Leukemias, lymphomas, and other hematologic cancers:
Indications for: CARVYKTI
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.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Cytokine release syndrome (CRS). Neurologic toxicities. Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Prolonged and recurrent cytopenia.
CARVYKTI 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.
CARVYKTI Classification:
BCMA-directed genetically modified autologous T cell immunotherapy.
CARVYKTI 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.
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).
Note:
Available only through a restricted REMS Program. For more information visit www.CarvyktiREMS.com or call (844) 672-0067.
REMS:
Generic Drug Availability:
NO
How Supplied:
Infusion bag (30mL, 70mL)—1
