TIVICAY TABLET 50MG

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

DOLUTEGRAVIR SODIUM 52.6MG EQV DOLUTEGRAVIR

Disponible depuis:

GLAXOSMITHKLINE PTE LTD

Code ATC:

J05AX12

Dosage:

50mg

forme pharmaceutique:

TABLET, FILM COATED

Composition:

DOLUTEGRAVIR SODIUM 52.6MG EQV DOLUTEGRAVIR 50mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

GLAXO OPERATIONS UK LTD (TRADING AS GLAXO WELLCOME OPERATIONS)

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2014-07-31

Notice patient

 
CONFIDENTIAL 

TIVICAY 
TM

DOLUTEGRAVIR 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Yellow, round, biconvex tablets debossed with ‘SV 572’ on
one side and ‘50’ on the 
other side. 
Each tablet contains 50 mg
of dolutegravir (as dolutegravir sodium). 
PHARMACEUTICAL FORM 
Film-coated tablets. 
CLINICAL PARTICULARS 
INDICATIONS 
TIVICAY is indicated in combination with other antiretroviral
agents for the treatment of 
human immunodeficiency virus type 1 (HIV-1) infection in
adults and children aged 12 
years and older and weighing at least 40kg. 
The following should be considered prior to
initiating treatment with TIVICAY: 
•  Poor virologic response was observed in subjects treated
with TIVICAY 50mg 
twice daily with an integrase strand transfer
inhibitor (INI)-resistance Q148H/K/R 
substitution plus 2
or more additional INI-resistance substitutions, including, but 
not limited to L74I, E138A/K/T, and G140A/C/S. 
DOSAGE AND ADMINISTRATION 
POSOLOGY 
_TIVICAY_ therapy should be initiated by a physician experienced
in the management of 
HIV infection.  
_TIVICAY_ can be taken with or without food. 
METHOD OF ADMINISTRATION 
ADULTS 
PATIENTS INFECTED WITH HIV-1 WITHOUT DOCUMENTED OR CLINICALLY
SUSPECTED RESISTANCE 
TO THE INTEGRASE CLASS 

CONFIDENTIAL 

The recommended dose of _TIVICAY_ is 50 mg once daily.  
_TIVICAY_ should be administered twice daily in this population
when co-administered 
with some medicines (e.g. efavirenz, nevirapine,
tipranavir/ritonavir, or rifampicin) (_see_ 
_Interactions_). 
PATIENTS INFECTED WITH HIV-1 WITH RESISTANCE TO THE INTEGRASE
CLASS (DOCUMENTED OR 
CLINICALLY SUSPECTED) 
The recommended
dose of _TIVICAY_ is 50 mg twice daily. The decision to
use _TIVICAY_ 
for such patients should be informed
by the integrase resistance pattern (_see_ _Clinical _
_studies_). 
Co-administration of _TIVICAY_ with

Résumé des caractéristiques du produit

1
TIVICAY
DOLUTEGRAVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg - White, round, biconvex tablets debossed with ‘SV 572’ on
one side and ‘10’ on
the other side.
25 mg - Pale yellow, round, biconvex tablets debossed with ‘SV
572’ on one side and
‘25’ on the other side.
50 mg - Yellow, round, biconvex tablets debossed with ‘SV 572’ on
one side and ‘50’ on
the other side.
Each tablet contains 10 mg, 25 mg, or 50 mg of dolutegravir (as
dolutegravir sodium).
CLINICAL INFORMATION
INDICATIONS
_TIVICAY_ is indicated in combination with other antiretroviral agents
for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in adults and
children aged 6
years and older and weighing at least 15 kg (see_ Warnings and
Precautions _
_–_
_ Dual _
_regimens_).
The following should be considered prior to initiating treatment with
_TIVICAY_:

Poor virologic response was observed in subjects treated with
_TIVICAY_ 50 mg
twice daily with an integrase strand transfer inhibitor
(INI)-resistance Q148H/K/R
substitution plus 2 or more additional INI-resistance substitutions,
including, but
not limited to L74I, E138A/K/T and G140A/C/S.
DOSAGE AND ADMINISTRATION
Pharmaceutical form:
Film-coated tablets.
POSOLOGY
_TIVICAY_ therapy should be initiated by a physician experienced in
the management of
HIV infection.
_TIVICAY_ can be taken with or without food.
METHOD OF ADMINISTRATION
2
ADULTS
PATIENTS INFECTED WITH HIV-1 WITHOUT DOCUMENTED OR CLINICALLY
SUSPECTED RESISTANCE
TO THE INTEGRASE CLASS
The recommended dose of _TIVICAY_ is 50 mg once daily.
_TIVICAY_ should be administered twice daily in this population when
co-administered
with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir,
or rifampicin) (see
_Interactions_).
PATIENTS INFECTED WITH HIV-1 WITH RESISTANCE TO THE INTEGRASE CLASS
(DOCUMENTED OR
CLINICALLY SUSPECTED)
The recommended dose of _TIVICAY_ is 50 mg twice daily. The decision
to use _TIVICAY_
for such patients should be informed by the integrase resistance
patt