Vafseo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Vadadustat

Available from:

Akebia Europe Limited

INN (International Name):

vadadustat

Therapeutic group:

Antianemic preparations

Therapeutic area:

Renal Insufficiency, Chronic; Anemia

Therapeutic indications:

Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Authorization status:

Authorised

Authorization date:

2023-04-24

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VAFSEO
150 MG FILM-COATED TABLETS
VAFSEO 300 MG FILM-COATED TABLETS
VAFSEO 450 MG FILM-COATED TABLETS
vadadustat
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, or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vafseo is and what it is used for
2.
What you need to know before you take Vafseo
3.
How to take Vafseo
4.
Possible side effects
5.
How to store Vafseo
6.
Contents of the pack and other information
1.
WHAT VAFSEO IS AND WHAT IT IS USED FOR
Vafseo is a medicine that increases the amount of haemoglobin (the
protein in your red blood cells
that carries oxygen around the body) and the number of red blood cells
in your blood. It contains the
active substance vadadustat.
Vafseo is used to treat symptomatic anaemia (low levels of red blood
cells or haemoglobin in your
blood) that is associated with chronic kidney disease (CKD) in adults
on chronic maintenance dialysis.
When the amount of haemoglobin or the number of red blood cells is
low, the cells in your body might
not receive enough oxygen. Anaemia can cause symptoms such as
tiredness, weakness, or shortness of
breath.
HOW VAFSEO WORKS
Vafseo increases the level of a substance called “Hypoxia-Inducible
Factor” (HIF), which increases
the production of red blood cells when oxygen levels are low.

Summary of Product characteristics

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
Vafseo 150 mg film-coated tablets
Vafseo 300 mg film-coated tablets
Vafseo 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vafseo
150 mg film-coated tablets
Each 150 mg film-coated tablet contains 150 mg of vadadustat
Vafseo
300 mg film-coated tablets
Each 300 mg film-coated tablet contains 300 mg of vadadustat
Vafseo
450 mg film-coated tablets
Each 450 mg film-coated tablet contains 450 mg of vadadustat
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Vafseo
150 mg film-coated tablets
Round, white tablets 8 mm in diameter, debossed with “VDT” on one
side and “150” on the other
side.
Vafseo 300 mg film-coated tablets
Oval, yellow tablets 8 mm in width, 13 mm in length, debossed with
“VDT” on one side and “300” on
the other side.
Vafseo 450 mg film-coated tablets
Oval, pink tablets 9 mm in width, 15 mm in length debossed with
“VDT” on one side and “450” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vafseo is indicated for the treatment of symptomatic anaemia
associated with chronic kidney disease
(CKD) in adults on chronic maintenance dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
3
Vadadustat should be initiated by a physician experienced in the
management of anaemia. All other
causes of anaemia should be evaluated prior to initiating therapy with
Vafseo, and when deciding to
increase the dose.
Anaemia symptoms and sequelae may vary with age, gender, and overall
burden of disease; a
physician’s evaluation of the individual patient’s clinical course
and condition is necessary. In addition
to the presence of symptoms of anaemia, criteria such as rate of fall
of hae