Sparsentan Tablets

What is this medication?

SPARSENTAN (spar SEN tan) treats kidney disease. It works by decreasing levels of protein in the urine. This helps protect the kidneys.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): FILSPARI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dehydration
• Heart failure
• Kidney disease
• Liver disease
• Low blood pressure
• An unusual or allergic reaction to sparsentan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time each day. Take it with food. You should always take it the same way. Keep taking it unless your care team tells you to stop.

Take this medication 2 hours BEFORE or 2 hours AFTER antacids.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Aliskiren
• Angiotensin receptor blockers, such as candesartan or losartan
• Certain medications for pulmonary hypertension, such as ambrisentan, bosentan, macitentan

This medication may also interact with the following:

• Antacids
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Potassium supplements or salt substitutes
• Stomach acid blockers, such as famotidine or pantoprazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. Check your blood pressure as directed. Know what your blood pressure should be and when to contact your care team.

You may need blood work done while you are taking this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before, during, and after taking this medication. Contraception is recommended before starting this medication, during treatment, and for 1 month after the last dose. Your care team can help find the option that works for you.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• High potassium level—muscle weakness, fast or irregular heartbeat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.