Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Abecma 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.
Abecma must be administered in a qualified treatment centre.
Abecma therapy should be initiated under the direction of and supervised by a healthcare professional experienced in the treatment of haematological malignancies and trained for the administration and management of patients treated with Abecma.
A minimum of one dose of tocilizumab for use in the event of cytokine release syndrome (CRS) and emergency equipment must be available prior to infusion of Abecma. The treatment centre must have access to an additional dose of tocilizumab within 8 hours of each previous dose. In the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, suitable alternative measures to treat CRS instead of tocilizumab must be available prior to infusion.
Abecma is intended for autologous use only (see section 4.4). Manufacture and release of Abecma 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.
Abecma is to be administered 2 days after completion of lymphodepleting chemotherapy, up to a maximum of 9 days. The availability of Abecma 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 Abecma.
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 Abecma.
Prophylactic use of systemic corticosteroids should be avoided as the use may interfere with the activity of Abecma. Therapeutic doses of corticosteroids should be avoided 72 hours prior to the start of lymphodepleting chemotherapy and following Abecma infusion except for the management of CRS, neurologic toxicities and other life-threatening emergencies (see section 4.4).
Abecma treatment should be delayed in some patient groups at risk (see section 4.4).
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.
There is no clinical experience in patients with active HIV, HBV or HCV infection. Screening for HBV, active HIV and active HCV must be performed before collection of cells for manufacturing. Leukapheresis material from patients with active HIV or active HCV infection will not be accepted for Abecma manufacturing (see section 4.4).
No dose adjustment is required in patients over 65 years of age (see section 5.1).
The safety and efficacy of Abecma in children and adolescents below 18 years of age have not been established. No data are available.
Abecma is for intravenous use only.
Administration:
For instructions on preparation, administration, accidental exposure and disposal of the medicinal product see section 6.6.
There are limited data regarding overdose with Abecma.
Abecma is stable for 1 year when stored in the vapour phase of liquid nitrogen (≤ -130°C).
Each bag must be infused within 1 hour from start of thaw. After thawing, the volume of the product intended for infusion should be kept at room temperature (20°C–25°C).
Store and transport frozen in the vapour phase of liquid nitrogen (≤ -130°C) and must remain frozen until the patient is ready for treatment to ensure viable live autologous cells are available for patient administration. Product must NOT be refrozen following thaw.
For storage conditions after thawing of the medicinal product, see section 6.3.
Ethylene vinyl acetate cryopreservation bag(s) with sealed addition tube containing 10-30 mL (50 mL bag), 30-70 mL (250 mL bag) or 55-100 mL (500 mL bag) of cell dispersion.
Each cryopreservation bag is individually packed in a metal cassette.
One individual treatment dose is comprised of one or more infusion bags of the same size and fill volume.
Abecma should be transported within the treatment centre in closed, break-proof, leak-proof containers.
This medicinal product contains human blood cells. Healthcare professionals handling Abecma should take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.
Prior to Abecma infusion, it must be confirmed that the patient’s identity matches the patient identifiers on the Abecma cassette(s), the infusion bag(s) and the release for infusion certificate (RfIC). The Abecma infusion bag must not be removed from the cassette if the information on the patient-specific label does not match the intended patient. The company must be contacted immediately if there are any discrepancies between the labels and the patient identifiers.
If more than one infusion bag has been received for treatment, thaw each infusion bag one at a time. The timing of thaw of Abecma and infusion should be coordinated. The infusion start time should be confirmed in advance and adjusted for thaw so that Abecma is available for infusion when the patient is ready.
Unused medicinal product and all material that has been in contact with Abecma (solid and liquid waste) should be handled and disposed of as potentially infectious waste in accordance with local guidelines on handling of human-derived material.
In case of accidental exposure local guidelines on handling of human-derived material should be followed. Work surfaces and materials which have potentially been in contact with Abecma must be decontaminated with appropriate disinfectant.
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