ALOFISEL

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

DARVADSTROCEL

Tilgjengelig fra:

TAKEDA ISRAEL LTD

ATC-kode:

L04AX08

Legemiddelform:

SUSPENSION FOR INJECTION

Sammensetning:

DARVADSTROCEL 5000000 CELLS/ML

Administreringsrute:

LOCAL INJECTION, LOCAL INJECTION

Resept typen:

Required

Produsert av:

TIGENIX, S.A.U.

Terapeutisk område:

DARVADSTROCEL

Indikasjoner:

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.

Autorisasjon dato:

2019-01-22

Informasjon til brukeren

Takeda Israel Ltd. | 25 Efal st. POB 4140., Kiryat Arie, Petach Tikva
4951125 | Tel. [phone] | www.takeda.co.il
This information brochure was developed by Takeda to assist patients
receiving
Alofisel
®
(Darvadstrocel). Please talk to your doctor about any questions
related to this medicine.
This brochure and its content was approved by the Ministry of Health
in May 2023.
C-ANPROM/IL/ALOFI/0029
PATIENT INFORMATION
BROCHURE
(darvadstrocel)
IS IT POSSIBLE TO GET AN INFECTION FROM TREATMENT
WITH ALOFISEL
®
?
Alofisel
®
is a live cell therapy and, therefore, the final product cannot be
sterilized. The
medicine is tested at various stages during its manufacture to ensure
that it is free of infection.
As the final test is performed just before Alofisel
®
is sent to the hospital, the results of this test
are not yet known when you receive the treatment. If the results
indicate an infection (this
is highly unlikely), your treatment team will be informed and will
tell you if you need any
laboratory tests or treatment for the infection. If you feel unwell or
have a fever following the
procedure, please tell your doctor as soon as possible.
It is important to report any suspected side effects. This allows
continued monitoring of the
medicine’s risk-benefit balance. Report any suspected side effect to
your doctor.
You can also report side effects to the Ministry of Health using the
online form for reporting
side effects on the Ministry of Health home page: www.health.gov.il
You can also use this link:
https://sideeffects.health.gov.il
To report side effects to Takeda Israel Ltd., send an e-mail to
[e-mail] or call 03-3733140
WHAT IS ALOFISEL
®
?
Alofisel
®
is a preparation used for the treatment of complex perianal fistulas
in adult patients
with Crohn's disease, when the other symptoms of the disease are
controlled or have a mild
intensity. Alofisel
®
is given when the fistulas have not responded sufficiently well to at
least
one conventional or biological treatment. Alofisel should be only used
after th

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
Alofisel
®
5 ×10
6
cells/mL suspension 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 suspension, corresponding to a concentration
of
5×10
6
cells/mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection (injection)
White to yellowish homogenous suspension containing a sediment, which
is readily dispersed on
shaking.
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 suspension. The full content of the 4 vials must be
administered for the
Patient information brochure
The marketing of Alofisel is subject to a risk management plan (RMP)
including a 'Patient
information brochure'. The 'Patient information brochure', emphasizes
important
safety information that the patient should be aware of before and
during treatment.
Please explain to the patient the need to review the brochure before
starting treatment.
Prescriber guide
This product is marketed with prescriber guide providing important
safety information. Please
ensure you are familiar with this material as it contains important
safety information.
2
treatment