Oxbryta

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Voxelotor

Saatavilla:

Pfizer Europe MA EEIG 

ATC-koodi:

B06AX03

INN (Kansainvälinen yleisnimi):

Voxelotor

Terapeuttinen ryhmä:

Other hematological agents

Terapeuttinen alue:

Anemia; Anemia, Hemolytic; Anemia, Sickle Cell

Käyttöaiheet:

Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-02-14

Pakkausseloste

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OXBRYTA 500 MG FILM-COATED TABLETS
voxelotor
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.
•
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oxbryta is and what it is used for
2.
What you need to know before you take Oxbryta
3.
How to take Oxbryta
4.
Possible side effects
5.
How to store Oxbryta
6.
Contents of the pack and other information
1.
WHAT OXBRYTA IS AND WHAT IT IS USED FOR
WHAT OXBRYTA IS AND HOW IT WORKS
Oxbryta contains the active substance voxelotor. Voxelotor works on a
protein in red blood cells
called haemoglobin to help it take up oxygen that red blood cells can
deliver throughout the body.
Patients with the condition called sickle cell disease have an altered
form of haemoglobin called sickle
haemoglobin which is different from the normal haemoglobin. When the
sickle haemoglobin gives up
oxygen to the tissues, it sticks together to form long rods and causes
red blood cells to alter their shape
to that of a crescent moon making these cells rigid and sickled shape.
Sickle red blood cells cannot
deliver oxygen as well as healthy red blood cells and are also broken
down more quickly, leading to
lowered levels of red blood cells (haemolytic anaemia). By improving
the way the altered
haemoglobin holds onto oxygen, Oxbryta improves the function of red
blood c

Valmisteyhteenveto

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
Oxbryta 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg of voxelotor.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow to yellow, oval shaped, biconvex, film-coated tablet of
approximately 18 mm × 10 mm,
debossed with “GBT 500” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxbryta is indicated for the treatment of haemolytic anaemia due to
sickle cell disease (SCD) in adults
and paediatric patients 12 years of age and older as monotherapy or in
combination with
hydroxycarbamide.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by physicians experienced in the
management of SCD.
Posology
The recommended dose of Oxbryta is 1,500 mg (three 500 mg film-coated
tablets) taken orally once
daily.
If a dose is missed, treatment should be continued on the day
following the missed dose.
_Paediatric population _
The recommended dose of Oxbryta in patients 12 to < 18 years of age is
the same as for adults.
The safety and efficacy of Oxbryta in paediatric patients below the
age of 12 years have not been
established yet. No data are available.
Special populations
_Renal impairment _
No dose adjustment is recommended in patients with mild to severe
renal impairment. Oxbryta has not
been evaluated in patients with end stage renal disease (ESRD)
requiring dialysis (see section 4.4).
3
_Hepatic impairment _
No dose adjustment of Oxbryta is recommended for patients with mild or
moderate hepatic
impairment. The recommended dose of voxelotor in patients with severe
hepatic impairment
(Child Pugh C) is 1,000 mg (two 500 mg film-coated tablets)