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WHAT IS FILSPARI^™ (sparsentan)?

FILSPARI is a prescription medicine to lower protein in the urine (proteinuria) in adults with primary IgA nephropathy who are at risk of their disease quickly getting worse. It is not known if FILSPARI is safe and effective in children.

FILSPARI has been approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether FILSPARI slows decline in kidney function.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about FILSPARI?

FILSPARI is only available through the FILSPARI Risk Evaluation and Mitigation Strategy (REMS) Program because of the serious risk of liver problems and serious birth defects. Before you begin taking FILSPARI, you must read and agree to all the instructions in the FILSPARI REMS Program.

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 FILSPARI, monthly for the first 12 months, and then every three 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: nausea or vomiting, pain on the upper right side of your stomach area, tiredness, loss of appetite, yellowing of the skin or the whites of your eyes (jaundice), dark “tea-colored” urine, fever, or itching.

FILSPARI can cause serious birth defects if taken during pregnancy. Patients must not be pregnant when they start taking FILSPARI, become pregnant during treatment, or for one month after stopping treatment. Patients who can become pregnant must have a negative pregnancy test before starting FILSPARI, monthly during treatment, and for one month after stopping 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 one 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.
• 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.
• Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.

Do not take FILSPARI if you:

• are pregnant, plan to become pregnant, or become pregnant during treatment with FILSPARI. FILSPARI can cause serious birth defects.
• are taking any of these medicines: an angiotensin receptor blocker, an endothelin receptor antagonist, or aliskiren. Ask your healthcare provider if you are not sure if you take one of these medicines.

Before taking FILSPARI, tell your healthcare provider about all of your medical conditions, including if you have high blood pressure or heart problems, or liver problems.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, grapefruit, and antacid medicines. FILSPARI and other medicines may affect how each other works 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

What should I avoid while taking FILSPARI?

• Do not get pregnant while taking FILSPARI. If you miss a menstrual period or think you might be pregnant, call your healthcare provider right away.
• 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.

What are the possible side effects of FILSPARI?

FILSPARI can cause serious side effects, including:

• Liver problems. See Medication Guide – What is the most important information I should know about FILSPARI?
• Serious birth defects. See Medication Guide – What is the most important information I should know about FILSPARI?
• Low blood pressure. This 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.
• Worsening of kidney function. Your healthcare provider will check your kidney function during treatment with FILSPARI.
• 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.
• 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: swelling of the hands, legs, ankles, and feet (peripheral edema), dizziness, and low red blood cells (anemia). 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 or www.fda.gov/medwatch. You may also report side effects to Travere Therapeutics at 1-877-659-5518.

For additional Important Safety Information, please see the full Prescribing Information, including serious side effects, and the Medication GuideMedication Guide.