SUNLENCA FILM-COATED TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

LENACAPAVIR AS SODIUM

متاح من:

GILEAD SCIENCES ISRAEL LTD

ATC رمز:

J05AX31

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

LENACAPAVIR AS SODIUM 300 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GILEAD SCIENCES IRELAND UC, IRELAND

المجال العلاجي:

LENACAPAVIR

الخصائص العلاجية:

Sunlenca film-coated 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.

تاريخ الترخيص:

2023-05-23

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists’ (Products)
Regulations - 1986
This medicine is to be supplied by doctor’s prescription only
Sunlenca
®
film-coated tablets
lenacapavir
Active ingredients
: Each tablet contains –
lenacapavir (as sodium)
300 mg
Inactive and allergenic substances:
see section 6
_“Additional information_
”.
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you
. This leaflet contains essential information about this medicine. If
you have any further questions, ask your doctor or pharmacist. Keep
this leaflet. You may need to read
it again. This medicine has been prescribed for you only. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
If you experience any side effects,
talk to your doctor or pharmacist. Even if you experience any side
effects that are not listed in this
leaflet (see section 4).
This medicine is intended for adults aged 18 years and over.
1.
What is the medicine intended for
Sunlenca film-coated 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.
Therapeutic group:
Antivirals for systemic use, other antivirals.
Sunlenca
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 developi

خصائص المنتج

Sunlenca
®
film-coated tablets
(lenacapavir (as sodium) 300 mg)
Per os
1.
NAME OF THE MEDICINAL PRODUCT
Sunlenca film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lenacapavir sodium equivalent to 300
mg of lenacapavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Beige, capsule-shaped, film-coated tablets of dimensions 10 mm x 21
mm, debossed with “GSI” on
one side of the tablet and “62L” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
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).
4.2
Posology and method of administration
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
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.
Posology
_ _
Initiation of treatment with lenacapavir requires Sunlenca film-coated
tablets to be taken as oral
loading prior to administration of Sunlenca injection.
_Initiation _
On treatment Day 1 and Day 2, the recommended dose of Sunlenca is 600
mg per day taken orally. On
treatment Day 8, the recommended dose is 300 mg taken orally. Then, on
treatment Day 15, the
recommended dose is 927 mg admin