Active ingredient
- pegaspargase
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/15/1070/002.
Oncaspar 750 U/ml powder for solution for injection/infusion
Package leaflet: Information for the user
Oncaspar 750 U/ml powder for solution for injection/infusion
pegaspargase
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Oncaspar is and what it is used for
2. What you need to know before you are given Oncaspar
3. How Oncaspar is given
4. Possible side effects
5. How to store Oncaspar
6. Contents of the pack and other information
1. What Oncaspar is and what it is used for
Oncaspar contains pegaspargase, which is an enzyme (asparaginase) that breaks down asparagine, an important building block of proteins without which cells cannot survive. Normal cells can make asparagine for themselves, while some cancer cells cannot. Oncaspar lowers asparagine level in blood cancer cells and stops the cancer cells growing.
Oncaspar is used to treat acute lymphoblastic leukaemia (ALL) in children from birth to 18 years and in adults. ALL is a white blood cell cancer type in which certain immature white cells (named lymphoblasts) start growing out of control thus preventing the production of functional blood cells. Oncaspar is used together with other medicines.
2. What you need to know before you are given Oncaspar
Do not use Oncaspar
Tell your doctor if any of these conditions apply to you. If you are the parent of a child who is being treated with Oncaspar, please tell the doctor if any of them apply to your child.
Warnings and precautions
Talk to your doctor before you are given Oncaspar. This medicine may not be suitable for you:
This medicine can lead to fluctuations in clotting factors and may increase the risk of bleeding and/or clotting.
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 with Oncaspar
During Oncaspar administration you will be closely watched for an hour after the start of treatment for any signs of serious allergic reactions.
Medical equipment to treat allergic reactions will be available nearby.
Additional monitoring tests
Blood and urine sugar levels, liver and pancreas function and other tests will be carried out regularly to monitor your health during and after treatment because this medicine can affect your blood and other organs.
Other medicines and Oncaspar
Tell your doctor if you are using, have recently used or might use any other medicines.
This is important as Oncaspar may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body. In addition, it is especially important to tell your doctor if you are also using any of the following medicines:
Oncaspar can also cause changes in liver function which can affect the way other medicines work.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not use Oncaspar if you are pregnant because its effects during pregnancy have not been studied. Your physician will decide whether your disease requires treatment. Women who are able to get pregnant must use reliable contraception during treatment, and for at least 6 months after Oncaspar treatment has been discontinued. Oral contraception is not an effective method of contraception while on treatment with Oncaspar. Ask your doctor for advice on the best contraceptive method that you can use. Men must also use effective contraception while they or their partners are being treated with Oncaspar.
It is not known whether pegaspargase is excreted in breast milk. As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and should not be re-started until after treatment with Oncaspar has been discontinued.
Driving and using machines
Do not drive or use machines when using this medicine because it may make you feel drowsy, tired or confused.
Oncaspar contains sodium
This medicine contains less than 1 mmol sodium per dose, that is to say essentially 'sodium-free'.
3. How Oncaspar is given
Your treatment with Oncaspar has been prescribed by a doctor experienced in medicines used to treat cancer. Your doctor will decide what dose of the medicine is needed and how often, based on your age and body surface area which is calculated from your height and weight.
The medicine is given as a solution by injection into a muscle or, if more suitable, into a vein.
If you are given too much Oncaspar
As your doctor will administer the medicine, it is very unlikely you will be given more than you need.
In the unlikely event of accidental overdose, you will be monitored carefully by medical staff and treated appropriately.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately if you get any of the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Other side effects
Talk to your doctor if you get any of the following:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects you think might be related to your chemotherapy, talk to your doctor.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Oncaspar
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
Do not freeze.
After the medicine has been reconstituted and diluted, the solution should be used immediately. If immediate use is not possible, the diluted solution can be stored at 2°C-8°C for up to 48 hours.
Do not use this medicine if you notice the reconstituted solution is cloudy or has visible particles.
Do not throw away any medicines via wastewater. Ask the pharmacist how to dispose of unused medicines. These measures will help protect the environment.
6. Contents of the pack and other information
What Oncaspar contains
The active substance is pegaspargase. Each vial contains 3,750 U of pegaspargase.
After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 U/ml).
The other ingredients are: disodium phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sucrose, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) (see section 2 "Oncaspar contains sodium").
What Oncaspar looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 11/2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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