JYNARQUE - United BioSource LLC (UBC)

The Tolvaptan for ADPKD Applicants must provide training to healthcare providers who prescribe tolvaptan for ADPKD.

The training includes the following educational materials: Program Overview, Prescriber Training and Prescriber Knowledge Assessment. The training must be available online and a hard copy format via mail or fax.

The Tolvaptan for ADPKD Applicants must provide training to pharmacies that dispense tolvaptan for ADPKD.

The training includes the following educational material: Program Overview. The training must be available online and a hard copy format via mail or fax.

To support REMS operations, the Tolvaptan for ADPKD Applicants must:

1. Authorize dispensing for each patient based on receipt of the Patient Status Form on the following schedule.
   1. For the first 18 months: within 115 calendar days of the date of the first patient shipment, then within every 115 calendar days of the receipt of the last Patient Status Form (i.e., 20 days after the 95-day deadline for provision of the form).
   2. After the first 18 months of treatment: within every 205 calendar days of receipt of the last Patient Status Form (i.e., 20 days after the 185-day deadline for provision of the form).

   If a completed Patient Status Form is not received to authorize the continuation of treatment, the patient is not authorized to receive the drug until a completed form is received.

2. Establish and maintain a REMS Website, www.TolvaptanADPKDSharedREMS.com. The REMS Website must include the capability to complete prescriber and pharmacy certification or enrollment online, the capability to enroll and manage patients online including patient authorization status, and the option to print the Prescribing Information and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
3. Make the REMS Website fully operational and all REMS materials available through website or Coordinating Center at the time that, but no later than 14 days of when, the first abbreviated new drug application (ANDA) joining a shared system REMS with JYNARQUE® (tolvaptan) receives full approval.
4. Establish and maintain a REMS Coordinating Center for REMS participants at 1-866-244-9446.
5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the Tolvaptan for ADPKD Shared System REMS.
6. Ensure prescribers and pharmacies are able to complete the certification process online or by fax.
7. Ensure outpatient pharmacies are able to obtain authorization to dispense by phone and online.
8. Ensure prescribers are able to report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS by phone or using the Patient Status Form online and by fax.
9. Ensure pharmacies are able to report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS by phone.
10. Provide the Program Overview and the Prescribing Information to REMS participants who:
    1. attempt to prescribe and are not yet certified or
    2. inquire about how to become certified
11. Notify prescribers and pharmacies within 2 business days after they become certified in the REMS.
12. Provide certified prescribers access to the database of certified pharmacies and enrolled patients.
13. Provide certified pharmacies access to the database of certified prescribers and enrolled patients.

To ensure REMS participants’ compliance with the REMS, the Tolvaptan for ADPKD Applicants must:

1. Ensure the Patient Status Form is received for each patient on the following schedule.
   1. For the first 18 months: if the form is not received within 95 calendar days of the date of receipt of the first patient shipment or the date the last Patient Status Form was received, the Tolvaptan for ADPKD Applicants must contact the prescriber to obtain the form. If the form is not received within 115 calendar days (i.e., 20 days after the 95-day deadline for provision of the form), the patient is not authorized to receive the drug until the form is received.
   2. After the first 18 months of treatment: if the form is not received for each patient within 185 calendar days, the Tolvaptan for ADPKD Applicants must contact the prescriber to obtain the form. If the form is not received within 205 calendar days (i.e., 20 days after the 185-day deadline for provision of the form), the patient is not authorized to receive the drug until the form is received.
2. Verify annually that the designated authorized representative for the pharmacy is the same. If different, the pharmacy must re-certify with a new authorized representative.
3. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: drug distribution and dispensing; certification of prescribers and pharmacies; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.
4. Establish and maintain a plan for addressing noncompliance with REMS requirements.
5. Monitor prescribers and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
6. Audit all pharmacies and wholesalers-distributors no later than 180 calendar days after they become certified/authorized, and audit a representative sample based on the audit plan annually thereafter, to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
7. Take reasonable steps to improve operations of and compliance with the requirements in the Tolvaptan for ADPKD Shared System REMS based on monitoring and evaluation of the Tolvaptan for ADPKD Shared System REMS.