Connex PSP

XEMBIFY^® Connex Patient Support Program
HOSPITAL/INFUSION CLINIC REGISTRATION AND CONSENT

Thank you for your interest in the XEMBIFY Connex Patient Support Program (PSP) which provides patients prescribed XEMBIFY (normal immunoglobulin (human) 20% solution for subcutaneous injection) with at-home nurse training on how to administer XEMBIFY, subcutaneous immunoglobulin (SCIg).

Hospitals/Infusion clinics must be registered to enrol patients in the Connex PSP. To register your hospital or infusion clinic for the program, please complete this form.

FACILITY ADMINISTRATOR DETAILS

First name*

Last name*

HOSPITAL / INFUSION CLINIC DETAILS ^*

Hospital/Infusion clinic*

Department*

Address*

Suburb*

State*

Postcode*

Primary Contact for this program:

First name*

Last name*

Position*

Email*

Phone*

Secondary Contact for this program:

First name

Last name

Position

Phone

*Primary and secondary contacts will receive communications from the Program Coordinator, including patient reports. Hospital contacts will be responsible for distributing information with their organisation as needed.

IMPORTANT INFORMATION

Please indicate who will be completing this form.

Primary Contact Secondary Contact

Please review and tick each box to confirm this important information has been read and understood.

At-home training is subject to institutional protocols and clinician recommendation. The Connex PSP will provide at-home SCIg infusion training to patients enrolled in the program for those institutions which require at home training. Patients who will be fully trained in the hospital setting and do not require at-home training are still eligible to receive the other components of the Connex PSP. *

The Connex PSP nurses, commissioned by Grifols, are only authorised to provide instruction and education regarding self-infusion of XEMBIFY. PSP nurses are not authorised to provide medical advice to patients enrolled in the program. Patients will be instructed to direct all questions regarding their condition and/or treatment to their physician/healthcare professional (or in the case of an emergency will be directed to call 000). All adverse events reported to the PSP nurses will be reported to Grifols Pharmacovigilance for investigation and follow-up as needed. PSP nurses will report emergency information directly to the prescribing physician noted on the patient enrolment form. *

All patients enrolled in the Connex PSP will receive a Connex Infusion Support Kit, which includes an initial supply of infusion-related consumables and patient educational materials and tools. *

All patients enrolled in the Connex PSP will be able to order subcutaneous infusion-related consumables (at no cost to the patient) for as long as they are treated with XEMBIFY. *

The Connex PSP does not provide infusion pumps for subcutaneous infusion of XEMBIFY. *

The hospital/infusion clinic is responsible for ordering and supplying XEMBIFY in accordance with normal hospital/infusion clinic procedures.*

The hospital/infusion clinic agrees to take responsibility for: *

Ensuring XEMBIFY is stored in accordance with the instructions contained in the approved Product Information
Instructing the patient on the correct storage and transportation of XEMBIFY
Distributing XEMBIFY and the Connex Infusion Support Kits only to patients who have been prescribed and are currently using XEMBIFY.

If you have any questions or require further information about the Connex PSP, please contact your Grifols Sales Representative.

HOSPITAL/INFUSION CLINIC TRAINING AND CONNEX INFUSION SUPPORT KITS

Please complete the following to allow the Connex PSP to be tailored to your hospital’s/infusion clinic’s specific requirements

1. Patients enrolled in the PSP are eligible to receive self-administration training with a PSP nurse and infusion-related consumables. Please confirm if patients will require at-home self-administration training with a PSP nurse and infusion-related consumables or consumables only? *

Patients WILL require at-home self-administration training with a PSP nurse AND infusion-related consumables
Patients will NOT require at-home training but will require infusion-related consumables, only. Full training on the self-administration of XEMBIFY will be provided by the hospital/infusion clinic

2. Patients will be required to meet the program’s competency criteria per Australasian Society of Clinical Immunology and Allergy (ASCIA) guidelines available here: [Training Checklist for Home Administered Subcutaneous Immunoglobulin (SCIg) Infusion Treatment (allergy.org.au)]. *

2a. Are patients also required to meet additional, hospital/clinic specific infusion competency criteria?

Yes No

3. Does the Connex PSP nurse providing the at-home training have to be assessed/validated or trained by the hospital/clinic/local area health? *

Yes No

LOGIN DETAILS

Please set your login details to access the XEMBIFY Connex PSP portal. Please select your own strong password with at least 8 characters in length and includes 1 capital letter,numbers and symbols.

Email*

Password*

Confirm Password*

FACILITY ADMINISTRATOR CONSENT

GRIFOLS AUSTRALIA

Grifols Australia reserves the right to modify or restrict the mechanisms for participation in the Connex PSP at any time without notice. Should any of these actions be taken all participants in the program will be informed as soon as possible via email/SMS and the program portal. A period to transition the patients on the PSP back to the hospital management may be required to assist with patients' adherence to their treatment.

CONNEX PSP PROGRAM COORDINATORS

Nuevo Health (an IQVIA Company) coordinates this program on behalf of Grifols Australia.

For additional information about the PSP or for program technical assistance, please contact connexpsp@nuevohealth.com.au or call 1800 313 033 between Monday to Friday from 8:30 am to 5:00 pm AEST/AEDT.

PRIVACY

Nuevo Health privacy policy: Privacy - IQVIA

I agree to give Nuevo Health permission to use any personal and hospital information, contact details and other relevant information relating to this hospital’s participation in the program. I understand that this permission may be revoked at any time by emailing connexpsp@nuevohealth.com.au *

I understand that my institution can end their involvement in the Connex PSP at any time by contacting my Grifols Sales Representative or the Connex Program Coordinator.

Authoriser’s:

First Name*

Last Name*

Date: 09 Sep 2024

A copy of this signed Consent Form will be sent to the nominated email address.

PBS Information: This product is not listed on the PBS.
Please refer to the National Blood Authority for details.

Please review the Consumer Medicine Information available from: https://www.gatewayhcpportal.com.au/documents/3523457/3528032/Xembify+Consumer+Medicine+Information.pdf

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

Nuevo Health (an IQVIA Company) coordinates this program on behalf of Grifols Australia. For program technical assistance, please contact connexpsp@nuevohealth.com.auor call 1800 313 033 between Monday to Friday from 8:30 am to 5:00 pm AEST/AEDT.

Manufactured by:
Grifols Therapeutics LLC
8368 US Hwy 70
West Clayton, North Carolina 27520 USA
Tel. +1 919 553 5011
www.grifols.com

Sponsored by:
Grifols Australia Pty Ltd
Unit 5/80 Fairbank Road,
Clayton South VIC 3169, Australia
Tel. +61 3 9535 9333
Email: australia_info@grifols.com