Sparsentan

What is Sparsentan?

• Sparsentan (Filspari) is an endothelin and angiotensin II receptor antagonist.

Sparsentan

Sparsentan 02

What are the uses of this medicine?

• Sparsentan (Filspari) is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease progressing quickly.

How does this medicine work?

• Sparsentan is a single molecule with antagonism of the endothelin type A receptor (ETAR) and the angiotensin II type 1 receptor (AT1R).
• Sparsentan has high affinity for both the ETAR and the AT1R, 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 contribute to the pathogenesis of IgAN via the ETAR and AT1R, respectively.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant, plan to become pregnant, or become pregnant during treatment with Filspari.
• are taking any of these medicines:
• an angiotensin receptor blocker, or
• an endothelin receptor antagonist, or
• aliskiren

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and grapefruit you are taking or plan to take.
• Filspari and other medicines may affect each other and cause side effects. Do not start any new medicine until you check with your healthcare provider.

Be sure to mention any of the following:

• nonsteroidal anti-inflammatory drugs (NSAIDs)
• potassium-containing medicines, potassium supplements or salt substitutes containing potassium
• blood pressure medicines
• Acid reducing agents
• Antacids: Avoid use within 2 hours before or after use of sparsentan. May decrease exposure to sparsentan.

Is this medicine FDA approved?

• It was approved for medical use in the United States in February 2023.

How should this medicine be used?

• Prior to initiating treatment with Filspari, discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors, endothelin receptor antagonists (ERAs), and aliskiren.

Recommended dosage:

• Initiate treatment with Filspari at 200 mg orally once daily.
• After 14 days, increase to the recommended dose of 400 mg once daily, as tolerated.
• When resuming treatment with Filspari after an interruption, consider titration of Filspari, starting at 200 mg once daily.
• After 14 days, increase to the recommended dose of 400 mg once daily.

Administration:

• Take Filspari exactly as your healthcare provider tells you to take it.
• Do not stop taking Filspari unless your healthcare provider tells you.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Filspari if you develop side effects.
• Swallow Filspari whole with water before your morning or evening meal.
• Take your dose with the same meal each day.
• If you miss a dose, take the next dose at the regularly scheduled time.
• Do not take 2 doses at the same time or take extra doses.
• Talk to your healthcare provider before using antacid medicines because they may affect how Filspari works.
• If you take too much Filspari, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 200 mg and 400 mg

This medicine is available in fallowing brand namesː

• Filspari

What side effects can this medication cause?

The most common side effects of this medicine may include:

• swelling of hands, legs, ankles and feet (peripheral edema)
• dizziness
• low red blood cells (anemia)

Less common, but serious side effects may include:

• Liver problems
• Serious birth defects
• Low blood pressure
• Worsening of Kidney function
• Increased potassium in your blood
• Fluid retention
• serious birth defects if taken during pregnancy.

What special precautions should I follow?

• Elevations in ALT or AST of at least 3-fold ULN have been observed in Filspari-treated patients. 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 .
• Based on data from animal reproduction studies, Filspari can cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. Advise patients who can become pregnant of the potential risk to a fetus. Obtain a pregnancy test prior to initiation of treatment with Filspari, monthly during treatment and one month after discontinuation of treatment. Advise patients who can become pregnant to use effective contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with Filspari.
• Hypotension has been observed in patients treated with ARBs and endothelin receptor antagonists(ERAs) and was observed in clinical studies with Filspari. If hypotension develops, despite elimination or reduction of other antihypertensive medications, consider a dose reduction or dose interruption of Filspari.
• Monitor kidney function periodically. Drugs that inhibit the renin-angiotensin system can cause acute kidney injury. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on Filspari.
• Monitor serum potassium periodically and treat appropriately. Patients with advanced kidney disease or taking concomitant potassium-increasing drugs (e.g., potassium supplements, potassium-sparing diuretics), or using potassium-containing salt substitutes are at increased risk for developing hyperkalemia. Dosage reduction or discontinuation of Filspari may be required.
• Fluid retention may occur with endothelin receptor antagonists and has been observed in clinical studies with Filspari. Filspari has not been evaluated in patients with heart failure.
• Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider.
• 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.
• Advise patients not to breastfeed during treatment with Filspari.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• decreased blood pressure

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.

Can this medicine be used in pregnancy?

• Based on data from animal reproductive toxicity studies, Filspari can cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy.

Can this medicine be used in children?

• The safety and efficacy of Filspari in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: sparsentan
• Inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, and sodium starch glycolate. Tablets are film coated with material containing macrogol/polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.

Who manufactures and distributes this medicine?

Distributed by:

• Travere Therapeutics, Inc., San Diego, CA
• Filspari is a registered trademark of Travere Therapeutics, Inc.

What should I know about storage and disposal of this medication?

• Store Filspari at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Filspari in the original container.
• The bottle has a child-resistant closure.

• Dailymed label info on Sparsentan
• FDA Sparsentan

Sparsentan Resources
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