ABECMA
- gCompany :Celgene Corporation
- Brand:ABECMA
- Salt:IDECABTAGENE VICLEUCEL
- Innovator’s Name:–
- Storage:Store in vapor phase of liquid nitrogen ≤ 130°C.
- Strength:300 to 460 x 106 chimeric antigen receptor (CAR)- positive T cells
- Dosage:Infusion
Product Description
Dosage form and Strength of Abecma (Idecabtagene Vicleucel) Injection:
It is a cell suspension for Intravenous Infusion.
A single dose contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags.
Mechanism of Action of Abecma (Idecabtagene Vicleucel) Injection:
It is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells.
Antigen-specific activation of this drug results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.
Administration of Abecma (Idecabtagene Vicleucel) Injection:
Do not use a leukodepleting filter.
Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion.
Premedicate with acetaminophen and an H1-antihistamine.
Avoid prophylactic use of dexamethasone or another systemic corticosteroid.
Therapeutic Use of Abecma (Idecabtagene Vicleucel) Injection:
It is used for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Usage Instruction of Abecma (Idecabtagene Vicleucel) Injection:
For Autologous and Intravenous use only.
Do not self-medicate the therapy.
Use it under a medical supervision only.
Side Effects:
Headache,
Diarrhoea,
High fever,
Nausea,
Fatigue,
Shivering,
Dizziness,
Difficulty in breathing,
Confusion,
Chills,
Shaking,
Fast or irregular heartbeat.
Safety Precautions:
Alcohol:
It may increase the risk of drowsiness and dizziness.
Avoid drinking while using this drug
However, it is advisable to consult a doctor for personalized advice.
Pregnancy:
The study of the drug in pregnant women is not known.
Pregnant women should consult their doctor for alternative treatment options.
Lactating Mothers:
The study of the drug in lactating mothers is not known.
Lactating mothers should seek medical advice for appropriate alternatives.
Driving:
It may affect the ability to drive, so it is recommended to avoid driving after taking the medication.
Consult your doctor for guidance on driving safety.
Renal Impairment:
Use of the medication in Renally Impaired patients is not known
However, it is important to consult a doctor for proper evaluation and potential dosage adjustments.
Hepatic Impairment:
Use of the medication in Hepatically Impaired patients is not known.
Consulting a doctor is crucial for appropriate guidance.
Contraindications:
Known hypersensitivity.
Known active infections.
Known Inflammatory disorders.
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