Sparsentan (spar-SEN-tan)

Reduces levels of protein in the urine.

Brand Name(s):

Filspari

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole with water before your morning or evening meal. Take it with the same meal each day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with aliskiren or other blood pressure medicine (including angiotensin receptor blocker, endothelin receptor blocker).
• Some medicines can affect how sparsentan works. Tell your doctor if you are using any of the following:
  • Bupropion, cyclosporine, itraconazole, rifampin
  • Diuretic (water pill)
  • Pain medicine (including NSAIDs)
  • Potassium supplements or salt substitutes
  • Stomach medicine
• Take this medicine 2 hours before or 2 hours after taking antacids.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. 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 the last dose to keep from getting pregnant. Ask your doctor which form of birth control is the right for you.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have liver disease, heart problems, or high blood pressure.
• This medicine may cause the following problems:
  • Liver problems
  • Low blood pressure
  • Kidney problems
  • Fluid retention
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Lightheadedness or fainting
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding or bruising

If you notice other side effects that you think are caused by this medicine, tell your doctor

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