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Abecma is a brand name for Idecabtagene Vicleucel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Abecma 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. 3
Verbatim from this product's EMA label. Tap a section to expand.
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.
4). 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 x 106 CAR-positive viable T cells within a range of 260 to 500 x 106 CAR-positive viable T cells.
See the accompanying release for infusion certificate (RfIC) for additional information pertaining to dose. Pre-treatment (lymphodepleting chemotherapy) Lymphodepleting chemotherapy consisting of cyclophosphamide 300 mg/m2/day intravenously (IV) and fludarabine 30 mg/m2/day 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 in Abecma 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 Abecma.
5 mg IV or 25 to 50 mg orally) or another H1-antihistamine, be administered approximately 30 to 60 minutes before the infusion of Abecma 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 Abecma.
Summary of the safety profile The safety data described in this section reflect the exposure to Abecma in the KarMMa, CRB-401 and KarMMa-3 studies in which 409 patients with relapsed and refractory multiple myeloma received Abecma.
8 months. 3 months. 9%). 2% of patients. 5%). 4%). 1%). 3%). 1 for the corresponding dose range of CAR-positive viable T cells in KarMMa) and from post-marketing reports. Adverse reactions are presented by MedDRA system organ class and by frequency.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
15 Table 3. Adverse reactions observed in patients treated with Abecma System organ class Adverse reaction All grades frequency Infections and infestationsa Infections – bacterial Infections – viral Infections – pathogen unspecified Infections – fungal Very common Very common Very common Common Neoplasms benign, malignant and unspecified (including cysts and polyps) Secondary malignancy of T cell origin Rare Blood and lymphatic system disorders Neutropenia Leukopenia Thrombocytopenia Febrile neutropenia Lymphopenia Anaemia Disseminated intravascular coagulation Very common Very common Very common Very common Very common Very common Common Immune system disorders Cytokine release syndrome Hypogammaglobulinaemia Haemophagocytic lymphohistiocytosis* Very common Very common Common Metabolism and nutrition disorders Hypophosphataemia Hypokalaemia Hyponatraemia Hypocalcaemia Hypoalbuminaemia Decreased appetite Hypomagnesaemia Very common Very common Very common Very common Very common Very common Very common Psychiatric disorders Insomnia Deliriumb Very common Common Nervous system disorders Encephalopathyc Headache* Dizzinessd Aphasiae Ataxiaf Motor dysfunctiong Tremor Seizure Hemiparesis Immune effector cell-associated neurotoxicity syndrome** Very common Very common Very common Common Common Common Common Common Uncommon Uncommon Cardiac disorders Tachycardia* Atrial fibrillation* Very common Common Vascular disorders Hypertension Hypotension*h Very common Very common Respiratory, thoracic, and mediastinal disorders Dyspnoea Cough Pulmonary oedema Hypoxia* Very common Very common Common Common Gastrointestinal disorders Vomiting Diarrhoea Nausea Constipation Gastrointestinal haemorrhagei Very common Very common Very common Very common Common 16 System organ class Adverse reaction All grades frequency Musculoskeletal and connective tissue disorders Arthralgia Myalgia Very common Common General disorders and administration site conditions Pyrexia* Fatigue*j Oedemak Chills* Asthenia Very common Very common Very common Very common Common Investigations Alanine aminotransferase increased Aspartate aminotransferase increased Blood alkaline phosphatase increased C-reactive protein increased* Very common Very common Common Common * Event that has been reported as a manifestation of CRS.
Traceability The traceability requirements of cell-based advanced therapy medicinal products must apply. To ensure traceability the name of the product, the batch number and the name of the treated patient must be kept for a period of 30 years after expiry date of the product.
Autologous use Abecma is intended solely for autologous use and must not, under any circumstances, be administered to other patients. Abecma must not be administered if the information on the product labels and the release for infusion certificate (RfIC) do not match the patient’s identity.
5 Rapidly progressing disease Before selecting patients for Abecma treatment, physicians should consider the impact of high-risk cytogenetic abnormalities, Revised International Staging System (R-ISS) stage III, presence of extramedullary plasmacytoma or high tumour burden, particularly for patients who have rapidly progressing disease that may affect their ability to receive CAR T infusion in due time.
For these patients, optimising bridging therapy may be particularly important. 1). Reasons to delay treatment Due to the risks associated with Abecma treatment, infusion should be delayed up to 7 days if a patient has any of the following conditions: • Unresolved serious adverse events (especially pulmonary events, cardiac events or hypotension) including those after preceding chemotherapies.
• Active infections or inflammatory disorders (including pneumonitis, myocarditis or hepatitis). • Active graft-versus-host disease (GVHD). Concomitant disease Patients with active central nervous system (CNS) disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Central nervous system pathology There is no experience of use of Abecma in patients with CNS involvement of myeloma or other pre- existing, clinically relevant CNS pathologies. Prior allogeneic stem cell transplantation It is not recommended that patients receive Abecma within 4 months after an allogeneic stem cell transplant (SCT) because of the potential risk of Abecma worsening GVHD.
1. Contraindications of the lymphodepleting chemotherapy must be considered.
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4). 4). Monitoring after infusion - Patients should be monitored for the first week following infusion at the qualified treatment centre for signs and symptoms of CRS, neurologic events and other toxicities. - After the first week 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 2 weeks following infusion. 4 Special populations Patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection 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. 4). 1). Paediatric population The safety and efficacy of Abecma in children and adolescents below 18 years of age have not been established.
No data are available. Method of administration Abecma is for intravenous use only. Administration • Do NOT use a leukodepleting filter. • Ensure that tocilizumab or suitable alternatives, in the exceptional case where tocilizumab is not available due to a shortage that is listed in the European Medicines Agency shortage catalogue, and emergency equipment are available prior to infusion and during the recovery period.
• Central venous access may be utilised for the infusion of Abecma and is encouraged in patients with poor peripheral access. • Before administration, it must be confirmed that the patient’s identity matches the unique patient information on the Abecma infusion bag and accompanying documentation.
4). 6.
** Event was not systematically collected in clinical trials. a Infections and infestations system organ class adverse events are grouped by pathogen type and selected clinical syndromes. b Delirium includes delirium, disorientation, agitation, hallucination, restlessness.
c Encephalopathy includes amnesia, bradyphrenia, cognitive […]
Leukapheresis for Abecma manufacturing should be performed at least 12 weeks after allogeneic SCT. Prior treatment with an anti-BCMA therapy There is limited experience with Abecma in patients exposed to prior BCMA directed therapy.
There is limited experience of retreating patients with a second dose of Abecma. Responses after Abecma retreatment were infrequent and less durable when compared to initial treatment. Additionally, fatal outcomes were observed in retreated patients.
Cytokine release syndrome CRS, including fatal or life-threatening reactions occurred following Abecma infusion. Nearly all patients experienced some degree of CRS. 8). Monitoring and management of CRS CRS should be identified based on clinical presentation.
Patients should be evaluated and treated for other causes of fever, hypoxia and hypotension. CRS has been reported to be associated with findings of haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) and the physiology of the syndromes may overlap.
MAS is a potentially life-threatening condition, and patients should be closely monitored for evidence of MAS. Treatment of MAS should be administered per institutional guidelines. 6 One dose of tocilizumab per patient must be on-site and available for administration prior to Abecma infusion.
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, the treatment centre must have access to suitable alternative measures instead of tocilizumab to treat CRS.
Patients should be monitored for the first week following Abecma infusion at the qualified treatment centre for signs and symptoms of CRS. After the first week following infusion, the patient should be monitored at the physician’s discretion.
Patients should be counselled to remain within proximity (within 2 hours of travel) of the qualified treatment centre for at least 2 weeks following infusion. Patients and caregivers should be informed about the potential late onset of CRS and instructed to seek immediate medical attention if patients experience any signs or symptoms of CRS at any time.
At the first sign of CRS, treatment with supportive care, tocilizumab or tocilizumab and corticosteroids should be instituted, as indicated in Table 1. 5). Patients who experience CRS should be closely monitored for cardiac and organ functioning until resolution of symptoms.
For severe or life-threatening CRS, intensive care unit level monitoring and supportive therapy should be considered. If concurrent neurologic toxicity is suspected during CRS, the neurologic toxicity should be managed according to the recommendations in Table 2 and use the more aggressive intervention of the two reactions specified in Tables 1 and 2.
e. g. hypoxia, hypotension) and/or HLH/MAS not improving in grade within 12 hours of first line interventions. 7 Table 1. g. fever, nausea, fatigue, headache, myalgia, malaise). If onset 72 hours or more after infusion, […]