STRIBILD

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CONSUMER MEDICINE
INFORMATION

STRIBILD
TM
TABLETS
(300 MG TENOFOVIR DISOPROXIL
FUMARATE / 200 MG
EMTRICITABINE/ 150 MG OF
ELVITEGRAVIR / 150 MG OF
COBICISTAT.)

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
STRIBILD 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
STRIBILD 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 STRIBILD?

STRIBILD consists of four
medicines VIREAD
®
(tenofovir
disoproxil fumarate, also called
tenofovir DF), EMTRIVA
®

(emtricitabine or FTC),
elvitegravir
and cobicistat,
combined in one tablet to help
control Human
Immunodeficiency Virus (HIV)
infection.

VIREAD and EMTRIVA belong
to a group of antiviral medicines
known as nucleoside and
nucleotide reverse transcriptase
inhibitors (NRTI). Elvitegravir
belongs to a new class of antiviral
medicines known as integrase
inhibitors. Cobicistat is a
“booster”, to help increase the
levels of elvitegravir. Tenofovir
DF and emtricitabine are
components of TRUVADA
®
and
ATRIPLA
®
tablets.

STRIBILD is used to treat HIV
infection. STRIBILD is for
people who have NEVER taken
HIV medicines before, or who do
not have a resistant HIV virus to
STRIBILD.

STRIBILD is for adults.

STRIBILD has not been studied
in children under the age of 18 or
adults over the age of 65.

HIV infection destroys CD4 T
cells, which are important to the
immune system. The immu

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PRODUCT INFORMATION

STRIBILD™ (TENOFOVIR DISOPROXIL
FUMARATE/EMTRICITABINE/ELVITEGRAVIR/COBICISTAT) TABLETS

NAME OF THE MEDICINE
STRIBILD (tenofovir disoproxil
fumarate/emtricitabine/elvitegravir/cobicistat) tablets.

The active substances in STRIBILD tablets are tenofovir disoproxil
fumarate (tenofovir DF),
emtricitabine, elvitegravir and cobicistat.

VIREAD
®
is the brand name for tenofovir DF, which is converted _in
vivo_ to tenofovir, an acyclic
nucleoside phosphonate (nucleotide) analog of adenosine
5′-monophosphate. EMTRIVA
®
is the
brand name for emtricitabine (FTC), a synthetic nucleoside analog of
cytidine. Tenofovir DF and
emtricitabine exhibit activity against HIV-1 reverse transcriptase
(RT). Tenofovir DF and
emtricitabine are the components of TRUVADA
®
. Elvitegravir is a human immunodeficiency
virus-1 (HIV-1) integrase strand transfer inhibitor. Cobicistat is a
mechanism-based inhibitor of
cytochrome P-450 (CYP) enzymes of the CYP3A family.

DESCRIPTION
_TENOFOVIR DISOPROXIL FUMARATE_: Tenofovir DF is a fumaric acid salt
of the _bis_-
isopropoxycarbonyloxymethyl ester derivative of tenofovir. The
chemical name of tenofovir DF
is 9-[(_R_)-2
[[bis[[(isopropoxycarbonyl)oxy] methoxy]phosphinyl]methoxy]propyl]adenine
fumarate (1:1). It has a molecular formula of C
19
H
30
N
5
O
10
P
• C
4
H
4
O
4
and a molecular weight of
635.52. It has the following structural formula:
N
N
N
N
O
P
O
O
O
O
O
O
NH
2
CH
3
CO
2
H
H
HO
2
C
H
O
O
O

CAS registry number: 202138-50-9

Tenofovir DF is a white to off-white crystalline powder with a
solubility of 13.4 mg/mL in water
at 25
°C. The partition coefficient (_log p_) for tenofovir disoproxil
is 1.25 and the pKa is 3.75.
_ _
_EMTRICITABINE:_ The chemical name of emtricitabine is
5-fluoro-1-(2_R_,5_S_)-[2-(hydroxymethyl)-
1,3-oxathiolan-5-yl]cytosine. Emtricitabine is the (-) enantiomer of
a thio analog of cytidine,
which differs from other

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