The safety and effectiveness of Zevalin have not been established in pediatric patients. ���� JFIF ` ` ��Exif II* b j ( 1 r 2 � i� � � �� Discontinue the Zevalin therapeutic regimen in patients experiencing a severe cutaneous or mucocutaneous reaction [see Boxed Warning and Adverse Reactions (6.2)]. This linker-chelator provides a high affinity, conformationally restricted chelation site for Yttrium-90. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No therapies exist for hemolytic uremic syndrome, which may result in these infections. HAMA and HACA response data on 446 patients from 8 clinical studies conducted over a 10-year time period are available. The results for PFS are presented in Figure 1 . The FDA granted fast track designation for Caprion Pharmaceuticals’ Shigamabsfor the treatment of shigatoxin-producing bacterial infections. The trial was conducted in 130 patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL); no patient had received prior rituximab. Discontinue rituximab and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [see Warnings and Precautions (5.3) and Adverse Reactions (6.2)]. 3 !1AQa"q�2���B#$R�b34r��C%�S���cs5���&D�TdE£t6�U�e���u��F'���������������Vfv��������7GWgw�������� 5 !1AQaq"2����B#�R��3$b�r��CScs4�%���&5��D�T�dEU6te����u��F���������������Vfv��������'7GWgw������� ? Inform women who become pregnant while receiving Zevalin of the potential fetal risks. Because the Zevalin therapeutic regimen includes the use of rituximab, see prescribing information for rituximab. Based on its radioactivity, Y-90 Zevalin may cause fetal harm. The median time to cytopenia was similar across patients with relapsed/refractory NHL and those completing first-line chemotherapy, with median ANC nadir at 61-62 days, platelet nadir at 49-53 days, and hemoglobin nadir at 68-69 days after Y-90-Zevalin administration. Table 2 displays selected adverse reaction incidence rates in patients who received any portion of the Zevalin therapeutic regimen (n=206) or no further therapy (n=203) following first-line chemotherapy (FIT study).
The kit contains four identification labels and the following four vials: Yttrium-90 Chloride Sterile Solution is shipped directly from the supplier upon placement of an order for the Y-90 Zevalin kit. Other efficacy outcome measures included time-to-disease-progression (TTP) and duration of response (DR). Grade 2-4 hematologic toxicity occurred in 86% of Zevalin-treated patients. Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients with relapsed or refractory NHL enrolled in clinical studies and 1.5% (8/535) of patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. H H ���� Adobe_CM �� Adobe d� �� � 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. Last updated on Sep 1, 2019. No formal drug interaction studies have been performed with Zevalin.
Do not shake or agitate the vial contents. East Windsor, NJ 08520. Do not administer Y-90 Zevalin to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve, Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen.
Information on hematopoietic growth factor use and platelet transfusions is based on 211 patients with relapsed/refractory NHL and 206 patients following first-line chemotherapy.
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