Sparsentan

Generic name: Sparsentan
Brand names: Filspari
Dosage form: oral tablet (200 mg; 400 mg)
Drug class: Miscellaneous cardiovascular agents

Usage of Sparsentan

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.

Sparsentan side effects

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.

Before taking Sparsentan

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.

Relate drugs

How to use Sparsentan

Usual Adult Dose for Primary Immunoglobulin A Nephropathy:

Initial dose: 200 mg orally once a day for 14 daysMaintenance dose: Following initial dose, increase to 400 mg orally once a day, as toleratedComments:-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.

Warnings

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

What other drugs will affect Sparsentan

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.

Disclaimer

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