Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Carvykti Generic Name & Formulations
Legal Class
Rx
General Description
Ciltacabtagene autoleucel (contains up to 1×108 CAR-positive T cells); per infusion bag; cell susp for IV infusion; contains dimethyl sulfoxide (DMSO).
Pharmacological Class
BCMA-directed genetically modified autologous T cell immunotherapy.
How Supplied
Infusion bag (30mL, 70mL)—1
Manufacturer
Generic Availability
NO
Carvykti Indications
Indications
In adults with relapsed or refractory multiple myeloma after ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Carvykti Dosage and Administration
Adult
For autologous and IV use only; confirm patient identity prior to infusion. Do not use a leukodepleting filter. Give lymphodepleting chemotherapy (cyclophosphamide 300mg/m2 IV + fludarabine 30mg/m2 IV) for 3 days. Premedicate with APAP and diphenhydramine or other H1-antihistamine approx. 30–60mins prior to Carvykti infusion; avoid prophylactic corticosteroids. Infuse Carvykti 2–4 days after lymphodepleting chemotherapy. Dose range: 0.5–1.0×106 CAR-positive T cells per kg; max: 1×108 CAR-positive T cells per single infusion. Management of severe adverse reactions: see full labeling.
Children
Not established.
Carvykti Contraindications
Not Applicable
Carvykti Boxed Warnings
Boxed Warning
Cytokine release syndrome (CRS). Neurologic toxicities. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Prolonged and recurrent cytopenia.
Carvykti Warnings/Precautions
Warnings/Precautions
Risk of CRS; do not give to patients with active infection and/or inflammatory disorders. Have tocilizumab and emergency equipment readily available. Monitor at least daily for 10 days at the healthcare facility following infusion for signs/symptoms of CRS and neurologic toxicities. Continue to monitor for CRS for 4 weeks after infusion; at 1st sign, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated (see full labeling). Risk of neurologic toxicities including immune effector cell-associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, peripheral neuropathies, cranial nerve palsies. Monitor for neurologic toxicities for 4 weeks after infusion and treat promptly (see full labeling). Evaluate for HLH/MAS if CRS or neurologic toxicities occur. Monitor for infection, febrile neutropenia; evaluate, manage and treat appropriately. Screen for CMV, HBV, HCV, and HIV prior to cell collection for manufacturing. Monitor blood counts (prior to and after initiation), immunoglobulin levels after treatment. Monitor for severe hypersensitivity reactions for 2hrs after infusion. Hepatic or renal impairment: not studied. Pregnancy: not recommended. Verify pregnancy status prior to initiation. Nursing mothers.
REMS
Carvykti Pharmacokinetics
See Literature
Carvykti Interactions
Interactions
Concomitant live virus vaccines: not recommended for ≥6 weeks prior to lymphodepleting chemotherapy, during Carvykti treatment, and until immune recovery. May cause false (+) results in certain HIV nucleic acid tests.
Carvykti Adverse Reactions
Adverse Reactions
Thrombocytopenia, neutropenia, anemia, aminotransferase elevation, hypoalbuminemia, pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections (pathogen unspecified), cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, vomiting; hypersensitivity reactions, secondary malignancies (monitor).
Carvykti Clinical Trials
See Literature
Carvykti Note
Notes
Available only through a restricted REMS Program. For more information visit www.CarvyktiREMS.com or call (844) 672-0067.
Carvykti Patient Counseling
See Literature
Images
