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”

Use of FILSPARI is contraindicated in patients who are pregnant 

Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren 

Clinically significant adverse reactions that appear in other sections of the label include:

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 400 mg/day in IgAN 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.

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

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.

The effect of FILSPARI on proteinuria and kidney function (estimated glomerular filtration rate, eGFR) was assessed in a randomized, double-blind, active-controlled, multicenter, global study (PROTECT,

Patients were randomized (1:1) to either FILSPARI (400 mg once daily following 200 mg once daily for 14 days) or irbesartan (300 mg once daily following 150 mg once daily for 14 days). Rescue immunosuppressive treatment could be initiated per investigator discretion during the trial. Concomitant use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, other RAS inhibitors, and aldosterone blockers were prohibited.

The primary efficacy endpoint for the interim analysis was the change from baseline in urine protein/creatinine ratio (UPCR) at Week 36 based on the first 281 randomized patients who had reached the Week 36 visit. The key secondary efficacy endpoint for the final analysis was the rate of change in eGFR over a 110-week period following initiation of randomized therapy.

The 404 patients who enrolled and received study medication had a mean age of 46 years (range 18 to 76 years); 70% were male, 67% White, 28% Asian, and 1% Black or African American. Approximately 78% had a history of hypertension, 11% had diabetes or impaired fasting glucose, and 56% had hematuria based on urine dipstick. At baseline, the mean eGFR was 57 mL/min/1.73 m

In the final analysis of 404 randomized patients, FILSPARI reduced the rate of decline in kidney function from baseline to Week 110 compared to irbesartan. The mean eGFR slope from baseline to Week 110 was -3.0 mL/min/1.73 m

FILSPARI is supplied in bottles of 30 film-coated tablets.

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.

Advise patients to read the FDA-approved patient labeling (Medication Guide).

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.

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

Discuss with the patient the requirement to measure serum aminotransferases every 3 months

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

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 patients not to breastfeed during treatment with FILSPARI

Advise patients to inform their healthcare provider of all concomitant medications, including prescription medications, over-the-counter drugs, vitamins/supplements, herbal products, and grapefruit

Inform patients of other risks associated with FILSPARI, including:

Advise patients to take the full daily dose with water prior to the morning or evening meal. Maintain the same dosing pattern in relationship to meals. If a dose is missed, take the next dose at the regularly scheduled time. Do not take double or extra doses

FILSPARI is a registered trademark of Travere Therapeutics, Inc.

NDC 68974-200-30

FILSPARI

200 mg

Rx Only

Manufactured for:

Manufactured by:

NDC 68974-400-30

FILSPARI

400 mg

Rx Only

Manufactured for:

Manufactured by: