BUSULFEX busulfan 60mg/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

busulfan, Quantity: 60 mg

Available from:

Otsuka Australia Pharmaceutical Pty Ltd

INN (International Name):

Busulfan

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: dimethylacetamide; macrogol 400

Administration route:

Intravenous

Units in package:

8 x 10 mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: clear solution, essentially free of particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-07-21

Patient Information leaflet

BUSULFEX
®
60 MG/10 ML INJECTION
_Busulfan_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BUSULFEX. 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 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
BEING GIVEN BUSULFEX, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BUSULFEX IS
USED FOR
BUSULFEX 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.
BUSULFEX contains the active
ingredient, busulfan. Busulfan
belongs to a group of medicines used
to treat some cancers. BUSULFEX
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 BUSULFEX
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU ARE GIVEN
BUSULFEX
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
BUSULFEX 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
BUSULFEX MUST 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
BUSULFEX and up to 6 months
after treatment.
Women must not breast-feed during
their treatment with BUSULFEX.
_BEFORE YOU ARE GIVEN IT_
BUSULFEX is a p

Summary of Product characteristics

BUSULFEX
1
AUSTRALIAN PRODUCT INFORMATION
BUSULFEX (BUSULFAN) INJECTION
1
NAME OF THE MEDICINE
Busulfan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial of Busulfex contains 60 mg (6 mg/mL) of busulfan.
Busulfan, the active ingredient of Busulfex, 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
Busulfex is an intravenous form of busulfan, a chemotherapeutic agent
commonly used as part
of a conditioning regimen prior to haematopoietic stem cell
transplantation.
Busulfex is supplied as a sterile solution in 10 mL single-use clear
glass vials each containing
60 mg of busulfan at a concentration of 6 mg/mL for intravenous use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Busulfex is indicated for use in combination with cyclophosphamide,
melphalan or fludarabine
in conditioning prior to haematopoietic stem cell transplantation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Busulfex 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:
BUSULFEX
2
ACTUAL BODY
WEIGHT (KG)
BUSULFEX DOSE
(MG/KG/DAY)
TOTAL BUSULFEX
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 Busulfex 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 dos