MYLERAN IV busulfan 60mg/10mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

busulfan

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Busulfan

Authorization status:

Registered

Patient Information leaflet

_Consumer Medicine Information_
_Myleran_
®
_ IV_
_Page 1 _
MYLERAN
® IV
BUSULFAN
60 MG/10 ML CONCENTRATED INJECTION
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS THIS LEAFLET?
This leaflet answers some common questions
about MYLERAN IV. It does not contain all
of the available information. It does not take
the place of talking to your doctor r
pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you being
given MYLERAN IV against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN
MYLERAN IV, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You
may need to read it again.
WHAT MYLERAN IV IS USED FOR
MYLERAN IV is used in adults, new-born
infants, children and adolescents as a treatment
prior to transplantation of either bone marrow
or blood stem cells. It is used in combination
with other chemotherapeutic drugs, namely
cyclophosphamide, melphalan or fludarabine.
MYLERAN IV contains the active ingredient,
Busulfan. Busulfan belongs to a group of
medicines called alkylating agents.
MYLERAN IV destroys the original bone
marrow before the transplant.
Your doctor may have prescribed this
medicine for another use.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT WHY MYLERAN IV HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN MYLERAN IV
MYLERAN IV injection is not suitable for
everyone.
_WHEN YOU MUST NOT BE GIVEN IT_
•
MYLERAN IV should not be given if you
are allergic to busulfan or any of the other
ingredients listed
_ _
in this leaflet.
•
MYLERAN IV should not be given if you
are pregnant, or you think you may be
pregnant.
_ _
_BEFORE YOU ARE GIVEN IT _
MYLERAN IV is a powerful cytotoxic drug
that results in a huge decrease of blood cells.
At the recommended dose, this is the desired
effect. Therefore careful monitoring will be
performed. It is possible that use of
MYLERAN IV may increase the risk of
suffering another malignancy in the future.
TELL YOUR DOCTOR IF YOU:
•
HAVE A LIVER, KIDNEY, HEART OR LUNG
PROBLEM.
•

Summary of Product characteristics

MYLERAN IV - Product Information
Page 1 of 19
PRODUCT INFORMATION
MYLERAN
® IV
60 MG/10 ML CONCENTRATED INJECTION
NAME OF DRUG
Busulfan, 1,4-butanediol dimethanesulfonate
Molecular Formula:
C
6
H
14
O
6
S
2
Molecular Weight:
246.31
Chemical Structure:
CAS Registry Number: 55-98-1
DESCRIPTION
Myleran IV is an intravenous form of busulfan, a chemotherapeutic
agent commonly used as part of
a conditioning regimen prior to haematopoietic stem cell
transplantation.
Busulfan, the active ingredient of Myleran IV, is a white crystalline
solid that is only very slightly
soluble in water, sparingly soluble in acetone and slightly soluble in
ethanol.
Each 10 mL vial of Myleran IV contains 60 mg (6 mg/mL) of busulfan and
the ingredients
dimethylacetamide (DMA) and macrogol 400.
The drug product Myleran IV is intended for
dilution with 0.9% sodium chloride solution for injection or 5%
glucose solution for injection.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Cytotoxic agents (alkylating agents). ATC
Code: L01AB01
Busulfan is a potent cytotoxic agent and a bifunctional alkylating
agent. In aqueous media, release of
the methanesulphonate groups produces carbonium ions which can
alkylate DNA, thought to be
an important biological mechanism for its cytotoxic effect.
PHARMACOKINETIC PROPERTIES
Absorption
and
distribution
pharmacokinetics
of
IV
busulfan
has
been
investigated.
The
information presented on metabolism and elimination is based on oral
busulfan.
MYLERAN IV - Product Information
Page 2 of 19
Absorption
The pharmacokinetics of IV busulfan was studied in 124 evaluable
patients following a 2- hour
intravenous infusion for a total of 16 doses over four days. Immediate
and complete availability of
the dose is obtained after intravenous infusion of busulfan. Similar
blood exposure was observed
when comparing plasma concentrations in patients receiving 1 mg/kg
oral and 0.8 mg/kg IV
busulfan. Low inter (CV=21%) and intra (CV=12%) patient variability on
drug exposure was
demonstrated through a population p