Tyenne

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Ingredient activ:

tocilizumab

Disponibil de la:

Fresenius Kabi Deutschland GmbH

Codul ATC:

L04AC07

INN (nume internaţional):

tocilizumab

Grupul Terapeutică:

Immunosuppressants

Zonă Terapeutică:

Arthritis, Rheumatoid; Cytokine Release Syndrome; Arthritis, Juvenile Rheumatoid; COVID-19 virus infection; Giant Cell Arteritis

Indicații terapeutice:

Tyenne, in combination with methotrexate (MTX), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.In these patients, Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. Tyenne can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.Tyenne in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.Tyenne can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tyenne is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Tyenne is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.

Statutul autorizaţiei:

Authorised

Data de autorizare:

2023-09-15

Prospect

131
B. PACKAGE LEAFLET
132
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYENNE 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
tocilizumab
▼
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section
4 for how to report side effects.
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 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.
In addition to this leaflet, you will be given a
PATIENT ALERT CARD
, which contains important safety
information that you need to be aware of before and during treatment
with Tyenne.
WHAT IS IN THIS LEAFLET
1.
What Tyenne is and what it is used for
2.
What you need to know before you are given Tyenne
3.
How Tyenne is given
4.
Possible side effects
5.
How to store Tyenne
6.
Contents of the pack and other information
1.
WHAT TYENNE IS AND WHAT IT IS USED FOR
Tyenne contains the active substance tocilizumab, which is a protein
made from specific immune
cells (monoclonal antibody), that blocks the action of a specific
protein (cytokine) called
interleukin-6. This protein is involved in inflammatory processes of
the body, and blocking it can
reduce the inflammation in your body. Tyenne helps to reduce symptoms
such as pain and swelling
in your joints and can also improve your performance of daily tasks.
Tyenne has been shown to
slow the damage to the cartilage and bone of the joints caused by the
disease and to improve your
ability to do normal daily activities.
•
TYENNE IS USED TO TREAT ADULTS
with moderate to severe
ACTIVE RHEUMATOID ARTHRITIS (RA)
,
an autoimmune disease, if previous therapies did not work well enough.
Tyenne is usually
given in combination with methotrexat

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification
of new safety information. Healthcare professionals are asked to
report any suspected adverse
reactions. See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Tyenne 20 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL concentrate contains 20 mg tocilizumab*.
Each vial contains 80 mg of tocilizumab* in 4 mL (20 mg/mL).
Each vial contains 200 mg of tocilizumab* in 10 mL (20 mg/mL).
Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
*humanised IgG1 monoclonal antibody against the human interleukin-6
(IL-6) receptor produced
in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear and colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tyenne, in combination with methotrexate (MTX), is indicated for:
•
the treatment of severe, active and progressive rheumatoid arthritis
(RA) in adults not
previously treated with MTX.
•
the treatment of moderate to severe active RA in adult patients who
have either responded
inadequately to, or who were intolerant to, previous therapy with one
or more disease-
modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor
(TNF) antagonists.
In these patients, Tyenne can be given as monotherapy in case of
intolerance to MTX or where
continued treatment with MTX is inappropriate.
Tocilizumab has been shown to reduce the rate of progression of joint
damage as measured by X-
ray and to improve physical function when given in combination with
methotrexate.
Tyenne is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults who are
receiving systemic corticosteroids and require supplemental oxygen or
mechanical ventilation.
Tyenne is indicated for the