Pronunciation:

spar-SEN-tan

Brand Names:

• Filspari

Dosage Forms:

• Tablet

Warnings:

Warning: Hepatotoxicity and Embryo-Fetal ToxicityBecause of the risks of hepatotoxicity and birth defects, sparsentan is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program.HepatotoxicitySome endothelin receptor antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferase (ALT or AST) of at least 3-times the upper limit normal (ULN) have been observed in up to 2.5% of sparsentan-treated patients, including cases confirmed with rechallenge.Measure transaminases and bilirubin before initiating treatment and monthly for the first 12 months, and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3x ULN.Sparsentan should generally be avoided in patients with elevated aminotransferases (greater than 3x ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be increased risk for serious hepatotoxicity.Embryo-Fetal ToxicitySparsentan can cause major birth defects if used by pregnant patients based on animal data. Therefore, pregnancy testing is required before the initiation of treatment, during treatment, and one month after discontinuation of treatment with sparsentan. Patients who can become pregnant must use effective contraception before the initiation of treatment, during treatment, and for one month after discontinuation of treatment sparsentan .

Classifications:

Therapeutic—

Genitourinary Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Sparsentan is used to reduce levels of protein in the urine (proteinuria) in patients who have a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease worsening quickly.

This medicine is available only under a restricted distribution program called Filspari™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sparsentan in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sparsentan in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Ambrisentan
• Azilsartan
• Azilsartan Medoxomil
• Bosentan
• Candesartan
• Eprosartan
• Irbesartan
• Losartan
• Macitentan
• Olmesartan
• Telmisartan
• Valsartan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abrocitinib
• Aceclofenac
• Amiloride
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Bupropion
• Cannabidiol
• Canrenoate
• Canrenone
• Carbamazepine
• Carisoprodol
• Carvedilol
• Celecoxib
• Cilostazol
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clopidogrel
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclophosphamide
• Cyclosporine
• Dexlansoprazole
• Diazepam
• Diclofenac
• Digoxin
• Diltiazem
• Dronedarone
• Ebrotidine
• Efavirenz
• Enzalutamide
• Eplerenone
• Erythromycin
• Escitalopram
• Esomeprazole
• Etravirine
• Everolimus
• Famotidine
• Flibanserin
• Fluconazole
• Fluvastatin
• Fluvoxamine
• Fosnetupitant
• Fosphenytoin
• Glimepiride
• Glyburide
• Idelalisib
• Ifosfamide
• Imatinib
• Indinavir
• Itraconazole
• Ketoconazole
• Lansoprazole
• Letermovir
• Lopinavir
• Lumacaftor
• Meprobamate
• Methadone
• Mitotane
• Nateglinide
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nizatidine
• Omeprazole
• Osilodrostat
• Pantoprazole
• Phenytoin
• Posaconazole
• Potassium
• Propranolol
• Rabeprazole
• Ranitidine
• Ranitidine Bismuth Citrate
• Rifampin
• Ritonavir
• Roxatidine
• Saquinavir
• Sirolimus
• Spironolactone
• St John's Wort
• Tacrolimus
• Telaprevir
• Telithromycin
• Tolbutamide
• Torsemide
• Triamterene
• Verapamil
• Voriconazole
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Liver disease—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.

It is very important that you understand the requirements of the Filspari™ REMS program and Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

Swallow the tablet whole with water before your morning or evening meal. Take it with the same meal each day.

Take this medicine 2 hour before or 2 hours after taking antacids.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For proteinuria:
    • Adults—At first, 200 milligrams (mg) once a day in the morning or evening. Your doctor may adjust your dose as needed or tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check for unwanted effects. Your doctor will do tests before starting treatment, every month for 12 months, and then every 3 months during treatment with this medicine.

Do not use this medicine together with aliskiren (Tekturna®) or other blood pressure medicine (eg, angiotensin receptor blocker, endothelin receptor blocker).

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor will do tests before starting, during treatment, and 1 month after stopping this medicine to make sure you are not pregnant. Use an effective form of birth control before starting, during treatment, and for 1 month after your final dose to keep from getting pregnant. Ask your doctor which form of birth control is right for you. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, severe stomach pain, or yellow eyes or skin.

Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness. These may be symptoms of hypotension (low blood pressure).

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness of the legs. These may be symptoms of hyperkalemia (high potassium in the blood).

This medicine may cause fluid retention (too much water in the body). Check with your doctor right away if you have decrease in amount of urine, noisy, rattling, or trouble breathing, swelling of the face, hands, feet, or lower legs, or weight gain.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

chills

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

irregular heartbeat

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pale skin

rapid weight gain

sweating

tingling of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

Less common

Agitation

coma

decreased urine output

depression

headache

hostility

irritability

lethargy

muscle twitching

stupor

swelling of the face, ankles, or hands

Incidence not known

Dark urine

loss of appetite

stomach pain, severe

yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.