DAKLINZA daclatasvir (as dihyrochloride) 60 mg tablet blister
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
daclatasvir dihydrochloride
Available from:
Bristol-Myers Squibb Australia Pty Ltd
INN (International Name):
daclatasvir dihydrochloride
Authorization status:
Registered
Patient Information leaflet
DAKLINZA
® TABLETS
_Daclatasvir (dak lat as vir)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking DAKLINZA. This leaflet
answers some common questions
about DAKLINZA.
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 DAKLINZA
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 DAKLINZA IS
USED FOR
DAKLINZA is a trade name
(manufacturer's name) for the
medicine, daclatasvir. DAKLINZA is
a direct acting antiviral agent (DAA)
against the hepatitis C virus (HCV).
DAKLINZA is an inhibitor of NS5A,
which is a protein that is required to
form new HCV particles.
You should not take DAKLINZA
alone to treat chronic (lasting a long
time) hepatitis C infection in adults.
DAKLINZA should only be used
together with other antiviral
medicines such as sofosbuvir, or
asunaprevir (SUNVEPRA), or
together with SUNVEPRA,
peginterferon alfa, and ribavirin.
_HOW DAKLINZA WORKS_
DAKLINZA (in combination with
other medicines) works by stopping
the HCV from multiplying and
infecting liver cells. After you stop
taking DAKLINZA, 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 DAKLINZA is safe
and effective in children under 18
years of age.
Ask your doctor if you have any
questions about why DAKLINZA
has been prescribed for you.
DAKLINZA is not addictive. This
medicine is available only with a
doctor's prescription.
BEFORE YOU TAKE
DAKLINZA
It is important that you check the
information below before you take
DAKLINZA.
_WHEN YOU MUST NOT TAKE_
_DAKLINZA_
DAKLINZA is sometimes used with
p
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Summary of Product characteristics
AU_PI_Daklinza_V8.0
1
AUSTRALIAN PRODUCT INFORMATION – DAKLINZA
®
(DACLATASVIR)
1
NAME OF THE MEDICINE
Daclatasvir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAKLINZA 30 mg daclatasvir (equivalent to 33 mg daclatasvir
dihydrochloride)
Excipients with known effect
Each 30 mg tablet contains 58 mg of lactose
DAKLINZA 60 mg daclatasvir (equivalent to 66 mg daclatasvir
dihydrochloride)
Excipients with known effect
Each 60 mg tablet contains 116 mg of lactose
Daclatasvir drug substance is white to yellow. Daclatasvir
dihydrochloride is freely soluble in water.
Full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DAKLINZA daclatasvir 30 mg tablets are green biconvex pentagonal
debossed with "BMS" on one
side and "213" on the other side.
DAKLINZA daclatasvir 60 mg tablets are light green biconvex pentagonal
debossed with “BMS” on
one side and “215” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DAKLINZA is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C virus (HCV) infection in adults [see 5.1 Pharmacodynamic
properties - Clinical trials and
4.2 Dose and method of administration].
4.2
D
OSE AND METHOD OF ADMINISTRATION
DAKLINZA is for oral administration and may be taken with or without
food.
The recommended dose of DAKLINZA is 60 mg once daily. DAKLINZA must be
administered in
combination with other agents [see Table 1]. For specific dose
recommendations for other agents in the
regimen, refer to the respective prescribing information.
Dosing recommendations in Table 1 include patients co-infected with
human immunodeficiency virus
(HIV). For dosing recommendations with specific HIV antiviral agents,
refer to INTERACTIONS
WITH OTHER MEDICINES (see Table 2).
AU_PI_Daklinza_V8.0
2
TABLE 1:
RECOMMENDED REGIMENS WITH DAKLINZA 60 MG ONCE DAILY COMBINATION
THERAPY
HCV GENOTYPE
PRIOR TREATMENT
TREATMENT
_ _
DURATION
Genotype 1 or 3
a
None,
or
failed
protease
inhibitor and/or peginterferon
alfa/ribavirin,
or
failed
so
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