Tavneos

Nazione: Unione Europea

Lingua: inglese

Fonte: EMA (European Medicines Agency)

Principio attivo:

Avacopan

Commercializzato da:

Vifor Fresenius Medical Care Renal Pharma France

Codice ATC:

L04

INN (Nome Internazionale):

avacopan

Gruppo terapeutico:

Immunosuppressants

Area terapeutica:

Microscopic Polyangiitis; Wegener Granulomatosis

Indicazioni terapeutiche:

Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Dettagli prodotto:

Revision: 4

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2022-01-11

Foglio illustrativo

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAVNEOS 10 MG HARD CAPSULES
avacopan
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for 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.
WHAT IS IN 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 TAVNEOS IS AND WHAT IT IS USED FOR
WHAT IS TAVNEOS?
Tavneos contains the active substance avacopan, which attaches to a
specific protein in the body,
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 granulomatosis with polyangiitis (GPA) and
microscopic polyangiitis (MPA):
•
GRANULOMATOSIS WITH POLYANGIITIS
mainly affects small blood vessels and tissues in the
kidneys, lung, throat, nose and sinuses, but also other organs.
Patients develop small lumps
(granulomas) in and around blood vessels, which are formed by tissue
damage caused by
inflammation.
•
MICROSCOPIC POLYANGIITIS
affects the smaller blood vessels. It often affects the kidneys but
may
also affect other organs.
Complement 5a receptor has a key role in stimulating inflammation.
This medicine attaches to it and
p

Scheda tecnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Tavneos 10 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg of avacopan.
Excipient with known effect
Each hard capsule contains 245 mg of macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Capsules with yellow body and light orange cap with “CCX168” in
black ink.
One capsule has a length of 22 mm and a diameter of 8 mm (size 0).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tavneos, in combination with a rituximab or cyclophosphamide regimen,
is indicated for the treatment
of adult patients with severe, active
granulomatosis with polyangiitis (GPA) or microscopic
polyangiitis (MPA) (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored by healthcare
professionals experienced in the diagnosis
and treatment of GPA or MPA.
Posology
The recommended dose is 30 mg Tavneos (3 hard capsules of 10 mg each)
taken orally twice daily,
morning and evening, with food.
Tavneos should be administered in combination with a rituximab or
cyclophosphamide regimen as
follows:
•
rituximab for 4 weekly intravenous doses or,
•
intravenous or oral cyclophosphamide for 13 or 14 weeks, followed by
oral azathioprine or
mycophenolate mofetil and,
•
glucocorticoids as clinically indicated.
For details on doses, concomitant glucocorticoids and data on efficacy
and safety for the
combinations, please see sections 4.8 and 5.1.
Clinical study data are limited to 52 weeks of exposure followed by 8
weeks of observation.
3
_Missed doses_
If a patient misses a dose, the missed dose is to be taken as soon as
possible, unless within three hours
of