Reyataz

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Atazanavir sulfate

Available from:

Bristol-Myers Squibb Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

REYATAZ
®
 CAPSULES

(RAY-UH-TAZ)
_Atazanavir (Ata-zan-a-vir)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Reyataz. This leaflet answers
some common questions about
Reyataz.
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 Reyataz
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 REYATAZ IS
USED FOR
Reyataz is a trade name
(manufacturer's name) for the
medicine, atazanavir. Reyataz
belongs to a group of medicines
called protease inhibitors.
Reyataz is used in combination with
other anti-HIV agents to treat adults
and children aged between 6 and 18
years of age who are infected with
Human Immunodeficiency Virus
(HIV).
WHAT IS HIV:
HIV is a virus that kills important
cells in the immune system over time
(e.g. CD4 cells). When HIV has
killed enough of the immune cells,
your body becomes prone to certain
types of infections. Some infections
are the cause of "AIDS-defining"
illnesses. This is when someone is
said to have developed the Acquired
Immunodeficiency Syndrome or
AIDS. AIDS is a serious condition
and can lead to death.
_HOW REYATAZ WORKS_
When HIV infects cells in the
immune system, it takes over part of
the cell's internal workings and uses
contents of the cells to produce new
viruses.
Reyataz helps to block HIV protease,
an enzyme that is needed for the HIV
virus to multiply. Reyataz may lower
the amount of HIV in your blood and
help your body keep its supply of
CD4 and T-cells. Interfering with the
production of new viruses helps to
reduce the total amount of HIV in the
body and slows down the damage to
the immune system.
Reyataz is not a cure for HIV
infection. Taking it will not
necessarily prevent the illnesses that
common

Summary of Product characteristics

 
Reyataz V14 
1 
PRODUCT INFORMATION 

REYATAZ


(atazanavir sulfate) 

CAPSULES 

NAME OF THE MEDICINE 
Chemically atazanavir sulfate is
(3_S_,8_S_,9_S_,12_S_)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-
dioxo-9-phenylmethyl-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-
pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1), it is
an azapeptide HIV-1 protease 
inhibitor with the following structure: 

CAS Registry No: 229975-97-7 
Molecular formula: C
38
H
52
N
6
O
7
.H
2
SO
4

Molecular mass: 802.9 (sulfate); 704.9 (free base). 

DESCRIPTION 

Atazanavir sulfate is an off-white to pale yellow
crystalline powder. 

Reyataz  capsules  contain  atazanavir  sulfate  equivalent  to  100  mg,  150  mg  or  200  mg  or 
300mg  atazanavir.  Inactive  ingredients  are  lactose,  crospovidone,  and  magnesium  stearate. 
The capsule shells contain gelatin and titanium dioxide, and are coloured with Indigo carmine 
CI73015  the  300mg  capsule  shell  also  contains  red  iron  oxide,  black  iron  oxide  and  yellow 
iron oxide. 

PHARMACOLOGY 

_PHARMACOKINETICS:_ 
The  pharmacokinetics  of  atazanavir  were  evaluated  in  healthy  adult  volunteers  and  in  HIV-
infected adult and paediatric patients. 

Reyataz V14 
2 
_HEALTHY ADULT VOLUNTEERS AND HIV-INFECTED PATIENTS _
The  pharmacokinetics  of  atazanavir  were  evaluated  in  healthy  adult  volunteers  and  in  HIV-
infected patients

after administration of Reyataz 400 mg once daily and after administration
of 
Reyataz 300 mg with ritonavir 100
mg once daily (see Table 1). 

TABLE 1. STEADY-STATE PHARMACOKINETICS OF ATAZANAVIR
IN HEALTHY ADULT SUBJECTS OR 
HIV-INFECTED ADULT PATIENTS IN THE FED STATE 

400 MG ONCE DAILY 
300 MG WITH RITONAVIR 100 MG ONCE DAILY 
P