filsparirems.com
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https://filsparirems.com/
Submission: On February 13 via api from US — Scanned from DE
Submission: On February 13 via api from US — Scanned from DE
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1 forms found in the DOM<form>
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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 * Do Not Sell or Share My Personal Information This website uses cookies for optimal site functionality. To understand more about the cookies we use, or to change your cookie preferences, click on "Cookie Settings." For more information, please see ourPrivacy Policies. 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