TAVNEOS 10 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tavneos 10 mg Hard Capsules

avacopan

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Tavneos and what is it used for

What is Tavneos?

Tavneos contains the active substance avacopan, which binds to a specific protein in the body called 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, called granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA):

• Granulomatosis with polyangiitis mainly affects small blood vessels and tissues of the kidneys, lungs, throat, nose, and sinuses, but also other organs. Patients develop small growths (granulomas) inside and around blood vessels, which are formed by tissue damage caused by inflammation.
• Microscopic polyangiitis affects the smallest 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 medicine binds to it and prevents it from working, which reduces the inflammation of blood vessels seen in these diseases.

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

2. What you need to know before you take Tavneos

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

Tell your doctor before you start taking Tavneos and during treatment if you have or have had:

• symptoms of liver damage such as feeling sick (nausea or vomiting), feeling tired, loss of appetite, yellowing of the skin or eyes, dark urine, itching, pain in the upper abdomen, high levels of bilirubin, the yellow breakdown product of blood pigment, or liver enzymes such as transaminases
• any infection, bruising, and unexpected bleeding (these two are common signs of bone marrow failure)
• hepatitis B, hepatitis C, HIV infection, or tuberculosis
• heart disease, such as a heart attack, heart failure, inflammation of the blood vessels of the heart.
• any type of cancer.

Tavneos is not recommended in patients with:

• active liver disease, or
• a severe and active infection.

Your doctor will perform blood tests before and when necessary during treatment to check:

• any problems with your liver (by measuring liver enzymes and total bilirubin in the blood)
• your risk of getting infections (by measuring lymphocyte count).

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

• Your doctor will also monitor signs and symptoms of an infection called Neisseria meningitidis. This is recommended in adult patients with GPA or MPA.

It is recommended that you receive treatment to prevent lung infection, pneumonia, caused by Pneumocystis jirovecii during treatment with Tavneos.

Vaccinations should be given before treatment with Tavneos or when there is no active disease (granulomatosis with polyangiitis or microscopic polyangiitis).

During treatment with Tavneos, cases of severe and often painful swelling under the skin, mainly in the face, have been reported. If this affects the throat, it can make breathing difficult. Stop treatment and seek urgent medical attention if you experience swelling of the face, lips, tongue, or throat or difficulty breathing.

Children and adolescents

Do not give this medicine to children under 18 years of age, as there is not enough information to determine if this medicine is safe and effective in this age group.

Other medicines and Tavneos

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is especially important that you talk to your doctor if you are using any of the following medicines:

• carbamazepine, phenobarbital, phenytoin: medicines to treat epilepsy and other conditions
• enzalutamide, mitotane: medicines to treat cancer
• rifampicin: a medicine to treat tuberculosis or other infections
• St. John's Wort; a herbal medicine used for mild depression

If you cannot avoid short-term use of one of these medicines during treatment with Tavneos, your doctor may check your condition regularly to see if Tavneos is working well.

Tavneos may affect or be affected by the following medicines:

• alfentanil: a pain reliever used during surgery with anesthesia
• boceprevir, telaprevir: medicines to treat hepatitis C
• bosentan: a medicine to treat pulmonary hypertension and ulcers on the fingers of the 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 suppress the immune system and prevent transplant rejection, treat severe skin diseases, and severe inflammation of the eyes or joints
• dabigatran: an anticoagulant medicine
• dihydroergotamine, ergotamine: medicines to treat migraine
• fentanyl: a strong pain reliever
• 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 production of cortisol in the body called Cushing's syndrome
• mibefradil: a medicine to treat irregular heartbeat and high blood pressure
• modafinil: a medicine to treat excessive daytime sleepiness
• nefazodone: a medicine to treat depression
• simvastatin: a medicine to reduce total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood
• 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 action of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

This medicine is not recommended during pregnancy or in women of childbearing potential who are not using contraception.

• Breastfeeding

It is not known if avacopan passes into breast milk. A risk to the baby cannot be excluded. Your doctor will help you decide whether to stop breastfeeding or stop Tavneos treatment.

Driving and using machines

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

Tavneos contains macrogolglycerol hydroxystearate

This may cause stomach upset and diarrhea.

3. How to take Tavneos

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is 3 capsules in the morning and 3 capsules in the evening.

Method of administration

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 in the evening.

If you take more Tavneos than you should

Talk to your doctor immediately.

If you forget to take Tavneos

If more than 3 hoursare left before your next scheduled dose, take the missed dose as soon as possible and then take the next dose at the correct time.

If less than 3 hoursare left 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 missed doses.

If you stop taking Tavneos

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately if you experience any of the following serious side effects:

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

• blood tests showing increased levels of:
  • liver enzymes (a sign of liver problems)
  • bilirubin: the yellow breakdown product of blood pigment.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• severe allergic reaction that causes swelling under the skin, mainly in the face, and can cause difficulty breathing (angioedema).

Frequency not known(cannot be estimated from the available data)

• severe liver damage and damage to the bile ducts (symptoms may include feeling sick (nausea or vomiting), feeling tired, loss of appetite, yellowing of the skin or eyes, dark urine, itching, pain in the upper abdomen. (See section 2).

Other side effects may occur with the following frequencies:

Very common

• upper respiratory tract infection
• sore and inflamed throat and nose
• headache
• nausea
• diarrhea
• vomiting
• decrease in white blood cell count in blood tests

Common

• inflammation of the lining of the nose that causes sneezing, itching, discharge, and nasal congestion
• urinary tract infections
• inflammation of the sinuses or bronchi
• inflammation of the lining of the stomach and intestines
• lower respiratory tract infection
• cellulitis
• herpes
• flu
• fungal infection caused by Candida or herpes in the mouth
• middle ear infection
• reduced number of lymphocytes called neutrophils (symptoms may include infections, fever, or pain when swallowing)
• upper abdominal pain
• increased level of the enzyme creatine phosphokinase in the blood (symptoms may include chest pain, confusion, muscle pain, sudden weakness, or numbness of the body).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tavneos

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tavneos contains

• The active substance is avacopan.

Each hard capsule contains 10 mg of avacopan.

• The other ingredients are:
  • macrogolglycerol hydroxystearate
  • 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 pack contents

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

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

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

Tavneos is available in:

• packs of 30 hard capsules or
• packs of 180 hard capsules or
• multi-packs of 540 hard capsules (3 individual packs of 180 hard capsules).

Not all pack sizes may be marketed.

Marketing authorisation holder

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

Tour Franklin La Défense 8

92042 Paris La Défense Cedex France

Manufacturer

Vifor France

100–101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

For further information on this medicine, contact the Marketing Authorisation Holder.

Date of last revision of this leaflet:

Other sources of information

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

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