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, the so-called complement 5a receptor.
What is Tavneos used for?
Tavneos is used to treat adults with a gradually worsening disease caused by inflammation of the small blood vessels called granulomatous polyangiitis (GPA) and microscopic polyangiitis MPA):
- Granulomatous polyangiitis mainly affects small blood vessels and tissue in the kidneys, lungs, pharynx, nose, and sinuses, but also other organs. Patients develop small nodules (granulomas) in and around the blood vessels, which are formed by tissue damage caused by inflammation a.
- Microscopic polyangiitis affects the smaller blood vessels, often in the kidneys but can also affect other organs.
The complement 5a receptor has a key role in stimulating inflammation. This drug attaches to the receptor and prevents it from working, reducing the inflammation of the blood vessels seen in these diseases.
Tavneos can be used together with other treatments prescribed by your doctor.
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
Talk to your doctor before taking Tavneos and during treatment if you have had or have:
- liver disease such as increased levels of total bilirubin, which is the yellow waste product after the breakdown of pigments in the blood, or increased levels of liver enzymes such as transaminases
- an infection, unexpected bruising, and bleeding (these two are common signs of bone marrow failure)
- hepatitis B, hepatitis C, HIV infection, or tuberculosis
- heart disease such as heart attack, heart failure, inflammation of the blood vessels of the heart
- any type of cancer.
Tavneos is not recommended for patients with
- active liver disease or
- an active serious infection.
The doctor will take blood samples before and if necessary during treatment to check:
- if you have any liver problems (by measuring liver enzymes and total bilirubin in the blood)
- your risk of getting an infection (by measuring the number of white blood cells ).
The doctor will decide to either temporarily pause your treatment or stop it permanently.
The doctor will also monitor you to see if you develop signs and symptoms of an infection called Neisseria meningitides . This is recommended for adult patients with GPA or MPA.
It is recommended that you receive treatment to prevent the lung infection Pneumocystis jirovecii pneumonia ( pneumonia ) during treatment with Tavneos.
It is recommended that vaccinations are given before starting treatment with Tavneos or when the disease is not active ( granulomatous polyangiitis or microscopic polyangiitis).
Severe and usually painful swelling under the skin, mainly in the face, has been reported during treatment with Tavneos. If this affects the pharynx, it can be difficult to breathe. Stop treatment and seek emergency medical attention if you develop swelling of the face, lips, tongue, or throat, or if you experience difficulty breathing.
Children and young people
Do not give this medicine to children under 18 years of age because there is not enough evidence to know 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 to tell the doctor if you are taking any of the following medicines:
- carbamazepine, phenobarbital, phenytoin: medicines to treat epilepsy and other disorders
- enzalutamide, mitotane: medicines to treat cancer
- 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 any of these medicines cannot be avoided during treatment with Tavneos, your doctor may check your condition regularly to see how well Tavneos is working.
Tavneos can affect or be affected by the following medicines:
- alfentanil: a pain-relieving drug used during operations with anesthetics
- boceprevir, telaprevir: medicines to treat hepatitis C
- bosentan: a medicine to treat high blood pressure in the lungs, and ulcers on the fingers and toes called scleroderma
- clarithromycin, telithromycin: antibiotics to treat bacterial infections
- conivaptan: a medicine to treat low levels of sodium in the blood
- ciclosporin: a medicine to suppress the immune system and prevent transplant rejection, treat severe skin diseases and severe eye or joint inflammation
- dabigatran: a blood-thinning medicine
- dihydroergotamine, ergotamine: medicine to treat migraine
- fentanyl: a powerful 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, so-called Cushing’s syndrome
- mibefradil: a medicine to treat irregular heart rhythms and high blood pressure
- modafinil: a drug to treat an extreme tendency to fall asleep
- nefazodone: a medicine to treat depression
- sirolimus, tacrolimus: drugs to suppress the immune system and prevent transplant rejection.
Tavneos with food and drink
Avoid grapefruit and grapefruit juice during treatment with Tavneos, as these can affect the effectiveness 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 using this medicine.
- Pregnancy
This medicine is not recommended during pregnancy or for women of childbearing potential who are not using contraception. - Breastfeeding
It is not known whether avacopa passes into breast milk. A risk to the child cannot be ruled out. The doctor will help you decide whether to stop treatment with Tavneos or stop breastfeeding.
Driving ability and use of machinery
It is considered unlikely that Tavneos would affect your ability to drive or use machines.
Tavneos contains macrogol glycerol hydroxy stearate
This can cause stomach upset and diarrhea.
How to take Tavneos
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 3 capsules in the morning and 3 capsules in the evening.
Mode of administration
Swallow the capsules whole with a glass of water. The capsules must not be crushed, chewed, or opened. Take the capsules with a meal, 3 capsules in the morning and 3 capsules in the evening.
If you have taken too much Tavneos
Talk to the doctor immediately.
If you forget to take Tavneos
If you have more than 3 hours until your next scheduled dose, take the missed dose as soon as possible and then take the next dose at the correct time.
If it is less than 3 hours until the next scheduled dose, do not take the missed dose. Just 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 seek emergency medical attention if you develop swelling of the face, lips, tongue, or throat, or if you experience difficulty breathing. In all other situations, do not stop taking this medicine without talking to your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following serious side effects:
Very common (may affect more than 1 in 10 users)
- blood tests showing increased levels of
- liver enzymes (signs of liver problems)
- bilirubin: a yellow breakdown substance of the pigment in the blood.
Common (may affect up to 1 in 10 users)
- pneumonia (symptoms may be wheezing, difficulty breathing, or chest pain).
Uncommon (may affect up to 1 in 100 users)
- severe allergic reactions that cause swelling under the skin, mainly in the face, and may cause breathing difficulties ( angioedema ).
Other side effects may occur with the following frequencies:
Very common
- upper respiratory tract infection
- sore throat and inflammation of the throat and nose
- headache
- nausea
- diarrhea
- vomiting
- decreased number of white blood cells seen in blood tests.
Usual
- inflammation inside the nose that causes sneezing, itching, runny and blocked nose
- urinary tract infection
- inflammation of the sinuses or trachea
- inflammation of the stomach and intestinal mucosa
- lower respiratory tract infection
- cellulitis ( inflammation of skin/connective tissue)
- shingles
- influenza
- infection with the yeast Candida or herpes in the mouth
- inflammation of the middle ear
- reduced number of white blood cells called neutrophils (symptoms may be infection, fever, or pain when swallowing)
- pain in the upper part of the abdomen
- increased levels of the enzyme creatinine phosphokinase in the blood (symptoms may be chest pain, confusion, aches and pains, sudden weakness, or numbness in the body).
How to store Tavneos
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton or can after “EXP”. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original jar. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is avacopa.
Each hard capsule contains 10 mg of avacopan. - Other ingredients are:
- macrogol glycerol hydroxy stearate
- macrogol (4000)
- gelatine
- polysorbate 80
- red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
- titanium dioxide (E171)
- shellac
- potassium hydroxide.
Appearance and package sizes of the medicine
Tavneo’s hard capsules consist of a yellow body and light orange body marked with “CCX168” in black ink.
The capsules are 22 mm long and have a diameter of 8 mm.
The capsules are packaged in plastic jars with child-resistant closures.
Tavneos are available in packs of 30 or 180 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
For France
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
ABOUT Pharma SA
R. da Indústria, 2
Quinta Grande
Amadora, 2610-088
Portugal
Contact the marketing authorization holder if you want to know more about this medicine.