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Manufacturing related supply constraints for NULOJIX® (belatacept)

In October 2016, Bristol-Myers Squibb (BMS) initiated communications with the U.S. Food and Drug Administration, European Medicines Agency, and other health authorities in applicable European and South American countries to notify them that a delay in transition to a more efficient manufacturing process, which is needed to meet growing demand for Nulojix, had created a potential supply constraint in 2017. At that time, steps were taken to mitigate the potential supply constraint. Based on growth in new prescriptions, BMS projects that the commercial supply of Nulojix in 2017 will not be sufficient to enable new patients to start treatment with Nulojix.

Starting March 15, 2017, no new patients will be able to start Nulojix. BMS is committed to maintaining supply for patients currently being treated with Nulojix. In order to preserve the ability of existing patients to receive Nulojix, you must register your existing patients in the Nulojix Distribution Program and receive a unique patient identification number, which will be required to order Nulojix. Distributors will request this information. The unique patient identification number can be obtained by completing the registration form and receiving notification of enrollment.

BMS anticipates that, subject to regulatory approval, the transition to the new manufacturing process will be completed at the end of 2017, which will enable supply to new patients again starting in 2018.

Information detailing the Nulojix Distribution Program will be communicated by your local BMS contacts. If you have any questions regarding this program, please call 1-855-511-6180 from 8 AM to 8 PM ET, Monday through Friday (except holidays).

6th Edition of the Council of Europe Guide to the Quality and Safety of Organs for Transplantation Published

This Guide contains the most updated information and guidance for all professionals involved in identifying possible organ donors, co-ordinators managing the process of donation after death and of living donation, professionals responsible for the allocation and clinical use of human organs, quality managers and Health Authorities responsible for overseeing donation and transplantation programmes.

In this 6th Edition, all of the chapters have been revised thoroughly to update their contents with the most recent advances in the field. In addition, new and important chapters have been added, including specific guidance for the determination of death by neurologic criteria, donation after circulatory death and living donation, among others.

This Guide has been elaborated by a dedicated and committed group of well-recognised international experts who did a tremendous job in sharing their expertise, in reviewing the literature and in extracting knowledge from numerous international guidelines, collaborative projects and diverse publications and websites with the aim of ensuring accessibility to all this information. The entire project has been an exceptional combined effort, with extensive discussions dedicated towards the common goal of increasing the safety, efficacy and quality of human organs for transplantation. The final result is this Guide, which constitutes a common European standard, based on the long-standing expertise and knowledge of the EDQM, Council of Europe. You may find more information about this Guide at https://go.edqm.eu/OTg.

With the aim of ensuring broad dissemination and use of this guidance document,  the electronic version of this Guide is available for free download at the EDQM’s dedicated website (https://www.edqm.eu/freepub) after a simple registration process. Paper copies will soon be available for purchase at the EDQM Store (http://store.edqm.eu).

Availability of DRAI Addenda to Assist with Screening for Risk of Zika Virus Infection

To assist with screening donors for risk of Zika virus (ZIKV) infection an addendum and relevant flowcharts are available for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms, and they are adaptable for use with any DRAI form style. Documents can be accessed at these links on the AATB website:

Zika Virus (ZIKV) Infection Addenda and Flowcharts 

Deceased Donor (ZIKV)

The tools for a “Deceased Donor” assist with developing policies and procedures to screen a deceased donor of organs, tissues or eyes for risk of infection with ZIKV, and use “as is” is encouraged.  The following guidance information was referenced to develop the tools:

A separate addendum and set of flowcharts should be used when screening a living donor who is a delivery mother of birth tissue (e.g., placenta).  Both sets of tools meet expectations described in the immediate guidance issued by FDA/CBER on March 1, and their recommendations should be implemented by March 29, 2016. 

NOTE: As knowledge is gained regarding risk of ZIKV infection associated with donation of organs, tissues or eyes, be aware that updates to the addenda and/or the flowcharts can occur.

Contact Scott Brubaker if you have questions after carefully reviewing all documents and published guidance.

Availability of DRAI Addendum to Assist with Screening for Risk of Ebola Virus Disease

To assist with screening for risk of Ebola Virus Disease (EVD), the American Association of Tissue Banks has made available a one-page addendum and relevant flowcharts for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms, adaptable for use with any DRAI form style.

These tools can assist with developing policies and procedures to screen for risk of infection with Ebola Virus. A background document is also available at the link above containing notes developed from meetings of AATB's Tissue Transmitted Diseases Advisory Group (TTDAG), a subgroup of the Physicians' Council, and comments received from members of the DRAI Stakeholder Review Group. The background document describes, "An addendum provides the opportunity to discontinue use if screening for EVD risk changes and is determined to no longer be relevant."

Guidance Regarding Ebola Virus Disease

The OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee (DTAC), after careful review of information available from the Centers for Disease Control (CDC), offers information to transplant centers and OPOs in light of the first case of Ebola virus disease (EVD) identified in the United States.

Organ Donation and Transplantation Alliance

Saving and Healing Lives Through Organ Donation (CME credits available)

Organ Donation Toolbox

Transplant Quality Resource Guide and Tools

Organ Procurement and Transplantation Network/United Network for Organ Sharing

Kidney allocation system resources

Kidney paired donation resources

Introduction to the New Pancreas Allocation System