Rezolsta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

darunavir, cobicistat

Available from:

Janssen-Cilag International N.V.

ATC code:

J05

INN (International Name):

darunavir, cobicistat

Therapeutic group:

Antivirals for systemic use, Antivirals for treatment of HIV infections, combinations

Therapeutic area:

HIV Infections

Therapeutic indications:

Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2014-11-19

Patient Information leaflet

42
B.
PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
REZOLSTA 800 MG/150 MG - FILM-COATED TABLETS
darunavir/cobicistat
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What REZOLSTA is and what it is used for
2.
What you need to know before you take REZOLSTA
3.
How to take REZOLSTA
4.
Possible side effects
5.
How to store REZOLSTA
6.
Contents of the pack and other information
1.
WHAT REZOLSTA IS AND WHAT IT IS USED FOR
WHAT IS REZOLSTA?
REZOLSTA contains the active substances darunavir and cobicistat.
Darunavir belongs to a group of HIV medicines called ‘protease
inhibitors’ which work by reducing
the amount of HIV in your body to a very low level. It is given with
cobicistat, which increases the
amount of darunavir in your blood.
Treatment with REZOLSTA will improve your immune system (your body’s
natural defences) and
reduce the risk of developing illnesses linked to HIV infection, but
REZOLSTA is not a cure for HIV
infection.
WHAT IT IS USED FOR?
REZOLSTA is used to treat adults and adolescents aged 12 years and
older who weigh at least
40 kilograms and who are infected by HIV (see How to take REZOLSTA).
REZOLSTA must be taken in combination with other HIV medicines. Your
doctor will discuss with
you which combination of medicines is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REZOLSTA
DO NOT TAKE REZOLSTA
-
if you are ALLERGIC to darunavir, cobicistat or any of the other
ingredients of this medicine (listed
in section 6).
-
if you have SEVERE LIVER PROB

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
REZOLSTA 800 mg/150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of darunavir (as ethanolate)
and 150 mg of cobicistat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on
one side and “TG” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REZOLSTA is indicated, in combination with other antiretroviral
medicinal products, for the
treatment of human immunodeficiency virus-1 (HIV-1) infection in
adults and adolescents (aged
12 years and older, weighing at least 40 kg).
Genotypic testing should guide the use of REZOLSTA (see sections 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a healthcare provider experienced in
the management of HIV infection.
Posology
The recommended dose regimen in adults and adolescents aged 12 years
and older, weighing at least
40 kg, is one tablet taken once daily with food.
_ART-naïve patients_
The recommended dose regimen is one film-coated tablet of REZOLSTA
once daily taken with food.
_ART-experienced patients_
One film-coated tablet of REZOLSTA once daily taken with food may be
used in patients with prior
exposure to antiretroviral medicinal products, but without darunavir
resistance associated mutations
(DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+
cell count
≥ 100 cells x 10
6
/L (see section 4.1).
*
DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V,
L89V.
In all other ART-experienced patients or if HIV-1 genotype testing is
not available, the use of
REZOLSTA is not appropriate and another antiretroviral regimen should
be used. Refer to the
Summary of Product Characteristics of other antiretroviral medicinal
products for dosing information.
_Advice on missed doses_
If REZOLSTA is missed within 12 hours of the