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ZEVALIN（ibritumomab，泽泽娃灵）-FDA批准第一个肿瘤放射性免疫治疗药物
【药品名称】
商品名：Zevalin
通用名：Ibritumomab Tiuxetan
中文名：泽娃灵
【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。
Indications and Usage
ZEVALIN® (ibritumomab tiuxetan) injection for intravenous use is a prescription medication that has three parts: two treatments of rituximab and one treatment of Yttrium-90 (Y-90) ZEVALIN. Rituximab is used to reduce the amount 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:
•Recurring, low-grade or follicular B-cell NHL, after other anticancer drugs are no longer working.
•Newly diagnosed follicular NHL following a response to initial anticancer therapy.
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 click here to see the full prescribing information for ZEVALIN. Additional information may also be found on this Web site or by speaking with your health care provider. Because ZEVALIN treatment includes the use of rituximab, please see the rituximab medication guide.
The ZEVALIN treatment can cause serious side effects including:
•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, 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:
•Leukemia and Myelodysplastic Syndrome (MDS): Among 204 patients who received Y-90 ZEVALIN, following anticancer therapy, 2 patients (1%) were diagnosed with Acute Myelogenous Leukemia (a type of cancer of the blood, AML) within 3 years of receiving ZEVALIN treatment. MDS (another type of cancer in the bone marrow) and/or AML were reported in 5.2% (11/211) of patients with recurring 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.
•ZEVALIN therapy may cause harm to an unborn baby, please tell your doctor if you are pregnant or plan to become pregnant.
•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.
•Do not get a vaccine that contains live virus for at least 12 months following ZEVALIN treatment.
•Your doctor will need to monitor your blood weekly to watch for dropping blood counts and platelet counts.
•Your doctor will discuss precautions with you to minimize radiation exposure.
•Creutzfeldt-Jakob Disease (CJD): CJD is a form of brain damage that leads to rapid decrease of mental function and movement. The ZEVALIN therapeutic regimen contains a protein made from human blood. Based on effective donor screening and product manufacturing processes, ZEVALIN carries a very low risk for transmission of viral diseases. The risk for getting CJD is also very low. No cases of transmission of viral diseases or CJD have ever been identified.
•Impairment of Fertility: There is a risk that ZEVALIN therapy will affect the male and female reproductive organs. Use birth control during treatment and for up to 12 months following ZEVALIN therapy.
•Nursing: Patients should be advised to discontinue nursing during and after ZEVALIN treatment.
Adverse Reactions (Side Effects):
•The most common adverse reactions of ZEVALIN are: decreases in blood counts, tiredness, abdominal (stomach) pain, nausea (upset stomach), inflammation of the nose and upper throat, weakness, diarrhea, cough, and fever. Common adverse reactions (≥40%) in clinical trials were: low neutrophil count (a type of white blood cell), decrease in number of white blood cells, decrease in platelets, decrease in red blood cells or hemoglobin, infection, lack of body strength and energy, muscles and bones symptoms, and stomach and intestinal symptoms.
•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 [41%], decrease in white blood cells [36%], decrease in lymphocytes [18%], and decrease in red blood cells or hemoglobin [5%]), and secondary cancers. Reductions in blood cells were more severe and more prolonged among eleven (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. 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), pneumonia, febrile neutropenia, fever, and biliary stent-associated cholangitis (bile duct infection)).
Zevalin (Ibritumomab Tiuxetan)
Zevalin (Ibritumomab Tiuxetan) is indicated in the treatment for follicular lymphoma, as a side treatment after inducing the remission. It is normally recommended to the patients who haven’t been through a previous treatment for such an unpleasant disease. It was also not established yet whether the drug can be used as a side treatment for chemotherapy.
Administration
Administering Zevalin (Ibritumomab Tiuxetan) is done with a high attention and care, only be a specially trained medically personnel. It is administered through a perfusion. The perfusion must be prepared according to the current safety and radiological measures.
Prior to getting this treatment, the patient must go through a similar, more powerful one – rituximab. The first day consists of an intravenous perfusion with rituximab that shouldn’t last for more than 4 hours. The doctor must administrate 250mg per square meter. The actual Zevalin (Ibritumomab Tiuxetan) treatment starts a week later. The patient will need a second 4 hours perfusion with rituximab, then an intravenous perfusion with Zevalin (Ibritumomab Tiuxetan) for 10 minutes.
According to the results, side reactions and health state of the patient, the specialist doctor may recommend a new cycle or not. There is no such thing as a maximum period for this treatment. It is taken for as long as the organism needs it.
In order to be efficient, the drug must have a radiochemical purity of over 95%.
Contraindications
This treatment is very risky if administered in an inappropriate way. If the patient presents any signs of hypersensitivity to any of the excipients of this drug, the doctor must find an alternative treatment instead.
It is also contraindicated in pregnant women. The tests on animals haven’t been conclusive enough. The same goes for nursing women. The medication can be transmitted to the baby through the milk, therefore the patient should stop nursing during the treatment.
The tests on children and old people have also proven to be unconvincing, therefore they shouldn’t take any risks at all. However, there haven’t been any major differences noticed between the young adults and the patients older than 65.
When it comes to concomitant administration with other drugs, there aren’t any known side effects, but at the same time, the tests are still ongoing.
Side effects
The radiation dose coming from this treatment can be extremely harmful for a lot of patients. Before actually involving with the Zevalin (Ibritumomab Tiuxetan) treatment, you must make sure the risks you take are worth. If they cannot outweigh the potential results, then you should probably change your mind. The side effects are severe and include infections, hemorrhages, nausea or vomiting.
附件:
201152323180125.pdf
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注：以下产品不同规格和不同价格，购买时请以咨询为准！
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产地国家: 美国
原产地英文商品名:
ZEVALIN IN-111 1kit
原产地英文药品名:
KIT FOR PREP INDIUM-111/IBRITUMOMAB TIUXETAN/ALBUMIN HUMAN
中文参考商品译名:
泽娃灵IN-111 1套
中文参考药品译名:
KIT FOR PREP INDIUM-111/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
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产地国家: 美国
原产地英文商品名:
ZEVALIN Y-90 1kit
原产地英文药品名:
KIT FOR PREP YTTRIUM-90/IBRITUMOMAB TIUXETAN/ALBUMIN HUMAN
中文参考商品译名:
泽娃灵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
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