can lead to death include:

• cytokine release syndrome
• life-threatening infections
• neurologic side effects
• lowers one or more types of your blood cells

What special precautions should I follow?

• 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.
• Patients may exhibit ≥Grade 3 cytopenias following CARVYKTI infusion. One or more recurrences of Grade 3 or higher cytopenias may occur after partial or complete recovery of cytopenias. Monitor blood counts prior to and after CARVYKTI infusion. Prolonged neutropenia has been associated with increased risk of infection.
• CARVYKTI should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections, occurred in patients after CARVYKTI infusion. Monitor patients for signs and symptoms of infection; treat appropriately.
• Hypogammaglobulinemia can occur in patients receiving treatment with CARVYKTI. Monitor and consider immunoglobulin replacement therapy.
• Hypersensitivity reactions have occurred in patients following ciltacabtagene autoleucel infusion. Monitor for hypersensitivity reactions during infusion.
• Patients treated with CARVYKTI may develop secondary malignancies. In the event that a secondary malignancy occurs after treatment with CARVYKTI, contact Janssen Biotech, Inc. at 1-800-526-7736.
• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI. Do not administer CARVYKTI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI. Provide supportive care and/or corticosteroids as needed.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI. HLH/MAS can occur with CRS or neurologic toxicities.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on the use of CARVYKTI in pregnant women.
• Therefore, CARVYKTI is not recommended for women who are pregnant, or for women of childbearing potential not using contraception.
• Pregnant women should be advised that there may be risks to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of CARVYKTI in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ciltacabtagene autoleucel
• Inactive ingredients: DMSO

Who manufactures and distributes this medicine?

• Manufactured/Marketed by: Janssen Biotech, Inc., Horsham, PA, USA
• Marketed by: Legend Biotech, Somerset, NJ, USA

What should I know about storage and disposal of this medication?

• Store and transport below -120°C, e.g., in a container for cryogenic storage in the vapor phase of liquid nitrogen.
• Store CARVYKTI in the original packaging containing the cassette protecting the infusion bag.
• Thaw CARVYKTI prior to infusion

• Dailymed label info on Ciltacabtagene autoleucel
• FDA Ciltacabtagene autoleucel

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