Bayer_Zev_ad.qxp 10/9/08 11:49 am Page 45
Give them the
progression-free time
of their lives
In advanced FL, consolidation with Zevalin
®
after induction regimen can*:
s ) N C R E A S E P R O G R E S S I O N
F R E E S U R V I V A L B Y
A P P R O X I M A T E L Y T W O Y E A R S
1
s # O N V E R T O F P A T I E N T S F R
1
O M 0 2 T O # 2
s ! C H I E V E A C O M P L E T E R E S P O N S E # 2 O R # 2 U
A S B E S T R E S P O N S E I N O F P A T I E N T S
1
Single Therapeutic Dose
®
Consolidation today, confidence for tomorrow.
*
The [
90
9 =
R A D I O L A B E L E D N
®
: Eis V A L Iindicated as Pregnancy and lactation. Warnings and precautions: use. After the use of Zevalin
®
, patients should generally be back pain, neck pain, pain, flulike symptoms, malaise, peripheral
C O N S O L I D A T I O N Y A T H E F T E R A P R R E M I S S I O N I N D U CRadiophar T I O N Imaceu N tical agents should only be used by qualified tested for HAMA before any further treatment with mouse edema, sweatingincreased. Uncommon: tachycardia. Rare:
P R E V I O U S L Y U N T R E A T E D P A T I E F O L L I C U L A N T S W I T H R L Y M P H O M Apersonnel with the appropriate government authorisation for the derived proteins. Patients experiencing a mucocutaneous meningioma, intracranial hemorrhage while thrombocytopenic
‡
.
4 H E B N E l T O F : E V A L I N
®
F O L L O W I N G R I T U X I M A B I N C O M B I N A T I O Nuse and manipulation of radionuclides. Severe and prolonged reaction should not receive any further component of the
‡
fatal outcome has been observed in clinical trials or in post-
W I T H C H E M O H E R A P T Y H A S N O T B E E N E S T A B L S I H E D cytopenia, generally reversible. The risk of hematologic toxicity Zevalin
®
regimen. Females of child-bearing potential, as marketing experience. In the study with 204 patients following
Name of the medicinal product: Zevalin
®
1.6 mg/ml, kit maybe increased when Zevalin
®
is administered shortly well as males, should use effective contraceptive measures first-line remission induction, infections were observed more
for radiopharmaceutical preparation for infusion. Qualitative (<4 months) after fludarabine containing regimens. Not to during treatment with Zevalin
®
and for 12 months afterwards. frequently than as described above (very common). In addition,
and quantitative composition: Ibritumomab tiuxetan
†
1.6 be administered to: patients likely to develop hematological The safety of immunization with any vaccine and the ability the following adverse drug reactions were observed in this
mg per ml. One vial contains 3.2 mg of ibritumomab tiuxetan. toxicity signs; patients in whom more than 25% of the bone to generate a humoral response to any vaccine following study: very common: fatigue, petechia. Common: hypertension,
Zevalin
®
is supplied as a kit for the preparation of yttrium-90 marrow has been infiltrated by lymphoma cells; patients therapy withZevalin
®
has not been studied. No dataare hypotension, amenorrhea. Post-marketing experience:
radiolabeled ibritumomab tiuxetan. Thefinal formulation after who have received external beam radiation involving more available on patients with CNS lymphoma. Close monitoring mucocutaneous reaction, including Stevens Johnson Syndrome
radiolabeling contains 2.08 mg ibritumomab tiuxetan in a total than 25% of active bone marrow; patients with platelet for evidence of extravasation during injection of Zevalin
®
with fatal outcome, has been rarely reported in post-marketing
volumeof 10 ml.
†
produced by a genetically engineered Chinese counts <100,000/mm
3
(monotherapy) or <150,000/mm
3
is required. If any signs or symptoms of extravasation have experience. Isolated reports of extravasation with subsequent
Hamster Ovary (CHO) cell line conjugated to the chelating (consolidation); patients with neutrophil counts <1,500/mm
3
; occurred, the infusion should be immediately terminated and infusion site reaction, like dermatitis, desquamation and site
agent MX-DTPA. Indications: The [
900
Y]-radiolabeled Zevalin
®
patients withprior bone marrow transplant or stem cell support; restarted in another vein. 5 N D E S I R A B L E F F E C T E Ve S ry common: ulcer have been received. Isolated reports have been received
is indicated as consolidation therapy after remission induction children and adolescents. Growth factors not to be used 2 thrombocytopenia, leukocytopenia, neutropenia, anemia, showing that Zevalin
®
–associated radiation might cause damage
in previously untreated patients with follicular lymphoma. weeksbeforeandafter Zevalin
®
. Special caution required with nausea, asthenia, pyrexia, rigors. Common: infection
‡
, to lymphoma-surrounding tissue and complications due to
The benefit of Zevalin
®
following rituximab in combination respect to bone marrow depletion. Patients who had received sepsis
‡
, pneumonia
‡
, urinary tract infection, oral moniliasis, lymphoma swelling. Because the Zevalin
®
therapeutic regimen 0
5
8
with chemotherapy has not been established. The [
90
Y]- murine-derived proteins before Zevalin
®
treatment should tumor pain, myelodysplastic syndrome/acute leukemia
‡
, includes the use of rituximab, see also prescribing information of 8
.0
radiolabeled Zevalin
®
is indicated for the treatment of adult be tested for HAMA. Severe reactions may occur during or febrile neutropenia, pancytopenia
‡
, lymphocytopenia, rituximab. / N P R E S C R I P T I O N Y Dateo O N Lf revision of the text:
patients with rituximab relapsed or refractory CD20+ follicular following rituximab infusion, see the prescribing information hypersensitivity reaction, anorexia, anxiety, insomnia, April 2008. 0 L E A S E N O T E For current prescribing information refer 8
.
2
0
0
B-cell non-Hodgkin’s lymphoma (NHL). # O N T R A I N D I C A T I O N Sof rituximab ; infusion-related reactions due to Zevalin
®
less dizziness, headache, hemorrhage while thrombocytopenic
‡
, to the package insert and/or contact your local Bayer Schering
.0
N
Hypersensitivity to ibritumomab tiuxetan, to yttrium chloride, to common and less severe. Medicinal products for the treatment cough, rhinitis, vomiting, abdominal pain, diarrhea, dyspepsia, Pharma organization. Bayer Schering Pharma AG, 13342 Berlin,
O
1.
rituximab, to other murine proteins or to any of the excipients. of hypersensitivity reactions should be available for immediate throat irritation, constipation, rash, pruritus, arthalgia, myalgia, Germany. 1. Hagenbeek A et al. Blood 2007;110(11), abstr. 643.
E
U
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