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FILSPARI sparsentan 200 mg Tablet, Film Coated, 30-count — NDC 68974-0200-30 package photo

FILSPARI sparsentan 200 mg Tablet, Film Coated, 30-count

by Travere Therapeutics, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE (68974-200-30)
NDC 68974-0200-30
🏷️ FDA NDC (as labeled) 68974-200-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled 🛡 REMS
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68974-200-30
Product NDC 68974-200
11-digit billing NDC 68974020030
NCPDP billing unit EA — each (per item)
RxCUI 2630540, 2630546, 2630548, 2630550
UNII 9242RO5URM
Application # NDA216403
SPL Set ID d7354af1-f304-f4d9-e053-2995a90ab219
Established class (EPC) Endothelin Receptor Antagonist; Angiotensin 2 Receptor Blocker
Mechanism of action Endothelin Receptor Antagonists; Angiotensin 2 Type 1 Receptor Antagonists; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C9 Inducers; Cytochrome P450 2C19 Inducers; P-Glycoprotein Inhibitors; Breast Cancer Resistance Protein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-17
Route ORAL
Dosage form TABLET, FILM COATED
Substance SPARSENTAN
GPI-14 56483065000320
GCN Seq No 084437
GCN 53742
HICL code 048721
Ingredient (HICL) Sparsentan
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4Q
Therapeutic class — specific (HIC3) Endothelin-Angiotensin Receptor Antagonist
AHFS code 24:32.92.00
AHFS class Renin-Angioten.-Aldost. Sys. Inhib, Misc
FDB label name FILSPARI 200 MG TABLET
FDB brand name Filspari
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 68974-200-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68974-0200-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Angiotensin 2 Receptor Blocker class.

Pharmacologic class Angiotensin 2 Receptor Blocker, Endothelin Receptor Antagonist
Drug family (ATC) Other agents acting on the renin-angiotensin system
How it works Endothelin Receptor Antagonists, Angiotensin 2 Type 1 Receptor Antagonists, P-Glycoprotein Inhibitors, Cytochrome P450 2C9 Inducers
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTravere Therapeutics, Inc.
Application holderTRAVERE THERAPEUTICS INC
FDA applicationNDA216403 (NDA)
Labeler code68974
First marketedFeb 2023
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FILSPARI 200 MG TABLET Ingredient Sparsentan
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
Imprint021
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $411.39 $12,341.76 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $434.42 $13,032.46 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Filspari 200 mgthis 68974-0200-30 Travere 30 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
First FDA approval
Feb 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 17, 2023 RLD RS ⏳ ~5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9993461 — method of use (U-3269)
US 9993461 — method of use (U-3269)
US 9993461 — method of use (U-3993)
US 9993461 — method of use (U-3993)
US 9662312 — method of use (U-4495)
US 9662312 — method of use (U-4495)
US 9993461 — method of use (U-4495)
US 9993461 — method of use (U-4495)
Exclusivity I-989
Exclusivity NCE
Exclusivity ODE-389
Exclusivity ODE-493
Exclusivity I-989
Exclusivity NCE
Exclusivity ODE-389
Exclusivity ODE-493
2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 9993461 ↗ Method of use U-3269 Mar 29, 2030
US 9993461 ↗ Method of use U-3269 Mar 29, 2030
US 9993461 ↗ Method of use U-3993 Mar 29, 2030
US 9993461 ↗ Method of use U-3993 Mar 29, 2030
US 9662312 ↗ Method of use U-4495 Mar 29, 2030
US 9662312 ↗ Method of use U-4495 Mar 29, 2030
US 9993461 ↗ Method of use U-4495 Mar 29, 2030
US 9993461 ↗ Method of use U-4495 Mar 29, 2030
FDA exclusivity
CodeWhat it grantsExpires
I-989New indication (3-year)Apr 13, 2029
NCENew Chemical Entity (5-year)Feb 17, 2028
ODE-389Orphan Drug Exclusivity (7-year)Feb 17, 2030
ODE-493Orphan Drug Exclusivity (7-year)Sep 5, 2031
I-989New indication (3-year)Apr 13, 2029
NCENew Chemical Entity (5-year)Feb 17, 2028
ODE-389Orphan Drug Exclusivity (7-year)Feb 17, 2030
ODE-493Orphan Drug Exclusivity (7-year)Sep 5, 2031
Common questions
Is there a generic version of FILSPARI 200 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for FILSPARI 200 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68974-0200-30, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
364
Units reimbursed last 4 qtrs
11.8K
Gross reimbursed last 4 qtrs
$4.86M
Avg / prescription
$13,345.38
Avg / unit
$411.39
Latest quarter Q4 2025
93Rx
Fee-for-service vs managed care ⓘ
93% FFS
Fee-for-service · 340 Rx Managed care · 24 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 6,519 units · 33.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 720 units · 6.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 4,569 units · 11.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.133.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 33.3 /100k
2 California 11.7 /100k
3 Ohio 6.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Filspari — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Filspari. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$22.73M
Claims incl. refills
1.6K
Beneficiaries
662
Spend / beneficiary
$34,333.36
Spend / claim
$14,214.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🛡
This drug has a REMS — FILSPARI REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68974-0200-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (68974-200-30) 2023-02-17 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68974-200-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68974-0200-30, written without dashes as 68974020030. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68974-0200-30, the first segment (68974) is the labeler code FDA assigned to Travere Therapeutics, Inc.; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Travere Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Travere Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program [see Warnings and Precautions ( 5.1 , 5.2 )] . Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure.

In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3-times ULN [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] .

FILSPARI should generally be avoided in patients with elevated aminotransferases (>3-times ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] . Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI.

Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • FILSPARI is only available through a restricted distribution program called the FILSPARI Risk Evaluation and Mitigation Strategies (REMS) because of the risk of hepatotoxicity ( 5.2 ): • Some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure ( 5.1 ). • Measure liver aminotransferases and total bilirubin prior to initiation of treatment and ALT and AST every 3 months during treatment ( 2.2 , 2.6 , 5.1 ). • Interrupt treatment and closely monitor patients developing aminotransferase elevations more than 3-times Upper Limit of Normal (ULN) ( 2.2 , 2.6 ). • Based on animal data, FILSPARI may cause fetal harm if used during pregnancy and is contraindicated in pregnancy ( 4 , 5.3 , 8.1 ). • For patients who can become pregnant, exclude pregnancy prior to the initiation of treatment with FILSPARI ( 2.3 , 5.3 , 8.3 ). • Use effective contraception prior to initiation of treatment, during treatment, and for two weeks after stopping FILSPARI ( 4 , 5.3 , 8.1 , 8.3 ). • When pregnancy is detected, discontinue FILSPARI as soon as possible ( 5.3 ).

🎯 Indications and Usage 148 words ▾

1 INDICATIONS AND USAGE FILSPARI is an endothelin and angiotensin II receptor antagonist indicated: • To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1 , 12.1 , 14.1 ). • To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2 , 12.1 , 14.2 ).

1.1Immunoglobulin A Nephropathy FILSPARI is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression [see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.1 )].

1.2Focal Segmental Glomerulosclerosis FILSPARI is indicated to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome [see Clinical Pharmacology ( 12.1 ), Clinical Studies ( 14.2 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Prior to initiating treatment with FILSPARI, discontinue use of renin- angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) ( 2.1 , 4 , 7.1 ). • IgAN (Adult Patients): Initiate treatment with FILSPARI at 200 mg orally once daily. After 14 days, increase to 400 mg once daily, as tolerated. ( 2.4 ) • FSGS (Adult and Pediatric Patients 8 years and older): • Greater than 50 kg: Initiate treatment with FILSPARI at 400 mg orally once daily.

After 14 days, increase to 800 mg once daily, as tolerated ( 2.4 ). • 50 kg and less: Initiate treatment with FILSPARI at 200 mg orally once daily. After 14 days, increase to 400mg once daily, as tolerated ( 2.4 ). • When resuming FILSPARI after interruption, consider re-titration ( 2.4 ). • Instruct patients to swallow tablets whole with water prior to the morning or evening meal ( 2.5 ). • For patients who are unable to swallow whole tablets, FILSPARI may be crushed and mixed with water immediately before administration ( 2.5 , 12.3 ).

2.1General Considerations Prior to initiating treatment with FILSPARI, discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] .

2.2Monitoring Initiate treatment with FILSPARI only after measuring aminotransferase levels and total bilirubin. Avoid initiation in patients with elevated aminotransferases greater than 3 times ULN. Continue required monitoring every 3 months during treatment with FILSPARI [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.1 )].

2.3Pregnancy Testing Exclude pregnancy before initiating treatment with FILSPARI [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )].

2.4Recommended Dosage The recommended dosing of FILSPARI in patients with IgAN and in patients with FSGS is described in Table 1 . When resuming treatment with FILSPARI in patients with IgAN or FSGS after an interruption, consider initiating at 50% of the recommended dose and titrating to the recommended dose after 14 days [see Dosage and Administration ( 2.5 ) and Drug Interactions ( 7.2 )]. Table 1: Recommended FILSPARI Dosing in Patients with IgAN and in Patients with FSGS Indication Starting Dose (orally once daily for 14 days and increase to recommended dose, as tolerated) Recommended Dose (orally once daily) IgAN (Adult Patients) 200 mg 400 mg FSGS (Adults and Pediatric Patients 8 Years and Older) Patients weighing greater than 50 kg 400 mg 800 mg Patients weighing less than or equal to 50 kg 200 mg 400 mg

2.5Administration • Instruct patient to swallow tablets whole with water prior to the morning or evening meal. • For patients who are unable to swallow whole tablets FILSPARI may be crushed and suspended in water immediately before administration prior to the morning or evening meal [see Clinical Pharmacology ( 12.3 )]. Administration of FILSPARI with other liquids has not been studied and is not recommended. • Preparation and Administration of FILSPARI Suspension in Water: 1. Crush the FILSPARI tablet in a clean pill crusher or mortar and pestle.

2. Suspend the crushed tablet in half cup of water and mix. 3.

Orally administer the entire prepared suspension immediately. If any portion of the tablet is left in the cup, add little more water to the cup, swirl and swallow immediately. 4.

Do not store suspension for later use. Take dose before the same meal each day. • If a dose is missed, take the next dose at the regularly scheduled time. Do not take double or extra doses.

2.6Dosage Adjustment for Aminotransferase Elevations If aminotransferase levels increase, adjust monitoring and treatment plan according to Table 2 . Do not resume treatment in patients who have experienced clinical symptoms of hepatotoxicity or in patients whose hepatic enzyme levels and bilirubin have not returned to pretreatment levels. Table 2: Dosage Adjustment an…

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS FILSPARI is supplied as film-coated, modified oval, white to off-white tablets debossed on one side and plain on the other in the following strengths: 200 mg debossed with “105” 400 mg debossed with “021” Tablets: 200 mg and 400 mg ( 3 ).

⛔ Contraindications 73 words ▾

4 CONTRAINDICATIONS Use of FILSPARI is contraindicated in patients who are pregnant [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 )] . Do not co-administer FILSPARI with ARBs, ERAs, or aliskiren [see Dosage and Administration ( 2.1 ), Drug Interactions ( 7.1 )]. • Pregnancy ( 4 ). • Concomitant use with angiotensin receptor blockers (ARBs), ERAs, or aliskiren ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypotension ( 5.4 ) • Acute Kidney Injury ( 5.5 ) • Hyperkalemia ( 5.6 ) • Fluid Retention ( 5.7 )

5.1Hepatotoxicity Elevations in ALT or AST of at least 3-fold ULN have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge [see Adverse Reactions ( 6.1 )] . While no concurrent elevations in bilirubin greater than 2-times ULN or cases of liver failure were observed in FILSPARI-treated patients in clinical trials, some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure. To reduce the risk of potential serious hepatotoxicity, measure serum aminotransferase levels and total bilirubin prior to initiation of treatment and then every 3 months during treatment [see Dosage and Administration ( 2.2 )] .

Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop treatment with FILSPARI and seek medical attention. If aminotransferase levels are abnormal at any time during treatment, interrupt FILSPARI and monitor as recommended [see Dosage and Administration ( 2.6 )] . Consider re-initiation of FILSPARI only when hepatic enzyme levels and bilirubin return to pretreatment values and only in patients who have not experienced clinical symptoms of hepatotoxicity [see Dosage and Administration ( 2.2 , 2.6 )] .

Avoid initiation of FILSPARI in patients with elevated aminotransferases (greater than 3-times ULN) because monitoring hepatotoxicity in these patients may be more difficult and these patients may be at increased risk for serious hepatotoxicity [see Dosage and Administration ( 2.2 , 2.6 ), and Warnings and Precautions ( 5.2 )].

5.2FILSPARI REMS For all patients, FILSPARI is available only through a restricted program under a REMS called the FILSPARI REMS because of the risk of hepatotoxicity [see Warnings and Precautions ( 5.1 )]. Important requirements of the FILSPARI REMS include the following: • Prescribers must be certified with the FILSPARI REMS by enrolling and completing training. • All patients must enroll in the FILSPARI REMS prior to initiating treatment and comply with monitoring requirements [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )]. • Pharmacies that dispense FILSPARI must be certified with the FILSPARI REMS and must dispense only to patients who are authorized to receive FILSPARI.

Further information is available at www.filsparirems.com or 1-833-513-1325.

5.3Embryo-Fetal Toxicity Based on data from animal reproduction studies, FILSPARI may cause fetal harm when administered to a pregnant patient and is contraindicated for use during pregnancy. The available human data for endothelin receptor antagonists do not establish the presence or absence of fetal harm related to the use of FILSPARI. Counsel patients who can become pregnant of the potential risk to a fetus.

Exclude pregnancy before initiating treatment with FILSPARI. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or their guardian(s) of the fetal risk and the need to use effective contraception once they reach reproductive potential.

When pregnancy is detected, discontinue FILSPARI as soon as possible [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Use in Specific Populations ( 8.1 , 8.3 )] .

5.4Hypotension Hypotension has been observed in patients treated with ARBs and endothelin receptor antagonists (ERAs) and was observed in clinical studies with FILSPARI. In clinical trials, there was a greater incidence of hypotension-associated adverse events, some serious, including dizziness, in patients treated with FILSPARI compared to irbesartan [see Adverse Reactions ( 6.1 )]. In patients…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the label include: • Hepatotoxicity [see Warnings and Precautions ( 5.1 )] • Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.3 )] • Hypotension [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury [see Warnings and Precautions ( 5.5 )] • Hyperkalemia [see Warnings and Precautions ( 5.6 )] • Fluid Retention [see Warnings and Precautions ( 5.7 )] Most common adverse reactions in patients with IgAN (≥5%) are hyperkalemia, hypotension (including orthostatic hypotension), peripheral edema, dizziness, anemia, and acute kidney injury ( 6.1 ).

Most common adverse reactions in patients with FSGS (≥5%) are peripheral edema, hypotension (including orthostatic hypotension), hyperkalemia, dizziness, and anemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Travere Therapeutics at 1-877-659-5518 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. IgAN The safety of FILSPARI was evaluated in PROTECT ( NCT03762850 ), a randomized, double-blind, active-controlled clinical study in adults with IgAN. The data below reflect FILSPARI exposure in 202 patients with a median duration of 110 weeks.

The most common adverse reactions are presented in Table 3 . Table 3: Adverse Reactions Reported in 2% or More of Subjects with IgAN Treated with FILSPARI (PROTECT) 1 Includes related terms. 2 Elevations in ALT or AST greater than 3-fold ULN.

FILSPARI (N = 202) n (%) Irbesartan (N = 202) n (%) Hyperkalemia 1 34 (17) 27 (13) Hypotension (including orthostatic hypotension) 33 (16) 13 (6) Peripheral edema 1 33 (16) 29 (14) Dizziness 1 32 (16) 14 (7) Anemia 16 (8) 9 (4) Acute kidney injury 12 (6) 5 (2) Transaminase elevations 2 7 (3.5) 8 (4.0) FSGS The safety of FILSPARI was evaluated in DUPLEX ( NCT03493685 ), a randomized, double-blind, active-controlled clinical study in adult and pediatric patients with FSGS [see Clinical Trials ( 14.2 )] . The data below reflects FILSPARI exposure in adult (n=168) and pediatric patients 9 years and older (n=16) with FSGS who received FILSPARI at the recommended dosing regimens for a median duration of 108 weeks The most common adverse reactions reported in adult and pediatric patients 9 years of age and older are presented in Table 4 .

Table 4: Adverse Reactions Reported in 2% or More of Subjects with FSGS Treated with FILSPARI (Overall DUPLEX Population) 1 Includes related terms. 2 Elevations in ALT or AST greater than 3-fold ULN. FILSPARI (N=184) n (%) Irbesartan (N = 187) n (%) Peripheral edema 1 42 (23) 45 (24) Hypotension (including orthostatic hypotension) 38 (21) 25 (13) Hyperkalemia 1 37 (20) 21 (11) Dizziness 1 25 (14) 21 (11) Anemia 24 (13) 10 (5) Acute kidney injury 8 (4) 13 (7) Transaminase elevations 2 7 (4) 5 (3) Laboratory Tests The incidence of a hemoglobin decrease >2 g/dL compared to baseline and below the lower limit of normal was greater for the FILSPARI arm compared to the irbesartan arm (19% vs 13% in PROTECT; 45% vs 18% in DUPLEX).

This decrease is thought to be in part due to hemodilution. There were no treatment discontinuations due to anemia or hemoglobin decrease in the PROTECT or DUPLEX clinical studies.

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Strong CYP3A inhibitors: Avoid concomitant use. Increased sparsentan exposure ( 2.7 , 7.2 , 12.3 ). • Moderate CYP3A inhibitors: Monitor adverse reactions. Increased sparsentan exposure ( 7.2 , 12.3 ). • Strong CYP3A inducers: Avoid concomitant use.

Decreased sparsentan exposure ( 7.3 , 12.3 ). • Non-steroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase (COX-2) inhibitors: Monitor for signs of worsening renal function. Increased risk of kidney injury ( 7.4 ). • CYP2B6, 2C9, and 2C19 substrates: Monitor for substrate efficacy. Decreased exposure of these substrates ( 7.5 , 12.3 ). • P-gp substrates: Monitor for adverse reactions of P-gp substrates with narrow therapeutic indices.

Increased exposure to substrates ( 7.6 , 12.3 ). • Agents Increasing Serum Potassium: Increased risk of hyperkalemia, monitor serum potassium frequently ( 5.6 , 7.7 ).

7.1Renin-Angiotensin System Inhibitors and ERAs Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren [see Dosage and Administration ( 2.1 ), Contraindications ( 4 )] . Combined use of these agents is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure).

7.2Strong and Moderate CYP3A Inhibitors Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt treatment with FILSPARI. When resuming treatment with FILSPARI, consider dose titration [see Dosage and Administration ( 2.4 , 2.7 ), Clinical Pharmacology ( 12.3 )] .

Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 )] . No FILSPARI dose adjustment is needed. Sparsentan is a CYP3A substrate.

Concomitant use with a strong CYP3A inhibitor increases sparsentan C max and AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of FILSPARI adverse reactions.

7.3Strong CYP3A Inducers Avoid concomitant use with a strong CYP3A inducer. Sparsentan is a CYP3A substrate. Concomitant use with a strong CYP3A inducer decreases sparsentan C max and AUC [see Clinical Pharmacology ( 12.3 )] , which may reduce FILSPARI efficacy.

7.4Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure [see Warnings and Precautions ( 5.5 )] .

These effects are usually reversible.

7.5CYP2B6, 2C9, and 2C19 Substrates Monitor for efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan is a weak inducer of CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases exposure of these substrates [see Clinical Pharmacology ( 12.3 )] , which may reduce efficacy related to these substrates.

7.6P-gp Substrates Monitor for adverse reactions and consider dose reduction of P-gp substrates with narrow therapeutic indices when co-administered with FILSPARI. FILSPARI is a weak P-gp inhibitor. Co-administration of FILSPARI may increase plasma concentrations of P-gp substrate drugs [see Clinical Pharmacology ( 12.3 )] .

7.7Agents Increasing Serum Potassium Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Advise not to breastfeed ( 8.2 ).

8.1Pregnancy Risk Summary Based on data from animal reproductive toxicity studies, FILSPARI may cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy [see Contraindications ( 4 )] . Available data from reports of pregnancy in clinical trials with FILSPARI are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available data from postmarketing reports and published literature over decades of use with ERA in the same class as FILSPARI have not identified an increased risk of fetal harm; however, these data are limited.

Methodological limitations of these postmarketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and missing data. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal ERA use. In animal reproduction studies, oral administration of sparsentan to pregnant rats throughout organogenesis at 10-times the maximum recommended human dose (MRHD) in mg/day caused teratogenic effects in rats, including craniofacial malformations, skeletal abnormalities, increased embryo-fetal lethality, and reduced fetal weights (see Data) .

Advise pregnant patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies in pregnant rats and rabbits, teratogenicity and/or developmental toxicity were observed, which were attributed to the antagonism of endothelin type A (ET A ) and angiotensin II type 1 (AT 1 ) receptors. In pregnant rats, oral administration of sparsentan throughout organogenesis at doses of 80, 160, and 240 mg/kg/day resulted in dose-dependent teratogenic effects in the form of craniofacial malformations, skeletal abnormalities, increased embryo-fetal lethality, and reduced fetal weights at all doses tested.

The area under the curve (AUC) at the lowest dose tested (80 mg/kg/day) was approximately 10 times the AUC at the MRHD of 400 mg/day. In pregnant rabbits, oral administration of sparsentan throughout organogenesis at doses of 2.5, 10 and 40 mg/kg/day resulted in maternal death and abortions at 10 and 40 mg/kg/day which provided exposures approximately 0.1 times and 0.2 times the AUC at the MRHD, respectively. An increase in a fetal variation (supernumerary cervical ribs) occurred at the high dose of 40 mg/kg/day.

In the pre- and postnatal development study in rats, oral administration of sparsentan during pregnancy and the lactational period at doses of 5, 20, or 80 mg/kg/day resulted in maternal death, body weight loss/reduced body weight gain, and adverse clinical signs at 80 mg/kg/day. An increase in pup deaths occurred at 80 mg/kg/day (approximately 10 times the AUC at MRHD) during the neonatal period through weaning, and decreased growth occurred at ≥ 20 mg/kg/day (approximately 2.6 times the AUC at the MRHD) after weaning.

The NOAEL for pre- and postnatal development in rats was 5 mg/kg/day, approximately 0.7 times the AUC at the MRHD.

8.2Lactation Risk Summary There are no data on the presence of sparsentan in human milk, the effects on the breastfed infant, or the effect on milk production. Because of the potential for adverse reactions, such as hypotension in breastfed infants, advise patients not to breastfeed during treatment with FILSPARI.

8.3 Females and Males of Reproductive Potential Based on data from animal reproduc…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on data from animal reproductive toxicity studies, FILSPARI may cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy [see Contraindications ( 4 )] . Available data from reports of pregnancy in clinical trials with FILSPARI are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available data from postmarketing reports and published literature over decades of use with ERA in the same class as FILSPARI have not identified an increased risk of fetal harm; however, these data are limited.

Methodological limitations of these postmarketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and missing data. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal ERA use. In animal reproduction studies, oral administration of sparsentan to pregnant rats throughout organogenesis at 10-times the maximum recommended human dose (MRHD) in mg/day caused teratogenic effects in rats, including craniofacial malformations, skeletal abnormalities, increased embryo-fetal lethality, and reduced fetal weights (see Data) .

Advise pregnant patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies in pregnant rats and rabbits, teratogenicity and/or developmental toxicity were observed, which were attributed to the antagonism of endothelin type A (ET A ) and angiotensin II type 1 (AT 1 ) receptors. In pregnant rats, oral administration of sparsentan throughout organogenesis at doses of 80, 160, and 240 mg/kg/day resulted in dose-dependent teratogenic effects in the form of craniofacial malformations, skeletal abnormalities, increased embryo-fetal lethality, and reduced fetal weights at all doses tested.

The area under the curve (AUC) at the lowest dose tested (80 mg/kg/day) was approximately 10 times the AUC at the MRHD of 400 mg/day. In pregnant rabbits, oral administration of sparsentan throughout organogenesis at doses of 2.5, 10 and 40 mg/kg/day resulted in maternal death and abortions at 10 and 40 mg/kg/day which provided exposures approximately 0.1 times and 0.2 times the AUC at the MRHD, respectively. An increase in a fetal variation (supernumerary cervical ribs) occurred at the high dose of 40 mg/kg/day.

In the pre- and postnatal development study in rats, oral administration of sparsentan during pregnancy and the lactational period at doses of 5, 20, or 80 mg/kg/day resulted in maternal death, body weight loss/reduced body weight gain, and adverse clinical signs at 80 mg/kg/day. An increase in pup deaths occurred at 80 mg/kg/day (approximately 10 times the AUC at MRHD) during the neonatal period through weaning, and decreased growth occurred at ≥ 20 mg/kg/day (approximately 2.6 times the AUC at the MRHD) after weaning.

The NOAEL for pre- and postnatal development in rats was 5 mg/kg/day, approximately 0.7 times the AUC at the MRHD.

🧒 Pediatric Use 109 words ▾

8.4Pediatric Use The safety and effectiveness of FILSPARI for reducing proteinuria in FSGS have been established in pediatric patients aged 8 years and older. Use of FILSPARI for this indication is supported by evidence from an adequate and well-controlled trial that enrolled 35 pediatric patients aged 9 years and older [see Dosage and Administration ( 2.4 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )]. The safety and effectiveness of FILSPARI in pediatric patients less than 8 years of age with FSGS have not been established.

The safety and effectiveness of FILSPARI in pediatric patients with IgAN have not been established.

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use Of the total number of subjects in the clinical studies of FILSPARI, 37 (8.3%) were 65 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

🆘 Overdosage 64 words ▾

10 OVERDOSAGE There is no experience with overdose with FILSPARI. Sparsentan has been given in doses up to 1600 mg/day in healthy volunteers, or up to 800 mg/day in patients. Overdose of FILSPARI may result in decreased blood pressure. In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because sparsentan is highly protein-bound.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ET A R) and the angiotensin II type 1 receptor (AT 1 R). Sparsentan has high affinity for both the ET A R (Ki= 12.8 nM) and the AT 1 R (Ki=0.36 nM), and greater than 500-fold selectivity for these receptors over the endothelin type B and angiotensin II subtype 2 receptors. Endothelin 1 and angiotensin II are thought to be involved in the pathogenesis of IgAN and FSGS via the ET A R and AT 1 R, respectively.

12.2Pharmacodynamics The exposure-response (E-R) relationship between sparsentan exposure and the percentage reduction from baseline in urine protein/creatinine ratio (UPCR) at Week 36 was not exposure-dependent across the observed exposure range for the recommended dose regimen. No E-R relationships were observed for hypotension of any grade, peripheral edema worst grade, and the incidence of hyperkalemia of any grade across the sparsentan exposure range for IgAN and FSGS populations. Cardiac Electrophysiology In a randomized, positive-, and placebo-controlled study in healthy subjects, sparsentan caused QTcF prolongation with maximal mean effect of 8.8 msec (90% CI: 5.9, 11.8) at 800 mg and 8.1 msec (90% CI: 5.2, 11.0) at 1600 mg.

The underlying mechanism behind the observed QTc prolongation is unknown but is unlikely to be mediated via direct inhibition of hERG channels. At the recommended dose, no clinically relevant QTc prolongation (i.e., >20 msec) is expected.

12.3Pharmacokinetics The pharmacokinetics of sparsentan are presented as geometric mean (% coefficient of variation) unless otherwise specified. The C max and AUC of sparsentan increase less than proportionally following administration of single doses of 200 mg to 1600 mg. Sparsentan showed time-dependent pharmacokinetics which may be related to the drug inducing its own metabolism over time.

Steady-state plasma levels are reached within 7 days with no accumulation of exposure at the approved recommended dosage. Following a single oral dose of 400 mg sparsentan, the mean C max and AUC are 7.0 μg/mL and 83.0 μg×h/mL, respectively. Following daily doses of 400 mg sparsentan, the steady-state mean C max and AUC are 6.5 μg/mL and 63.6 μg×h/mL, respectively.

Following a single oral dose of 800 mg sparsentan, the mean C max and AUC were 8.6 μg/mL and 161 μg×h/mL, respectively. Following daily doses of 800 mg sparsentan, the steady-state mean Cmax and AUC are 9.8 μg/mL and 96.9 μg×h/mL, respectively. Results were comparable when FILSPARI was administered orally as a whole tablet or as a crushed tablet in water.

Absorption Following a single oral dose of sparsentan, the median (minimum to maximum) time to peak plasma concentration is approximately 3 hours (2 to 8 hours). Effect of Food Sparsentan AUC and C max increased by 22% and 108%, respectively, following administration of a single oral 800 mg dose with a high fat, high calorie meal (1000 kcal, 50% fat) [see Dosage and Administration ( 2.5 )]. No clinically significant differences in sparsentan pharmacokinetics were observed following administration of a single 200 mg dose with a high fat, high calorie meal.

Distribution The apparent volume of distribution for sparsentan at steady state is

61.4 L at 400 mg and

86.5L at 800 mg, respectively. Sparsentan is >99% bound to human plasma proteins. Elimination The clearance of sparsentan is time-dependent which may be related to the drug inducing its own metabolism over time. The apparent clearance (CL/F) of sparsentan is

3.88 L/h following the initial 400 mg dose then increases to

5.11L/h at steady state. The apparent clearance (CL/F) of sparsentan is

5.47 L/h following the initial 800 mg dose then increases to

7.21L/h at steady state. The half-life of sparsentan is estimated to be 9.6 hours at steady state. Metabolism Cytochrome P450 3A is the major isozyme responsible for the metabolism of sparsentan. Excretion After a single dose of…

🧬 Mechanism of Action 96 words ▾

12.1Mechanism of Action Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ET A R) and the angiotensin II type 1 receptor (AT 1 R). Sparsentan has high affinity for both the ET A R (Ki= 12.8 nM) and the AT 1 R (Ki=0.36 nM), and greater than 500-fold selectivity for these receptors over the endothelin type B and angiotensin II subtype 2 receptors. Endothelin 1 and angiotensin II are thought to be involved in the pathogenesis of IgAN and FSGS via the ET A R and AT 1 R, respectively.

📦 How Supplied / Storage and Handling 104 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING FILSPARI is supplied in bottles of 30 film-coated tablets. 200 mg tablets are film-coated, modified oval, white to off-white, debossed with “105” on one side and plain on the other side, available in bottles of 30 tablets with child-resistant caps (NDC 68974-200-30). 400 mg tablets are film-coated, modified oval, white to off-white, debossed with “021” on one side and plain on the other side, available in bottles of 30 tablets with child-resistant caps (NDC 68974-400-30).

Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store FILSPARI in its original container.

📋 Description 127 words ▾

11 DESCRIPTION FILSPARI (sparsentan) is an endothelin and angiotensin II receptor antagonist. The chemical name of sparsentan is 2-[4-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-2-(ethoxymethyl)phenyl]-N-(4,5-dimethyl-1,2-oxazol-3-yl)benzenesulfonamide. Sparsentan is a white to off-white powder, which is practically insoluble in water.

Sparsentan has pH-dependent solubility, with intrinsic solubility of 1.48 and 0.055 mg/mL under pH 1.2 and 6.8, respectively. Sparsentan has a molecular weight of 592.76 g/mol, a molecular formula of C 32 H 40 N 4 O 5 S, and the following structure: FILSPARI is available as film-coated 200 mg and 400 mg strength immediate release tablets for oral administration. The inactive ingredients in FILSPARI are colloidal silicon dioxide, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, and sodium starch glycolate.

Film-coating is composed of macrogol/polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. Sparsentan Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Restricted Access Advise the patient that FILSPARI is only available through a restricted access program called the FILSPARI REMS because of the risk of hepatotoxicity, and that FILSPARI is available only from certified pharmacies that are enrolled in the FILSPARI REMS. As a component of the FILSPARI REMS, prescribers must review the contents of the FILSPARI Medication Guide with the patient before initiating FILSPARI and patients must sign the FILSPARI REMS Patient Enrollment Form to confirm that they understand the risks of FILSPARI.

Instruct patients of the risk of hepatotoxicity associated with FILSPARI. Hepatotoxicity Advise patients with symptoms suggesting hepatotoxicity (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching) to immediately stop taking FILSPARI and seek medical attention [see Dosage and Administration ( 2.2 , 2.4 , 2.6 ), Warnings and Precautions ( 5.1 )] . Discuss with the patient the requirement to measure serum aminotransferases every 3 months [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 , 5.2 )] .

Embryo-Fetal Toxicity Counsel patients who can become pregnant about the need to use effective methods of contraception prior to treatment with FILSPARI, during treatment, and for two weeks after treatment discontinuation. Patients who can become pregnant should have a negative pregnancy test prior to initiation of treatment with FILSPARI [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )]. Patients should be instructed to immediately contact their physician if they suspect they may be pregnant.

Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed. Educate and counsel patients who can become pregnant on the use of emergency contraception in the event of unprotected sex or contraceptive failure. Advise pre-pubertal females and/or their guardian(s) of the fetal risk and the need to use effective contraception once they reach reproductive potential.

Lactation Advise patients not to breastfeed during treatment with FILSPARI [see Use in Specific Populations ( 8.2 )]. Drug Interactions Advise patients to inform their healthcare provider of all concomitant medications, including prescription medications, over-the-counter drugs, vitamins/supplements, herbal products, and grapefruit [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 ), Drug Interactions ( 7 )]. Other Risks Associated with FILSPARI Inform patients of other risks associated with FILSPARI, including: Hypotension: Advise patients to remain hydrated [see Warnings and Precautions ( 5.4 )].

Hyperkalemia: Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider [see Warnings and Precautions ( 5.6 )]. Dosing Advise patients to take the full daily dose with water prior to the morning or evening meal. Patients who cannot swallow whole tablets can crush and suspend the tablet(s) in half cup of water, mix and orally administer the entire prepared suspension immediately after preparation.

If any portion of the tablet is left in the cup, add a small amount of additional water, swirl to mix and swallow immediately. Do not store the solution for later use [see Dosage and Administration ( 2.5 )]. Instruct patients to take the dose before the same meal each day.

If a dose is missed, take the next dose at the regularly scheduled time. Do not take double or extra doses [see Dosage and Administration ( 2.5 )]. Distributed by Travere Therapeutics, Inc., San Diego, CA 92130 FILSPARI is a registered trademark of Travere Therapeutics, Inc. v5

💬 Medication Guide ~3 min read ▾

Medication Guide FILSPARI ® (fil spah ree) (sparsentan) tablets What is the most important information I should know about FILSPARI? FILSPARI can cause serious side effects, including: • Liver problems. o FILSPARI can cause changes in liver tests. Liver failure was not observed in people treated with FILSPARI in clinical studies, but some medicines that are like FILSPARI have caused liver failure.

Your healthcare provider will do blood tests to check your liver before starting treatment with FILSPARI and then every 3 months during treatment. Your healthcare provider may temporarily stop or permanently stop treatment with FILSPARI if you have changes in your liver tests. Stop taking FILSPARI and get medical help right away if you develop any of the following signs of liver problems during treatment with FILSPARI: • nausea or vomiting • pain on the upper right side of your stomach area • tiredness • loss of appetite • yellowing of your skin or the white part of your eyes (jaundice) • dark “tea-colored” urine • fever • itching Because of the risk for liver problems, FILSPARI is only available through a restricted access program called the FILSPARI Risk Evaluation and Mitigation Strategy (REMS).

Before you begin treatment with FILSPARI, your healthcare prescriber will explain the FILSPARI REMS, you must read, and agree to all of the requirements of the FILSPARI REMS. • Serious birth defects. FILSPARI can cause serious birth defects if taken during pregnancy. o Patients who can become pregnant should not be pregnant when they start taking FILSPARI or become pregnant during treatment with FILSPARI or for two weeks after stopping treatment with FILSPARI. o Patients who can become pregnant should have a negative pregnancy test before starting treatment with FILSPARI.

Patients who can become pregnant are those who: ▪ have entered puberty, even if they have not started their menstrual period, and ▪ have a uterus, and ▪ have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed. Patients who cannot become pregnant are those who: ▪ have not yet entered puberty, or ▪ do not have a uterus, or ▪ have gone through menopause.

Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or ▪ are infertile for any other medical reason and this infertility is permanent and cannot be reversed. o Patients who can become pregnant should use effective birth control before starting treatment with FILSPARI, during treatment with FILSPARI, and for two weeks after stopping FILSPARI because the medicine may still be in your body. ▪ Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with FILSPARI. ▪ If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another effective form of birth control. o Do not have unprotected sex.

Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control. o Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant. o If you are the parent or caregiver of a female child who started taking FILSPARI tablets before reaching puberty, you should check your child regularly to see if they are developing signs of puberty. Tell their healthcare provider right away if you notice that your child is developing breast buds or pubic hair.

Their healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having their first menstrual period. S…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.