JULUCA FILM-COATED TABLET 50MG25MG

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Dolutegravir sodium 52.62mg eqv Dolutegravir; Rilpivirine hydrochloride 27.50mg eqv Rilpivirine

Tersedia dari:

GLAXOSMITHKLINE PTE LTD

Kode ATC:

Pending

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

Dolutegravir sodium 52.62mg eqv Dolutegravir 50mg; Rilpivirine hydrochloride 27.50mg eqv Rilpivirine 25mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

2019-03-22

Selebaran informasi

Page 1 of 9
PATIENT LEAFLET
JULUCA FILM COATED TABLETS
DOLUTEGRAVIR-RILPIVIRINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again. If you have any
questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you personally. Don’t pass it
on to other people - it
may harm them even if their symptoms seem to be the same as yours.
IN THIS LEAFLET
1.
WHAT JULUCA IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE JULUCA
3.
HOW TO TAKE JULUCA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE JULUCA
6.
FURTHER INFORMATION
1. WHAT JULUCA IS AND WHAT IT IS USED FOR
JULUCA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS.
JULUCA contains two active ingredients that are used to treat HIV
infection:
dolutegravir plus rilpivirine. Dolutegravir belongs to a group of
anti-retroviral medicines
called
_integrase inhibitors _
(INIs). Rilpivirine belongs to a group of anti-retroviral
medicines called
_non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs)_
.
JULUCA does not cure HIV infection; it keeps the amount of virus in
your body at a low
level. This helps maintain the number of CD4+ cells in your blood.
CD4+ cells are a type
of white blood cells that are important in helping your body to fight
infection.
Not everyone responds to treatment with JULUCA in the same way. Your
doctor will
monitor the effectiveness of your treatment.
Page 2 of 9
2. BEFORE YOU TAKE JULUCA
DON’T TAKE JULUCA
•
if
YOU’RE ALLERGIC _(HYPERSENSITIVE)_ TO DOLUTEGRAVIR OR RILPIVIRINE
or to any of the
other ingredients of JULUCA (listed in Section 6).
•
if you’re taking any of these medicines:
o
DOFETILIDE
or
PILSICAINIDE
(to treat heart conditions)
o
FAMPRIDINE
(also known as dalfampridine; used in multiple sclerosis).
o
CARBAMAZEPINE, OXCARBAZEPINE, PHENOBARBITAL,
or
PHENYTOIN
(also
known as anticonvulsants used to treat epilepsy and prevent seizures)
o
RIFAMPICIN
or
RIFAPENTINE
(to treat some bacterial infections such as
tuberculosis)

Karakteristik produk

JULUCA
DOLUTEGRAVIR/RILPIVIRINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pink, film-coated, oval, biconvex tablets debossed with ‘SV J3T’
on one side.
Each film-coated tablet contains 50 mg of dolutegravir (as
dolutegravir sodium) and
25 mg of rilpivirine (as rilpivirine hydrochloride).
CLINICAL INFORMATION
INDICATIONS
_JULUCA_
is indicated for the treatment of human immunodeficiency virus-1
(HIV-1)
infection to replace the current antiretroviral regimen in adults who
are virologically
suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral
regimen for at least 6
months with no history of virological failure and without known or
suspected resistance
to either antiretroviral component.
DOSAGE AND ADMINISTRATION
Pharmaceutical Form
Film-coated tablets.
Therapy should be initiated by a physician experienced in the
management of HIV
infection.
If the patient misses a dose of
_JULUCA_
, the patient should take it with a meal as soon as
they remember if it is more than 12 hours until the next dose. If the
next dose is due
within 12 hours, the patient should skip the missed dose and resume
the usual dosing
schedule.
Separate preparations of dolutegravir and rilpivirine are available
where dose adjustment
or discontinuation of one of the individual components is indicated (
_see Interactions_
). In
these cases the physician should refer to the individual product
information.
ADULTS
The recommended dose of
_JULUCA_
in adults is one tablet once daily taken orally with a
meal.
ADOLESCENTS AND CHILDREN
_JULUCA_
is not recommended in pediatric patients below 18 years of age due to
insufficient safety and efficacy data.
ELDERLY
No dose adjustment of
_JULUCA_
is required in elderly patients. There are limited data
available on the use of
_JULUCA_
in patients aged 65 years and over (
_see _
_Pharmacokinetics – Special Patient Populations_
).
RENAL IMPAIRMENT
No dosage adjustment of
_JULUCA_
is required in patients with renal impairment (
_see _
_Pharmacokinetics — Special Patient Populations_
).
HEPATIC IMPAIRMEN