Celsentri Film-Coated Tablet 150mg

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Maraviroc

Dostępny od:

GLAXOSMITHKLINE PTE LTD

Kod ATC:

J05AX09

Dawkowanie:

150mg

Forma farmaceutyczna:

TABLET, FILM COATED

Skład:

Maraviroc 150mg

Droga podania:

ORAL

Typ recepty:

Prescription Only

Wyprodukowano przez:

Pfizer Manufacturing Deutschland GmbH

Status autoryzacji:

ACTIVE

Data autoryzacji:

2009-04-30

Ulotka dla pacjenta

Page 1 of 23 

TRADENAMES 
The tradename for this product is CELSENTRI. 
FORMULATION AND STRENGTHS 

Film-coated tablets. 

Each tablet contains either 150 mg or 300 mg of maraviroc: 

150 mg blue, biconvex, oval film-coated tablets
debossed with “MVC 150” on one side. 
300 mg blue, biconvex, oval film-coated tablets
debossed with “MVC 300” on one side. 

CLINICAL INFORMATION 

INDICATIONS 

Maraviroc, in combination with other
antiretroviral medicinal products, is indicated for treatment-experienced adult 
patients infected with only CCR5-tropic HIV-1, who have
evidence of viral replication and HIV-1 strains resistant to 
multiple antiretroviral agents. 

This indication is based on safety and
efficacy data from two double-blind, placebo-controlled trials
in treatment-
experienced patients (_see_ _Clinical Studies_). 

The following points should be considered when
initiating therapy with maraviroc: 
• Treatment history should guide the
use of CELSENTRI. Tropism testing is required for the
appropriate 
use of maraviroc (_see Warnings and Precautions_). 
• Use of maraviroc is not recommended in patients
with dual/mixed or CXCR4-tropic HIV-1 as efficacy 
was not demonstrated in a phase 2 study of this patient group. 
• The safety and efficacy of maraviroc have not been established
in treatment-naïve adult patients or 
pediatric patients. 

DOSAGE AND ADMINISTRATION 

Therapy should be initiated by a physician experienced in the
management of HIV infection. 

Before taking maraviroc it has to be confirmed that only
CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or 
dual/mixed tropic virus not detected) using an adequately
validated and sensitive detection method on a newly 
drawn blood sample. The Monogram Trofile assay was used in the
clinical studies of maraviroc (see sections 4.4 
and 5.1). Other phenotyp

Charakterystyka produktu

Page 1 of 25
TRADENAMES
The tradename for this product is CELSENTRI.
FORMULATION AND STRENGTHS
Each tablet contains either 150 mg or 300 mg of maraviroc:
_150 mg Tablets:_
blue, biconvex, oval film-coated tablets debossed with “MVC 150”
on one side.
_300 mg Tablets:_
blue, biconvex, oval film-coated tablets debossed with “MVC 300”
on one side.
CLINICAL INFORMATION
INDICATIONS
Maraviroc, in combination with other antiretroviral medicinal
products, is indicated for treatment-experienced adult
patients infected with only CCR5-tropic HIV-1, who have evidence of
viral replication and HIV-1 strains resistant to
multiple antiretroviral agents.
This indication is based on safety and efficacy data from two
double-blind, placebo-controlled trials in treatment-
experienced patients (
_see_
_Clinical Studies_
).
The following points should be considered when initiating therapy with
maraviroc:
• Treatment history should guide the use of CELSENTRI. Tropism
testing is required for the appropriate
use of maraviroc (
_see Warnings and Precautions_
).
• Use of maraviroc is not recommended in patients with dual/mixed or
CXCR4-tropic HIV-1 as efficacy
was not demonstrated in a phase 2 study of this patient group.
• The safety and efficacy of maraviroc have not been established in
treatment-naïve adult patients or
pediatric patients.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Film-coated tablets
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Before taking maraviroc it has to be confirmed that only CCR5-tropic
HIV-1 is detectable (i.e. CXCR4 or
dual/mixed tropic virus not detected) using an adequately validated
and sensitive detection method on a newly
drawn blood sample. The Monogram Trofile assay was used in the
clinical studies of maraviroc. Other phenotypic
and genotypic assays are currently being evaluated. The viral tropism
cannot be safely predicted by treatment history
and assessment of stored samples.
There are currently no data regarding the reuse of maraviroc in