Filspari

Package leaflet: Information for the patient

Filspari 200 mg film-coated tablets, 400 mg film-coated tablets

sparsentan
Medicinal product subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• The package contains a patient card. Please read it carefully, as it contains important safety information you should be aware of before and during treatment with Filspari.

Contents of this leaflet

1. What Filspari is and what it is used for
2. What you need to know before taking Filspari
3. How to take Filspari
4. Possible side effects
5. How to store Filspari
6. Contents of the pack and other information

1. What Filspari is and what it is used for

Filspari contains the active substance sparsentan. Filspari works by blocking the receptors (targets) of two hormones, endothelin and angiotensin, which are involved in regulating kidney function.
Filspari is used to treat primary immunoglobulin A nephropathy (IgAN) in adults with a urinary protein excretion ≥ 1.0 g/day (or urine protein-to-creatinine ratio ≥ 0.75 g/g).
Primary IgAN is a disease caused by the immune system (the body's natural defenses) producing a defective form of an antibody called immunoglobulin A (IgA), which accumulates in clusters of tiny blood vessels in the kidney, called glomeruli, that filter the blood.
This accumulation damages the glomeruli, leading to blood and protein loss in the urine.
Filspari blocks the receptors (targets) of two hormones, endothelin and angiotensin, which play a role in regulating processes in the kidney, such as inflammation, that contribute to the progression of kidney damage. By blocking these receptors, Filspari reduces the amount of protein lost in the urine and thus helps slow the progression of the disease.

2. What you should know before taking Filspari

Do not take Filspari if

• you are allergic to sparsentan or to any of the other ingredients of this medicine (listed in section 6).
• you are pregnant, think you may be pregnant, or are planning a pregnancy (see section 2 “Pregnancy and breastfeeding”).
• you are taking any of the following medicines used primarily to treat high blood pressure: angiotensin receptor blockers (such as irbesartan, losartan, valsartan, candesartan, telmisartan), endothelin receptor blockers (such as bosentan, ambrisentan, macitentan, sitaxentan), or renin inhibitors (such as aliskiren).

Warnings and precautions
Talk to your doctor or pharmacist before taking Filspari if:

• you have low blood pressure (hypotension). A drop in blood pressure may occur more frequently in elderly patients – your doctor may monitor your blood pressure during treatment and may change the dose of Filspari or stop treatment with Filspari, if necessary.
• you have reduced kidney function – your doctor may carry out additional tests to monitor how well your kidneys are working (by measuring creatinine and potassium levels in the blood).
• you have swelling in your hands, ankles, or feet due to fluid retention – your doctor may ask you to take an additional medicine to remove excess fluid from the body or may adjust the dose of Filspari.
• you have liver problems – your doctor will prescribe blood tests before starting treatment and at regular intervals during treatment to check whether your liver is functioning properly; your doctor may stop treatment with Filspari, if necessary. Signs that your liver may not be working properly include: nausea (feeling sick), vomiting, fever (high temperature), stomach (abdominal) pain, jaundice (yellowing of the skin or whites of the eyes), dark-coloured urine, skin itching, lethargy or fatigue (unusual tiredness), flu-like symptoms (joint and muscle pain with fever). If you notice any of these signs, contact your doctor immediately.

Children and adolescents
Filspari is not recommended for children under 18 years of age and has not been studied in this age group.

Other medicines and Filspari
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking medicines used to treat high blood pressure. Do not take Filspari if you are taking any of the following medicines: angiotensin receptor blockers, endothelin receptor blockers, or renin inhibitors (medicines containing aliskiren) (see section 2 “Do not take Filspari”).

Talk to your doctor or pharmacist if you are taking any of the following medicines:
Concomitant use of Filspari with the following medicines may cause more side effects:

• enalapril or lisinopril (or similar medicines called ACE inhibitors), usually used to treat high blood pressure or for other reasons. Side effects may include low blood pressure when standing up from a lying or sitting position, high levels of potassium in the blood, and reduced kidney function.
• spironolactone or eplerenone (or similar medicines called MRAs), usually used to remove excess fluid or to treat heart conditions, as they may increase potassium levels in the blood.
• potassium supplements, potassium-sparing medicines (such as water-removing medicines or diuretics), or potassium-containing salt substitutes, as they may increase potassium levels in the blood.
• medicines used to treat fungal infections (such as itraconazole, fluconazole).
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin).

The effect of Filspari may be reduced by medicines such as:

• rifampicin, used to treat bacterial infections.
• some medicines for treating HIV infection, such as efavirenz.
• medicines for treating epilepsy, such as carbamazepine, phenytoin, phenobarbital.
• St. John’s wort (Hypericum perforatum), used for depression and other conditions.
• corticosteroids, such as dexamethasone, used mainly to treat inflammation.

The effect of Filspari may be increased by medicines such as:

• boceprevir or telaprevir, used to treat hepatitis C.
• conivaptan, used to treat low blood sodium levels.
• some medicines for treating HIV infection, such as indinavir, lopinavir/ritonavir, nelfinavir, ritonavir.
• nefazodone, used to treat depression.
• medicines to suppress the immune system and prevent organ transplant rejection, such as ciclosporin and tacrolimus.

Filspari with food and drinks
Grapefruit and grapefruit juice must not be consumed by people who have been prescribed Filspari. This is because grapefruit and grapefruit juice may cause more side effects when taken with Filspari.

Pregnancy and breastfeeding
Do not take Filspari if you are pregnant or planning to become pregnant. Filspari may harm the unborn baby.
If you are a woman of childbearing age, your doctor will ask you to have a pregnancy test before starting Filspari.

• If you could become pregnant, use a reliable method of birth control (contraception) while taking Filspari and for 1 month after stopping treatment. Discuss this with your doctor.
• If you become pregnant or think you may be pregnant while taking Filspari or shortly after stopping Filspari (up to 1 month), contact your doctor immediately.

It is not yet known whether Filspari passes into breast milk. Do not breastfeed while taking Filspari. Discuss this with your doctor.

Driving and using machines
Filspari may cause side effects such as dizziness, which may have a minor effect on the ability to drive or use machines (see section 4). Wait until these effects have passed before driving or using machines.

Filspari contains lactose
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

Filspari contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, and is therefore essentially “sodium-free”.

3. How to take Filspari

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage
The recommended starting dose is one 200 mg tablet taken once daily. After 14 days, your doctor will increase the dose to 400 mg (either 2 tablets containing 200 mg of Filspari or 1 tablet containing 400 mg of Filspari) taken once daily, depending on your tolerance to Filspari.

How to take the medicine
Swallow the tablet whole to avoid the bitter taste. Take with one glass of water.

If you take more Filspari than you should
If you have taken more tablets than prescribed, symptoms of low blood pressure may occur.
If you have taken too many tablets, contact your doctor immediately.

If you forget to take Filspari
Skip the missed dose. Then take your next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Very common (may affect more than 1 in 10 people):

• low blood pressure (hypotension)

Common (may affect up to 1 in 10 people):

• feeling dizzy or lightheaded when standing up or sitting down due to a drop in blood pressure (orthostatic hypotension)
• dizziness
• high levels of potassium in the blood (hyperkalaemia)
• fluid retention in the body (oedema or swelling), especially in the ankles and feet
• fatigue
• reduced kidney function (especially at the beginning of treatment; renal impairment)
• sudden kidney failure (especially at the beginning of treatment, acute kidney injury)
• increased levels of creatinine in the blood (a breakdown product of muscle eliminated by the kidneys)
• headache
• changes in liver function, detected by blood tests.

Uncommon (may affect up to 1 in 100 people):

• reduced number of red blood cells (anaemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Filspari

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Filspari contains

• The active substance is sparsentan: each Filspari 200 mg film-coated tablet contains 200 mg of sparsentan. Each Filspari 400 mg film-coated tablet contains 400 mg of sparsentan.
• The other components are: microcrystalline cellulose, lactose (see section 2, “Filspari contains lactose”), sodium starch glycolate (type A) (see section 2, “Filspari contains sodium”), anhydrous colloidal silica, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E171).

Description of the appearance of Filspari and package contents
Filspari 200 mg film-coated tablets are film-coated tablets, white to off-white in colour, oval-shaped, with the number “105” on one side. The tablet dimensions are approximately 13 mm × 7 mm.
Filspari 400 mg film-coated tablets are film-coated tablets, white to slightly off-white in colour, oval-shaped, with the number “021” on one side. The tablet dimensions are approximately 18 mm × 8 mm.
Filspari 200 mg film-coated tablets are available in a bottle containing 30 film-coated tablets. Filspari 400 mg film-coated tablets are available in a bottle containing 30 film-coated tablets and in a multipack containing 90 film-coated tablets (3 packs of 30 film-coated tablets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Vifor France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu