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VARIOUS › THERAPEUTIC RADIOPHARMACEUTICALS › OTHER THERAPEUTIC RADIOPHARMACEUTICALS › Various therapeutic radiopharmaceuticals
ibritumomab tiuxetan (90Y)
V10XX02
Forms & Strengths
- Kit for the preparation of Yttrium-90 ibritumomab tiuxetan: 3.2 mg/2 mL sterile solution in a single-use vial
- Indium-111 ibritumomab tiuxetan: 0.3 mg/1.2 mL or 1.3 mL in a single-use vial for diagnostic imaging/dosimetry
Adult Dosing
- Rituximab predosing: 250 mg/IV infusion prior to radiolabeled ibritumomab tiuxetan administration
- Indium-111 regimen (Day 1): 250 mg rituximab IV, followed by 5 mCi (185 MBq) In-111 ibritumomab tiuxetan IV over 10 minutes
- Yttrium-90 regimen (Day 7, 8, or 9): 250 mg rituximab IV, followed by 0.4 mCi/kg (14.8 MBq/kg) Y-90 ibritumomab tiuxetan IV (max dose 32 mCi / 1184 MBq) for patients with normal platelet counts
- Y-90 dosing for mild thrombocytopenia (platelets 100,000 to 149,000 cells/mm³): 0.3 mCi/kg (11.1 MBq/kg)
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma (NHL)
- Rituximab-refractory follicular non-Hodgkin's lymphoma
Mechanism of Action
- Monoclonal antibody (IgG1 kappa) directed against the CD20 antigen found on the surface of normal and malignant B-lymphocytes
- Tiuxetan is a murine chelator covalently linked to ibritumomab, forming a stable high-affinity bond with Yttrium-90
- Delivers beta radiation directly to the targeted B-cell and neighboring cells, inducing cellular apoptosis via radiation and antibody-dependent cytotoxicity
Contraindications
- Known hypersensitivity to murine proteins, ibritumomab, rituximab, yttrium, or any component of the product
- Pregnancy and lactation
- Altered biodistribution determined by Indium-111 imaging prior to Yttrium-90 administration
Adverse Reactions
- Severe and prolonged cytopenias (thrombocytopenia, neutropenia, anemia)
- Infusion reactions (hypotension, angioedema, bronchospasm, nausea, vomiting, rash)
- Severe cutaneous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis)
- Secondary malignancies (Myelodysplastic syndrome, acute myeloid leukemia)
- Serious infections and hemorrhage due to bone marrow suppression
Drug Interactions
- Drugs that affect hemostasis or platelet function (e.g., anticoagulants, antiplatelet agents, NSAIDs) increase the risk of severe bleeding when combined with radiation-induced thrombocytopenia
- Hematopoietic growth factors (e.g., G-CSF, GM-CSF) should not be administered within 2 weeks prior to or 2 weeks following treatment due to potential bone marrow hypersensitivity
Curated Content: Needs Vetting Before Put to Clinical Use