You must not be given Zevalin:
- if you are allergic (hypersensitive) to any of the following: - ibritumomab tiuxetan, yttrium chloride or to any of the other ingredients of Zevalin (listed in section 6 ?What Zevalin contains?) - rituximab or other murine-derived proteins
- if you are pregnant or breast-feeding (see also section ?pregnancy and breast feeding?).
Take special care with Zevalin In the following cases, Zevalin use is not recommended since its safety and efficacy have not been established more than a quarter of your bone marrow contains malignant abnormal cells. If you have had external beam radiation a type of radiotherapy to more than a quarter of your bone marrow. If you receive Zevalin alone and the number of your blood platelets is fewer than 100,000mm3If the number of your blood platelets is fewer than 150,000mm3 after chemotherapy
If the number of your white blood cells is fewer than 1,500mm3If you have had a bone marrow transplant or have received blood stem cells in the past.
If you have been treated with other proteins (especially mouse-derived) before Zevalin treatment, you may be more likely to have an allergic reaction. You may, therefore, need to be tested for special antibodies.
In addition, Zevalin is not recommended for the use in patients with non-Hodgkin?s lymphoma involving the brain and/or spinal cord as those patients were not included in clinical studies.
Zevalin is not recommended for use in children below age 18 since safety and efficacy have not been established.
Limited data in elderly patients (aged 65 years or over) are available. No overall differences in safety or efficacy were observed between these patients and younger patients.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
In particular, your doctor will need to interrupt treatment with growth factors such as filgrastim for a period of three weeks before giving you Zevalin to two weeks after Zevalin treatment. If you are given Zevalin less than 4 months after chemotherapy containing the active substance fludarabine, you may have a higher risk of having a reduced number of blood cells. Please tell your doctor that you were given Zevalin if you are due for vaccination after using it.
Pregnancy and breast-feeding
Zevalin must not be used during pregnancy. Your doctor will perform tests to exclude pregnancy before you start the treatment. Women of child-bearing potential and male patients must use reliable contraception during treatment with Zevalin and for up to one year after stopping treatment. There is a potential risk that ionizing radiation by Zevalin could harm your ovaries and testicles. Please ask your doctor how this may affect you, especially if you are planning on having children in the future.
Women must not breast-feed during treatment and for 12 months following the treatment. .
Driving and using machines
Zevalin can affect your abilityto drive and use machines, as dizziness is a common side effect. Please be cautious until you are sure you are not affected.
Important information about some of the ingredients of Zevalin
This medicine contains up to 28 mg sodium per dose, depending on the radioactivity concentration. To be taken into consideration by patients on a controlled sodium diet.