BUSULFAN ACCORD busulfan 60 mg/10 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

busulfan, Quantity: 60 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: macrogol 400; dimethylacetamide

Administration route:

Intravenous Infusion

Units in package:

1, 8

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Busulfan Accord is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Product summary:

Visual Identification: A clear, colourless solution in a glass vial, practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-08-02

Patient Information leaflet

Version 1.0
Page 1 of 3
BUSULFAN ACCORD
_Busulfan Concentrated Injection 60 mg/10 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Busulfan Accord.
It does not contain all the available
information. Some of the information
contained in this leaflet may not apply
to you.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given this medicine against
the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BUSULFAN ACCORD
IS USED FOR
Busulfan Accord 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.
Busulfan Accord contains the active
ingredient, busulfan. Busulfan belongs
to a group of medicines called
alkylating agents. Busulfan Accord
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 BUSULFAN
ACCORD HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
BUSULFAN ACCORD
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN BUSULFAN
ACCORD IF YOU HAVE AN ALLERGY TO:
•
busulfan, the active ingredient, or
any of the other ingredients listed in
this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin
BUSULFAN ACCORD SHOULD NOT BE GIVEN
IF YOU ARE PREGNANT, OR YOU THINK YOU
MAY BE PREGNANT OR ARE BREAST-
FEEDING.
Women should avoid becoming
pregnant during treatment with
Busulfan Accord and up to 6 months
after treatme

Summary of Product characteristics

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
BUSULFAN ACCORD (BUSULFAN) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Busulfan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains 6 mg busulfan.
1 vial of 10 mL concentrated injection for infusion contains 60 mg
busulfan.
Busulfan is a white crystalline solid that is only very slightly
soluble in water, sparingly soluble in acetone
and slightly soluble in ethanol.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Busulfan Accord is a clear, colourless, sterile concentrated injection
for infusion.
Busulfan Accord is intended for dilution with 0.9% sodium chloride
solution for injection or 5% glucose
solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Busulfan Accord is indicated for use in combination with
cyclophosphamide, melphalan or fludarabine
in conditioning prior to haematopoietic stem cell transplantation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Busulfan Accord administration should be supervised by a physician
experienced in conditioning
treatment prior to HSCT.
DOSAGE
In adult patients eligible for myeloablative HSCT the proposed dosage
recommendation is 3.2 mg/kg
body weight/day for four days, giving a total dose of 12.8 mg/kg.
In new-born infants, children and adolescents (0 to 17 years) eligible
for myeloablative HSCT it is
recommended that dosing is based on a patient's body weight as
follows:
ACTUAL BODY
WEIGHT (KG)
BUSULFAN
ACCORD DOSE
(MG/KG/DAY)
TOTAL
BUSULFAN
ACCORD DOSE
(MG/KG)
<9
9 to <16
16 to 23
>23 to 34
>34
4.0
4.8
4.4
3.8
3.2
16.0
19.2
17.6
15.2
12.8
The Busulfan Accord daily dose may be given as a single three-hour
infusion once daily (od) over 4
consecutive days for a total of 4 doses. Alternatively, the daily dose
may be divided and given as a two
to three hour infusion every 12 hours (bd) for four days, giving a
total of 8 doses, or every 6 hours (qid)
for four days, giving a total of 16 doses.
In a non-myeloablative conditioning regimen (also known as a
reduced-intens