Sparsentan

What it is used for

FILSPARI is an endothelin and angiotensin II receptor antagonist indicated: To slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression ( 1.1, 12.1, 14.1 ). To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome ( 1.2, 12.1, 14.2 ).

Immunoglobulin A Nephropathy FILSPARI is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. Focal Segmental Glomerulosclerosis FILSPARI is indicated to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.

The most important thing to know

FILSPARI can cause serious side effects, including: Liver problems. o FILSPARI can cause changes in liver tests. Liver failure was not observed in people treated with FILSPARI in clinical studies, but some medicines that are like FILSPARI have caused liver failure. Your healthcare provider will do blood tests to check your liver before starting treatment with FILSPARI and then every 3 months during treatment.

Your healthcare provider may temporarily stop or permanently stop treatment with FILSPARI if you have changes in your liver tests. Stop taking FILSPARI and get medical help right away if you develop any of the following signs of liver problems during treatment with FILSPARI: nausea or vomiting pain on the upper right side of your stomach area tiredness loss of appetite yellowing of your skin or the white part of your eyes (jaundice) dark “tea-colored” urine fever itching Because of the risk for liver problems, FILSPARI is only available through a restricted access program called the FILSPARI Risk Evaluation and Mitigation Strategy (REMS).

Before you begin treatment with FILSPARI, your healthcare prescriber will explain the FILSPARI REMS, you must read, and agree to all of the requirements of the FILSPARI REMS. Serious birth defects. FILSPARI can cause serious birth defects if taken during pregnancy. o Patients who can become pregnant should not be pregnant when they start taking FILSPARI or become pregnant during treatment with FILSPARI or for two weeks after stopping treatment with FILSPARI.

o Patients who can become pregnant should have a negative pregnancy test before starting treatment with FILSPARI. Patients who can become pregnant are those who: ▪ have entered puberty, even if they have not started their menstrual period, and ▪ have a uterus, and ▪ have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.

Patients who cannot become pregnant are those who: ▪ have not yet entered puberty, or ▪ do not have a uterus, or ▪ have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or ▪ are infertile for any other medical reason and this infertility is permanent and cannot be reversed.

o Patients who can become pregnant should use effective birth control before starting treatment with FILSPARI, during treatment with FILSPARI, and for two weeks after stopping FILSPARI because the medicine may still be in your body. ▪ Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with FILSPARI.

▪ If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another effective form of birth control. o Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed.

Your healthcare provider may talk with you about using emergency birth control. o Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant. o If you are the parent or caregiver of a female child who started taking FILSPARI tablets before reaching puberty, you should check your child regularly to see if they are developing signs of puberty.

Tell their healthcare provider right away if you notice that your child is developing breast buds or pubic hair. Their healthcare provider should decide if your child has reached puberty. Your child may reach puberty before having their first menstrual period. See “

How to take it

FILSPARI will be provided to you by a certified pharmacy. Your healthcare provider will give you complete details. Take FILSPARI exactly as your healthcare provider tells you to take it. Do not stop taking FILSPARI unless your healthcare provider tells you. Take FILSPARI tablets whole with water before your morning or evening meal.

Take your dose of FILSPARI before the same meal each day. If you cannot swallow the tablet whole, you may crush FILSPARI and mix it in water only right before you take it. Do not mix FILSPARI with other liquids. 1. Crush the FILSPARI tablet in a clean pill crusher or mortar and pestle. 2. Mix the crushed FILSPARI in half a cup of water.

The crushed medicine will not completely dissolve in the water. 3. Drink all of the mixture right away. 4. If any of the pieces are left in the cup, add a little more water to the cup, swirl to mix, and drink right away. 5. Do not store the mixed solution for later use. If you miss a dose, take the next dose at the regularly scheduled time.

Do not take 2 doses at the same time or take extra doses. If you take too much FILSPARI, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of FILSPARI? FILSPARI can cause serious side effects, including: Liver Problems. Serious birth defects. Low blood pressure.

Low blood pressure is common during treatment with FILSPARI and can also be serious. Tell your healthcare provider if you feel dizzy, light-headed, or faint. Stay hydrated during treatment with FILSPARI. Worsening of kidney function. This is common during treatment with FILSPARI and can also be serious. Your healthcare provider will check your kidney function during treatment with FILSPARI.

Increased potassium in your blood. This is common during treatment with FILSPARI and can also be serious. Your healthcare provider will check your potassium blood level during treatment with FILSPARI. Fluid retention. FILSPARI can cause your body to hold too much water. Tell your healthcare provider right away if you have any unusual weight gain or swelling of your ankles or legs.

The most common side effects of FILSPARI also include: swelling of hands, legs, ankles, and feet (peripheral edema) dizziness low red blood cells (anemia) Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with FILSPARI if you develop side effects. These are not all of the possible side effects of FILSPARI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects, and when to stop

” for more information about side effects. What is FILSPARI? FILSPARI is a prescription medicine used to slow kidney function decline in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk for their disease getting worse. lower protein in the urine in adults and children aged 8 years and older with a kidney disease called focal segmental glomerulosclerosis (FSGS) who do not have a condition called nephrotic syndrome.

It is not known if FILSPARI is safe and effective in children less than 8 years of age with FSGS. It is not known if FILSPARI is safe and effective in children with IgAN.

Who should not take it

Do not take FILSPARI if you: are pregnant, plan to become pregnant, or become pregnant during treatment with FILSPARI. FILSPARI may cause serious birth defects. are taking an angiotensin receptor blocker, endothelin receptor antagonist, or aliskiren. Ask your healthcare provider or pharmacist if you are not sure if you take any of these medicines.

Before taking FILSPARI, tell your healthcare provider about all of your medical conditions, including if you: have liver problems are pregnant or plan to become pregnant during treatment with FILSPARI. FILSPARI may cause serious birth defects. are breastfeeding or plan to breastfeed. It is not known if FILSPARI passes into your breast milk.

Do not breastfeed during treatment with FILSPARI. Talk to your healthcare provider about the best way to feed your baby during treatment with FILSPARI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and grapefruit. FILSPARI and other medicines may affect each other and cause side effects.

Do not start any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take: nonsteroidal anti-inflammatory drugs (NSAIDs) potassium-containing medicines, potassium supplements, or salt substitutes containing potassium blood pressure medicines Ask your healthcare provider or pharmacist if you are not sure if you take one of these medicines.

Storing it

Store FILSPARI at room temperature between 68°F to 77°F (20°C to 25°C). Store FILSPARI in the original container. The bottle has a child-resistant closure. Keep FILSPARI and all medicines out of the reach of children.