Myleran 2 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Busulfan

Available from:

Aspen Pharma Trading Limited

ATC code:

L01AB; L01AB01

INN (International Name):

Busulfan

Dosage:

2 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Alkyl sulfonates; busulfan

Authorization status:

Not marketed

Authorization date:

1979-04-01

Patient Information leaflet

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYLERAN 2 MG FILM-COATED TABLETS
busulfan
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 about your illness or your medicine,
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, pharmacist, or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4
_._
.
WHAT IS IN THIS LEAFLET
1
What Myleran is and what it is used for
2
What you need to know before you take Myleran
3
How to take Myleran
4
Possible side effects
5
How to store Myleran
6
Contents of the pack and other information
1.
WHAT MYLERAN IS AND WHAT IT IS USED FOR
Myleran tablets contain an active substance called busulfan which
belongs to a group of medicines called
alkylating agents (a type of cytotoxic drugs or chemotherapy).
This medicine is used for certain blood disorders including some
cancers. It works by reducing the number
of new blood cells your bone marrow makes.
Myleran may be used in combination with other cytotoxic drugs such as
cyclophosphamide.
Your doctor will be able to explain how Myleran helps in your
particular condition.
Myleran is used for:

CHRONIC MYELOID LEUKAEMIA
- a type of cancer affecting certain blood-forming cells of the bone
marrow (where blood cells are made) resulting in an increase in the
number of white blood cells in the
blood. This can cause infections and bleeding.

POLYCYTHAEMIA VERA
a disease which increases the number of red cells in your blood. This
makes the
blood thicken and causes blood clots. This can result in symptoms such
as headaches, dizziness and
shortness of breath, etc.

THROMBOCYTHAEMIA
a disease which affects platelets (blood cells that help b

Summary of Product characteristics

Health Products Regulatory Authority
12 July 2022
CRN00D0PX
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Myleran 2 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of the active substance busulfan.
Excipient with known effect:
Each tablet also contains 92.5mg of lactose.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, biconvex tablets engraved ‘GX EF3’ on one side
and ‘M’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Myleran is indicated for the palliative treatment of the chronic phase
of chronic myeloid leukaemia.
Myleran is effective in producing prolonged remission in polycythaemia
vera, particularly in cases with marked thrombocytosis.
Myleran may be useful in selected cases of essential thrombocythaemia
and myelofibrosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Myleran tablets are usually given in courses or administered
continuously. The dose must be adjusted for the individual patient
under close clinical and haematological control. Should a patient
require an average daily dose of less than the content of the
available Myleran tablets, this can be achieved by introducing one or
more busulfan free days between treatment days.
The tablets should not be divided (see section 6.6).
_Obese patients_
Dosing based on body surface area or adjusted ideal body weight should
be considered in the obese (see section 5.2).
The relevant literature should be consulted for full details of
treatment schedules.
_Use in the elderly_
No special comment.
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12 July 2022
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Page 2 of 12
Chronic myeloid leukaemia
_Induction in adults_
Treatment is usually initiated as soon as the condition is diagnosed.
The dose is 0.06 mg/kg/day, with an initial daily maximum of 4 mg,
which may be given as a single dose.
There is individual variation in the response to Myleran and in a
small proportion of patients the bone marrow