Busulfan

Main information

  • Trade name:
  • Busulfan APOTEX busulfan 60mg/10mL injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Busulfan APOTEX busulfan 60mg/10mL injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210228
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210228

Busulfan APOTEX busulfan 60mg/10mL injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

9/10/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Busulfan APOTEX busulfan 60mg/10mL injection vial

Product Type

Single Medicine Product

Effective date

4/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

transplantation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Busulfan APOTEX busulfan 60mg/10mL injection vial

Dosage Form

Injection, solution

Route of Administration

Intravenous Infusion

Visual Identification

A clear and colorless solution

Active Ingredients

Busulfan

60 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:58:55 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Busulfan APOTEX

Injection 60mg/10mL

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

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about busulfan. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Busulfan APOTEX Injection. It

contains the active ingredient

busulfan.

It 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.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Busulfan 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.

Use in children

This medicine may be used in new-

born infants, children and

adolescents.

Before you are given

this medicine

When you must not be given

it

Do not take this medicine if:

You are pregnant.

Busulfan may affect your

developing baby if you are given

it during pregnancy.

You are breastfeeding.

Busulfan may pass into human

breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

busulfan or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, 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.

If you think you are having an

allergic reaction, contact your

doctor immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

BUSULFAN APOTEX INJECTION 60 MG/10 ML

Before you are given it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

have a liver, kidney, heart or lung

problem

have a history of seizures.

You are currently pregnant or you

plan to become pregnant. You

must not be given this medicine

whilst pregnant. Women should

avoid becoming pregnant during

treatment with busulfan and up to

6 months after treatment. Men

treated with busulfan are advised

not to father a child during and up

to 6 months after treatment.

It may no longer be possible for

you to achieve a pregnancy

(infertility) after treatment with

busulfan. If you are concerned

about having children, you should

discuss this with your doctor

before treatment.

You are currently breastfeeding

or you plan to breast-feed. You

must not be given this medicine

whilst breastfeeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

busulfan. These include:

itraconazole (used for certain

types of infections)

ketobemidone (used to treat pain)

cyclophosphamide and

melphalan, often used in

combination with busulfan,

should not be taken for 24 hours

after busulfan injection

paracetamol within 72 hours of

(and during) busulfan

administration should be used

with caution.

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with busulfan.

How this medicine is

given

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much is given

Your doctor will determine how

much of this medicine you will be

given. This will depend on your

condition and whether you are taking

any other medicines.

Adults

The dose will be calculated

according to your body weight.

The recommended dose of busulfan

is up to 3.2 mg per kg of body weight

per day, in combination with

cyclophosphamide, melphalan or

fludarabine.

In new-born infants, children and

adolescents (0 to 17 years)

The recommended dose is based on

body weight and may be up to 4.8

mg/kg/day

How it is given

Busulfan is given by a qualified

healthcare professional as a central

intravenous infusion, after dilution of

the individual vial. Each infusion will

last 2 to 3 hours. Blood samples may

be taken for testing the levels of

busulfan in your blood.

Before receiving busulfan you will

be given anticonvulsive drugs to

prevent seizures (phenytoin or

benzodiazepines) and antiemetic

drugs to prevent vomiting

When it is given

Busulfan will be given 1 to 4 times a

day for up to 4 days prior to

transplant.

If you take too much

(overdose)

As busulfan is given to you in

hospital under the supervision of

your doctor, it is unlikely that you

will receive an overdose.

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Symptoms of busulfan overdose

include the side effects listed below

in the Possible side effects section,

but are usually of a more severe

nature.

While you are being

given this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

BUSULFAN APOTEX INJECTION 60 MG/10 ML

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you are being given this medicine.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Busulfan is a powerful cytotoxic

drug that results in a huge decrease

of blood cells. It is possible that use

of busulfan may increase the risk of

suffering another malignancy in the

future.

Busulfan can also produce symptoms

of menopause and in pre-adolescent

girls it can prevent the onset of

puberty.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

being given busulfan or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

The most serious side effects may

include decrease in circulation blood

cell counts (intended effect of the

drug to prepare you for your

transplant infusion), infection, liver

disorders including blocking of a

liver vein, graft versus host disease

(the graft attacks your body) and

pulmonary complications. Your

doctor will monitor your blood

counts and liver enzymes regularly to

detect and manage these events.

Tell your doctor as soon as possible

if you notice any of the following:

These side effects of busulfan are

very common (reported in more than

1 patient out of 10):

Blood: decrease of blood

circulating cells (red and white)

and platelets.

Infections and Infestations:

infections, fever, chills.

Nervous system: insomnia,

anxiety, dizziness, and

depression.

Nutrition: loss of appetite,

decrease in magnesium, calcium,

potassium, phosphate in blood

and increase in blood sugar.

Cardiac: increase in heart rate,

increase or decrease of blood

pressure, vasodilation (a state of

increased calibre of the blood

vessels) and blood clots.

Respiratory: shortness of breath,

nasal secretion (rhinitis), sore

throat, cough, hiccup, nosebleeds,

abnormal breath sounds.

Gastro-intestinal: nausea,

inflammation of the mucosa of

the mouth, vomiting, abdominal

pain, diarrhoea, constipation,

heart burn, anus discomfort,

liquid in the abdomen.

Hepatic: enlarged liver, jaundice.

Skin: loss of hairs.

Muscle and bone: back, muscle

and joint pain.

Renal: increase in creatinine

elimination, discomfort in

urination, and decrease in urine

output.

General: fever, headache,

weakness, chills, pain, oedema,

general pain or inflammation at

injection site, chest pain,

inflammation of the mucosa.

Investigations: elevated liver

enzymes, increased weight.

Less common side effects (reported

in 1 to 10 out of 100 patients)

include:

Nervous system: confusion.

Nutrition: low blood sodium.

Cardiac: changes and

abnormalities in heart rhythm,

fluid retention or inflammation

around the heart, decrease heart

output.

Respiratory: increase in breath

rhythm, respiratory failure,

alveolar haemorrhages, asthma,

collapse of small portions of the

lung, fluid around the lung.

Gastro-intestinal: inflammation of

the mucosa oesophagus, paralysis

of the gut, vomiting blood.

Skin: skin colour disorder,

redness of the skin, skin peeling.

Renal: increase in the amount of

nitrogen components in the blood

stream, blood in urines, moderate

renal insufficiency.

Uncommon side effects (reported in

1 to 10 out of 1000 patients) include:

Nervous system: delirium,

nervousness, hallucination,

agitation, abnormal brain

function, cerebral haemorrhage,

and seizure.

Cardiac: clotting of femoral

artery, thrombosis, extra heart

beats, decrease in heart rate,

diffuse leak of fluid from the

capillaries (small blood vessels).

Respiratory: decrease in blood

oxygen.

Gastro-intestinal: bleeding in the

stomach and/or the gut.

Febrile neutropenia, tumor lysis

syndrome, thrombotic micro-

angiopathy (TMA), severe bacterial,

viral and fungal infections and sepsis

have also been observed during

treatment.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to busulfan, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

BUSULFAN APOTEX INJECTION 60 MG/10 ML

cough, 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

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 2-8°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor stops giving you this

medicine or it has passed its expiry

date, the medical staff will dispose of

the remaining medicine safely.

Product description

What Busulfan APOTEX

Injection looks like

Busulfan APOTEX Injection 60 mg/

10 mL appears as a clear colourless

solution. It is a sterile solution that

contains no antimicrobial agent.

Busulfan APOTEX Injection is for

single use in one patient only and is

supplied in cartons each containing 8

single-dose 10 mL clear glass vials

(type I).

Ingredients

Each vial contains 60 mg of busulfan

as the active ingredient.

It also contains the following inactive

ingredients:

dimethylacetamide (DMA)

macrogol 400

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Busulfan APOTEX Injection 60 mg/

10 (pack of 8 glass vials): AUST R

210228

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

June 2015

BUSULFAN APOTEX INJECTION 60 MG/10 ML

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