Active Ingredient: Lisocabtagene maraleucel
Lisocabtagene maraleucel is indicated for the treatment of adult patients with follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
100,000,000 - 100,000,000 [CCID_50]
From 100,000,000 To 100,000,000 [CCID_50] once every day
Lisocabtagene maraleucel is intended for autologous use only.
Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR+ viable T cells in one or more vials. Each vial contains 4.6 mL cell dispersion.
The target dose is 100 × 106 CAR+ viable T cells (consisting of a target 1:1 ratio of CD4+ and CD8+ cell components) within a range of 44-120 × 106 CAR+ viable T cells. See the accompanying release for infusion certificate (RfIC) for additional information pertaining to dose.
Lymphodepleting chemotherapy consisting of cyclophosphamide 300 mg/m²/day and fludarabine 30 mg/m²/day, administered intravenously for three days. See the prescribing information for fludarabine and cyclophosphamide for information on dose adjustment in renal impairment.
Lisocabtagene maraleucel is to be administered 2 to 7 days after completion of lymphodepleting chemotherapy.
If there is a delay of more than 2 weeks between completing lymphodepleting chemotherapy and the infusion of lisocabtagene maraleucel, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving the infusion.
To minimise the risk of infusion reactions, the patient is to be pre-medicated with paracetamol and diphenhydramine (25-50 mg, intravenously or orally) or another H1-antihistamine, approximately 30 to 60 minutes before infusion of lisocabtagene maraleucel. Prophylactic use of systemic corticosteroids should be avoided, as the use may interfere with the activity of lisocabtagene maraleucel.
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