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ibritumomab tiuxetan
Overview
What is Zevalin?
Zevalin (ibritumomab tiuxetan) is the immunoconjugate resulting from a stable thiourea covalent bond between the monoclonal antibody ibritumomab and the linker-chelator tiuxetan [N-[2-bis(carboxymethyl)amino]-3-(p-isothiocyanatophenyl)-propyl]-[N-[2-bis(carboxymethyl)amino]-2-(methyl)-ethyl]glycine. This linker-chelator provides a high affinity, conformationally restricted chelation site for Indium-111 or Yttrium-90. The approximate molecular weight of ibritumomab tiuxetan is 148 kD. The antibody moiety of Zevalin is ibritumomab, a murine IgG kappa monoclonal antibody directed against the CD20 antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservative-free solution that may contain translucent particles. Each single-use vial includes 3.2 mg of ibritumomab tiuxetan in 2 mL of 0.9% Sodium Chloride.
Physical/Radiochemical Characteristics of Y-90
Yttrium-90 decays by emission of beta particles, with a physical half-life of 64.1 hours (2.67 days). The product of radioactive decay is non-radioactive Zirconium-90. The range of beta particles in soft tissue (χ) is 5 mm. Radiation emission data for Y-90 are summarized in Table 5.
External Radiation
The exposure rate for 1 mCi (37 MBq) of Y-90 is 8.3 x 10 C/kg/hr (32 R/hr) at the mouth of an open Y-90 vial.
To allow correction for physical decay of Y-90, the fractions that remain at selected intervals before and after the time of calibration are shown in Table 6.
What does Zevalin look like?
What are the available doses of Zevalin?
3.2 mg ibritumomab tiuxetan per 2 mL in a single-use vial.
What should I talk to my health care provider before I take Zevalin?
How should I use Zevalin?
Zevalin is indicated for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL).
Recommended Dosing Schedule:
What interacts with Zevalin?
Sorry No Records found
What are the warnings of Zevalin?
Sorry No Records found
What are the precautions of Zevalin?
Sorry No Records found
What are the side effects of Zevalin?
Sorry No records found
What should I look out for while using Zevalin?
None.
What might happen if I take too much Zevalin?
Severe cytopenias which may require stem cell support have occurred at doses higher than the recommended maximum total dose of 32 mCi (1184 MBq).
How should I store and handle Zevalin?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.Rituximab (Rituxan, Biogen Idec and Genentech USA) must be ordered separately.StorageStore the kit at 2-8°C (36-46°F). Do not freeze.A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.Rituximab (Rituxan, Biogen Idec and Genentech USA) must be ordered separately.StorageStore the kit at 2-8°C (36-46°F). Do not freeze.A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.Rituximab (Rituxan, Biogen Idec and Genentech USA) must be ordered separately.StorageStore the kit at 2-8°C (36-46°F). Do not freeze.A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.Rituximab (Rituxan, Biogen Idec and Genentech USA) must be ordered separately.StorageStore the kit at 2-8°C (36-46°F). Do not freeze.A kit is used for preparing Y-90 radiolabeled Zevalin (NDC 68152-103-03). The contents of all vials are sterile, pyrogen-free, contain no preservatives, and are not radioactive. The kit contains four identification labels and the following four vials:Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit.Rituximab (Rituxan, Biogen Idec and Genentech USA) must be ordered separately.StorageStore the kit at 2-8°C (36-46°F). Do not freeze.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (K) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM. The CD20 antigen is expressed on pre-B and mature B lymphocytes and on > 90% of B-cell non-Hodgkin’s lymphomas (NHL). The CD20 antigen is not shed from the cell surface and does not internalize upon antibody binding.
The chelate tiuxetan, which tightly binds Y-90, is covalently linked to ibritumomab. The beta emission from Y-90 induces cellular damage by the formation of free radicals in the target and neighboring cells.
Ibritumomab tiuxetan binding was observed on lymphoid cells of the bone marrow, lymph node, thymus, red and white pulp of the spleen, and lymphoid follicles of the tonsil, as well as lymphoid nodules of other organs such as the large and small intestines.
Non-Clinical Toxicology
None.When given concurrently the following drugs may interact with thiazide diuretics:
Alcohol, barbiturates, or narcotics
Antidiabetic drugs
Other antihypertensive drugs
Cholestyramine and colestipol resins
Corticosteroid, ACTH
Pressor amines (e.g., norepinephrine)
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine)
Lithium
Non-steroidal anti-inflammatory drugs
See also prescribing information for rituximab.
Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe, including fatal, infusion reactions. These reactions typically occur during the first rituximab infusion with time to onset of 30 to 120 minutes. Signs and symptoms of severe infusion reactions may include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, and cardiogenic shock. Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. Immediately discontinue rituximab and Y-90 Zevalin administration for severe infusion reactions. Only administer Rituxan/Zevalin in facilities where immediate access to resuscitative measures is available [and ].
The following serious adverse reactions are discussed in greater detail in other sections of the label:
The most common adverse reactions of Zevalin are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.
The most serious adverse reactions of Zevalin are prolonged and severe cytopenias (thrombocytopenia, anemia, lymphopenia, neutropenia) and secondary malignancies.
Because the Zevalin therapeutic regimen includes the use of rituximab, see prescribing information for rituximab.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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