Alofisel

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

darvadstrocel

Saadav alates:

Takeda Pharma A/S

ATC kood:

L04

INN (Rahvusvaheline Nimetus):

darvadstrocel

Terapeutiline rühm:

Immunosuppressants

Terapeutiline ala:

Rectal Fistula

Näidustused:

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

Toote kokkuvõte:

Revision: 11

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-03-23

Infovoldik

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALOFISEL 5 × 10
6 CELLS/ML DISPERSION FOR INJECTION
darvadstrocel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 surgeon.
−
If you get any side effects, talk to your surgeon or doctor. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alofisel is and what it is used for
2.
What you need to know before you are given Alofisel
3.
How Alofisel is given
4.
Possible side effects
5.
How to store Alofisel
6.
Contents of the pack and other information
1.
WHAT ALOFISEL IS AND WHAT IT IS USED FOR
The active ingredient of Alofisel is darvadstrocel which consists of
stem cells which are taken from
the fat tissue of a healthy adult donor (so-called allogenic stem
cells) and then grown in a laboratory.
Adult stem cells are a special type of cells found in many adult
tissues, whose primary role is the
repair of the tissue in which they are found.
Alofisel is a medicine used for the treatment of complex perianal
fistulas in adult patients with
Crohn´s disease (a disease causing inflammation of the gut) when the
other symptoms of the disease
are controlled or have a mild intensity. Perianal fistulas are
abnormal channels that connect parts of
the lower bowel (rectum and anus) and the skin near the anus, so that
one or more openings appear
near the anus. Perianal fistulas are described as complex if they have
multiple channels and openings,
if they penetrate deep inside your body or if they are associated with
other complications such as
collections of pus (infected liquid also called abscesses). Perianal
fistulas can cause pain, irritation and
discharge of pus through the openings to the skin.
Alofisel is used when the fistulas have not responded sufficiently
well to previous treatment. When
injected close to th

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Alofisel 5 × 10
6
cells/mL dispersion for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Alofisel (darvadstrocel) is expanded human allogeneic mesenchymal
adult stem cells extracted from
adipose tissue (expanded adipose stem cells - eASC).
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30 × 10
6
cells (eASC) in 6 mL of dispersion, corresponding to a concentration
of
5 × 10
6
cells/mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for injection (injection).
The dispersion of cells may have settled in the bottom of the vial
forming a sediment. After gentle
re-suspension, the product is a white to yellowish homogeneous
dispersion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alofisel is indicated for the treatment of complex perianal fistulas
in adult patients with
non-active/mildly active luminal Crohn’s disease, when fistulas have
shown an inadequate response to
at least one conventional or biologic therapy. Alofisel should be used
only after conditioning of the
fistulas (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Alofisel should only be administered by specialist physicians
experienced in the diagnosis and
treatment of conditions for which Alofisel is indicated.
Posology
A single dose of darvadstrocel consists of 120 × 10
6
cells supplied in 4 vials. Each vial contains
30 × 10
6
cells in 6 mL of dispersion. The full content of the 4 vials must be
administered for the
treatment of up to two internal openings and up to three external
openings. This means that with a
dose of 120 × 10
6
cells it is possible to treat up to three fistula tracts that open to
the perianal area.
The efficacy or safety of repeat administration of Alofisel has not
been established.
_ _
Special populations
_ _
_Elderly _
Data on the use of darvadstrocel in the elderly population are
limited, however, given the cell-based
nature of darvadstrocel a