Reviews Ibritumomab Tiuxetan


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Zevalin Drug Description
ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

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 WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Discontinue rituximab, In-111
Zevalin, 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 the Zevalin
therapeutic regimen 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, In-111 Zevalin, 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).
Do not administer Y-90 Zevalin to patients with altered biodistribution as determined
by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION



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...
Read All Potential Side Effects for 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-(pisothiocyanatophenyl)- 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 IgG1 kappa monoclonal antibody directed against the CD20
antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservativefree
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 In-111
Indium-111 decays by electron capture, with a physical half-life of 67.3 hours
(2.81 days). The product of radioactive decay is non-radioactive Cadmium-111.
Radiation emission data for In-111 are summarized in Table 5.
Table 5 : Principal In-111 Radiation Emission Data



Radiation
Mean % per Disintegration
Mean Energy (keV)


Gamma-2
90.2
171.3


Gamma-3
94.0
245.4



External Radiation
The exposure rate constant for 1 mCi (37 MBq) of In-111 is 8.3 x 10-4 C/kg/hr
(3.2 R/hr) at 1 cm.
To allow correction for physical decay of In-111, the fractions that remain
at selected intervals before and after the time of calibration are shown in
Table 6.
Table 6 : Physical Decay Chart: In-111 Half-life 2.81 Days
(67.3 Hours)



Calibration Time
(Hrs.)
Fraction Remaining


-48
1.64


-42
1.54


-36
1.45


-24
1.28


-12
1.13


-6
1.06


0
1.00


6
0.94


12
0.88


24
0.78


36
0.69


42
0.65


48
0.61



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 (χ90) is 5 mm.
Radiation emission data for Y-90 are summarized in Table 7.
Table 7 : 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 8.
Table 8 : 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



Last reviewed on RxList: 9/18/2009




Zevalin Drug Description
ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

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 WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Discontinue rituximab, In-111
Zevalin, 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 the Zevalin
therapeutic regimen 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, In-111 Zevalin, 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).
Do not administer Y-90 Zevalin to patients with altered biodistribution as determined
by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION



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...
Read All Potential Side Effects for 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-(pisothiocyanatophenyl)- 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 IgG1 kappa monoclonal antibody directed against the CD20
antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservativefree
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 In-111
Indium-111 decays by electron capture, with a physical half-life of 67.3 hours
(2.81 days). The product of radioactive decay is non-radioactive Cadmium-111.
Radiation emission data for In-111 are summarized in Table 5.
Table 5 : Principal In-111 Radiation Emission Data



Radiation
Mean % per Disintegration
Mean Energy (keV)


Gamma-2
90.2
171.3


Gamma-3
94.0
245.4



External Radiation
The exposure rate constant for 1 mCi (37 MBq) of In-111 is 8.3 x 10-4 C/kg/hr
(3.2 R/hr) at 1 cm.
To allow correction for physical decay of In-111, the fractions that remain
at selected intervals before and after the time of calibration are shown in
Table 6.
Table 6 : Physical Decay Chart: In-111 Half-life 2.81 Days
(67.3 Hours)



Calibration Time
(Hrs.)
Fraction Remaining


-48
1.64


-42
1.54


-36
1.45


-24
1.28


-12
1.13


-6
1.06


0
1.00


6
0.94


12
0.88


24
0.78


36
0.69


42
0.65


48
0.61



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 (χ90) is 5 mm.
Radiation emission data for Y-90 are summarized in Table 7.
Table 7 : 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 8.
Table 8 : 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



Last reviewed on RxList: 9/18/2009




Zevalin Drug Description
ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

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 WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Discontinue rituximab, In-111
Zevalin, 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 the Zevalin
therapeutic regimen 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, In-111 Zevalin, 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).
Do not administer Y-90 Zevalin to patients with altered biodistribution as determined
by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION



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...
Read All Potential Side Effects for 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-(pisothiocyanatophenyl)- 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 IgG1 kappa monoclonal antibody directed against the CD20
antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservativefree
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 In-111
Indium-111 decays by electron capture, with a physical half-life of 67.3 hours
(2.81 days). The product of radioactive decay is non-radioactive Cadmium-111.
Radiation emission data for In-111 are summarized in Table 5.
Table 5 : Principal In-111 Radiation Emission Data



Radiation
Mean % per Disintegration
Mean Energy (keV)


Gamma-2
90.2
171.3


Gamma-3
94.0
245.4



External Radiation
The exposure rate constant for 1 mCi (37 MBq) of In-111 is 8.3 x 10-4 C/kg/hr
(3.2 R/hr) at 1 cm.
To allow correction for physical decay of In-111, the fractions that remain
at selected intervals before and after the time of calibration are shown in
Table 6.
Table 6 : Physical Decay Chart: In-111 Half-life 2.81 Days
(67.3 Hours)



Calibration Time
(Hrs.)
Fraction Remaining


-48
1.64


-42
1.54


-36
1.45


-24
1.28


-12
1.13


-6
1.06


0
1.00


6
0.94


12
0.88


24
0.78


36
0.69


42
0.65


48
0.61



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 (χ90) is 5 mm.
Radiation emission data for Y-90 are summarized in Table 7.
Table 7 : 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 8.
Table 8 : 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



Last reviewed on RxList: 9/18/2009




Zevalin Drug Description
ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

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 WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Discontinue rituximab, In-111
Zevalin, 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 the Zevalin
therapeutic regimen 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, In-111 Zevalin, 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).
Do not administer Y-90 Zevalin to patients with altered biodistribution as determined
by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION



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...
Read All Potential Side Effects for 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-(pisothiocyanatophenyl)- 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 IgG1 kappa monoclonal antibody directed against the CD20
antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservativefree
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 In-111
Indium-111 decays by electron capture, with a physical half-life of 67.3 hours
(2.81 days). The product of radioactive decay is non-radioactive Cadmium-111.
Radiation emission data for In-111 are summarized in Table 5.
Table 5 : Principal In-111 Radiation Emission Data



Radiation
Mean % per Disintegration
Mean Energy (keV)


Gamma-2
90.2
171.3


Gamma-3
94.0
245.4



External Radiation
The exposure rate constant for 1 mCi (37 MBq) of In-111 is 8.3 x 10-4 C/kg/hr
(3.2 R/hr) at 1 cm.
To allow correction for physical decay of In-111, the fractions that remain
at selected intervals before and after the time of calibration are shown in
Table 6.
Table 6 : Physical Decay Chart: In-111 Half-life 2.81 Days
(67.3 Hours)



Calibration Time
(Hrs.)
Fraction Remaining


-48
1.64


-42
1.54


-36
1.45


-24
1.28


-12
1.13


-6
1.06


0
1.00


6
0.94


12
0.88


24
0.78


36
0.69


42
0.65


48
0.61



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 (χ90) is 5 mm.
Radiation emission data for Y-90 are summarized in Table 7.
Table 7 : 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 8.
Table 8 : 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



Last reviewed on RxList: 9/18/2009




Zevalin Drug Description
ZEVALIN®
(ibritumomab tiuxetan) Injection for Intravenous Use

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 WARNINGS AND PRECAUTIONS
and ADVERSE REACTIONS]. Discontinue rituximab, In-111
Zevalin, 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 the Zevalin
therapeutic regimen 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, In-111 Zevalin, 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).
Do not administer Y-90 Zevalin to patients with altered biodistribution as determined
by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].

DRUG DESCRIPTION



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...
Read All Potential Side Effects for 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-(pisothiocyanatophenyl)- 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 IgG1 kappa monoclonal antibody directed against the CD20
antigen.
Ibritumomab tiuxetan is a clear, colorless, sterile, pyrogen-free, preservativefree
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 In-111
Indium-111 decays by electron capture, with a physical half-life of 67.3 hours
(2.81 days). The product of radioactive decay is non-radioactive Cadmium-111.
Radiation emission data for In-111 are summarized in Table 5.
Table 5 : Principal In-111 Radiation Emission Data



Radiation
Mean % per Disintegration
Mean Energy (keV)


Gamma-2
90.2
171.3


Gamma-3
94.0
245.4



External Radiation
The exposure rate constant for 1 mCi (37 MBq) of In-111 is 8.3 x 10-4 C/kg/hr
(3.2 R/hr) at 1 cm.
To allow correction for physical decay of In-111, the fractions that remain
at selected intervals before and after the time of calibration are shown in
Table 6.
Table 6 : Physical Decay Chart: In-111 Half-life 2.81 Days
(67.3 Hours)



Calibration Time
(Hrs.)
Fraction Remaining


-48
1.64


-42
1.54


-36
1.45


-24
1.28


-12
1.13


-6
1.06


0
1.00


6
0.94


12
0.88


24
0.78


36
0.69


42
0.65


48
0.61



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 (χ90) is 5 mm.
Radiation emission data for Y-90 are summarized in Table 7.
Table 7 : 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 8.
Table 8 : 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



Last reviewed on RxList: 9/18/2009





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