Filspari is a brand-name oral tablet that’s prescribed for a certain type of kidney disease. Filspari contains the active ingredient sparsentan.
Filspari is FDA-approved to treat primary IgA nephropathy. (“Primary” means the condition is not caused by another health problem.) Filspari is used in certain adults to lower protein levels in the urine.
Drug details
You’ll find key information about Filspari below.
- Drug class: dual endothelin and angiotensin II receptor blocker
- Drug form: oral tablet
- Generic available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2023
- Accelerated approval?
yes
Filspari has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Filspari precautions” and “Things to consider when taking Filspari” sections.
Filspari is available only as a brand-name medication. It’s not currently available in generic form.
A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.
The Filspari dosage your doctor prescribes will depend on several factors. These include:
- other medical conditions you may have
- other medications you may be taking
The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug form and strengths
Filspari comes as an oral tablet. It’s available in two strengths: 200 milligrams (mg) and 400 mg.
Dosage for IgA nephropathy
Filspari is prescribed for certain adults with primary IgA nephropathy. For more details, see the “Filspari uses” section.
For this use, the starting dosage of Filspari is 200 mg once daily. After 2 weeks, your doctor may increase your dosage to 400 mg once daily.
About taking Filspari
Below you’ll find information about key dosage issues.
- When to take: You should take Filspari once each day, before a morning or evening meal. Taking the medication before the same meal each day helps keep a steady level of the drug in your body. This helps Filspari work effectively.
- If you miss a dose: If you miss a dose of Filspari, skip your missed dose and take your next dose at the regular time.
- Taking Filspari with food: You should take Filspari before a morning or evening meal.
- Crushing, splitting, or chewing Filspari: Filspari tablets should not be crushed, split, or chewed. You’ll swallow the tablet whole. If you have trouble swallowing tablets, you can talk with your doctor or pharmacist. You can also refer to this article for tips.
- Length of use: Filspari is meant to be used as a long-term treatment. If you and your doctor determine that Filspari is safe and effective for you, you’ll likely take it long term.
- Length of time to work: Filspari starts working right after you take your first dose of the drug. Your doctor will give you kidney function tests, including urine protein tests, to help monitor how well the drug is working. In clinical trials, many people had lower urine protein levels after 4 weeks of Filspari treatment.
Overdose
Taking more than the recommended dosage of Filspari can lead to serious side effects. Do not take more Filspari than your doctor recommends.
Overdose symptoms
Symptoms of an overdose can include low blood pressure.
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.
Filspari can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Filspari. These lists do not include all possible side effects.
For more information about the possible side effects of Filspari, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Filspari, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Filspari. To learn about other mild side effects, talk with your doctor or pharmacist or view Filspari’s prescribing information.
Mild side effects of Filspari can include:
- anemia (low level of red blood cells)
- dizziness
- swelling of your hands, legs, ankles, or feet
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Filspari aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- low blood pressure, which may include orthostatic hypotension and symptoms such as:
- dizziness
- lightheadedness
- fainting
- sudden worsening of kidney function, which may include symptoms such as:
- confusion
- fatigue
- urinating a lesser amount than usual
- high potassium levels in your blood, which may not cause any symptoms
- fetal harm*
- liver damage†
* Filspari has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Things to consider when taking Filspari” section.
† Filspari has a boxed warning for this side effect. To learn more, see the “Filspari precautions” section.
ALLERGIC REACTIONFor some people, Filspari can cause an allergic reaction. But this side effect wasn’t reported in the drug’s clinical trials.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Filspari, your doctor may recommend taking a different medication instead.
The Food and Drug Administration (FDA) approves prescription drugs such as Filspari to treat certain conditions.
Filspari for IgA nephropathy
Filspari is approved to treat primary IgA nephropathy in certain adults.
Primary IgA nephropathy is a type of kidney disease. (“Primary” means the condition is not caused by another health problem.) Symptoms may include blood in your urine, kidney pain, and swelling in your hands or feet.
When you have IgA nephropathy, an antibody (protein) called IgA builds up in your kidneys. This causes kidney damage and inflammation, which prevents your kidneys from removing waste substances from your body. As a result, IgA nephropathy can lead to high protein levels in your urine, which can further worsen this condition.
Filspari can be prescribed to lower urine protein levels in adults with IgA nephropathy who are at risk of their condition getting worse. Doctors may use the results of urine protein tests to decide whether Filspari can be prescribed.
To learn more about Filspari for IgA nephropathy, talk with your doctor.
Filspari and children
Filspari is not FDA-approved for use in children. It’s not known for sure whether the drug is safe or effective for children.
Filspari can interact with several other medications. It can also interact with certain supplements as well as certain foods.
Before taking Filspari, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
Interactions with medications, foods, and supplements
Below is a list of medications, supplements, and foods that can interact with Filspari. This list does not contain all drugs that may interact with Filspari. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Medications that can interact with Filspari | • angiotensin II receptor blockers, such as losartan (Cozaar) and valsartan (Diovan) • antacids, such as calcium carbonate (TUMS) and aluminum hydroxide/magnesium hydroxide (Maalox) • endothelin receptor antagonists, such as ambrisentan (Letairis) and bosentan (Tracleer) • H2 blockers, such as cimetidine (Tagamet HB) and famotidine (Pepcid AC) • nonsteroidal anti-inflammatory drugs, such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn, others) • potassium-sparing diuretics, eplerenone (Inspra) and spironolactone (Aldactone, Carospir) • proton pump inhibitors, such as esomeprazole (Nexium) and omeprazole (Prilosec) • aliskiren (Tekturna) • bupropion (Aplenzin, Wellbutrin XL, others) • cyclosporine (Gengraf, Neoral) • itraconazole (Sporanox, Tolsura) • rifampin (Rifadin, Rimactane) |
---|---|
Supplements that can interact with Filspari | potassium supplements |
Foods that can interact with Filspari | • grapefruit • salt substitutes that contain potassium |
Alcohol interaction
Alcohol is not known to interact with Filspari. However, your doctor may advise you to limit alcohol consumption while taking Filspari.
This is because consuming large amounts of alcohol over a long period of time can lead to liver damage. Filspari has a boxed warning about the risk of liver damage.* Drinking alcohol while taking the drug could increase this risk.
If you have questions about how much alcohol is safe to drink while taking Filspari, talk with your doctor or pharmacist.
* A boxed warning is the most serious warning from the FDA. To learn more, see the “Filspari precautions” section.
As with all medications, the cost of Filspari can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Drug coupons: You can visit Optum Perks for price estimates for Filspari. These estimates are based on the use of Optum Perks coupons.
Note: Optum Perks coupons cannot be used with any insurance copays or benefits.
Financial and insurance assistance: If you need financial support to pay for Filspari or if you need help understanding your insurance coverage, help is available.
A program called Travere TotalCare is available for Filspari. For more information and to find out whether you’re eligible for support, call 833-345-7727 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Generic version: Filspari is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.
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Other drugs are available that can treat IgA nephropathy. Some may be a better fit for you than others. If you’re interested in finding an alternative to Filspari, talk with your doctor. They can tell you about other medications that may work well for you.
Examples of drugs that are alternatives to Filspari include:
- angiotensin II receptor blockers, such as valsartan (Diovan)
- angiotensin-converting enzyme inhibitors, such as lisinopril (Qbrelis, Zestril)
- corticosteroids, such as budesonide (Tarpeyo)
- immunosuppressants, such as mycophenolate mofetil (CellCept, Myhibbin)
If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.
Risk of fetal harm
Filspari has a boxed warning about the risk of fetal harm if taken during pregnancy. A boxed warning is the most serious warning from the FDA.
This risk wasn’t reported in clinical trials of Filspari. However, animal studies suggest that taking Filspari during pregnancy could lead to pregnancy loss or congenital anomalies (also known as birth defects). This can include low birth weight and problems with the development of the head or face.
Keep in mind that findings from animal studies may not always apply to humans.
Due to this risk, the drug is prescribed only through the Filspari risk evaluation and mitigation strategy (REMS) program. The Filspari REMS program ensures that you and your doctor understand the risks of taking Filspari during pregnancy.
To learn more about Filspari and pregnancy, see the sections just below or talk with your doctor.
Filspari and pregnancy
Filspari should not be taken during pregnancy. (For details, see “Risk of fetal harm” above.)
If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. They’ll likely have you take a pregnancy test before you start Filspari treatment. Your doctor may also have you take monthly pregnancy tests during Filspari treatment and another test at least 1 month after stopping treatment.
If you become pregnant while taking Filspari, stop taking the drug and tell your doctor right away. They’ll likely recommend a different treatment option for your condition during pregnancy.
Filspari and birth control
Filspari is not safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Filspari.
Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.
For females taking Filspari
Females who can become pregnant should use birth control while taking Filspari and for at least 1 month after stopping treatment. If you have questions, talk with your doctor about the birth control method that’s best for you.
For males taking Filspari
The manufacturer of Filspari hasn’t given birth control recommendations for males who are taking the drug. If you’re a male taking Filspari and have a sexual partner who can become pregnant, talk with your doctor. They’ll advise you on your birth control needs.
Filspari and breastfeeding
Filspari should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Filspari.
This drug comes with several precautions.
FDA warnings
This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Risk of fetal harm: Taking Filspari during pregnancy may cause fetal harm. For details, see the “Things to consider when taking Filspari” section.
Risk of liver damage: Taking Filspari may cause high levels of liver enzymes, which could be a sign of liver damage.
Liver damage may cause symptoms such as:
- jaundice
- loss of appetite
- nausea and vomiting
- pain in the right side of your abdomen
High liver enzymes were a less common side effect in Filspari’s clinical trials. There were no reports of severe liver damage or liver failure in these trials. However, liver damage has been reported with drugs that are similar to Filspari.
Before starting your Filspari treatment, your doctor will check your liver function with blood tests. They’ll repeat these tests every month for at least the first year of treatment. After that, your doctor may check your liver function every 3 months.
If your liver function test results are abnormal, your doctor will decide whether to stop Filspari temporarily or permanently.
Due to the risk of liver damage, doctors can prescribe the drug only through the Filspari risk evaluation and mitigation strategy (REMS) program. This program helps you and your doctor manage the risk of liver damage with Filspari.
To learn more about this warning, talk with your doctor.
Other precautions
Before taking Filspari, discuss your health history with your doctor. Filspari may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- liver problems, such as liver failure
- heart-related problems, including high blood pressure and heart failure
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Filspari, see the “Filspari side effects” section.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.