Xaluprine (previously Mercaptopurine Nova Laboratories)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

6-mercaptopurine monohydrate

Available from:

Nova Laboratories Ireland Limited

ATC code:

L01BB02

INN (International Name):

mercaptopurine

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Lymphoid

Therapeutic indications:

Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2012-03-09

Patient Information leaflet

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
XALUPRINE 20 MG/ML ORAL SUSPENSION
mercaptopurine
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, pharmacist or
nurse.
-
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 Xaluprine is and what it is used for
2.
What you need to know before you take Xaluprine
3.
How to take Xaluprine
4.
Possible side effects
5.
How to store Xaluprine
6.
Contents of the pack and other information
1.
WHAT XALUPRINE IS AND WHAT IT IS USED FOR
Xaluprine contains mercaptopurine. This belongs to a group of
medicines called cytotoxics (also
called chemotherapy).
Xaluprine is used for acute lymphoblastic leukaemia (also called acute
lymphocytic leukaemia or
ALL). This is a fast-growing disease which increases the number of new
white blood cells. These new
white blood cells are immature (not fully formed) and unable to grow
and work properly. They
therefore cannot fight infections and may cause bleeding.
Ask your doctor if you would like more explanation about this disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XALUPRINE
-
DO NOT TAKE XALUPRINE if you are allergic to mercaptopurine or any of
the other ingredients of
this medicine (listed in section 6).
-
DO NOT GET VACCINATED with yellow fever vaccine whilst you are taking
Xaluprine because it
may be fatal.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Xaluprine
-
if you have been vaccinated with yellow fever vaccine
-
if you have kidney or liver problems, as your doctor will need to
check that they are working
properly.
-
if you have a condition w

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xaluprine 20 mg/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains 20 mg mercaptopurine (as monohydrate).
Excipients with known effect
One ml of suspension contains 3 mg aspartame, 1 mg methyl
hydroxybenzoate (as the sodium salt),
0.5 mg ethyl hydroxybenzoate (as the sodium salt) and sucrose (trace).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
The suspension is pink to brown in colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xaluprine is indicated for the treatment of acute lymphoblastic
leukaemia (ALL) in adults, adolescents
and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xaluprine treatment should be supervised by a physician or other
healthcare professionals experienced
in the management of patients with ALL.
Posology
The dose is governed by cautiously monitored haematotoxicity and the
dose should be carefully
adjusted to suit the individual patient in accordance with the
employed treatment protocol. Depending
on phase of treatment, starting or target doses generally vary between
25-75 mg/m
2
body surface area
(BSA) per day, but should be lower in patients with reduced or absent
Thiopurine Methyl Transferase
(TPMT) enzyme activity (see section 4.4).
3
25 MG/M
2
50 MG/M
2
75 MG/M
2
BSA (m
2
)
Dose
(mg)
Volume
(ml)
BSA (m
2
)
Dose
(mg)
Volume
(ml)
BSA (m
2
)
Dose
(mg)
Volume
(ml)
0.20 - 0.29
6
0.3
0.20 - 0.23
10
0.5
0.20 - 0.23
16
0.8
0.30 - 0.36
8
0.4
0.24 – 0.26
12
0.6
0.24 - 0.26
20
1.0
0.37 - 0.43
10
0.5
0.27 - 0.29
14
0.7
0.27 - 0.34
24
1.2
0.44 - 0.51
12
0.6
0.30 - 0.33
16
0.8
0.35 - 0.39
28
1.4
0.52 - 0.60
14
0.7
0.34 - 0.37
18
0.9
0.40 - 0.43
32
1.6
0.61 - 0.68
16
0.8
0.40 - 0.44
20
1.0
0.44 - 0.49
36
1.8
0.69 - 0.75
18
0.9
0.45 - 0.50
24
1.2
0.50 - 0.55
40
2.0
0.76 - 0.84
20
1.0
0.51 - 0.58
28
1.4
0.56 - 0.60
44
2.2
0.85 - 0.99
24
1.2
0.59 - 0.66
32
1.6
0.61 - 0.65
48
2.4
1.0 - 1.16
28
1.4
0.67 - 0.74
36
1.8
0.66 - 0