Sparsentan is used to lower levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy.

Sparsentan is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of sparsentan.

Sparsentan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Use effective birth control.

Tell your doctor about all your other medicines. Some drugs should not be used with sparsentan.

Sparsentan may cause serious liver problems. Stop taking sparsentan and call your doctor right away if you have nausea, vomiting, loss of appetite, right-sided upper stomach pain, tiredness, weight loss, jaundice, dark urine, fever, or itching.

Sparsentan is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Sparsentan is usually taken once per day. Follow your doctor's dosing instructions very carefully.

Swallow the tablet whole with a full glass of water before a meal. Take it the same way each time. Drink plenty of liquids while you are taking sparsentan.

Your condition may get worse if you stop using sparsentan suddenly. Ask your doctor before stopping the medicine.

You may need frequent medical tests, even if you have no symptoms.

You will need frequent blood tests to check your liver function, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat. Store sparsentan in the original container.

Usual Adult Dose for Primary Immunoglobulin A Nephropathy:

Initial dose: 200 mg orally once a day for 14 days
Maintenance dose: Following initial dose, increase to 400 mg orally once a day, as tolerated

Comments:
-Consider dose titration when resuming treatment after interruption: Start with initial dose for 14 days, then increase to recommended maintenance dose.

Use: To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression (generally a urine protein-to-creatinine ratio of 1.5 g/g or greater); indication is based on accelerated approval, and continued approval may be contingent on confirmatory clinical trial.

Some drugs should not be used with sparsentan. Your treatment plan may change if you also use:

• aliskiren;

• medicine to treat high blood pressure in the lungs--macitentan, bosentan, ambrisentan and others; or

• heart or blood pressure medication--enalapril, candesartan, lisinopril, irbesartan, losartan, olmesartan, valsartan, telmisartan.

Tell your doctor if you have ever had:

• high blood pressure;

• heart problems; or

• liver or kidney disease.

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while using sparsentan and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

Ask your doctor about the best form of birth control while you are using sparsentan.

You will need to have a negative pregnancy test before starting this treatment. You will need to take a pregnancy test during and after treatment with sparsentan.

Do not breastfeed.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sparsentan?

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Grapefruit may interact with sparsentan and cause side effects. Avoid consuming grapefruit products.

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.

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.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Sparsentan may cause serious liver problems. Stop taking sparsentan and call your doctor right away if you have nausea, vomiting, loss of appetite, right-sided upper stomach pain, tiredness, weight loss, jaundice, dark urine, fever, or itching.

Sparsentan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• kidney problems--swelling, urinating less, feeling tired or short of breath;

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection).

Common side effects of sparsentan may include:

• dizziness;

• swelling of hands, legs, ankles and feet; or

• anemia (low red blood cells).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Avoid taking an antacid within 2 hours before or after you take sparsentan.

Tell your doctor about all your current medicines. Many drugs can affect sparsentan, especially:

• blood pressure or heart medications;

• a diuretic or "water pill" that may increase blood potassium such as spironolactone, triamterene, amiloride; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect sparsentan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.