Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using ONCASPAR?
ONCASPAR contains pegaspargase which is a form of an enzyme called asparaginase. Pegaspargase
may sometimes be called pegylated (or "PEG") asparaginase. ONCASPAR is used to treat
leukaemia. It belongs to a group of medicines called antineoplastic or cytotoxic medicines.
You may also hear of these being called chemotherapy medicines.
For more information, see Section
1. Why am I using ONCASPAR? in the full CMI.
2. What should I know before I use ONCASPAR?
Do not use if you have ever had an allergic reaction to ONCASPAR or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use ONCASPAR? in the full CMI.
3. What if I am taking other medicines?
4. How do I use ONCASPAR?
ONCASPAR must only be given by healthcare professionals trained in administering anticancer
medicines. ONCASPAR is given by injection into a muscle (intramuscular) or, if not
suitable, into a vein (intravenous). Your doctor will decide upon the doses you will
receive and how often. This depends on your, age, body weight and height. ONCASPAR
may be given in combination with other drugs. Your doctor will decide whether premedication
is necessary.
More instructions can be found in Section
4. How do I use ONCASPAR? in the full CMI.
5. What should I know while using ONCASPAR?
|
Things you should do
|
Remind any doctor, nurse, dentist or pharmacist you visit that you are using ONCASPAR.
Keep all appointments with your doctor and always discuss with your doctor any problems
during or after treatment with ONCASPAR.
|
|
Things you should not do
|
Do not start taking any other medicines, prescription or over-the-counter, without
first telling your doctor.
|
|
Driving or using machines
|
Do not drive or use machines when using ONCASPAR because it may make you feel drowsy,
tired or confused.
|
|
Looking after your medicine
|
It is unlikely that you will be asked to store ONCASPAR yourself. It will usually
be stored in the pharmacy or on the hospital/clinic ward.
|
6. Are there any side effects?
Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well
while you are being given ONCASPAR. ONCASPAR, like all other medicines, may cause
unwanted side effects. Side effects are very common with anti-cancer medicines such
as ONCASPAR and they may be serious. You may need medical treatment if you get some
of the side effects.
If you experience serious allergic reactions with symptoms such as rash, itching,
swelling, hives, shortness of breath, fast heartbeat and drop in blood pressure, severe
skin reaction called toxic epidermal necrolysis, violent shaking (seizures) and loss
of consciousness, very high fever, severe stomach pain which may spread to your back,
vomiting, increase in blood sugar levels, headaches, high blood pressure, visual disturbances,
change in urine output, swelling of the feet and ankles, change in colour of your
skin or urine or stool, fast heart rate, breathing difficulty and weakness, leg pain,
chest pain or shortness of breath after taking ONCASPAR – please seek urgent medical
attention.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Pegaspargase powder for solution for injection/infusion
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ONCASPAR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ONCASPAR.
Where to find information in this leaflet:
1. Why am I using ONCASPAR?
ONCASPAR contains pegaspargase which is a form of an enzyme called asparaginase. This
enzyme breaks down asparagine, an important building block in making proteins, without
which cells cannot survive. Normal cells can make asparagine for themselves, while
some cancer cells cannot. ONCASPAR lowers asparagine levels in blood cancer cells
and stops the cancer growing.
Pegaspargase may sometimes be called pegylated (or "PEG") asparaginase.
ONCASPAR is used to treat leukaemia. It belongs to a group of medicines called antineoplastic
or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I use ONCASPAR?
Warnings
Do not use ONCASPAR if:
you are allergic to pegaspargase or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
have severe hepatic (liver) disease.
have ever had pancreatitis (inflammation of the pancreas).
have ever had blood clots following asparaginase therapy.
have ever had severe bleeding following asparaginase therapy.
You should tell your doctor:
if you have had serious allergic reactions to other forms of asparaginase, for example
itching, flushing or swelling of the airways, because major allergic reactions to
ONCASPAR can occur.
if you suffer from a bleeding disorder or have had serious blood clots.
if you get a fever. This medicine may make you more susceptible to infections.
if you have had poor liver function or are taking other medicines which may harm the
liver. When ONCASPAR is used in combination with other cancer treatments, liver and
central nervous system damage can occur.
if you have or have had liver, lung or heart disease.
if you suffer abdominal pain. Inflammation of the pancreas can occur with ONCASPAR
that in some cases can cause death if left untreated.
This medicine can lead to fluctuations in clotting factors and may increase the risk
of bleeding and/or clotting.
A side effect called osteonecrosis (bone damage) has been reported in children and
adolescents receiving ONCASPAR (higher incidence seen in girls), when taken at the
same time as glucocorticoids (e.g. dexamethasone). Glucocorticoids are medicines used
to treat many different conditions including severe allergies, asthma, skin problems,
and inflammatory diseases.
If you have not told your doctor about any of the above, tell your doctor before you
are given ONCASPAR.
If you are the parent of a child being treated with ONCASPAR, tell the doctor if any
of the above conditions apply to your child.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
It is important to tell your doctor if you are pregnant or intend to become pregnant,
or if you are breastfeeding or intend to breastfeed.
Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
Like most cytotoxic medicines ONCASPAR is not recommended for use during pregnancy.
If there is any need to consider this medicine during your pregnancy, your doctor
will discuss with you the benefits and risks of using it. Men must also use effective
contraception while they or their partners are being treated with ONCASPAR.
Breastfeeding
Do not breastfeed if you are taking this medicine.
The active ingredient in ONCASPAR may pass into breast milk and there is a possibility
that your baby may be affected.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and ONCASPAR may interfere with each other. In particular, it is especially
important to tell your doctor if you are using any of the following medicines:
immunisation with live vaccines within 3 months of completing your leukaemia treatment.
This will increase the risk of severe infections.
other medicines used to treat leukaemia or cancer
medicines which reduce blood clotting such as anticoagulants (e.g. warfarin and heparin),
dipyridamol, aspirin and other anti-inflammatory medicines. If used at the same time
as ONCASPAR, there is a higher risk of bleeding disorders.
medicines which require cell division for their effect, for example, methotrexate
(a medicine used for cancer as well as arthritis treatment) may have a decrease in
its effect.
prednisone, a steroid medicine. If used at the same time as ONCASPAR, the effects
on the clotting ability of your blood are increased.
Glucocorticoids when used at the same time as ONCASPAR may increase the risk of steroid-induced
osteonecrosis (bone damage) in children and adolescents, with a higher incidence seen
in girls. Therefore, if you experience any new bone pain (i.e. pain in hip, knee or
back), inform your doctor as soon as possible.
ONCASPAR can also cause changes in liver function which can affect how other medicines
work.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ONCASPAR.
4. How do I use ONCASPAR?
You should be treated with ONCASPAR by a doctor who is trained in treating patients
with leukaemia. Treatment will normally take place in a hospital because of the need
for hospital facilities and skilled personnel.
How much is given
ONCASPAR must only be given by healthcare professionals trained in administering anticancer
medicines.
Your doctor will decide upon the doses you will receive and how often. This depends
on your age, body weight and height.
ONCASPAR may be given in combination with other drugs.
How ONCASPAR is given
ONCASPAR is given by injection into a muscle (intramuscular) or, if not suitable,
into a vein (intravenous). Before administration, you might receive a combination
of medicines which may include paracetamol, and an antihistamine to help reduce your
chances of getting allergic reactions. Your doctor will decide whether such premedication
is necessary.
Ask your doctor if you want more information about the dose of ONCASPAR and the other
medicines you will be receiving and how they are given while you are being treated
with ONCASPAR.
If you use too much ONCASPAR
As ONCASPAR is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much.
However, if you experience severe side effects after being given this medicine, tell
your doctor or nurse immediately.
You may need urgent medical attention.
5. What should I know while using ONCASPAR?
Things you should do
Keep all appointments with your doctor and always discuss with your doctor any problems
during or after treatment with ONCASPAR.
Do not start taking any other medicines, prescription or over-the-counter, without
first telling your doctor.
Driving or using machines
Do not drive or use machines when using this medicine because it may make you feel
drowsy, tired or confused.
Looking after your medicine
It is unlikely that you will be asked to store ONCASPAR yourself. It will usually
be stored in the pharmacy or on the hospital/clinic ward.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
Serious side effects
|
What to do
|
|
Gastrointestinal
Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach
pain which may spread to your back
Vomiting
Kidney and liver related
Loss of kidney function (e.g. change in urine output, swelling of feet and ankles)
Problems with your liver (e.g. change in colour of your skin or urine or stool
Respiratory and heart
Chest pain or shortness of breath (which may be a symptom of blood clots in the lungs,
called pulmonary embolism)
Fast heartbeat, fast heart rate, breathing difficulty, and weakness
Blood and investigations
Increase in blood sugar levels (hyperglycaemia)
Drop in blood pressure
Musculoskeletal
Bone damage (osteonecrosis)
Leg pain (which could be a symptom of thrombosis)
Nervous system
Headaches, high blood pressure and visual disturbances, which are symptoms of a condition
called encephalopathy
Serious allergic reactions that may cause loss of consciousness and could be life-threatening
(anaphylactic shock)
Violent shaking (seizures) and loss of consciousness
Skin
Rash, itching, swelling, hives
Severe skin reaction called toxic epidermal necrolysis
General
Very high fever
|
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Gastrointestinal
Loss of appetite, feeling sick, being sick, stomach cramps, diarrhoea, general weakness
or weight loss
Build-up of fluid in the stomach (ascites)
Cysts in your pancreas
Kidney and liver related
Laboratory results of elevated liver enzymes or bilirubin)
Liver failure, jaundice, blocked bile flow from the liver (cholestasis), destruction
of liver cells (liver cell necrosis)
Respiratory and heart
Palpitations
Blood and investigations
Blood clots
Fever with low counts of white blood cells
Severe bleeding or bruising
Decreased number of red blood cells
Decreased number of white blood cells and platelets
High levels of fat and cholesterol in your blood
Low potassium in your blood
Reduced thyroid function which may cause tiredness, weight gain and feeling cold
High levels of urea in your blood
Antibodies against ONCASPAR
High levels of ammonia in your blood
Decreased blood sugar levels
Anaemia
Increased level of calcium in your blood (hypercalcemia)
Abnormally low level of sodium in your blood (hyponatremia)
Musculoskeletal
Back, joint or abdominal pain
Bone damage (osteonecrosis)
Pain or swelling at the injection site
Mouth
Mouth sores
Swollen salivary glands (parotitis)
Nervous system
Changes in EEG (a trace of the electrical activity of your brain)
Mild twitching of the fingers
Sleepiness, confusion
Damage to, or disease affecting nerves (peripheral neuropathy), which may impair sensation,
movement, gland or organ function
Encephalopathy, characterised by headache, confusion, seizures and visual loss which
resolves after some time
Stroke
General
Severe infection with very high fever
Fever and flu-like symptoms
Dehydration
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people. Your doctor has information
on monitoring for such side effects and their treatment.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
Each vial contains 750 units pegaspargase per 1 mL (3,750 units in 5 mL)
What ONCASPAR contains
|
Active ingredient
(main ingredient)
|
Pegaspargase powder for solution for injection/infusion
|
|
Other ingredients
(inactive ingredients)
|
Sodium dihydrogen phosphate monohydrate
Disodium phosphate heptahydrate
Sodium chloride
Sucrose
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
|
Do not take this medicine if you are allergic to any of these ingredients.
What ONCASPAR looks like
ONCASPAR is a white to off white powder. After reconstitution, the solution is clear,
colourless and free from visible foreign particles.
Each pack contains 1 glass vial with 3,750 U pegaspargase.
(Aust R 303807).
Who distributes ONCASPAR
Servier Laboratories (Aust.) Pty. Ltd.
Level 4, Building 9
588A Swan Street
Burnley, 3121, Victoria
Phone: 1800 153 590
This leaflet was prepared in June 2023.