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 three 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. Manufacture and release of idecabtagene vicleucel usually takes about 4-5 weeks.
Treatment consists of a single dose for infusion containing a dispersion of CAR-positive viable T cells in one or more infusion bags. The target dose is 420 × 106 CAR-positive viable T cells within a range of 260 to 500 × 106 CAR-positive 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 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 of more than 4 weeks between completing lymphodepleting chemotherapy and the infusion, then the patient should be re-treated with lymphodepleting chemotherapy prior to receiving idecabtagene vicleucel.
To minimise the risk of infusion reactions, the patient should be pre-medicated with paracetamol (500 to 1,000 mg orally) and diphenhydramine (12.5 mg IV or 25 to 50 mg orally) or another H1-antihistamine, approximately 30 to 60 minutes before infusion of idecabtagene vicleucel.
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.
Patients should be monitored for the first 10 days following infusion at the qualified treatment centre for signs and symptoms of CRS, neurologic events and other toxicities.
After the first 10 days following infusion, the patient should be monitored at the physician’s discretion.
Patients should be instructed to remain within proximity (within 2 hours of travel) of the qualified treatment centre for at least 4 weeks following infusion.
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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