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Zevalin

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Zevalin

ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

Zevalin

WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS

Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion [see BOXED WARNING and ADVERSE REACTIONS]. Discontinue rituximab and Y-90 Zevalin infusions in patients who develop severe infusion reactions.

Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Dosing: The dose of Y-90 Zevalin should not exceed 32.0 mCi (1184 MBq) [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION

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 Yttrium-90. The approximate molecular weight of ibritumomab tiuxetan is 148 kD. The antibody moiety of Zevalin is ibritumomab, a murine IgGi 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 (%90) is 5 mm. Radiation emission data for Y-90 are summarized in Table 5.

Table 5. Principal Y-90 Radiation Emission Data

Radiation Mean % per
Disintegration
Mean
Energy (keV)
Beta minus 100 750-935

External Radiation

The exposure rate for 1 mCi (37 MBq) of Y-90 is 8.3 x 10-3 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.

Table 6. Physical Decay Chart: Y-90 Half-life 2.67 Days (64.1 Hours)

Calibration
Time (Hrs.)
Fraction
Remaining
Calibration
Time (Hrs.)
Fraction
Remaining
-36 1.48 0 1.00
-24 1.30 1 0.99
-12 1,14 2 0.98
-8 1.09 3 0.97
-7 1.08 4 0.96
-6 1.07 5 0.95
-5 1.06 6 0.94
-4 1.04 7 0.93
-3 1.03 8 0.92
-2 1.02 12 0.88
-1 1.01 24 0.77
0 1.00 36 0.68

What are the possible side effects of ibritumomab (In-111 Zevalin, Y-90 Zevalin)?

Some people receiving an ibritumomab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, trouble breathing, chest pain or heavy feeling, or pain spreading to the arm or shoulder. These reactions can occur during the injection or within 24 hours afterward.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or...

Read All Potential Side Effects and See Pictures of Zevalin »

What are the precautions when taking ibritumomab tiuxetan (Zevalin)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or to other medications in the treatment plan (rituximab, Yttrium-90, Indium-111); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (e.g., neutropenia, thrombocytopenia), recent/current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery,...

Read All Potential Precautions of Zevalin »

Last reviewed on RxList: 12/21/2011
This monograph has been modified to include the generic and brand name in many instances.

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