SUNLENCA SOLUTION FOR INECTION

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

LENACAPAVIR AS SODIUM

Fáanlegur frá:

GILEAD SCIENCES ISRAEL LTD

ATC númer:

J05AX31

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

LENACAPAVIR AS SODIUM 309 MG/ML

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

GILEAD SCIENCES IRELAND UC, IRELAND

Lækningarsvæði:

LENACAPAVIR

Ábendingar:

Sunlenca solution for 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.

Leyfisdagur:

2023-05-23

Upplýsingar fylgiseðill

Patient leaflet in accordance with the Pharmacists’ (Products)
Regulations - 1986
This medicine is to be supplied by doctor’s prescription only
Sunlenca
®
solution for injection
lenacapavir 463.5 mg/vial
Active ingredients
: Each ml contains –
lenacapavir (as sodium)
309 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 solution for 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.
Therapeutic group:
Antivirals for systemic use, other antivirals.
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 infec

Vara einkenni

SUNLENCA
®
SOLUTION FOR INJECTION
(LENACAPAVIR (AS SODIUM) 463.5 MG)
SOLUTION FOR S.C. INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Sunlenca 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 s.c. injection (injection).
Clear, yellow to brown solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sunlenca solution for 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 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 administered by subcutaneous inject