Entyvio

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

vedolizumab

Saatavilla:

Takeda Pharma A/S

ATC-koodi:

L04AA

INN (Kansainvälinen yleisnimi):

vedolizumab

Terapeuttinen ryhmä:

Selective immunosuppressants

Terapeuttinen alue:

Colitis, Ulcerative; Crohn Disease

Käyttöaiheet:

Ulcerative colitisEntyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.Crohn’s diseaseEntyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.PouchitisEntyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Tuoteyhteenveto:

Revision: 25

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-05-22

Pakkausseloste

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENTYVIO 300 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
vedolizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Entyvio is and what it is used for
2.
What you need to know before you are given Entyvio
3.
How Entyvio will be given
4.
Possible side effects
5.
How to store Entyvio
6.
Contents of the pack and other information
1.
WHAT ENTYVIO IS AND WHAT IT IS USED FOR
WHAT ENTYVIO IS
Entyvio contains the active substance ‘vedolizumab’. Vedolizumab
belongs to a group of biological
medicines called monoclonal antibodies (MAbs).
HOW ENTYVIO WORKS
Entyvio works by blocking a protein on the surface of white blood
cells that cause the inflammation in
ulcerative colitis, Crohn’s disease and pouchitis. This reduces the
amount of inflammation.
WHAT ENTYVIO IS USED FOR
Entyvio is used to treat the signs and symptoms in adults of:
•
moderately to severely active ulcerative colitis
•
moderately to severely active Crohn’s disease
•
moderately to severely active chronic pouchitis
Ulcerative colitis
Ulcerative colitis is a disease that causes inflammation of the large
bowel. If you have ulcerative
colitis, you will first be given other medicines. If you do not
respond well enough or cannot tolerate
these medicines, your doctor may give you Entyvio to reduce the signs
and symptoms of your disease.
Crohn’s disease
Crohn’s disease is a disease that causes inflammation of the
digestive system. If you have Crohn’s
disease you will first be given other medicines. If you do not respond
well enough or cannot tolerate
these medicines, your doctor may give you Entyvio to redu

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entyvio 300 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of vedolizumab.
After reconstitution, each mL contains 60 mg of vedolizumab.
Vedolizumab is a humanised IgG
1
monoclonal antibody produced in Chinese hamster ovary (CHO)
cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ulcerative colitis
Entyvio is indicated for the treatment of adult patients with
moderately to severely active ulcerative
colitis who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist.
Crohn’s disease
Entyvio is indicated for the treatment of adult patients with
moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumour necrosis factor-alpha (TNFα)
antagonist.
Pouchitis
Entyvio is indicated for the treatment of adult patients with
moderately to severely active chronic
pouchitis, who have undergone proctocolectomy and ileal pouch anal
anastomosis for ulcerative
colitis, and have had an inadequate response with or lost response to
antibiotic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialist healthcare
professionals experienced in the
diagnosis and treatment of ulcerative colitis, Crohn’s disease or
pouchitis (see section 4.4). Patients
should be given the package leaflet.
3
Posology
_Ulcerative colitis _
The recommended dose regimen of intravenous vedolizumab is 300 mg
administered by intravenous
infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter.
Therapy for patients with ulcerative colitis s