Oncaspar 750 U/ml powder for solution for injection/infusion

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not use Oncaspar:

• if you are allergic to pegaspargase or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe hepatic disease.
• if you ever had pancreatitis.
• if you ever had severe bleeding following asparaginase therapy.
• if you ever had blood clots following asparaginase therapy.

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:

• 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 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 using 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 suffer abdominal pain. Inflammation of the pancreas, that in some cases caused death, can occur with Oncaspar treatment.

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 aftertreatment 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:

• immunisation with live vaccines within three months of completing your leukaemia treatment. This will increase the risk of severe infections.
• vincristine, another cancer medicine. If used at the same time as Oncaspar there is an increased risk of side effects or allergic reactions.
• medicines which reduce the bloods ability to clot such as anticoagulants (e.g., coumarin/warfarin and heparin), dipyridamole, acetylsalicylic acid or non-steroidal anti»inflammatory medicines (such as ibuprofen or naproxen). 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.
• cytarabine, a medicine which can be used in cancer treatment, and could interfere with the effects of Oncaspar.

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 treated with Oncaspar.

lt is not known whether pegaspargase is excreted into the 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, i.e., it is essentially 'sodium-free'.

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.

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)

• Inflammation or other disorders of the pancreas (pancreatitis) causing severe stomach pain which may spread to your back. vomiting. increase in blood sugar levels;
• Serious allergic reactions with symptoms such as rash. itching, swelling, hives, shortness of breath, fast heart beat and drop in blood pressure;
• Severe infection with very high fever;
• Blood clots.

Common (may affect up to 1 in 10 people)

• Severe bleeding or bruising;
• Violent shaking (seizures) and loss of consciousness;
• Problems with your liver (e.g., change in colour of your skin or urine or stool and laboratory results of elevated liver enzymes or bilirubin).

Rare (may affect up to 1 in 1,000 people)

• Liver failure.

Not known (frequency cannot be estimated from the available data)

• Severe skin reaction called toxic epidermal necrolysis;
• Loss of kidney function (e.g., change in urine output, swelling of feet and ankles);
• Stroke;
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening (anaphylactic shock).

Other side effects

Talk to your doctor if you get any of the following:

Very common (may affect more than 1 in 10 people)

• Changes in the function of the pancreas;
• Weight loss;
• Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism);
• Loss of appetite, general weakness, vomiting, diarrhoea, nausea;
• Increased blood sugar levels.

Common (may affect up to 1 in 10 people)

• Decreased number of red blood cells;
• Build-up of fluid in the stomach (ascites);
• Fever and flu-like symptoms;
• Mouth sores;
• Back, joint or abdominal pain;
• High levels of fat and cholesterol in your blood; low potassium in your blood.

Rare (may affect up to 1 in 1,000 people)

• Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome characterised by headache, confusion, seizures and visual loss which resolves after some time.

Not known (frequency cannot be estimated from the available data)

• Decreased number of white blood cells and platelets;
• Palpitations;
• Cysts in your pancreas, swelling of the salivary glands;
• High levels of urea in your blood; antibodies against Oncaspar; high levels of ammonia in your blood; decreased blood sugar levels;
• Sleepiness, confusion, mild twitching of the fingers.

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.

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.

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