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CARVYKTI
Ciltacabtagene Autoleucel
$810815.00
1 syringes
BrandBranded medicine· By Janssen Biotech
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FDA boxed warningCytokine release syndrome, neurologic toxicities, hlh/mas, prolonged and recurrent cytopenia, and secondary hematological malignancies
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
Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI
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
Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI
Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI
Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI.
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred following treatment with CARVYKTI. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI.
About CARVYKTI
Overview
CARVYKTI (ciltacabtagene autoleucel) is an immunotherapy made from a patient’s own genetically modified T cells. It treats adults with multiple myeloma that has returned or has not responded to treatment, after at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, and whose disease no longer responds or does not respond to lenalidomide. The modified T cells recognise and destroy cells carrying a protein called BCMA.
What it treats
Relapsed or refractory multiple myeloma in adults who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and whose disease no longer responds to lenalidomide.
Safety information
Side effects
Common side effects include fever, cytokine release syndrome, low antibody levels, low blood pressure, muscle and joint pain, tiredness, infections, cough, chills, diarrhea, nausea, changes in brain function, reduced appetite, upper respiratory tract infections, headache, fast heartbeat, dizziness, shortness of breath, swelling, blood-clotting problems, constipation and vomiting. Contact a doctor promptly if you develop an infection, an allergic reaction, changes in brain function, blood-clotting problems, or prolonged or severe diarrhea. Serious risks include: • Cytokine release syndrome. • Severe reductions in blood cells, including white blood cells, platelets and red blood cells. Low counts can persist or return after recovery. Prolonged low neutrophil counts increase the risk of infection. Blood counts need monitoring before and after treatment. • Low antibody levels, which require monitoring and may need antibody replacement treatment. • Allergic reactions during infusion. • Immune-related inflammation of the intestines, which can cause prolonged and severe diarrhea in the months after treatment. • New blood cancers after treatment, including myelodysplastic syndrome, acute myeloid leukemia and T-cell cancers.
FDA boxed warning
Cytokine release syndrome, neurologic toxicities, hlh/mas, prolonged and recurrent cytopenia, and secondary hematological malignancies
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
Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI
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
Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI
Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI
Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI.
Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred following treatment with CARVYKTI. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The FDA label lists no contraindications to CARVYKTI. Conditions requiring caution and monitoring include low blood cell counts, infections and low levels of protective antibodies (hypogammaglobulinemia). Severely low blood cell counts may persist or return after recovery, and prolonged low neutrophil counts can increase infection risk. Blood counts should be checked before and after treatment; antibody replacement therapy may be considered. Hypersensitivity reactions can occur and require monitoring during infusion. Prolonged, severe diarrhea may develop months after treatment because of immune-related bowel inflammation. Secondary blood cancers have occurred after treatment, including myelodysplastic syndrome, acute myeloid leukemia and T-cell malignancies.
Interactions
CARVYKTI may cause a false-positive result on some HIV nucleic acid tests (NATs). Tell your doctor that you have received CARVYKTI if you are having an HIV test.
Using CARVYKTI
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label CARVYKTI (CILTACABTAGENE AUTOLEUCEL) INJECTION, SUSPENSION [JANSSEN BIOTECH, INC.] (DailyMed, retrieved 19 September 2026).
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