Active Ingredient: Idecabtagene vicleucel
Idecabtagene vicleucel is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 420,000,000 idecabtagene vicleucel, one dose.
Idecabtagene vicleucel is intended for autologous use only.
The target dose is 420 × 106 CAR-positive viable T cells within a range of 260 to 500 × 106 CAR-positive viable T cells.
Lymphodepleting chemotherapy consisting of cyclophosphamide 300 mg/m² intravenously (IV) and fludarabine 30 mg/m² IV should be administered for 3 days. See the prescribing information for cyclophosphamide and fludarabine for information on dose adjustment in renal impairment.
Idecabtagene vicleucel is to be administered 2 days after completion of lymphodepleting chemotherapy, up to a maximum of 9 days. The availability of idecabtagene vicleucel must be confirmed prior to starting the lymphodepleting chemotherapy. If there is a delay in idecabtagene vicleucel infusion of more than 9 days, then the patient should be re-treated with lymphodepleting chemotherapy after a minimum of 4 weeks from last lymphodepleting chemotherapy prior to receiving idecabtagene vicleucel.
It is recommended that premedication with paracetamol (500 to 1,000 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally) or another H1-antihistamine, be administered approximately 30 to 60 minutes before the infusion of idecabtagene vicleucel to reduce the possibility of an infusion reaction.
Prophylactic use of systemic corticosteroids should be avoided as the use may interfere with the activity of idecabtagene vicleucel. Therapeutic doses of corticosteroids should be avoided 72 hours prior to the start of lymphodepleting chemotherapy and following idecabtagene vicleucel infusion except for the management of CRS, neurologic toxicities and other life-threatening emergencies.
Do NOT use a leukodepleting filter.
Central venous access may be utilised for the infusion of Abecma and is encouraged in patients with poor peripheral access.
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