Sparsentan

IMPORTANT WARNING:

Sparsentan may cause liver damage. Tell your doctor if you have or have ever had liver disease; cirrhosis (scarring) of the liver; history of liver disease following use of any drug; or recurrent gall stones. Your doctor may tell you not to take sparsentan. Also tell your doctor if you drink or have ever drunk large amounts of alcohol. Avoid heavy use of alcoholic beverages during your treatment with sparsentan because drinking alcoholic beverages may increase the risk that you will develop liver damage. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness, pain in the upper right part of the stomach, nausea, vomiting, yellowing of the skin or eyes, or dark yellow urine.

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.

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 (http://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 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 just prior to meals once a day. Take sparsentan at around the same time every day and always the same spacing from meals. 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; 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 tablet. 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, 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 or heart problems.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

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. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling of hands, legs, ankles or feet
• dizziness, feeling light-headed or faint
• fatigue

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking sparsentan and call your doctor immediately or get emergency medical treatment:

• muscle cramps, irregular heart beat, or feeling of rapid heart rate
• 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 (http://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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.