TAVNEOS 10 мг Капсулы

Содержание инструкции

1. Tavneos 10 mg hard capsules
   1. What is Tavneos and what it is used for
   2. What you need to know before taking Tavneos
   3. How to take Tavneos
   4. Possible side effects
   5. How to store Tavneos
   6. Package Contents and Other Information

Tavneos 10 mg hard capsules

avacopan

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Tavneos and what it is 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 progressively worsening disease caused
by inflammation of small blood vessels, called granulomatosis with polyangiitis (GPA) and
microscopic polyangiitis (MPA):

• Granulomatosis with polyangiitisprimarily affects small blood vessels and tissues of the kidneys, lungs, throat, nose and sinuses, but also other organs. Patients develop small nodules (granulomas) inside and around blood vessels, formed by tissue damage caused by inflammation.
• Microscopic polyangiitisaffects smaller blood vessels, often 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, thus reducing the inflammation of the blood
vessels observed in these diseases.
Tavneos can be used in combination with other treatments prescribed by the doctor.

2. What you need to know before taking 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
Talk to your doctor before taking Tavneos and during treatment if you have had or have:

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

Tavneos is not recommended in patients with

• an ongoing liver disease, or
• a serious ongoing infection.

The doctor will perform blood tests before and when necessary during treatment, with
the aim of checking:

• any liver problems (by measuring liver enzymes and total bilirubin in the blood)
• the risk of contracting infections (by measuring the white blood cell count). The doctor will decide to temporarily or permanently stop treatment.

The doctor will also monitor you for any signs and symptoms of an infection called

Neisseria meningitidis. This option is recommended for adult patients with GPA or MPA.
During treatment with Tavneos, it is recommended to undergo treatment to prevent
Pneumocystis jiroveciipneumonia.
It is recommended to administer vaccinations before treatment with Tavneos or in the
disease remission phase (granulomatosis with polyangiitis or microscopic polyangiitis).
During treatment with Tavneos, a severe swelling under the skin, often
painful, mainly on the face, has been reported. If it affects the throat, it can compromise breathing. Stop the
treatment and consult a doctor urgently 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
evidence to show whether 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 important to tell your doctor especially if you are taking any of the following medicines:

• carbamazepine, phenobarbital, phenytoin: medicines to treat epilepsy and other conditions
• enzalutamide, mitotane: medicines for the treatment of oncological diseases
• rifampicin: a medicine to treat tuberculosis or some other infections
• St John's wort: a herbal medicine used for mild depression. If short-term use of one of these medicines cannot be avoided during treatment with Tavneos, your doctor may regularly check your condition to verify the effectiveness of Tavneos.

Tavneos can also affect or be affected by the following medicines:

• alfentanil: a painkiller used during surgery where anesthetics are used
• boceprevir, telaprevir: medicines for the treatment of hepatitis C
• bosentan: a medicine for the treatment of high blood pressure in the lungs and sores on the fingers of the hands and feet known as scleroderma
• clarithromycin, telithromycin: antibiotic medicines for the treatment of bacterial infections
• conivaptan: a medicine for the treatment of low sodium levels in the blood
• cyclosporine: a medicine to suppress the immune system and prevent transplant rejection, treat severe skin diseases or severe eye or joint inflammation
• dabigatran: a blood-thinning medicine
• dihydroergotamine, ergotamine: medicines for the treatment of migraine
• fentanyl: a potent painkiller
• indinavir, efavirenz, etravirine, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir: medicines for the treatment of HIV infections
• itraconazole, posaconazole, voriconazole: medicines for the treatment of fungal infections
• ketoconazole: a medicine to treat symptoms caused by excessive production of cortisol by the body known as Cushing's syndrome
• mibefradil: a medicine for the treatment of irregular heartbeat and hypertension
• modafinil: a medicine to treat excessive sleepiness
• nefazodone: medicines to treat depression
• simvastatin: a medicine used to reduce total cholesterol levels, “bad” cholesterol (cholesterol LDL, acronym of Low Density Lipoproteins, low-density lipoproteins) and fats called triglycerides in the blood
• sirolimus, tacrolimus: medicines to suppress the immune system and prevent transplant rejection.

Tavneos with food and drink
During treatment with Tavneos, avoid consuming grapefruit and grapefruit juice, as
they can affect the effect of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

• PregnancyThis medicine is not recommended during pregnancy or in women of childbearing potential who are not using contraceptive measures.
• BreastfeedingIt is not known whether avacopan is excreted in breast milk. The risk to infants cannot be excluded. The doctor will help you decide whether to stop treatment with Tavneos or stop breastfeeding.

Driving and using machines
It is unlikely that Tavneos will affect your ability to drive or operate machinery.

Tavneos contains hydroxystearyl macrogolglycerol
This may cause stomach upset and diarrhea.

3. How to take Tavneos

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult 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. Donot crush, chew or open the capsules. Take the
capsules during a meal, 3 capsules in the morning and 3 capsules in the evening.

If you take more Tavneos than you should
Seek immediate medical attention.

If you forget to take Tavneos
If more than 3 hoursremain until the next scheduled dose, take the forgotten dose as soon as
possible and then take the next dose at the usual time.
If less than 3 hoursremain until the next dose, do not take the forgotten dose. Take the next
dose at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Tavneos
Stop treatment and consult a doctor urgently 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.
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.

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-colored substance obtained from the breakdown of a blood pigment.

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

• pneumonia (symptoms may be wheezing, difficulty breathing, or chest pain).

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

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

Not known(frequency cannot be estimated from available data)

• severe liver and bile duct injury (symptoms may be feeling unwell (nausea or vomiting), feeling tired, loss of appetite, yellowing of the skin or eyes, dark urine, itching, or pain in the upper part of the stomach). (See section 2).

Other side effects may occur with the following frequencies:
Very common

• upper respiratory tract infection
• irritated and inflamed throat and nose
• headache
• nausea
• diarrhea
• vomiting
• decreased white blood cell count observed in blood tests.

Common

• inflammation of the internal nasal mucosa causing sneezing, itching, runny nose and stuffy nose
• urinary tract infections
• inflammation of the sinuses or bronchial tubes
• inflammation of the stomach and intestinal wall
• lower respiratory tract infection
• cellulitis
• Herpes Zoster
• influenza
• Candida or herpes fungal infection in the mouth
• middle ear infection
• reduced number of white blood cells called neutrophils (symptoms may be infections, fever or painful swallowing)
• pain in the upper abdomen
• increased blood level of the enzyme creatine phosphokinase (symptoms may be chest pain, confusion, muscle pain and pain, sudden weakness or numbness in the body).

Reporting of side effects
If you get 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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 package and the bottle after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original container to protect from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Tavneos contains

• The active ingredient is avacopan. Each hard capsule contains 10 mg of avacopan.
• The other ingredients are:
• macrogol hydroxystearate
• macrogol (4000)
• gelatin
• polysorbate 80
• red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
• titanium dioxide (E171).
• shellac
• potassium hydroxide.

Description of Tavneos and package contents
The Tavneos hard capsules consist of a yellow body and a light orange cap
bearing “CCX168” in black ink.
The capsules are 22 mm long, with a diameter of 8 mm.
The capsules are packaged in plastic bottles with a child-resistant closure.
Tavneos is available in

• packs containing 30 hard capsules or
• packs containing 180 hard capsules or
• multipacks containing 540 hard capsules (3 individual packs of 180 hard capsules each).

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 medicinal product, contact the marketing authorisation holder.

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website, https://www.ema.europa.eu . Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.
More detailed information on this medicinal product is also available at the following link:
https://www.tavneos-patient.eu .

Annex IV
Scientific conclusions and justifications for variations to the terms of marketing authorisations
Scientific conclusions
Considering the assessment by the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Reports (PSUR) for avacopan, the PRAC’s scientific conclusions are as follows:
In light of the available data on the timing of abnormal liver function tests detected, serious cases of drug-induced liver injury (DILI) including fatal cases reported in the post-marketing setting, and the absence of recommendations regarding the frequency or interval of liver function test monitoring in the latest recommendations from the European Alliance of Associations for Rheumatology (EULAR) for the management of anti-neutrophil cytoplasmic antibody-associated vasculitis, the PRAC considers that the frequency of liver function monitoring (i.e. liver transaminases and total bilirubin) should be further specified in the product information. The PRAC concluded that the product information for products containing avacopan should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products (CHMP) agrees with its overall conclusions and with the justification for the recommendation.

Justifications for variations to the terms of marketing authorisations
Based on the scientific conclusions on avacopan, the CHMP considers that the benefit/risk ratio of the medicinal product containing avacopan remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisations.