Stelara

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Ustekinumab

Available from:

Janssen-Cilag International NV

ATC code:

L04AC05

INN (International Name):

ustekinumab

Therapeutic group:

Immunosuppressants

Therapeutic area:

Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative

Therapeutic indications:

Crohn’s DiseaseStelara 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 TNFα antagonist or have medical contraindications to such therapies.Ulcerative colitisSTELARA 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 biologic or have medical contraindications to such therapies.Plaque psoriasisStelara is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen ultraviolet A.Paediatric plaque psoriasisStelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Psoriatic arthritisStelara, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.

Product summary:

Revision: 44

Authorization status:

Authorised

Authorization date:

2009-01-15

Patient Information leaflet

101
B. PACKAGE LEAFLET
102
PACKAGE LEAFLET: INFORMATION FOR THE USER
STELARA 130 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ustekinumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
THIS LEAFLET HAS BEEN WRITTEN FOR THE PERSON TAKING THE MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 Stelara is and what it is used for
2.
What you need to know before you use Stelara
3.
How Stelara will be given
4.
Possible side effects
5.
How to store Stelara
6.
Contents of the pack and other information
1.
WHAT STELARA IS AND WHAT IT IS USED FOR
WHAT STELARA IS
Stelara contains the active substance ‘ustekinumab’, a monoclonal
antibody. Monoclonal antibodies
are proteins that recognise and bind specifically to certain proteins
in the body.
Stelara belongs to a group of medicines called
‘immunosuppressants’. These medicines work by
weakening part of the immune system.
WHAT STELARA IS USED FOR
Stelara is used to treat the following inflammatory diseases:

Moderate to severe Crohn’s disease - in adults

Moderate to severe ulcerative colitis - in adults
CROHN’S DISEASE
Crohn’s disease is an inflammatory disease of the bowel. If you have
Crohn’s disease you will first be
given other medicines. If you do not respond well enough or are
intolerant to these medicines, you
may be given Stelara to reduce the signs and symptoms of your disease.
ULCERATIVE COLITIS
Ulcerative colitis is an inflammatory disease of the bowel. If you
have ulcerative colitis you will first
be given other medicines. If you do not respond well enough or are
intolerant to these medicines, you
may be given Stelara to reduce the signs and symptoms of your disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STELARA
DO N

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
STELARA 130 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin
(IL)-12/23 produced in a
murine myeloma cell line using recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The solution is clear, colourless to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Crohn’s Disease
STELARA 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 TNFα antagonist or have medical
contraindications to such therapies.
Ulcerative colitis
STELARA 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 biologic or have medical contraindications
to such therapies (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
STELARA concentrate for solution for infusion is intended for use
under the guidance and supervision
of physicians experienced in the diagnosis and treatment of Crohn's
disease or ulcerative colitis.
STELARA concentrate for solution for infusion should only be used for
the intravenous induction
dose.
Posology
Crohn’s Disease and Ulcerative Colitis
STELARA treatment is to be initiated with a single intravenous dose
based on body weight. The
infusion solution is to be composed of the number of vials of STELARA
130 mg as specified in
Table 1 (see section 6.6 for preparation).
3
_Table 1_
_Initial intravenous dosing of STELARA_
BODY WEIGHT OF PATIENT AT THE TIME OF
DOSING
RECOMMENDED DOSE
a
NUMBER OF 130 MG
STELARA VIALS
≤ 55 kg
260 mg
2
> 55 kg to ≤