Prospect: information for the patient

Tavneos 10 mg hard capsules

avacopan

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1.What Tavneos is and for what it is used

2.What you need to know before starting to take Tavneos

3.How to take Tavneos

4.Possible adverse effects

5.Storage of Tavneos

6.Contents of the package and additional information

¿What is Tavneos?

Tavneos contains the active ingredient avacopan, which binds to a specific protein in the body, known as the complement 5a receptor.

What is Tavneos used for?

Tavneos is used to treat adults with a disease that gradually worsens due to inflammation of small blood vessels, known as: granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (PAM):

•Granulomatosis with polyangiitisaffects mainly small blood vessels and kidney, lung, throat, nose, and nasal sinus tissues, but also other organs. Patients develop small growths (granulomas) inside and around blood vessels, formed by tissue damage caused by inflammation.

•Microscopic polyangiitisaffects smaller blood vessels. It often affects the kidneys, but can also affect other organs.

The complement 5a receptor plays a key role in stimulating inflammation. This medication binds to it and prevents it from functioning, reducing the inflammation of blood vessels observed in these diseases.

Tavneos can be used in conjunction with other treatments prescribed by your doctor.

Do not take Tavneos

•if you are allergic to avacopan or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Tavneos and during treatment, if you have or have had:

•liver disease such as elevated total bilirubin levels, a yellow pigment breakdown substance, or liver enzymes such as transaminases

•any infection, unexpected bleeding and bruising (these are common signs of bone marrow insufficiency)

•hepatitis B, hepatitis C, HIV infection, or tuberculosis

•heart disease, such as a heart attack, heart failure, or inflammation of the heart's blood vessels.

•any type of cancer.

Tavneos is not recommended for patients with

•active liver disease, or

•an active and severe infection.

Your doctor will perform blood tests before and as needed during treatment to monitor:

•any liver problems (measuring liver enzymes and total bilirubin in the blood)

•your risk of getting infections (measuring lymphocyte count).

Your doctor will decide to temporarily interrupt or permanently discontinue treatment.

•Your doctor will also monitor the signs and symptoms of an infection calledNeisseria meningitidis. This is recommended for adult patients with GPA or PAM.

It is recommended that you receive treatment to prevent Pneumocystis jirovecii pneumonia during treatment with Tavneos.

It is recommended to administer vaccines before starting treatment with Tavneos or when there is no active disease (granulomatosis with polyangiitis or microscopic polyangiitis).

During treatment with Tavneos, cases of intense and often painful swelling under the skin, mainly on the face, have been reported. If this affects the throat, it may make breathing difficult. Stop treatment and seek urgent medical attention if facial swelling, lips, tongue, or throat occurs, or if breathing difficulties occur.

Children and adolescents

Do not administer this medicine to children under 18 years of age, as there is insufficient evidence to know if this medicine is safe and effective in this age group.

Other medicines and Tavneos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

It is essential to discuss with your doctor, especially if you use any of the following medicines:

•carbamazepine, phenobarbital, phenytoin: medicines to treat epilepsy and other diseases

•enzalutamide, mitotane: medicines to treat cancer

•rifampicin, a medicine to treat tuberculosis or other infections

•St. John's Wort, a herbal medicine used to treat mild depression

If you cannot avoid using one of these medicines for a short period during treatment with Tavneos, your doctor may regularly check your condition to see if Tavneos is working well.

Tavneos may affect or be affected by the following medicines:

•alfentanil: an analgesic used during surgery with anesthesia

•boceprevir, telaprevir: medicines to treat hepatitis C

•bosentan: a medicine to treat pulmonary hypertension and skin ulcers on hands and feet in scleroderma

• clarithromycin, telithromycin: antibiotic medicines to treat bacterial infections

•conivaptan: a medicine to treat low sodium levels in the blood

•ciclosporin: a medicine to inhibit the immune system and prevent transplant rejection, treat severe skin diseases, and severe eye or joint inflammation

•dabigatran: an anticoagulant medicine

•dihydroergotamine, ergotamine: medicines to treat migraines

•fentanyl: a strong analgesic

•indinavir, efavirenz, etravirine, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir: medicines to treat HIV infections

•itraconazole, posaconazole, voriconazole: medicines to treat fungal infections

•ketoconazole: a medicine to treat symptoms caused by excessive cortisol production in the body, known as Cushing's syndrome

•mibefradil: a medicine to treat irregular heart rhythm and high blood pressure

•modafinil: a medicine to treat excessive daytime sleepiness

•nefazodone: a medicine to treat depression

•sirolimus, tacrolimus: medicines to suppress the immune system and prevent transplant rejection.

Taking Tavneos with food and drinks

Avoid grapefruit and grapefruit juice during treatment with Tavneos, as they may affect the medicine's effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

•Pregnancy

This medicine is not recommended during pregnancy or in women of childbearing age who do not use contraceptive methods.

•Breastfeeding

The safety of avacopan in breastfeeding women has not been established. Your doctor will help you decide whether to interrupt treatment with Tavneos or interrupt breastfeeding.

Driving and operating machines

Tavneos is unlikely to affect your ability to drive or operate machines.

Tavneos contains macrogolglycerol hydroxystearate.

This may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is3 capsules in the morning and 3 capsules at night.

Administration Form

Swallow the capsules whole with a glass of water.Do notcrush, chew, or open the capsules. Take the capsules with a meal, 3 capsules in the morning and 3 capsules at night.

If you take more Tavneos than you should

Speak with your doctor immediately.

If you forgot to take Tavneos

Ifmore than 3 hourshave passed before your next scheduled dose, take the missed dose as soon as possible and then take the next dose at the correct time.

Ifless than 3 hourshave passed before your next scheduled dose, do not take the missed dose. Simply take the next dose at the usual time.

Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Tavneos

Stop treatment and seek urgent medical attention if swelling of the face, lips, tongue, or throat, or difficulty breathing occurs. In any other situation, do not stop taking this medication without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if any of the following serious side effects occur:

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

•blood tests showing an increase in levels of

• liver enzymes (a sign of liver problems)
• bilirubin: a yellow substance resulting from the breakdown of blood pigment.

Common(may affect up to 1 in 10 people)

•lung inflammation (symptoms may include wheezing, difficulty breathing, or chest pain).

Rare(may affect 1 in 100 people)

•severe allergic reaction causing swelling under the skin, mainly on the face, and may cause difficulty breathing (angioedema).

Other side effects may occur with the following frequencies:

Very common

•upper respiratory tract infection

•sore and inflamed throat and nose

•headache

•unpleasant feeling (nausea)

•diarrhea

•vomiting

•decrease in white blood cell count in blood tests

Common(may affect up to 1 in 10 people)

•inflammation of the nasal mucosa causing sneezing, itching, discharge, and nasal congestion

•urinary tract infections

•inflammation of the nasal sinuses or bronchi

•inflammation of the stomach and intestinal lining

•lower respiratory tract infection

•cellulitis

•herpes

•influenza

•yeast infection (Candida or herpes) in the mouth

•middle ear infection

•reduced number of neutrophil white blood cells (symptoms may include infections, fever, or difficulty swallowing)

•upper abdominal pain

•increase in blood levels of the enzyme creatine phosphokinase (symptoms may include chest pain, confusion, muscle pain, sudden weakness, or numbness of the body).

Reporting side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the bottle after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original bottle to protect it from light.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. This way, you will help protect the environment.

What Tavneos contains

•The active ingredient is avacopan.

Each hard capsule contains 10 mg of avacopan.

•The other components are:

• hydroxyestearate of macrogolglycerol
• macrogol (4000)
• gelatin
• polysorbate 80
• iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
• titanium dioxide (E171)
• shellac
• potassium hydroxide

Appearance of Tavneos and contents of the packaging

Tavneos hard capsules are composed of a yellow body and an orange-yellow cap with "CCX168" written in black ink.

The capsules are 22 mm long with a diameter of 8 mm.

The capsules are packaged in plastic bottles with child-resistant closures.

Tavneos is available in packaging of 30 or 180 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Vifor Fresenius Medical Care Renal Pharma France 100-101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 París La Défense Cedex Francia

Manufacturer

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 París La Défense Cedex

Francia

For more information about this medicine, please contact the Marketing Authorization Holder.

Last review date of this leaflet: 10/2023

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites about rare diseases and orphan medicines.

You can find detailed information about this medicine on the following URL:http://www.tavneos-patient.eu.