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ZEVALIN
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ZEVALIN
 
Package:
KIT (for the preparation of yttrium-90 radiolabelled Ibritumomab tiuxetan: Ibritumab tiuxetan solution 3.2 mg/ml 2 ml; sodium acetate solution 2 ml; formulation buffer solution 10 ml; 10 ml reaction vial. The final formulation after radiolabeling contains 2.08 mg ibritumomab tiuxetan in a total volume of 10 ml.
Dosage:
Should be used following pre-treatment with rituximab. The prepared infusion solution must be given as a slow I.V. administration over 10 minutes. Do not use as an I.V. bolus. If the average radiochemical purity is less than 95%, the preparation should not be administered. 
For patients with 150,000 platelets per mm3 and more: 15 MBq [90Y]-radiolabelled Zevalin per kg body weight up to a maximum of 1,200 MBq. 
For patients with less than 150,000 but more than 100,000 platelets per mm3: 11 MBq [90Y]-radiolabelled Zevalin per kg body weight up to a maximum of 1,200 MBq. 
May be infused directly by stopping the flow from an infusion bag and administering it directly into the line. A 0.2 or 0.22 micron low protein binding filter must be on line between the patient and the infusion port. Flush the line with at least 10 ml of sodium chloride 9 mg/ml (0.9%) solution after the infusion of [90Y]-radiolabelled Zevalin. 
Treatment consists of two I.V. administrations of rituximab and one administration of [90Y]-radiolabelled Zevalin in the following order: Day 1: An I.V. infusion of rituximab 250 mg/m2. Day 7, 8 or 9: An I.V. infusion of rituximab, 250 mg/m2, shortly before the administration of [90Y]-radiolabelled Zevalin. [90Y]-radiolabelled Zevalin infusion: 10 minute I.V. infusion is given up to a maximum dose of 1,200 MBq.
Prescribing Restrictions:  Kupah Pharmacy Only Medical Division Approval 


Indications:
For the treatment of adult patients with rituximab relapsed or refractory CD20+ folicular B-cell non-Hodgkin's lymphoma (NHL).
As consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
Contra-Indications:
Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, to other murine proteins or to any of the excipients. Pregnancy and lactation. See prescribing information for full details.
Special Precautions:
Must not be mixed with other medicinal products. Should be used following pre-treatment with rituximab. The prepared infusion must be given as a slow I.V. administration over 10 minutes. Should only be used in designated settings by qualified personnel with the appropriate government authorization for the use and manipulation of radionuclides. Should not be administered to patients who are likely to develop life-threatening, hematological toxicity signs. Should not be administered to: patients in whom more than 25% of the bone marrow has been infiltrated by lymphoma cells; patients who have received prior external beam radiation involving more than 25% of active bone marrow; patients with platelet counts <100,000/mm3 or neutrophil counts <1,500/mm3; patients who have received prior bone marrow transplant or stem cell support; children and adolescents under 18 years of age. Bone marrow depletion. Patients who have received murine-derived proteins before treatment, should be tested for human anti-mouse antibodies (HAMA). Patients who have developed HAMA may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins. Patients should generally be tested for HAMA before any further treatment with mouse derived proteins. Females of child-bearing potential, as well as males, should use effective contraceptive measures during treatment and for 12 months afterwards. Could affect the ability to drive and to use machines, as dizziness has been reported. Pregnancy and lactation: Pregnancy must be excluded before the start of treatment. Women must discontinue breast-feeding. See prescribing information for full details.
Side Effects:
The radiation dose resulting from therapeutic exposure may result in secondary malignancies and in development of hereditary defects. It is necessary to ensure that the risks of the radiation are less than from the disease itself. Very common: Anemia, leukocytopenia, neutropenia, thrombocytopenia. Nausea, asthenia, pyrexia, rigors. Common: Febrile neutropenia, lymphocytopenia, pancytopenia. Abdominal pain, constipation, diarrhea, dyspepsia, throat irritation, vomiting. Flu syndrome, hemorrhage while thrombocytopenic. Malaise, pain, peripheral edema. Hypersensitivity. Infection, oral moniliasis, pneumonia, sepsis, urinary tract infection. Anorexia, arthralgia, back pain, myalgia, neck pain. Tumor pain, dizziness (except vertigo), headache, insomnia, anxiety, cough, rhinitis. Pruritis, rash, increased sweating. See prescribing information for full details.
Drug Interactions:
No known interactions. See prescribing information for full details.