EVIPLERA

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

EMTRICITABINE; RILPIVIRINE AS HYDROCHLORIDE; TENOFOVIR DISOPROXIL AS FUMARATE

Tilgængelig fra:

J-C HEALTH CARE LTD

ATC-kode:

J05AG05

Lægemiddelform:

FILM COATED TABLETS

Sammensætning:

TENOFOVIR DISOPROXIL AS FUMARATE 245 MG; RILPIVIRINE AS HYDROCHLORIDE 25 MG; EMTRICITABINE 200 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

JANSSEN CILAG S.P.A., ITALY

Terapeutisk gruppe:

RILPIVIRINE

Terapeutisk område:

RILPIVIRINE

Terapeutiske indikationer:

EVIPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).The following points should be considered when initiating therapy with EVIPLERA in adult patients with no antiretroviral treatment history: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies (14)]. • Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [See Clinical Studies (14)]. • The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology (12.4)]• More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology (12.4)].

Autorisation dato:

2018-02-28

Indlægsseddel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
EVIPLERA
®
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND THEIR QUANTITIES IN EACH
FILM-COATED TABLET:
Emtricitabine 200 mg / Rilpivirine 25 mg (as hydrochloride) /
Tenofovir disoproxil 245 mg (as fumarate)
Inactive and allergenic ingredients in the preparation – see
section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may harm them, even
if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Eviplera contains three active ingredients (emtricitabine,
rilpivirine and tenofovir disoproxil) in one tablet intended to
treat HIV infection (AIDS).
Each of these active ingredients is known as an antiretroviral
medicine that interferes with the activity of an enzyme (a
protein called reverse transcriptase) that is essential for the
virus to multiply.
Eviplera reduces the amount of HIV in your body, thus
improving the immune system and reducing the risk of
developing illnesses linked to HIV infection.
Eviplera is a treatment for HIV infection in adults aged 18
years and over who have not been treated before with other
medicines for treatment of HIV and whose viral burden before
commencement of treatment does not exceed 100,000
copies per ml, and in certain adults with a viral burden below
50 copies per ml at the beginning of treatment in order to
replace a current medicinal anti-HIV treatment.
THERAPEUTIC GROUP
• Emtricitabine, nucleoside reverse transcriptase inhibitors
(NRTI)
• Rilpivirine, non-nucleoside reverse transcriptase inhibitors
(NNRTI)
• Tenofovir disoproxil, nucleotide reverse transcriptase
inhibitors (NtRTI)
2. BEFORE USING THE MEDICINE

Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT
Eviplera
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine,
25 mg of rilpivirine (as hydrochloride) and
245 mg of tenofovir disoproxil (as fumarate).
Excipients with known effect
Each film-coated tablet contains 277 mg lactose monohydrate and 4
micrograms sunset yellow
aluminium lake (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Purplish-pink, capsule-shaped, film-coated tablet debossed on one side
with “GSI” and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EVIPLERA, a combination of two nucleoside analog HIV 1 reverse
transcriptase inhibitors
(emtricitabine and tenofovir disoproxil) and one non-nucleoside
reverse transcriptase inhibitor
(rilpivirine), is indicated for use as a complete regimen for the
treatment of HIV-1 infection in
adult patients with no antiretroviral treatment history and with HIV-1
RNA less than or equal
to 100,000 copies/mL at the start of therapy, and in certain
virologically-suppressed (HIV-1
RNA <50 copies/mL) adult patients on a stable antiretroviral regimen
at start of therapy in
order to replace their current antiretroviral treatment regimen (see
below).
The following points should be considered when initiating therapy with
EVIPLERA
in adult
patients with no antiretroviral treatment history:
•
More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000
copies/mL at the
start of therapy experienced virologic failure (HIV-1 RNA ≥50
copies/mL) compared to
rilpivirine-treated subjects with HIV-1 RNA less than or equal to
100,000 copies/mL
_[See _
_Pharmacodynamic properties(5.1)]_
.
•
Regardless of HIV-1 RNA level at the start of therapy, more
rilpivirine-treated subjects
with CD4+ cell count less than 200 cells/mm
3
experienced virologic failure compared to
rilpivirine-treated subjects with CD4+ cell count greater than or
equal to 200 cells/mm
3
_[See Pharmacodynamic properties(5.1)]_
.
•
The obs