Prescribing companion
Filspari (sparsentan) Filspari REMS, liver monitoring, titration and prior authorization criteriaFor prescribers and their offices treating IgA nephropathy: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
REMS-certified prescriber and pharmacy, REMS enrollment form, baseline ALT, AST and bilirubin, and a negative pregnancy test where it applies, before the first ship.
Example PA threshold
Express Scripts example: biopsy, proteinuria above 1g a day or UPCR 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, eGFR 30 or higher.
Monitoring
ALT, AST and bilirubin at baseline and every 3 months for the length of treatment; the REMS blocks refills without them.
Support line
Travere TotalCare, 1-833-345-7727, nurse educator, $0 copay for commercial plans, free at-home REMS liver draws for eligible patients.
Before the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Certify in the FILSPARI REMS | Only certified prescribers can prescribe and only certified pharmacies can dispense. A retail pharmacy cannot fill it; a stray prescription is a routing error and the office resends it. | FDA label |
| Enroll the patient in the REMS | The REMS Patient Enrollment Form documents counseling on hepatotoxicity. The FILSPARI Patient Start Form, separately, enrolls the patient with Travere TotalCare, which assigns a nurse educator and routes the prescription to a certified pharmacy. | Travere TotalCare |
| Baseline labs | ALT, AST and bilirubin before the first dose, and a pregnancy test for anyone who can become pregnant. The pharmacy confirms the result in the REMS before it ships, so a result the office already holds should be sent to the REMS rather than redrawn. | FDA label |
| Stop the ACEi or ARB | Sparsentan is contraindicated with ARBs, other endothelin receptor antagonists and aliskiren, and the label says to discontinue ACE inhibitors or ARBs before starting. In PROTECT the switch was made the day before the first dose. | FDA label |
| Counsel on contraception | The label requires effective contraception during treatment and for 2 weeks after the last dose, and a report to the prescriber at once if pregnancy is suspected. | FDA label |
Prior authorization criteria and what to document
One public policy as the example: Express Scripts, February 28, 2024. Approval 9 months for the first approval, then 1 year at a time if the protein level has come down. This policy was written while Filspari held accelerated approval for proteinuria and before the FDA's full approval to slow kidney decline, so other plans and newer versions may set a lower protein threshold. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | IgA nephropathy confirmed by kidney biopsy, age 18 or older | Pathology report with date | Express Scripts policy |
| Proteinuria | Above 1g a day, or UPCR 1.5g/g or higher, in this policy; later policies and the full approval may set a lower bar | Urine protein or UPCR result with date and method | Express Scripts policy |
| RAS blockade | At least 12 weeks at the maximum tolerated dose of an ACE inhibitor or ARB | Agent, dose, start date, and why the dose is the maximum tolerated if below the labeled maximum | Express Scripts policy |
| Supportive care | At least 3 months of blood pressure control, lifestyle and cardiovascular risk measures | Blood pressure readings and the dated plan | Express Scripts policy |
| Kidney function | eGFR 30 or higher | Creatinine and eGFR with date | Express Scripts policy |
| No combination | Not taken with an ACE inhibitor, ARB, another endothelin receptor antagonist or aliskiren | Medication list showing the stop date of the ACEi or ARB | Express Scripts policy |
| Prescriber | Prescribed by or in consultation with a nephrologist | Specialty on the request, or the consult note | Express Scripts policy |
Filspari dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 200mg once daily, swallowed whole with water before the same meal each day, morning or evening. Tablets may be crushed into half a cup of water immediately before the dose; no other liquid, no storage of the mixture. | FDA label |
| Day 15 | Increase to 400mg once daily if the first 14 days were tolerated. New strength, so the pharmacy needs the 400mg prescription in time for this date. | FDA label |
| After an interruption | The label says to consider restarting at half the usual dose and titrating back up after 14 days, as at initiation. | FDA label |
| Missed dose | Skip and take the next dose at the usual time; no double or extra dose. | Medication Guide |
Monitoring the Filspari label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | ALT, AST and bilirubin; pregnancy test where it applies | Required before the first dose; the pharmacy will not ship without the result in the REMS | FDA label |
| Every 3 months | ALT, AST and bilirubin for the length of treatment | The REMS requires the result before each refill; Travere TotalCare offers the draw at home for eligible patients | FDA label |
| Any time | Symptoms the label ties to hepatotoxicity: nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever or itching | The label says to stop the drug and seek medical attention at once rather than wait for the next scheduled test | FDA label |
| First weeks | Blood pressure and volume status | Hypotension occurred in 16% and fluid retention in the trials; the label asks prescribers to review other antihypertensives and consider a diuretic or dose change for significant edema | FDA label |
| Ongoing | Potassium | Hyperkalemia occurred in 17% in the IgAN trial; the label says to watch potassium with supplements and salt substitutes | FDA label |
Filspari drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindicated | ARBs, other endothelin receptor antagonists, aliskiren; ACE inhibitors are to be discontinued before starting | FDA label |
| Avoid | Strong CYP3A inhibitors, such as some azole antifungals and macrolide antibiotics | FDA label |
| Use with care | NSAIDs, because of the kidney; potassium supplements and salt substitutes, because of hyperkalemia | FDA label |
| Pregnancy | Contraindicated; effective contraception during treatment and for 2 weeks after the last dose; breastfeeding advised against | FDA label |
Why a first fill stalls, and the fix
- The REMS does not show a current liver testThe pharmacy cannot ship until it does. Ask the nurse educator about the free at-home draw, or ask the doctor's office to send the result to the REMS.
- The prescription went to a retail pharmacyOnly REMS-certified specialty pharmacies can fill Filspari. The nurse educator or the prescriber's office redirects it. This is a routing error, not a denial.
- Prior authorization not yet approvedThe insurer wants the criteria below documented, most often the biopsy, the protein level and the 12 weeks on an ACE inhibitor or ARB. The nephrologist's office supplies the records, and the nurse educator can track it.
- Step therapy or a non-formulary noticeSome plans require a documented trial of an ACE inhibitor or ARB first. If you have had one, the records settle it. If the plan excludes the drug, Travere TotalCare and the foundations' funds are the next calls.
- A copay you cannot payCommercial insurance: the Travere $0 copay program, up to an annual maximum. Medicare or Medicaid: the copay program is barred by law, so the nurse educator points to charity funds, and our help paying page lists which are open.
Travere TotalCare
- A nurse educator for the whole course of treatment, by phone, text, email or video, in English, Spanish and Mandarin
- $0 copay program for eligible people with commercial insurance, up to an annual maximum, not available on Medicare, Medicaid or TRICARE
- Free at-home REMS liver testing for eligible patients
- Help understanding coverage on Medicare and Medicaid, and a check for other support if you have no insurance
Questions prescribers' offices ask about Filspari
What does the Filspari REMS require before the first fill?
A REMS-certified prescriber and pharmacy, the patient's REMS enrollment form, and ALT, AST and bilirubin before the first dose, plus a pregnancy test for anyone who can become pregnant. The certified pharmacy confirms the lab result in the REMS before it ships, per the April 2026 label.
How often are liver tests required on Filspari?
Every 3 months for as long as the patient takes Filspari, after the baseline ALT, AST and bilirubin. The REMS requires the result before each refill, and Travere TotalCare offers the draw at home for eligible patients.
What is the Filspari titration schedule?
200mg once daily for 14 days, then 400mg once daily if tolerated. The label says to consider restarting at half the dose and titrating again after an interruption.
Does the ACE inhibitor or ARB have to stop before Filspari?
Yes. Sparsentan is contraindicated with ARBs, other endothelin receptor antagonists and aliskiren, and the label says to discontinue ACE inhibitors or ARBs before starting. In PROTECT the switch was made the day before the first dose.
What do insurers ask for to approve Filspari?
The Express Scripts policy shown on this page asks for biopsy-confirmed IgA nephropathy, proteinuria above 1g a day or UPCR of 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, 3 months of supportive care, eGFR of 30 or higher and a nephrologist. It predates the full approval, so newer policies may set a lower protein bar.
Sources
- FILSPARI (sparsentan) prescribing information, sections 2, 5, 7, 16 and 17, revised April 2026, Travere Therapeutics, via openFDA and DailyMed, 2026-04-09.
- FILSPARI Medication Guide, How should I take FILSPARI, Travere Therapeutics, via DailyMed, 2026-04-09.
- Travere TotalCare patient support for FILSPARI, Travere Therapeutics, 2026-05-01.
- Nephrology, Filspari Prior Authorization Policy, Express Scripts, 2024-02-28.
A reference drawn from the April 9, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Not a treatment recommendation and not a substitute for the prescribing information. Trial Friend takes no money from any drugmaker, pharmacy, insurer or program named here.