Medication Guide
FILSPARITM (fil spah’ ree)
(sparsentan)
tablets |
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What is the most important information I should know about FILSPARI?
FILSPARI is only available through the FILSPARI REMS Program. Before you begin taking FILSPARI, you must read and agree to all of the instructions in the FILSPARI REMS Program.
FILSPARI can cause serious side effects, including:
Liver problems.
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FILSPARI can cause changes in liver tests. Some medicines that are like FILSPARI can cause liver failure. Your healthcare provider will do blood tests to check your liver before starting treatment with FILSPARI, monthly for the first 12 months, 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.
Tell your healthcare provider right away if you develop any of the following signs of liver problems during treatment with FILSPARI:
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- nausea or vomiting
- pain on the upper right side of your stomach area
- tiredness
- loss of appetite
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- yellowing of your skin or the white part of your eyes (jaundice)
- dark “tea-colored” urine
- fever
- itching
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Serious birth defects.
FILSPARI can cause serious birth defects if taken during pregnancy.
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Patients who can become pregnant must not be pregnant when they start taking FILSPARI or become pregnant during treatment with FILSPARI or for 1 month after stopping treatment with FILSPARI.
- Patients who can become pregnant must have a negative pregnancy test before starting FILSPARI and must have a monthly negative pregnancy test during treatment and 1 month after stopping 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.
Patients who can become pregnant must use effective birth control during treatment with FILSPARI and for 1 month after stopping FILSPARI because the medicine may still be in your body.
- If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods may be used alone, and no other form of birth control is needed.
- 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.
See the chart below for acceptable birth control options during treatment with FILSPARI.
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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.
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Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
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What is FILSPARI?
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.
It is not known if FILSPARI is safe and effective in children.
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Do not take FILSPARI if you:
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are pregnant, plan to become pregnant, or become pregnant during treatment with FILSPARI. FILSPARI can cause serious birth defects. (See “What is the most important information I should know about FILSPARI?”)
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are taking any of these medicines:
- an angiotensin receptor blocker, or
- an endothelin receptor antagonist, or
- aliskiren.
Ask your healthcare provider if you are not sure if you take one of these medicines. |
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Before taking FILSPARI, tell your healthcare provider about all of your medical conditions, including if you have:
- high blood pressure or heart problems
- liver problems
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and grapefruit. 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.
Especially tell your healthcare provider if you take:
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- potassium-containing medicines, potassium supplements or salt substitutes containing potassium
- blood pressure medicines
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How should I take FILSPARI?
- FILSPARI will be provided to you by a certified pharmacy. Your healthcare provider will give you complete details.
- 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.
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What should I avoid while taking FILSPARI?
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Do not get pregnant while taking FILSPARI. (See the serious birth defects section of the Medication Guide above called “What is the most important information I should know about FILSPARI?”) If you miss a menstrual period, or think you might be pregnant, call your healthcare provider right away.
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It is not known if FILSPARI passes into your breast milk. You should not breastfeed if you are taking FILSPARI. Talk to your healthcare provider about the best way to feed your baby during treatment with FILSPARI.
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What are the possible side effects of FILSPARI?
FILSPARI can cause serious side effects, including:
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Liver problems. See “What is the most important information I should know about FILSPARI?”
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Serious birth defects. See “What is the most important information I should know about FILSPARI?”
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Low blood pressure. Low blood pressure is common during treatment with FILSPARI and can also be serious. Tell your healthcare provider if you feel dizzy, light-headed, or faint. Stay hydrated during treatment with FILSPARI.
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Worsening of Kidney function. Your healthcare provider will check your kidney function during treatment with FILSPARI.
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Increased potassium in your blood. This is common during treatment with FILSPARI and can also be serious. Your healthcare provider will check your potassium blood level during treatment with FILSPARI.
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Fluid retention. FILSPARI can cause your body to hold too much water. Tell your healthcare provider right away if you have any unusual weight gain or swelling of your ankles or legs.
The most common side effects of FILSPARI include: |
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- swelling of hands, legs, ankles and feet (peripheral edema)
- dizziness
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- low red blood cells (anemia)
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These are not all the possible side effects of FILSPARI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store FILSPARI?
- 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.
Keep FILSPARI and all medicines out of the reach of children. |
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General information about the safe and effective use of FILSPARI
Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use FILSPARI for a condition for which it was not prescribed. Do not give FILSPARI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about FILSPARI that is written for health professionals.
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What are the ingredients in FILSPARI?
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.
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Distributed by Travere Therapeutics, Inc., San Diego, CA 92130
FILSPARI is a registered trademark of Travere Therapeutics, Inc.
For more information, go to www.FILSPARI.com or call 1-877-659-5518.
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| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: February 2023 |