SOFOVIR (SOFOSBUVIR TABLETS 400MG)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Sofosbuvir

Available from:

SYNERRV SDN BHD

INN (International Name):

Sofosbuvir

Units in package:

28 Tablets

Manufactured by:

Hetero Labs Limited

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SOFOVIR SOFOSBUVIR TABLETS 400MG
Sofosbuvir (400 mg)
1
WHAT IS IN THIS LEAFLET
1.
What SOFOVIR is used for
2.
How SOFOVIR works
3.
Before you use SOFOVIR
4.
How to use SOFOVIR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SOFOVIR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SOFOVIR IS USED FOR
SOFOVIR
is
used
in
combination
with
other medicinal products for the treatment
of chronic hepatitis C in adults.
HOW SOFOVIR WORKS
Hepatitis C is a virus that infects the liver.
This
medicine
works
by
lowering
the
amount of hepatitis C virus in your body
and removing the virus from your blood
over
a
period
of time.
This
product
is
always taken with other medicines. It will
not work on its own. It is commonly taken
with either: Ribavirin, or Peginterferon alfa
and ribavirin.
It is very important that you also read the
leaflets for the other medicines that you
will be taking with Sofovir. If you have
any questions about your medicines, please
ask your doctor or pharmacist.
BEFORE YOU USE SOFOVIR
-
_When you must not use it _
Do not take SOFOVIR if you:
•
You
are
allergic
(hypersensitive)
to
sofosbuvir or to any one of the ingredients
of this medicine.
-
_Before you start to use it _
Tell your doctor if you have any of the
following:
a)
Have liver problems other than
hepatitis C, e.g. if you are awaiting a liver
transplantation.
b)
Have a current or previous infection
with the hepatitis B virus, since your
doctor may want to monitor you more
closely.
c)
Have kidney problems
d)
Currently take, or have taken in the last
few months, the medicine amiodarone to
treat irregular heartbeats (your doctor may
consider alternative treatments if you have
taken this medicine) Tell you doctor
immediately if you are taking any
medicines for heart problems and during
treatment you experience:
- Shortness of breath or worsening of any
shortness of breath you already have
- Light-headedness
- Palpitations
- Fainting
e)

Summary of Product characteristics

1
SOFOVIR
SOFOSBUVIR TABLETS 400 MG
SOFOVIR (SOFOSBUVIR TABLETS 400 MG)
Each film-coated tablet contains Sofosbuvir 400 mg.
PRODUCT DESCRIPTION
Orange oval, bevel biconvex, film coated tablets debossed with ‘H’
on one side and ‘S14’ on the other
side.
PHARMACODYNAMICS
Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AP08
Mechanism of action
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent
RNA polymerase, which is
essential for viral replication. Sofosbuvir is a nucleotide prodrug
that undergoes intracellular metabolism
to form the pharmacologically active uridine analog triphosphate
(GS-461203), which can be
incorporated into HCV RNA by the NS5B polymerase and acts as a chain
terminator. In a biochemical
assay, GS-461203 inhibited the polymerase activity of the recombinant
NS5B from HCV genotype 1b, 2a,
3a and 4a with a 50% inhibitory concentration (IC
50
) value ranging from 0.7 to
2.6 μM. GS-461203 (the active metabolite of sofosbuvir) is not an
inhibitor of human DNA and RNA
polymerases nor an inhibitor of mitochondrial RNA polymerase.
Antiviral activity
In HCV replicon assays, the effective concentration (EC
50
) values of sofosbuvir against full-length
replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05,
0.05 and 0.04 μM, respectively, and
EC
50
values of sofosbuvir against chimeric 1b replicons encoding NS5B from
genotype 2b, 5a or 6a were
0.014 to 0.015 μM. The mean ± SD EC
50
of sofosbuvir against chimeric replicons encoding NS5B
sequences from clinical isolates was 0.068 ± 0.024 μM for genotype
1a (n = 67),
0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for
genotype 2 (n = 15) and
0.085 ± 0.034 μM for genotype 3a (n = 106). In these assays, the _in
vitro _antiviral activity of sofosbuvir
against the less common genotypes 4, 5 and 6 was similar to that
observed for genotypes 1, 2 and 3.
The presence of 40% human serum had no effect on the anti-HCV activity
of sofosbuvir.
Resistance
_In cell culture _
HCV replicons with re