ZEVALIN(TM)（ibritumomab，泽泽娃灵）-第一个得到批准的用于治疗复发或顽固性低度恶性非霍奇金氏淋巴瘤的放射免疫治疗制剂
【药品名称】
商品名：Zevalin
通用名：Ibritumomab Tiuxetan
中文名：泽娃灵(替伊莫单抗/人血白蛋白)
【来    源】 
Zevalin为一种用放射性核素铟111（Indium-111，In–111）或钇90（Yttrium–90，Y–90）标记的抗CD20单抗。
【作用机制】
本品为携带放射性核素铟111或钇90的抗CD20单克隆抗体。注入患者体内后，单克隆抗体会与表达CD20的成熟B细胞和B系肿瘤细胞相结合，由其携带的放射性核素释放放射线杀死这些细胞。
【适应证】
复发或难治性低度恶性的滤泡型或转化型B细胞非霍奇金淋巴瘤（NHL）。对Rituxan (rituximab)耐药的难治性滤泡型NHL患者，本品已被批准用于作为Rituxan治疗方案的一部分。
【药代动力学】
铟111Zevalin物理半衰期67.3小时(2.81天)。钇90Zevalin物理半衰期64.1小时(2.67天)。中位用药时间62天有核细胞降到最低值，53天血小板降到最低值，68天血红蛋白降到最低值。
【相互作用】
尚无正式关于本品与其他药物相互作用的研究报道，但是由于本品可以引起血小板减少，故同时应用影响血小板功能的药物或者抗凝剂时应谨慎。
【单药有效率】 
本品对75%的患者具有疗效。其中15%~30%达到完全缓解。
【用法用量】 
出于对安全的考虑，zevalin治疗方案目前只被批准用于那些对其他治疗方案无效的患者。仅遵医嘱。

ZEVALIN® (ibritumomab tiuxetan)
Indications and Usage
ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two infusions of rituximab and one injection of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the number of B-cells in your blood and Y-90 ZEVALIN is given to treat your non-Hodgkin's lymphoma (NHL).
The ZEVALIN therapeutic regimen is used to treat patients with:
•Low-grade or follicular B-cell NHL that has relapsed during or after treatment with other anticancer drugs.
•Newly diagnosed follicular NHL following a response to initial anticancer therapy.
Patient Important Safety Information
What Is the Most Important Safety Information I Should Know About ZEVALIN Treatment?
The following section provides an overview of the most important safety information you should know about ZEVALIN, including side effects. Not all of the safety information about ZEVALIN treatment is included here. For complete safety information, please see the accompanying full prescribing information for ZEVALIN. Additional information may also be found on the ZEVALIN Website (www.ZEVALIN.com) or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).
WARNING: ZEVALIN TREATMENT CAN CAUSE SERIOUS SIDE EFFECTS:
•Serious Infusion Reactions: Rituximab, alone or as part of the ZEVALIN treatment, may cause serious infusion reactions. Deaths have occurred within 24 hours of rituximab infusion, an important component of the ZEVALIN treatment. Tell your doctor or infusion nurse or get medical treatment right away if you develop fever or chills, a rash, itching, dizziness, swelling of your hands, feet or face, throat irritation or trouble breathing during or after receiving the ZEVALIN treatment.
•Extended and Severe Decreases in Your Blood Counts (Cytopenias): Your doctor will monitor your blood counts after receiving the ZEVALIN treatment. Decreased blood counts can occur late and continue for more than 12 weeks after receiving ZEVALIN. Tell your doctor if you have a fever, feel too tired to do daily activities, feel weak, develop bruises or pinpoint red or purple spots on your skin, have unusual bleeding or notice blood in your urine or stool.
•Severe Skin or Mucous Membrane Reactions: If you experience any reactions related to your skin or mucous membranes (e.g. mouth, nose), your infusion of rituximab and Y-90 ZEVALIN should be discontinued.
Dosing Warning: The dose of Y-90 ZEVALIN should not exceed 32.0 mCi (1184 MBq).
Additional Safety Information:
•Risk of Developing Myelodysplastic Syndrome, Leukemia and Other Malignancies (Cancers): The radiation dose resulting from therapeutic exposure to Y-90 ZEVALIN may result in secondary malignancies.
Myelodysplastic syndrome (MDS; a type of pre-cancerous bone marrow abnormality) and/or Acute Myelogenous Leukemia (AML, a type of cancer of the blood) were reported in 5.2% (11/211) of patients treated with Y-90 ZEVALIN for relapsed or refractory non-Hodgkin's lymphoma (NHL) in clinical studies, and 1.5% (8/535) of all patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to diagnosis of MDS or AML was 1.9 years following the ZEVALIN therapy; however, the total incidence continues to increase.
Among 204 newly diagnosed patients who received Y-90 ZEVALIN, following complete or partial response to initial anticancer therapy, 7 patients (3.4%) were diagnosed with MDS/AML after receiving ZEVALIN treatment, compared to one patient (0.5%, 1/205) in the control arm, with a median follow-up of 7.3 years. Deaths due to secondary new malignancies occurred in 8 (3.9%) patients treated with ZEVALIN compared to 3 (1.5%) patients in the control arm of the study. Deaths due to MDS or AML occurred in 5 (2.5%) patients treated with ZEVALIN compared to no patients in the control arm.
•Infusion Site Leakage: ZEVALIN may leak from your vein or infusion site. Your doctor will monitor you during treatment and will stop the infusion and switch to another vein, if this occurs during treatment.
•Immunization: Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
•Precautions During and After Administration: Your doctor will discuss precautions with you to minimize radiation exposure.
•Potential for Birth Defects: ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
•Reproductive Organs: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for a minimum of 12 months following ZEVALIN therapy.
•Nursing Mothers: Discontinue nursing during and after ZEVALIN treatment.
•Adverse Reactions (Side Effects): The most common adverse reactions (≥10%) in clinical trials with ZEVALIN were: decreases in blood counts, tiredness, inflammation of the nose and upper throat, nausea (upset stomach), abdominal (stomach) pain, weakness, cough, diarrhea, and fever. The most serious adverse reactions of ZEVALIN are prolonged and severe reduction in the number of blood counts and secondary cancers.
When administered following initial anticancer therapy, grade 3/4 adverse reactions of ZEVALIN include prolonged and severe decrease in blood counts (decrease in platelets [51%], decrease in neutrophils (a type of white blood cell) [41%], decrease in total white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers (12.7%). Reductions in blood cells were more severe and more prolonged among 11 (5%) patients who received ZEVALIN after first-line fludarabine or a fludarabine-containing anticancer regimen as compared to patients receiving non-fludarabine-containing regimens. Grade 3/4 infections occurred in 8% of ZEVALIN-treated patients and in 2% of controls and included neutropenic sepsis (fever and infection due to decrease in the number of neutrophils [1%]), bronchitis, catheter sepsis (bacterial infection in the blood related to catheter), diverticulitis (inflammation in the intestines), shingles or blistering skin rash caused from herpes virus reactivation, flu, lower air passage infection, sinusitis (swelling of the sinuses), and upper air passage infection.
Grade 3/4 adverse reactions of ZEVALIN in recurring NHL patients include prolonged and severe reduction of blood cells (decrease in platelets [63%], decrease in neutrophils [60%], decrease in red blood cells or hemoglobin [17%], and ecchymosis (small blue or purple patch on the skin or mucous membrane [<1%])) and secondary cancers (5.2%). Serious infections occurred in 3% of patients (urinary tract infection, febrile neutropenia, sepsis, pneumonia, cellulitis (type of skin infection), colitis (swelling of the large intestine), diarrhea, osteomyelitis (bone infection), and upper-air passage infection). Life-threatening infections were reported in 2% of patients (sepsis, empyema (collection of pus in a cavity in the body), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).
Please click here to see the full Prescribing Information, including the BOXED WARNINGS, for ZEVALIN. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide (www.rituxan.com).
http://www.kegg.jp/medicus-bin/japic_med?japic_code=00054618
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产地国家: 日本
原产地英文商品名:
Zevalin indium injection（ゼヴァリンインジウム（111In）静注用セット）Y-90 1kit
原产地英文药品名:
KIT FOR PREP YTTRIUM-90/Ibritumomab Tiuxetan（genetical recombination）
中文参考商品译名:
泽娃灵（ゼヴァリンインジウム（111In）静注用セット）Y-90 1套
中文参考药品译名:
KIT FOR PREP YTTRIUM-90/替伊莫单抗/人血白蛋白
生产厂家中文参考译名:
SPECTRUM PHARMS
生产厂家英文名:
SPECTRUM PHARMS