Sunlenca

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

Lenacapavir sodium

から入手可能:

Gilead Sciences Ireland Unlimited Company

ATCコード:

J05AX

INN（国際名）:

lenacapavir

治療群:

Antivirals for systemic use

治療領域:

HIV Infections

適応症:

Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4.2 and 5.1).Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).

製品概要:

Revision: 01

認証ステータス:

Authorised

承認日:

2022-08-17

情報リーフレット

47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUNLENCA 464 MG SOLUTION FOR INJECTION
lenacapavir
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 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 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 Sunlenca is and what it is used for
2.
What you need to know before you are given Sunlenca
3.
How Sunlenca is given
4.
Possible side effects
5.
How to store Sunlenca
6.
Contents of the pack and other information
1.
WHAT SUNLENCA IS AND WHAT IT IS USED FOR
Sunlenca contains the active substance lenacapavir. This is an
antiretroviral medicine known as a
capsid inhibitor.
Sunlenca is a long acting medicine and
IS USED IN COMBINATION WITH OTHER ANTIRETROVIRAL MEDICINES
to treat type 1 human immunodeficiency virus (HIV), the virus that
cause acquired immunodeficiency
syndrome (AIDS).
It is used to treat HIV infection in adults with limited treatment
options (for example when other
antiretroviral medicines are not sufficiently effective or are not
suitable).
Treatment with Sunlenca in combination with other antiretrovirals
reduces the amount of HIV in your
body. This will improve the function of your immune system (the
body’s natural defences) and reduce
the risk of developing illnesses linked to HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SUNLENCA
_ _
DO NOT RECEIVE SUNLENCA
•
If you are
allergic to lenacapavir or any of the other ingredients of this
medicine (listed in
section 6)
•
If you are taking any of these medicines:
-
RIFAMPICIN

製品の特徴

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
Sunlenca 464 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose vial contains lenacapavir sodium equivalent to 463.5
mg of lenacapavir in 1.5 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear, yellow to brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sunlenca injection, in combination with other antiretroviral(s), is
indicated for the treatment of adults
with multidrug resistant HIV-1 infection for whom it is otherwise not
possible to construct a
suppressive anti-viral regimen (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Each injection should be administered by a healthcare professional.
Prior to starting lenacapavir, the healthcare professional should
carefully select patients who agree to
the required injection schedule and counsel patients about the
importance of adherence to scheduled
dosing visits to help maintain viral suppression and reduce the risk
of viral rebound and potential
development of resistance associated with missed doses. In addition,
the healthcare professional
should counsel patients about the importance of adherence to an
optimised background regimen
(OBR) to further reduce the risk of viral rebound and potential
development of resistance.
If Sunlenca is discontinued, it is essential to adopt an alternative,
fully suppressive antiretroviral
regimen where possible, no later than 28 weeks after the final
injection of Sunlenca (see section 4.4).
Posology
_Initiation _
On treatment Day 1 and Day 2, the recommended dose of Sunlenca