IMPORTANT WARNING: Sparsentan may cause liver damage. Tell your...

IMPORTANT WARNING: Sparsentan may cause liver damage. Tell your doctor if you have or have ever had liver disease. Your doctor will order a blood test to be sure your liver is working normally before you start taking sparsenten, every month during the first 12 months of your treatment, and then every 3 months thereafter. Keep all appointments with your doctor and the laboratory. If you experience any of the following symptoms, stop taking sparsentan and call your doctor immediately: extreme tiredness, fatigue, pain in the upper right part of the stomach, nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark colored urine, fever, or itching. Your doctor may reduce your dose, or temporarily or permanently stop your treatment with sparsentan if you experience side effects or have abnormal lab results.Sparsentan must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that sparsentan will cause the baby to be born with birth defects (physical problems that are present at birth). You will be asked to take a pregnancy test before starting sparsentan, during treatment with sparsentan, and then one month after stopping sparsentan. Patients who can become pregnant must use effective birth control before starting sparsentan, during sparsentan treatment, and for one month after stopping sparsentan treatment. Talk to your doctor about birth control methods that will work for you. In most cases you will be required to use two forms of birth control.Because of the risks with this medication, sparsentan is available only through a special restricted distribution program. A program called FILSPARI Risk Evaluation and Mitigation Strategies (REMS) program. You, your doctor, and your pharmacy must be enrolled in the FILSPARI REMS program before you can receive this medication.Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sparsentan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.Talk to your doctor about the risks of taking sparsentan.

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