Tavneos 10 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Tavneos 10 mg hard capsules
avacopan
This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, since it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Tavneos is and what it is used for
- What you need to know before taking Tavneos
- How to take Tavneos
- Possible side effects
- How to store Tavneos
- Contents of the pack and other information
1. What Tavneos is 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 gradually worsening disease caused by 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 nodules (granulomas) inside and around blood vessels, formed due to tissue damage caused by inflammation.
- Microscopic polyangiitis affects the smallest blood vessels. It often affects the kidneys, but may also involve other organs.
The complement 5a receptor plays a key role in promoting inflammation. This medicine binds to it and prevents it from functioning, thereby reducing the blood vessel inflammation seen in these diseases.
Tavneos may be used together with other treatments prescribed by your doctor.
2. What you need to know before taking Tavneos
Do not take Tavneos
- if you are allergic to avacopan or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before starting Tavneos and during treatment if you have or have had:
- symptoms of liver damage such as feeling unwell (nausea or vomiting), fatigue, loss of appetite, yellowing of the skin or eyes, dark urine, itching, upper stomach pain, elevated levels of total bilirubin, the yellow breakdown product of blood pigment, or of liver enzymes such as transaminases
- any infection, bruising and unexpected bleeding (these are common signs of bone marrow failure)
- hepatitis B, hepatitis C, HIV infection or tuberculosis
- a heart condition, such as heart attack, heart failure, or inflammation of blood vessels in the heart
- any type of cancer.
Tavneos is not recommended in patients with
- active liver disease, or
- an active and serious infection.
Your doctor will perform blood tests before and as needed during treatment to monitor:
- any problems with your liver (by measuring liver enzymes and total bilirubin in the blood)
- your risk of developing infections (by measuring lymphocyte count).
Your doctor may decide to temporarily interrupt or permanently discontinue treatment.
- Your doctor will also monitor for signs and symptoms of infection caused by Neisseria meningitidis. This is recommended in adult patients with GPA or MPA.
Prophylactic treatment to prevent Pneumocystis jirovecii pneumonia is recommended during treatment with Tavneos.
Vaccination is recommended prior to starting Tavneos or when there is no active disease (granulomatosis with polyangiitis or microscopic polyangiitis).
Severe and often painful swelling under the skin, mainly in the face, has been reported during treatment with Tavneos. If swelling affects the throat, it may cause difficulty breathing. Stop treatment and seek immediate medical attention if you experience swelling of the face, lips, tongue, or throat, or have difficulty breathing.
Children and adolescents
Do not give this medicine to children under 18 years of age, as there is insufficient evidence to determine 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 need to take any other medicines.
It is important that you talk to your doctor, especially if you are taking any of the following medicines:
- carbamazepine, phenobarbital, phenytoin: medicines used to treat epilepsy and other conditions
- enzalutamide, mitotane: medicines used to treat cancer
- rifampicin: a medicine used to treat tuberculosis or other infections
- St. John’s wort; a herbal medicine used for mild depression
If short-term use of any of these medicines cannot be avoided during treatment with Tavneos, your doctor may regularly monitor your condition to ensure Tavneos remains effective.
Tavneos may affect or be affected by the following medicines:
- alfentanil: an analgesic used during surgery under anesthesia
- boceprevir, telaprevir: medicines used to treat hepatitis C
- bosentan: a medicine used to treat pulmonary hypertension and skin ulcers in hands and feet due to scleroderma
- clarithromycin, telithromycin: antibiotic medicines used to treat bacterial infections
- conivaptan: a medicine used to treat low blood sodium levels
- cyclosporine: a medicine used to suppress the immune system to prevent organ transplant rejection, or to treat severe skin diseases and severe eye or joint inflammation
- dabigatran: an anticoagulant medicine
- dihydroergotamine, ergotamine: medicines used to treat migraine
- fentanyl: a strong painkiller
- indinavir, efavirenz, etravirine, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir: medicines used to treat HIV infection
- itraconazole, posaconazole, voriconazole: medicines used to treat fungal infections
- ketoconazole: a medicine used to treat symptoms caused by excessive cortisol production in the body, known as Cushing's syndrome
- mibefradil: a medicine used to treat irregular heart rhythm and high blood pressure
- modafinil: a medicine used to treat excessive sleepiness
- nefazodone: a medicine used to treat depression
- simvastatin: a medicine used to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides in the blood
- sirolimus, tacrolimus: medicines used to suppress the immune system and prevent organ transplant rejection.
Taking Tavneos with food and drink
Avoid grapefruit and grapefruit juice during treatment with Tavneos, as they may affect the medicine’s action.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
- Pregnancy
This medicine is not recommended during pregnancy or in women of childbearing potential who are not using contraception.
- Breastfeeding
It is unknown whether avacopan passes into breast milk. A risk to the breastfed infant cannot be excluded. Your doctor will help you decide whether to discontinue Tavneos or to stop breastfeeding.
Driving and using machines
It is unlikely that Tavneos will affect your ability to drive or use machines.
Tavneos contains macrogolglycerol hydroxystearate.
This may cause stomach discomfort and diarrhoea.
3. How to take Tavneos
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
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 not crush, 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
Speak to your doctor immediately.
If you forget to take Tavneos
If more than 3 hours remain until your next scheduled dose, take the missed dose as soon as possible, then take the next dose at the usual time.
If less than 3 hours remain until your next 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 a missed dose.
If you stop treatment with Tavneos
Stop taking the medicine and seek urgent medical attention if you experience swelling of the face, lips, tongue or throat, or have difficulty breathing. In any other situation, do not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Contact your doctor immediately if the following serious adverse effects occur:
Very common (may affect more than 1 in 10 people)
- blood tests showing increased levels of:
- liver enzymes (a sign of liver problems)
- bilirubin: a yellow substance 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).
Uncommon (may affect 1 in 100 people)
- severe allergic reaction causing swelling under the skin, mainly in the face, which may lead to 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 unwell (nausea or vomiting), feeling tired, loss of appetite, yellowing of the skin or eyes, dark urine, itching, pain in the upper stomach). (See section 2).
Other adverse effects may occur with the following frequencies:
Very common
- upper respiratory tract infection
- sore and inflamed throat and nose
- headache
- malaise (nausea)
- diarrhoea
- vomiting
- decreased white blood cell count in blood tests
Common
- inflammation of the inner lining of the nose causing sneezing, itching, runny nose, and nasal congestion
- urinary tract infections
- inflammation of the sinuses or bronchi
- inflammation of the stomach and intestinal lining
- lower respiratory tract infection
- cellulitis
- herpes
- influenza
- fungal infection by Candida yeast 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 blood levels of the enzyme creatine phosphokinase (symptoms may include chest pain, confusion, muscle pain, sudden weakness, or numbness of the body).
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and vial following "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions. Store in the original vial to protect it from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This 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 components are:
- macrogol glyceryl hydroxystearate
- macrogol (4000)
- gelatin
- polysorbate 80
- iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172)
- titanium dioxide (E171)
- shellac
- potassium hydroxide
What Tavneos looks like and contents of the pack
Tavneos hard capsules consist of a yellow body and a light orange cap, with "CCX168" printed in black ink.
The capsules are 22 mm in length and have 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).
Only certain pack sizes may be marketed.
Marketing Authorization 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, please contact the Marketing Authorization Holder.
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also available.
You can find detailed information on this medicinal product at the following URL: https://www.tavneos-patient.eu.https://www.tavneos-patient.eu.