Sparsentan

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.

WHY is this medicine prescribed?

Sparsentan is used to reduce proteinuria (increased protein in urine) in certain patients with primary immunoglobulin A (IgA) nephropathy (a kidney disease where IgA deposits build up in the kidneys causing inflammation). Sparsentan is in a class of medications called endothelin and angiotensin II receptor antagonists. It works by blocking two substances, endothelin and angiotensin II, that play a role in the progression of kidney disease.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sparsentan comes as a tablet to take by mouth. It is usually taken once a day before your morning meal or before your evening meal. Take sparsentan at around the same time every day and before the same meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sparsentan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with water; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of sparsentan and increase your dose after 14 days.

Sparsentan controls proteinuria from IgA nephropathy but does not cure it. Continue to take sparsentan even if you feel well. Do not stop taking sparsentan without talking to your doctor.

Sparsentan can cause low blood pressure. It is important to drink plenty of water while receiving sparsentan to keep blood pressure from dropping too low.

What SPECIAL PRECAUTIONS should I follow?

Before taking sparsentan,

• tell your doctor and pharmacist if you are allergic to sparsentan, any other medications, or any of the ingredients in sparsentan tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• Some medications should not be taken with sparsentan. Other medications may cause dosing changes or extra monitoring when taken with sparsentan. Make sure you have discussed any medications you are currently taking or plan to take before starting sparsentan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking sparsentan, please get the advice of your doctor or pharmacist.

• if you are taking antacids containing ingredients such as calcium carbonate, magnesium oxide or aluminum hydroxide, take them 2 hours before or after sparsentan.

• The following nonprescription or herbal products may interact with sparsentan: St. John's wort, esomeprazole, lansoprazole, omeprazole, famotidine, ranitidine, ibuprofen, or naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking sparsentan. Do not start any of these medications while taking sparsentan without discussing with your healthcare provider.

• tell your doctor if you have or have ever had low or high blood pressure, high levels of potassium in your blood, or congestive heart failure.

• you should know that sparsentan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication. Also, talk to your doctor before using salt substitutes containing potassium.

What should I do IF I FORGET to take a dose?

If a dose is missed, take the next dose at the normally scheduled time. Do not take double or extra doses.

What SIDE EFFECTS can this medicine cause?

Sparsentan may cause side effects. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• swelling of hands, feet, ankles, or lower legs
• unusual weight gain
• feeling dizzy, light-headed, or faint
• muscle cramps or weakness or fast or irregular heart beat
• urinating too much or too little
• shortness of breath or chest pain

Sparsentan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep sparsentan in its original bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• feeling dizzy, light-headed, or faint

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sparsentan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.