EVIPLERA tenofovir disoproxil fumarate 300 mg /emtricitabine 200 mg /rilpivirine (as HCl) 25 mg tablet bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

emtricitabine, Quantity: 200 mg; tenofovir disoproxil fumarate, Quantity: 300 mg; rilpivirine hydrochloride, Quantity: 27.5 mg (Equivalent: rilpivirine, Qty 25 mg)

Disponible depuis:

Gilead Sciences Pty Ltd

DCI (Dénomination commune internationale):

Emtricitabine,rilpivirine hydrochloride,Tenofovir disoproxil fumarate

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; microcrystalline cellulose; croscarmellose sodium; polysorbate 20; povidone; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; triacetin; iron oxide red; macrogol 3350; indigo carmine aluminium lake

Mode d'administration:

Oral

Unités en paquet:

30 tablets/bottle

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

EVIPLERA is indicated for the treatment of HIV infection in treatment-na?ve 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 CLINICAL TRIALS). Patients must not have a history of resistance to any of the components of EVIPLERA (tenofovir DF, emtricitabine or rilpivirine).

Descriptif du produit:

Visual Identification: Purplish-pink, capsule-shaped film-coated tablet; debossed with 'GSI' on one side, and plain faced on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Statut de autorisation:

Licence status A

Date de l'autorisation:

2012-01-30

Notice patient

EVIPLERA Consumer Medicine Information v12.0 – (15 July 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 amount of

Résumé des caractéristiques du produit

EVIPLERA Product Information v17.0 – (15 July 2020)
Page
1
AUSTRALIAN PRODUCT INFORMATION - EVIPLERA
®
(TENOFOVIR DISOPROXIL
FUMARATE, EMTRICITABINE AND RILPIVIRINE) TABLETS
1
NAME OF THE MEDICINE
EVIPLERA (tenofovir disoproxil fumarate/emtricitabine/rilpivirine).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate
(tenofovir DF) which is
equivalent to 245 mg of tenofovir disoproxil, 200 mg emtricitabine
(FTC), and 27.5 mg rilpivirine
hydrochloride which is equivalent to 25 mg rilpivirine (RPV).
Tenofovir DF is a white to off-white crystalline powder.
Emtricitabine is a white to off-white crystalline powder.
Rilpivirine hydrochloride is a white to almost white powder.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each EVIPLERA tablet is capsule-shaped, film-coated and purplish-pink
in colour. Each tablet is
debossed with ‘GSI’ on one side and plain on the other side. The
tablets are supplied in bottles
with child resistant closures.
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, FTC or RPV).
EVIPLERA Product Information v17.0 – (15 July 2020)
Page
2
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults:_
The recommended dose of EVIPLERA is one tablet once daily taken orally
with food.
DOSAGE ADJUSTMENT
_Renal impairment:_
EVIPLERA is not recommended for use in patients with moderate or
severe
renal impairment (creatinine clearance (CrCl) < 50 mL/min). Patient