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  药店国别: 美国药房
产地国家: 美国
所属类别: 肾移植->肾移植
处方药:处方药
包装规格: 250毫克/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
百时美施贵宝
生产厂家英文名:
BRISTOL MYERS SQUIBB
该药品相关信息网址1:
http://www.nulojix.com/hcp/index.aspx
该药品相关信息网址2:
http://www.businesswire.com/news/home/20110901005348/en/Data-Bristol-Myers-Squibb-NULOJIX%C2%AE-belatacept-Presented-2011
原产地英文商品名:
NULOJIX 250MG/VIAL
原产地英文药品名:
BELATACEPT
中文参考商品译名:
NULOJIX 250毫克/瓶
中文参考药品译名:
BELATACEPT
原产地国家批准上市年份:
2011/06/15
英文适应病症1:
Kidney transplant
英文适应病症2:
The prevention of acute rejection
临床试验期:
完成
中文适应病症参考翻译1:
肾移植
中文适应病症参考翻译2:
预防急性排斥反应
药品信息:

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 详细处方信息以本药内容附件PDF文件(201221222075230.pdf)的“原文Priscribing Information”为准
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部分中文Nulojix处方资料(仅供参考)

Nulojix(belatacept)用于肾移植成人患者以预防急性排斥反应
    美国食品和药物管理局(FDA)批准Nulojix(belatacept)用于肾移植成人患者以预防急性排斥反应。并批准该药物与其他免疫抑制剂联用,尤其是巴利昔单抗、吗替麦考酚酯和皮质类固醇。

    Nulojix属于选择性T细胞共刺激因子阻断剂。该药物有助于预防肾移植后的器官排斥。如果没有免疫抑制,机体可排斥移植器官,因为免疫系统识别该新器官为外来物质(移植排斥反应)。经静脉输注Nulojix,通过防止排斥反应,与其他免疫抑制剂一起维持新肾脏发挥作用。

    两项招募了1200余名患者的开放、随机、对照、多中心3期研究对Nulojix进行了评估,并比较了Nulojix与其他免疫抑制剂环孢菌素的两种给药方案。这些试验表明,建议的Nulojix方案可安全有效地预防急性器官排斥。

    试验中,移植患者的常见不良反应包括:贫血、便秘、肾脏及膀胱感染、腿脚肿胀等症状。此外,服用者必须尽量减少日晒时间,以预防皮肤癌的发生。

    Nulojix携带的一个黑框警告是,其可增加移植后淋巴组织增生性疾病(PTLD)风险。EB病毒(EBV)可引起单核细胞增多症,对于那些从来没有接触过EBV的移植患者,PTLD风险更高。没有接触过EB病毒的移植患者在移植后感染该病毒时很难产生有效的免疫反应;通常他们在移植时会接触该病毒,因为大约80%的捐赠器官携带有该病毒。患者应检测EBV,如果测试显示他们已接触过EBV ,则应仅接受Nulojix。Nulojix标签上的另一个黑框警告与其他免疫抑制剂标签上的一样,即增加严重感染和其他癌症的风险。

    根据器官获取和移植网络,美国有超过8.9万例的患者正在等待肾移植。

    Nulojix是经静脉输注用药,输注时间为30分钟。

    Nulojix由座落于美国新泽西州普林斯顿的百时美施贵宝公司销售

NULOJIX® (belatacept) is approved for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.
Use NULOJIX only in patients who are Epstein-Barr virus (EBV) seropositive.
Use of NULOJIX for prophylaxis of organ rejection in transplanted organs other than kidney has not been established.

Selected Important Safety Information:
NULOJIX is associated with increased risk for post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS).
NULOJIX is contraindicated in patients who are EBV seronegative or with unknown serostatus because the risk of PTLD is particularly increased in patients who are EBV seronegative.
NULOJIX is to be used only in patients who are EBV seropositive.
Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms.
Higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressives is not recommended.
Immunosuppression may result in increased susceptibility to infection and development of malignancies.
NULOJIX should be prescribed only by physicians experienced in immunosuppressive therapy and management of kidney transplant patients.
Use in liver transplant patients is not recommended due to an increased risk of graft loss and death. Continue to read Important Safety Information >>

Dosage Formulation and Strength: 250 mg lyophilized powder for injection, for intravenous use.
 
IMPORTANT SAFETY INFORMATION
Post-Transplant Lymphoproliferative Disorder (PTLD)
NULOJIX patients are at increased risk for developing PTLD, predominantly involving the central nervous system (CNS)
Recipients without immunity to EBV (ie, seronegative) are at particularly increased risk; therefore, NULOJIX is contraindicated in transplant recipients who are EBV seronegative or unknown serostatus
Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms
As the total burden of immunosuppression is a risk factor for PTLD, higher than recommended doses or more frequent dosing of NULOJIX or concomitant immunosuppressive agents are not recommended
Other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy
CMV prophylaxis is recommended for at least 3 months after transplantation
Use T-cell-depleting therapy to treat acute rejection cautiously
Patients who are EBV seropositive and CMV seronegative may be at increased risk of PTLD
Since CMV seronegative patients are at increased risk for CMV disease (a known risk factor for PTLD), the clinical significance of CMV serology for PTLD remains to be determined; however, these findings should be considered when prescribing NULOJIX

Management of Immunosuppression
Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX
Patients should be managed in facilities with adequate laboratory and supportive medical resources 
The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient

Progressive Multifocal Leukoencephalopathy (PML)
NULOJIX® (belatacept) patients are at increased risk for PML, often a rapidly progressive and fatal opportunistic infection
In clinical trials, two cases were reported in patients receiving NULOJIX at higher cumulative doses and more frequently than the recommended regimen, along with MMF and corticosteroids; one occurred in a kidney transplant recipient and one occurred in a liver transplant recipient
As PML has been associated with high levels of immunosuppression, higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressive agents, including MMF, are not recommended
Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms
PML is usually diagnosed by brain imaging, cerebrospinal fluid testing for JC viral DNA by polymerase chain reaction, and/or brain biopsy
Consultation with a specialist should be considered
If PML is diagnosed, consider reduction or withdrawal of immunosuppression, weighing risk to the graft

Other Malignancies and Serious Infections
Increased susceptibility to infection and possible development of malignancies may result from immunosuppression
Patients should avoid prolonged exposure to ultraviolet light and sunlight
Patients receiving immunosuppressants, including NULOJIX, are at increased risk for bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis.  Some infections were fatal
Polyoma virus-associated nephropathy can lead to deteriorating renal function and graft loss; consider reduction in immunosuppression, weighing risk to the graft
Tuberculosis was more frequently observed in patients receiving NULOJIX. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use
CMV and Pneumocystis jiroveci prophylaxis is recommended after transplantation

Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids

Immunizations: avoid use of live vaccines during NULOJIX treatment

Pregnancy Category C: based on animal data, NULOJIX may cause fetal harm. NULOJIX should not be used in pregnancy unless potential benefit to the mother outweighs potential risk to the fetus. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-6877

Nursing Mothers: discontinue NULOJIX® (belatacept) or nursing, considering importance of NULOJIX to the mother

Most Common Adverse Reactions (≥20%): anemia (45%), diarrhea (39%), urinary tract infection (37%), peripheral edema (34%), constipation (33%), hypertension (32%), pyrexia (28%), graft dysfunction (25%), cough (24%), nausea (24%), vomiting (22%), headache (21%), hypokalemia (21%), hyperkalemia (20%), and leukopenia (20%)

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 详细处方信息以本药内容附件PDF文件(201221222075230.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-2-13
附件:




201221222075230.PDF    

 
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