TAVNEOS

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

AVACOPAN

Disponibbli minn:

CTS LTD

Kodiċi ATC:

L04AA59

Għamla farmaċewtika:

HARD CAPSULE

Kompożizzjoni:

AVACOPAN 10 MG

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., SWITZERLAND

Żona terapewtika:

AVACOPAN

Indikazzjonijiet terapewtiċi:

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).

Data ta 'l-awtorizzazzjoni:

2023-07-05

Fuljett ta 'informazzjoni

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
– 1986
The medicine is dispensed with a doctor’s prescription only
TAVNEOS
HARD CAPSULES
Each capsule contains 10 mg Avacopan
Inactive and allergenic ingredients in the preparation -
see Section 6 and the section “Important
information about some of the ingredients of the medicine”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar.
1.
WHO IS THE MEDICINE INTENDED FOR?
Tavneos, in combination with Rituximab or Cyclophosphamide, is
designed for the treatment of
adult patients with severe and active granulomatosis with polyangiitis
(GPA) or microscopic
polyangiitis (MPA).
THERAPEUTIC GROUP: Complement system inhibitors
Tavneos contains the active ingredient avacopan, which attaches to a
specific protein in the
body called the complement 5a receptor.
The complement 5a receptor plays a key role in stimulating
inflammation. Tavneos binds to this
protein and prevents it from working, thereby reducing inflammation of
blood vessels observed
in these diseases.
Tavneos can be used together with other treatments prescribed by your
doctor.

Granulomatosis with polyangiitis (GPA)
–
mainly affects small blood vessels and tissues
in the kidneys, lungs, throat, nose and sinuses, but affects other
organs as well. Patients
develop small lumps (granulomas) in and around the blood vessels,
which are formed as
a result of tissue damage caused by inflammation.

Microscopic polyangiitis (MPA) - affects the smaller blood vessels. It
usually affects the
kidneys, but may also affect other organs.
2.
BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to avacopan, or to any of the other
ingredients of th

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
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.
2
_Missed doses_
If a patient misses a dose, the missed dose is to be taken as soon as
possible, unless within three hours
of the next scheduled dose. If within three hours, then the missed
dose is not to be taken.
_Dose management_
Treatment must be re-assessed clinically and temporarily stopped if:
•
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is
more than 3 t