Xevudy

Land: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

Sotrovimab

Fáanlegur frá:

GlaxoSmithKline Trading Services Limited

ATC númer:

J06BD05

INN (Alþjóðlegt nafn):

sotrovimab

Meðferðarhópur:

Immune sera and immunoglobulins,

Lækningarsvæði:

COVID-19 virus infection

Ábendingar:

Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19.

Vörulýsing:

Revision: 11

Leyfisstaða:

Authorised

Leyfisdagur:

2021-12-17

Upplýsingar fylgiseðill

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XEVUDY 500 MG CONCENTRATE FOR SOLUTION FOR INFUSION
sotrovimab
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 RECEIVE THIS MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xevudy is and what it is used for
2.
What you need to know before you are given Xevudy
3.
How Xevudy is given
4.
Possible side effects
5.
How to store Xevudy
6.
Contents of the pack and other information
1.
WHAT XEVUDY IS AND WHAT IT IS USED FOR
Xevudy contains the active substance sotrovimab. Sotrovimab is a
_monoclonal antibody_
, a type of
protein designed to recognise a specific target on the SARS-CoV-2
virus, the virus that causes
COVID-19.
Xevudy is used to treat COVID-19 in adults and adolescents (from 12
years and weighing at least
40 kg). It targets the spike protein that the virus uses to attach to
cells, blocking the virus from entering
the cell and making new viruses. By preventing the virus from
multiplying in the body, Xevudy can
help your body overcome the infection and prevent you from getting
seriously ill.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN_ _XEVUDY
_ _
YOU MUST NOT RECEIVE XEVUDY
•
if you are allergic to sotrovimab or any of the other ingredients of
this medicine (listed in
section 6).

CHECK WITH YOUR DOCTOR
if you think this applies to you.
WARNINGS AND PRECAUTIONS
ALLERGIC REACTIONS
Xevudy can cause allergic reactions.

See ‘Allergic reactions’ in Section 4
.
INFUSION-RELATED REACTIONS
Xevudy can cause infusion-related reactions.

See ‘Infusion-related reactions’ in

Vara einkenni

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
Xevudy 500 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg of sotrovimab in 8 mL (62.5 mg/mL).
Sotrovimab is a monoclonal antibody (IgG1, kappa) 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)
A clear, colourless or yellow to brown solution, free from visible
particles, with a pH of approximately
6 and an osmolality of approximately 290 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xevudy is indicated for the treatment of adults and adolescents (aged
12 years and over and weighing
at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not
require oxygen
supplementation and who are at increased risk of progressing to severe
COVID-19 (see section 5.1).
The use of Xevudy should take into account information on the activity
of sotrovimab against viral
variants of concern (see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xevudy should be administered under conditions where management of
severe hypersensitivity
reactions, such as anaphylaxis, is possible and patients can be
monitored during and for at least one
hour after administration (see section 4.4).
It is recommended that Xevudy is administered within 5 days of onset
of symptoms of COVID-19 (see
section 5.1).
Posology
_Adults and adolescents (from 12 years and 40 kg body weight)_
The recommended dose is a single 500 mg intravenous infusion
administered following dilution (see
sections 4.4 and 6.6).
Special populations
_Elderly _
3
No dose adjustment is required in elderl