Busulfan ARX busulfan 60mg/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

busulfan, Quantity: 60 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Busulfan

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: dimethylacetamide; macrogol 400

Administration route:

Intravenous Infusion

Units in package:

8

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Busulfan injection 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 and colorless solution; 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:

Licence status A

Authorization date:

2014-10-09

Patient Information leaflet

BUSULFAN APOTEX
INJECTION
_Contains the active ingredient busulfan_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. 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 taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Busulfan APOTEX Injection 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 APOTEX Injection
contains the active ingredient
busulfan and belongs to a group of
medicines called alkylating agents.
Busulfan destroys the original bone
marrow before the transplant.
There is no evidence that this
medicine is addictive.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
busulfan or any of the ingredients
listed at the end of 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,
throat or other parts of the body
•
rash, itching or hives on the skin
•
fainting or hay fever-like
symptoms
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT, THINK YOU MAY BE
PREGNANT OR ARE BREASTFEEDING.
Busulfan may affect your developing

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
BUSULFAN APOTEX (BUSULFAN) INJECTION
1
NAME OF THE MEDICINE
Busulfan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial of busulfan injection contains 60 mg (6 mg/mL) of
busulfan.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Busulfan APOTEX Injection is supplied as a sterile solution in 10 mL
single-use clear glass
vials.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Busulfan injection 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
IV busulfan administration should be supervised by a physician
experienced in conditioning
treatment prior to HSCT.
It is intended for dilution with 0.9% sodium chloride solution for
injection or 5% glucose solution
for injection.
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)
IV BUSULFAN DOSE
(MG/KG/DAY)
TOTAL IV BUSULFAN
DOSE (MG/KG)
< 9
4.0
16.0
9 to < 16
4.8
19.2
16 to 23
4.4
17.6
> 23 to 34
3.8
15.2
> 34
3.2
12.8
The IV busulfan 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.
2
In a non-myeloablative conditioning regimen (also known as a
reduced-intensity conditioning
regimen) a lower IV busulfan daily dose may be administered and/or the
dose may be
administered for less than four days, resulting in a lower total dose.
In clinical trials IV busulfan
total