Eviplera

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Emtricitabine 200mg;  ;  ;  ; Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg;  ; Tenofovir disoproxil fumarate 300mg;  ;  ;  

Available from:

Gilead Sciences (NZ)

INN (International Name):

Emtricitabine 200 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Emtricitabine 200mg       Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25 mg   Tenofovir disoproxil fumarate 300mg       Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Polysorbate 20 Povidone Pregelatinised maize starch Purified water

Units in package:

Bottle, plastic, HDPE with PP cap and desiccant, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Union Quimico Farmaceutica SA (Uquifa SA)

Therapeutic indications:

EVIPLERA is indicated for the treatment of HIV infection in treatment-na?ve adult patients with plasma HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy. EVIPLERA is also indicated 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 CLINICAL TRIALS). Patients must not have a history of resistance to any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine).

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP cap and desiccant - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2012-02-29

Patient Information leaflet

EVIPLERA Consumer Medicine Information v13.0 – (06 November 2020)
Page
1
EVIPLERA
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 25 mg
rilpivirine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before
you start taking this medicine.
This leaflet answers some of the
common questions about EVIPLERA
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
Keep this leaflet with your EVIPLERA
medicine. You may need to read it
again.
This medicine has been prescribed for
you personally and you should not pass
it on to others. It may harm them, even
if their symptoms are the same as yours.
WHAT IS EVIPLERA
EVIPLERA is used to treat Human
Immunodeficiency Virus (HIV-1)
infection in adults.
EVIPLERA consists of three medicines:
•
tenofovir disoproxil fumarate, also
called tenofovir DF
•
emtricitabine or FTC
•
rilpivirine
These are
combined in one tablet to help
control Human Immunodeficiency Virus
(HIV-1) infection.
Tenofovir disoproxil fumarate and
emtricitabine belong to a group of
antiviral medicines known as nucleoside
and nucleotide reverse transcriptase
inhibitors (NRTI).
Rilpivirine belongs to a group of
antiviral medicines known as non-
nucleoside reverse transcriptase
inhibitors (NNRTI).
_HOW EVIPLERA WORKS _
HIV-1 infection destroys CD4 T cells,
which are important to the immune
system. The immune system helps fight
infection. After a large number of T
cells are destroyed, acquired immune
deficiency syndrome (AIDS) may
develop.
EVIPLERA helps block HIV-1 reverse
transcriptase, a viral chemical in your
body (enzyme) that is needed for HIV-1
to multiply. EVIPLERA lowers the
amount of HIV-1 in the blood (viral
load). EVIPLERA may also help to
increase the number of T cells (CD4
+
cells), allowing your immune system to
improve. Lowering the amoun

Summary of Product characteristics

EVIPLERA Data Sheet v11.0 – (06 November 2020) Page 1
DATA SHEET
1. EVIPLERA
®
(TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND
RILPIVIRINE) TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/25 mg
rilpivirine
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
EVIPLERA tablets are capsule shaped, film-coated and purplish-pink in
colour. Each tablet is
debossed with ‘GSI’ on one side and plain on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EVIPLERA is indicated for the treatment of HIV infection in
treatment-naïve adult patients with
plasma HIV-1 RNA ≤ 100,000 copies/mL at the start of therapy.
EVIPLERA is also indicated 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 section 5.1 Pharmacodynamic
properties, Clinical trials).
Patients must not have a history of resistance to any of the
components of EVIPLERA (tenofovir
DF, emtricitabine or rilpivirine).
4.2 DOSE AND METHOD OF ADMINISTRATION
_Adults:_
The recommended dose of EVIPLERA is one tablet once daily taken orally
with food.
When discontinuation of EVIPLERA is necessary due to one of the
components, or where dose
modification is necessary, separate preparations of tenofovir DF,
emtricitabine and rilpivirine
should be used. Please refer to the product information for these
products (see section 4.5
Interactions with other medicines and other forms of interactions).
_ _
_Paediatric population: _
EVIPLERA is not recommended for use in children below 18 years of age
due to insufficient data on safety and efficacy.
_SPECIAL POPULATIONS _
_RENAL IMPAIRMENT:_
EVIPLERA is not recommended for use in patients with moderate or
severe
renal impairment (Creatinine Clearance (CrCl) < 50 mL/min). Patients
with moderate or severe
renal impairment require dose interval adjustments of tenofovir