filsparirems.com Open in urlscan Pro
40.142.56.134  Public Scan

URL: https://filsparirems.com/
Submission: On February 13 via api from US — Scanned from DE

Form analysis 1 forms found in the DOM

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Text Content

 * Certified Outpatient Pharmacies
 * US PRESCRIBING INFORMATION, including BOXED WARNING
 * LOGIN

Toggle navigation
 * Home
 * Prescribers
 * Patients
 * Outpatient
   Pharmacies
 * Inpatient
   Pharmacies
 * Resources

The FILSPARI™ REMS (Risk Evaluation and Mitigation Strategy)

The FILSPARI REMS is a safety program that manages the risks of liver problems
and serious birth defects when taking FILSPARI. The FILSPARI REMS is required by
the Food and Drug Administration (FDA).


THE GOAL OF THE FILSPARI REMS IS TO MITIGATE THE RISKS OF HEPATOTOXICITY AND
EMBRYO-FETAL TOXICITY ASSOCIATED WITH FILSPARI:

 * Objective 1: Monitor for elevations in liver enzymes in patients exposed to
   FILSPARI
 * Objective 2: Ensure that patients who can become pregnant are not pregnant
   before initiating FILSPARI
 * Objective 3: Minimize exposure in patients who may become pregnant while
   taking FILSPARI


 * PRESCRIBERS
   CLICK HERE TO LEARN HOW TO PRESCRIBE FILSPARI

 * To prescribe FILSPARI:
   * 1
     Review the Prescribing Information and Prescriber and Pharmacy Guide
     
   * 2
     Certify by enrolling in the FILSPARI REMS by completing the Prescriber
     Enrollment Form and submitting it to the FILSPARI REMS
     
   * 3
     Counsel patients on the risks associated with FILSPARI using the Patient
     Guide
     
   * 4
     Assess the patient's liver function
     
   * 5
     Assess the patient's reproductive status as defined in the Prescriber and
     Pharmacy Guide
     
   * 6
     Assess pregnancy status in patients who can become pregnant
     
   * 7
     Enroll patients in the FILSPARI REMS by completing and submitting the
     Patient Enrollment Form to the FILSPARI REMS
     
   * 8
     Monitor patients based on REMS requirements
     
   * 9
     Report any changes in the reproductive status of a patient via the Change
     in Reproductive Potential Status Form
     
 * Resources for Prescribers
   * Prescriber and Pharmacy Guide
   * Prescriber Enrollment Form
   * Patient Enrollment Form
     English Spanish Chinese
   * Patient Guide
     English Spanish Chinese
   * Change in Reproductive Potential Status Form
   


 * PATIENTS
   CLICK HERE TO LEARN HOW TO RECEIVE FILSPARI

 * To receive FILSPARI:
   * 1
     Review the Patient Guide
     
   * 2
     Get a liver test prior to initiating FILSPARI, monthly for the first 12
     months, then every 3 months during treatment
     
   * 3
     For patients who can become pregnant:
      * Get a pregnancy test prior to initiating FILSPARI, monthly during
        treatment, and one month after discontinuing treatment
      * Use effective birth control while taking FILSPARI and for one month
        after treatment discontinuation
   
     
   * 4
     Receive counseling from your prescriber at treatment initiation and from
     the outpatient pharmacy prior to refills to understand the risks associated
     with FILSPARI
     
   * 5
     Enroll in the FILSPARI REMS by completing the Patient Enrollment Form with
     your prescriber
     
 * Resources for Patients
   * Patient Guide
     English Spanish Chinese


 * OUTPATIENT PHARMACIES
   CLICK HERE TO LEARN HOW TO DISPENSE FILSPARI

 * To dispense FILSPARI:
   * 1
     Designate an authorized representative to carry out the certification
     process and oversee implementation and compliance with the FILSPARI REMS on
     behalf of the pharmacy
     
   * 2
     Have the authorized representative review the Prescriber and Pharmacy Guide
     
   * 3
     Have the authorized representative certify by enrolling in the FILSPARI
     REMS by completing the Outpatient Pharmacy Enrollment Form, and submitting
     it to the FILSPARI REMS
     
   * 4
     Train staff involved in dispensing FILSPARI and comply with REMS
     requirements
     
   * 5
     Before dispensing:
      * Contact the FILSPARI REMS online or by phone to verify the patient is
        enrolled in the FILSPARI REMS and the prescriber is certified
      * Counsel the patient on the risks associated with FILSPARI
      * Verify and document the patient's liver testing is complete or the
        prescriber authorizes the refill, and the reproductive status has not
        changed
      * Verify and document pregnancy testing is complete for patients who can
        become pregnant or the prescriber authorizes the refill
   
     
   * 6
     Dispense no more than a 30-days’ supply
     
   * 7
     Provide dispensing data to the FILSPARI REMS
     
   
 * Resources for Outpatient Pharmacies
   * Prescriber and Pharmacy Guide
   * Outpatient Pharmacy Enrollment Form
   * Patient Guide
     English Spanish Chinese
   


 * INPATIENT PHARMACIES
   CLICK HERE TO LEARN HOW TO DISPENSE FILSPARI

 * To dispense FILSPARI:
   * 1
     Designate an authorized representative to carry out the certification
     process and oversee implementation and compliance with the FILSPARI REMS on
     behalf of the pharmacy
     
   * 2
     Have the authorized representative review the Prescriber and Pharmacy Guide
     
   * 3
     Have the authorized representative certify by enrolling in the FILSPARI
     REMS by completing the Inpatient Pharmacy Enrollment Form, and submitting
     it to the FILSPARI REMS
     
   * 4
     Train staff involved in dispensing FILSPARI and comply with REMS
     requirements
     
   * 
   * 5
     Before dispensing:
      * Counsel the patient on the risks associated with FILSPARI
      * Verify and document the patient is enrolled or will be enrolled prior to
        discharge, the patient is under the care of a certified prescriber, and
        liver testing is complete
      * Verify and document pregnancy testing is complete for patients who can
        become pregnant
   
     
   * 6
     Dispense no more than a 30-days' supply at discharge
     
   
 * Resources for Inpatient Pharmacies
   * Prescriber and Pharmacy Guide
   * Inpatient Pharmacy Enrollment Form
   * Patient Guide
     English Spanish Chinese
   



To learn more about the serious risks associated with FILSPARI, please refer to
the US Prescribing Information including Boxed Warning, the Prescriber and
Pharmacy Guide and the Patient Guide.







Report adverse events suggestive of hepatotoxicity and pregnancies to the
FILSPARI REMS at 1-833-513-1325.

Report all other suspected adverse events, or product quality complaints
associated with FILSPARI to Travere Therapeutics, Inc. at 1-877-659-5518 or FDA
at 1-800-FDA-1088 or online at www.fda.gov/medwatch.

For FILSPARI REMS information contact:
Phone: 1-833-513-1325
Fax: 1-833-483-4736

 * Privacy Policy
 * Terms of Use
 * Contact Us
   
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