Spevigo

국가: 유럽 연합

언어: 영어

출처: EMA (European Medicines Agency)

유효 성분:

Spesolimab

제공처:

Boehringer Ingelheim International GmbH

ATC 코드:

L04AC22

INN (국제 이름):

spesolimab

치료 그룹:

Immunosuppressants

치료 영역:

Psoriasis

치료 징후:

Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

승인 상태:

Authorised

승인 날짜:

2022-12-09

환자 정보 전단

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SPEVIGO 450 MG CONCENTRATE FOR SOLUTION FOR INFUSION
spesolimab
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, 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 Spevigo is and what it is used for
2.
What you need to know before you are given Spevigo
3.
How Spevigo will be given
4.
Possible side effects
5.
How to store Spevigo
6.
Contents of the pack and other information
1.
WHAT SPEVIGO IS AND WHAT IT IS USED FOR
WHAT SPEVIGO IS
Spevigo contains the active substance spesolimab. Spesolimab belongs
to a group of medicines called
interleukin (IL) inhibitors. This medicine works by blocking the
activity of a protein called IL36R,
which is involved in inflammation.
WHAT SPEVIGO IS USED FOR
Spevigo is used alone in adults to treat flares of a rare inflammatory
skin disease called generalised
pustular psoriasis (GPP). During a flare, patients may experience
painful skin blisters that develop
suddenly over large areas of the skin. These blisters, also called
pustules, are filled with pus. The skin
may become red, itchy, dry, cracked or scaly. Patients may also
experience more general signs and
symptoms, such as fever, headache, extreme tiredness, or a burning
sensation of the skin.
Spevigo improves skin clearance and reduces symptoms of GPP during a
flare.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SPEVIGO
A doctor experienced in treating patients with inflammatory skin
diseases will start and supervise your
treatment.
YOU MUST NOT RECEIVE SPEVIGO IF

제품 특성 요약

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
Spevigo 450 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 450 mg spesolimab in 7.5 mL.
Each mL of concentrate for solution for infusion contains 60 mg
spesolimab.
After dilution, each mL of the solution contains 9 mg spesolimab (see
section 6.6).
Spesolimab is produced in Chinese hamster ovary 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 to slightly opalescent, colourless to slightly brownish-yellow
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spevigo is indicated for the treatment of flares in adult patients
with generalised pustular psoriasis
(GPP) as monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by physicians experienced
in the management of patients
with inflammatory skin diseases.
Posology
The recommended dose is a single dose of 900 mg (2 vials of 450 mg)
administered as an intravenous
infusion.
If flare symptoms persist, an additional 900 mg dose may be
administered 1 week after the initial dose.
Clinical data for treatment of subsequent flares is very limited (see
section 4.4).
Clinical data for concomitant use of other GPP treatments with
spesolimab is limited. Spesolimab
should not be used in combination with other GPP treatments, e.g.
systemic immunosuppressants, to
treat a flare (see sections 4.4 and 4.5).
_Elderly_
No dose adjustment is required.
3
_Renal or hepatic impairment_
Spesolimab has not been studied in these patient populations. These
conditions are generally not
expected to have any clinically relevant imp