SUNVEPRA asunaprevir 100 mg capsule blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

asunaprevir

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

asunaprevir

Authorization status:

Registered

Patient Information leaflet

SUNVEPRA
® CAPSULES
_Asunaprevir (a soo na pre veer)_
CONSUMER MEDICINE INFORMATION
WARNINGS AND
PRECAUTIONS
WHILE YOU ARE ARE TAKING
SUNVEPRA, YOUR DOCTOR WILL
FREQUENTLY MONITOR YOU FOR SIGNS OF
HOW WELL YOUR LIVER IS WORKING.
THIS WILL BE DONE WITH REGULAR
BLOOD TESTS.
IF THE RESULTS OF THESE TESTS SHOW A
DECLINE IN HOW WELL YOUR LIVER IS
WORKING, A DECISION WILL BE MADE TO
STOP YOUR TREATMENT WITH
SUNVEPRA.
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking SUNVEPRA. This leaflet
answers some common questions
about SUNVEPRA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SUNVEPRA
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT SUNVEPRA IS
USED FOR
SUNVEPRA is a trade name
(manufacturer's name) for the
medicine, asunaprevir. SUNVEPRA
is a direct acting antiviral agent
(DAA) against the hepatitis C virus
(HCV). SUNVEPRA is an inhibitor
of the HCV protein 3/4A (NS3/4A),
a protease that is required to form
new HCV particles.
You should not take Sunvepra alone
to treat chronic (lasting a long time)
hepatitis C infection in adults.
SUNVEPRA should only be used
together with another antiviral
medicine, daclatasvir (DAKLINZA),
or together with DAKLINZA,
peginterferon alfa, and ribavirin.
_HOW SUNVEPRA WORKS_
SUNVEPRA (in combination with
other medicines) works by stopping
the HCV from multiplying and
infecting liver cells. After you stop
taking SUNVEPRA, your doctor will
monitor your blood for HCV. If HCV
is still not detected in your blood at
least 12 weeks after stopping
treatment, you have what is called a
sustained virologic response (SVR),
also referred to as virologic cure.
It is not known if SUNVEPRA is
safe and effective in children under
18 years of age.
Ask your doctor if yo

Summary of Product characteristics

AU_PI_Sunvepra_V5.0
1
AUSTRALIAN PRODUCT INFORMATION - SUNVEPRA
®
(ASUNAPREVIR)
1
NAME OF THE MEDICINE
Asunaprevir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUNVEPRA is available for oral administration as soft-gelatin capsules
containing 100 mg of
asunaprevir. Asunaprevir drug substance is a white to off-white
powder. The aqueous solubility
at pH 5.72 is 0.0003 mg/mL.
For full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SUNVEPRA is supplied as oval, opaque white to pale-yellow, soft
gelatin capsules containing
100 mg of asunaprevir. Capsules are imprinted with “BMS” in black
on one line and “711” in
black on a second line below “BMS” and filled with a clear
solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SUNVEPRA (asunaprevir) is indicated in combination with other
medicinal products for the
treatment of chronic hepatitis C virus (HCV) infection in adults with
compensated liver disease
(including cirrhosis) [see 5.1 Pharmacodynamic properties – Clinical
trials and 4.2 Dose and
Method of Administration].
4.2
D
OSE AND METHOD OF ADMINISTRATION
SUNVEPRA is for oral administration and may be taken with or without
food.
The recommended dose of SUNVEPRA is 100 mg twice daily. SUNVEPRA must
be
administered in combination with DAKLINZA or with DAKLINZA,
peginterferon alfa, and
ribavirin. Recommended regimens and treatment duration are shown in
Table 1. For specific
dosage instructions for DAKLINZA, peginterferon alfa, and ribavirin,
refer to the respective
product information.
WARNING: POTENTIAL FOR HEPATOTOXICITY
FOR PATIENTS RECEIVING SUNVEPRA-CONTAINING REGIMENS, FREQUENT
MONITORING OF LIVER
ENZYMES (ALANINE AMINOTRANSFERASE (ALT), ASPARTATE AMINOTRANSFERASE
(AST)) AND
BILIRUBIN IS REQUIRED UNTIL COMPLETION OF THERAPY (SEE 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE).
DISCONTINUE SUNVEPRA IMMEDIATELY AND DO NOT RESUME IN PATIENTS WHO
EXPERIENCE:

ON-TREATMENT ELEVATIONS IN ALT LEVELS 10 X ULN OR GREATER, OR

ON-TREATMENT ELEVATIONS IN BOTH ALT LEV