CARVYKTI Risk Evaluation Mitigation strategy Instructions
- September 26, 2024
- CARVYKTI
Table of Contents
Risk Evaluation Mitigation strategy
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Product Information
Specifications
- Product Name: CARVYKTI
- Manufacturer: Janssen Biotech, Inc
- Contact Phone: 1-844-672-0067
- Contact Fax: 1-877-778-3865
- Contact Email: CARVYKTI@JanssenREMS.com
- Website: www.CARVYKTIREMS.com
Product Usage Instructions
Hospital Enrollment Form
In order to dispense CARVYKTI, Hospitals and their Associated
Clinics must be certified in the CARVYKTI REMS and have on-site
immediate access to tocilizumab. Hospitals and their Associated
Clinics must designate an Authorized Representative to:
Hospitals and Associated Clinics Information
Complete the following fields:
- Hospital and Associated Clinics Name
- REMS ID
- Address
- City
- State
- Zip Code
- Phone
- Fax
Authorized Representative Information
Complete the following fields:
- First Name
- Last Name
- Credentials (DO, MD, R.Ph, NP/PA, RN, Other)
- Phone
- Fax
Authorized Representative Responsibilities
The Authorized Representative is responsible for overseeing
implementation and coordinating activities of the CARVYKTI REMS. By
signing the form, the Authorized Representative agrees to comply
with all REMS Requirements.
FAQ
Q: Where can I find additional information about CARVYKTI
REMS?
A: For any questions or additional information, please visit the
REMS website at www.CARVYKTIREMS.com or call
the
CARVYKTI REMS Coordinating Center at
1-844-672-0067.
Q: What are the responsibilities of the Authorized
Representative?
A: The Authorized Representative is designated to ensure
compliance with all REMS requirements and oversee implementation of
the CARVYKTI REMS within the Hospital and Associated Clinics.
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CARVYKTI® RISK EVALUATION MITIGATION STRATEGY (REMS)
Hospital Enrollment Form
Phone: 1-844-672-0067 Fax: 1-877-778-3865 E-mail: CARVYKTI@JanssenREMS.com www.CARVYKTIREMS.com
Instructions
CARVYKTI® (ciltacabtagene autoleucel) is only available through the CARVYKTI
Risk Evaluation and Mitigation Strategy (REMS).
In order to dispense CARVYKTI, Hospitals and their Associated Clinics must be
certified in the CARVYKTI REMS and have on-site immediate access to
tocilizumab (the “Hospitals and their Associated Clinics”). Hospitals and
their Associated Clinics must designate an Authorized Representative to:
· Complete the certification process by completing the Hospital Enrollment
Form on behalf of the Hospital and Associated Clinics.
· Oversee implementation and compliance with the CARVYKTI REMS requirements as
outlined below.
To comply:
· Please complete all required fields below and submit this enrollment form to
the REMS Coordinating Center via fax to
1-877-778-3865, e-mail at
CARVYKTI@JanssenREMS.com or complete it online at www.CARVYKTIREMS.com. You
will receive a confirmation via e-mail.
· Completion of this form does not guarantee your Hospital and Associated
Clinics will be certified to administer CARVYKTI.
· The CARVYKTI REMS will assess and provide confirmation of certification via
e-mail after processing this enrollment form.
· Product orders cannot be placed until the Hospital and Associated Clinics
certification is complete.
If you have any questions, require additional information, or need further
copies of any of the CARVYKTI REMS materials, please visit the REMS website at
www.CARVYKTIREMS.com or call the CARVYKTI REMS Coordinating Center at
1-844-672-0067.
Hospitals and Associated Clinics Information (All Fields Required)
New Certification Change in Authorized Representative Hospital and Associated
Clinics Name:
Hospital and Associated Clinics REMS ID:
Address:
City:
State:
Zip Code:
Phone:
(XXX) XXX-XXXX
Fax:
(XXX) XXX-XXXX
Authorized Representative Information (All Fields Required)
First Name:
Last Name:
Credentials:
DO MD R.Ph NP/PA RN Other (please specify)
Phone:
(XXX) XXX-XXXX
Fax:
(XXX) XXX-XXXX
e-mail:
Authorized Representative Signature
Date (MM/DD/YYYY)
March2024
CARVYKTI® RISK EVALUATION MITIGATION STRATEGY (REMS)
Hospital Enrollment Form
Authorized Representative Responsibilities
On behalf of my Hospital and Associated Clinics, I am the Authorized
Representative, designated by my Hospital and Associated Clinics, to oversee
implementation and coordinate the activities of the CARVYKTI REMS. By signing
this form, I agree, on behalf of myself and my Hospital and Associated
Clinics, to comply with all REMS Requirements. I will:
· Complete the Hospital Enrollment Form. · Submit the Hospital Enrollment Form
to the REMS Coordinating Center via fax to
1-877-778-3865, e-mail at
CARVYKTI@JanssenREMS.com, or complete it online at www.CARVYKTIREMS.com.
· Oversee implementation and compliance with the CARVYKTI REMS. · Ensure that
my Hospital and Associated Clinics establishes processes and procedures that
are subject to monitoring by
Janssen Biotech, Inc, or a third party acting on behalf of Janssen Biotech,
Inc to ensure compliance with the requirements of the CARVYKTI REMS, including
the following, before administering CARVYKTI: a. Prior to dispensing CARVYKTI,
put processes and procedures in place to verify on-site, immediate access to
at least
two doses of tocilizumab for each patient, for administration within two hours
after infusion. As a condition of certification, the Hospital and Associated
Clinics shall: · Ensure that if the Hospital and Associated Clinics designate
a new Authorized Representative, the new Authorized
Representative must complete a new Hospital Enrollment Form and submit the
form via fax to 1-877-778-3865, e-mail
at CARVYKTI@JanssenREMS.com or complete it online at www.CARVYKTIREMS.com. ·
At all times, staff should report suspected adverse events or product quality
complaints to Janssen at 1-800-Janssen
(1-800-526-7736) or the FDA at
1-800-FDA-1088 or online at www.fda.gov/medwatch. · Dispense CARVYKTI to
patients only after verifying on-site, immediate access to at least two doses
of tocilizumab for each patient, for administration within 2 hours after
infusion. · Maintain documentation of all processes and procedures for the
CARVYKTI REMS and provide documentation upon request by Janssen Biotech, Inc
or third party acting on behalf of Janssen Biotech, Inc. · Comply with audits
by Janssen Biotech, Inc, or a third party acting on behalf of Janssen Biotech,
Inc.
March2024