Blinatumomab received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL). The drug’s unique administration procedures have prompted nurses to evaluate their practice for safety.
Monoclonal antibody (bispecific) targeting and binding with CD-19 on precursor B cells and with CD3 on the surface of T cells.
Adults and children with B-cell precursor ALL in first or second complete remission with at least 0.1% minimal residual disease (MRD) or those with relapsed or refractory B-cell precursor ALL.
Fixed dose for patients weighing at least 45 kg; adjusted for smaller patients based on body surface area. Toxicities require dose adjustments.
Premedicate with dexamethasone. Infuse over 24 or 48 hours via a dedicated IV line primed with the drug. Calculate dose carefully to account for priming the IV line to ensure a full dose. Do not flush the IV line after infusion. Discard tubing with any remaining solution. Use IV tubing containing a sterile, nonpyrogenic, low protein-binding, 0.2 micron inline filter. The dose may be prepared in bacteriostatic 0.9% sodium chloride injection and infused over seven days in patients weighing more than 22 kg without an inline filter. Administer as a continuous infusion at a constant flow rate using a nonelastometric infusion pump that is programmable, lockable, and alarmed.
- Life-threatening cytokine release syndrome (CRS) may occur, with median onset about two days after infusion initiation.
- Neurologic toxicity occurs in approximately 65% of patients, mostly in the first two weeks of treatment (e.g., seizures, encephalopathy, speech and balance disorders, confusion, headache, tremors). Patients should not drive or operate heavy or potentially dangerous machinery.
- Bone marrow suppression may result in neutropenia, anemia, or thrombocytopenia.
- Pancreatitis may require either temporary treatment interruption or discontinuation.
- Monitor for and provide hydration and other measures to prevent tumor lysis syndrome.
- Liver enzymes may increase within three days of treatment.
- Strictly follow preparation and administration instructions to prevent underdosing or overdosing.
- Use polyolefin, PVC- and DEHP-free, or EVA infusion bags, pump cassettes, and IV tubing sets.
- Prepare with preservative-free saline for patients weighing less than 22 kg to prevent serious adverse reactions.
- When treating MRD-positive B-cell precursor ALL, hospitalize patients for the first three days of the first cycle and the first two days of the second cycle.
- When treating relapsed or refractory B-cell precursor ALL, hospitalize patients for the first nine days of the first cycle and the first two days of the second cycle.
- Monitor for elevated liver enzymes and pancreatitis.
- FDA requires patients to participate in the Risk Evaluation and Mitigation Strategy program.
- Avoid live vaccines for at least two weeks before, during, and until immune recovery after the final treatment cycle.
- Review the signs and symptoms of CRS (e.g., fever, fatigue, nausea, vomiting, chills, hypotension, rash, wheezing).
- Discuss risk, signs, and symptoms of infection.
- Describe neurotoxicity risks (e.g., speech disorders, confusion, seizures) and risks of activities that require mental alertness or coordination (e.g., driving or operating heavy machinery).
- Instruct patients not to change pump settings and to notify the healthcare team immediately if the pump malfunctions.
- Avoid live vaccines until immune recovery after the final cycle.
Patients older than 65 experienced no change in efficacy but had increased risk of infections and neurologic toxicities.
May cause fetal harm when administered to pregnant women. No carcinogenicity or genotoxicity studies have been conducted.
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