Exviera

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dasabuvir sodium

Available from:

AbbVie Ltd

ATC code:

J05AP09

INN (International Name):

dasabuvir

Therapeutic group:

Antivirals for systemic use,

Therapeutic area:

Hepatitis C, Chronic

Therapeutic indications:

Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. For hepatitis C virus (HCV) genotype specific activity.,

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2015-01-14

Patient Information leaflet

57
B. PACKAGE LEAFLET
58
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EXVIERA 250 MG FILM-COATED TABLETS
dasabuvir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Exviera is and what it is used for
2. What you need to know before you take Exviera
3. How to take Exviera
4. Possible side effects
5. How to store Exviera
6. Contents of the pack and other information
1.
WHAT EXVIERA IS AND WHAT IT IS USED FOR
Exviera is an antiviral medicine used to treat adults with chronic
(long-term) hepatitis C (an infectious
disease that affects the liver, caused by the hepatitis C virus). It
contains the active substance
dasabuvir.
Exviera works by stopping the hepatitis C virus from multiplying and
infecting new cells, thus
clearing the virus from your blood over a period of time.
Exviera tablets do not work on their own. They are always taken with
another antiviral medicine
containing ombitasvir/paritaprevir/ritonavir. Some patients may also
take an antiviral medicine called
ribavirin. Your doctor will talk with you about which of these
medicines to take with Exviera.
It is very important that you also read the package leaflets for the
other antiviral medicines that you
take with Exviera. If you have any questions about your medicines,
please ask your doctor or
pharmacist.
2.
W

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions
.
1.
NAME OF THE MEDICINAL PRODUCT
Exviera 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of dasabuvir (as sodium
monohydrate).
Excipient with known effect: each film-coated tablet contains 44.94 mg
lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Beige, ovaloid, film-coated tablets with dimensions of 14.0 mm x 8.0
mm and debossed on one side
with ‘AV2’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Exviera is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Exviera should be initiated and monitored by a
physician experienced in the
management of chronic hepatitis C.
Posology
The recommended dose of dasabuvir is 250 mg (one tablet) twice daily
(morning and evening).
Exviera must not be administered as monotherapy. Exviera should be
used in combination with other
medicinal products for the treatment of HCV (see section 5.1). Refer
to the Summary of Product
Characteristics of the medicinal products that are used in combination
with Exviera.
The recommended co-administered medicinal product(s) and treatment
duration for Exviera
combination therapy are provided in table 1.
3
TABLE 1. RECOMMENDED CO-ADMINISTERED MEDICINAL PRODUCT(S) AND
TREATMENT DURATION FOR
EXVIERA BY PATIENT POPULATION
PATIENT POPULATION
TREATMENT*
DURATION
GENOTYPE 1B, WITHOUT CIRRHOSIS OR
WITH COMPENSATED CIRRHOSIS
Exviera +
ombitasvir/paritaprevir/ritonavir
12 weeks
8 w