InfoCons Consumer Protection informs you – Oncaspar – Package Leaflet

Before anything else

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.

ℹ️ 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. Onca spar 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 k now before you are given Oncaspar

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 have ever had pancreatitis.
• if you have ever had severe bleeding following asparaginase therapy.
• if you have 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 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 using other medicines which may harm the liver.

29 – if Oncaspar is used in combination with other cancer treatments, liver damage ( severe, life- threatening, and potential ly fatal cases of hepatic veno -occlusive disease (VOD)) may occur with Oncaspar.

• if Oncaspar is used in combination therapy this may result in injury to central nervous system .
• 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.

A side effect called osteonecrosis (bone damage) has been reported in the post -marketing setting in children and adolescents receiving Oncaspar (higher incidence seen in girls), when taken concomitantly with glucocorticoids (e.g. dexamethasone).

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 increa se 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 blood´s ability to clot such as anticoagulants (e.g., coumarin/ warfarin and heparin ), dipyridamol, acetylsalicylic acid or non- steroidal anti-inflammatory medicines (such as ibuprofen or naproxen). If u sed 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 taken at the same time as part of recommended leukamia treatment, 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), please inform your doctor as soon as possible.
• 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.

30 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 con traception 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

Before administration, y ou might receive combination of medicines to help reduce your chances of getting allergic reactions . Your doctor will decide whether such pre medication is necessary.

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 i s 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 s taff 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 c ommon (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 o f breath, fast heart beat and drop in blood pressure ;
• Blood clots;
• Fever with low counts of white blood cells.

Common (may affect up to 1 in 10 people)

• Severe bleeding or bruising;

31 – Violent shaking (seizures) and loss of consciousness;

• Severe infection wit h very high fever;
• 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;
• Jaundice;
• Blocked bile flow from the liver (cholestasis);
• Destruction of liver cells (liver cell necrosis).

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) ;
• Bone damage (osteonecrosis).
• A serious type of liver damage Hepatic veno- occlusive disease (VOD) : symptoms may include rapid weight gain, fluid retention in the abdomen (ascites) causing abdominal swelling and enlarged liver (hepatomegaly).

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, ca lled pulmonary embolism);
• Loss of appetite, general weakness, vomiting, diarrhoea , nausea;
• Increased blood sugar levels;
• Decreased number of white blood cells .

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 characteri sed 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 platelets;
• Fever;
• 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 32 the national reporting system listed in Appendix V . 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 medicin e 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 monoh ydrate, 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

Les Laboratoires Servier 50, rue Carnot 92284 Suresnes cedex France

Manufacturer

Les Laboratoires Servier Industrie 905 Route de Saran 45520 Gidy France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien S.A. Servier Benelux N.V.

Tél/Tel: +32 (0)2 529 43 11 Lietuva UAB “SERVIER PHARMA” Tel: +370 (5) 2 63 86 28 България Сервие Медикал ЕООД Тел.: +359 2 921 57 00 Luxembourg/Luxemburg S.A. Servier Benelux N.V.

Tel: +32 (0)2 529 43 11 Česká republika Servier s.r.o.

Tel: +420 222 118 111 Magyarorsz ág Servier Hungaria Kft.

Tel: +36 1 238 7799 Danmark Servier Danmark A/S Tlf: +45 36 44 22 60 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 Deutschland Servier Deutschland GmbH Tel: +49 (0)89 57095 01 Nederland Servier Nederland Farma B.V.

Tel: + 31 (0)71 5246700 Eesti Servier Laboratories OÜ Tel:+ 372 664 5040 Norge Servier Danmark A/S Tlf: +45 36 44 22 60 Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: + 30 210 939 1000 Österreich Servier Austria GmbH Tel: +43 (1) 524 39 99 España Laboratorios Servier S.L.

Tel: + 34 91 748 96 30 Polska Servier Polska Sp. z o.o.

Tel: + 48 (0) 22 594 90 00 France Les Laboratoires Servier Tél: + 33 (0)1 55 72 60 00 Portugal Servier Portugal, Lda Tel: + 351 21 312 20 00 Hrvatska Servier Pharma, d. o. o.

Tel: + 385 (0)1 3016 222 România Servier Pharma SRL Tel: + 4 021 528 52 80 Ireland Servier Laboratories (Ireland) Ltd.

Tel: + 353 (0)1 663 8110 Slovenija Servier Pharma d. o. o.

Tel: + 386 (0)1 563 48 11 Ísland Servier Laboratories c/o Icepharma hf Sími: + 354 540 8000 Slovenská republika Servier Slovensko spol. s r.o.

Tel: + 421 2 5920 41 11 Italia Servier Italia S.p.A.

Tel: + 39 (06) 669081 Suomi/Finland Servier Finland Oy P. /Tel: +358 (0)9 279 80 80 Κύπρος CA Papaellinas Ltd.

Τηλ: + 357 22 741 741 Sverige Servier Sverige AB Tel : +46 (0)8 522 508 00 Latvija SIA Servier Latvia Tel: + 371 67502039 United Kingdom (Northern Ireland) Servier Laboratories (Ireland) Ltd. Tel: +44 (0)1753 666409

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . —————————————————————————————————————————

🩺 Information intended for healthcare professionals only

It is strongly reco mmended that every time Oncaspar is administered to a patient, the name and lot number of the product are recorded in order to link the patient and the lot of the product.

In view of the unpredictability of adverse reactions, Oncaspar should be administered only by health care personnel experienced in the use of cancer chemotherapeutic medicinal products.

Particularly in patients with known hypersensitivity to the other forms of L-asparaginase, hypersensitivity reactions to Oncaspar can occur during the therapy, e.g., anaphylaxis. A routine precaution is to observe the patients for an hour with resuscitation equipment and other items required for the treatment of anaphylaxis in readiness (epinephrine, oxyg en, intravenous steroids etc.).

Patients should be informed about possible hypersensitivity reactions to Oncaspar, including immediate anaphylaxis. Patients who receive Oncaspar are at increased risk of bleeding and thrombotic disorders. It should be explained to patients that Oncaspar should not be used at the same time as other medicines associated with an increased risk of bleeding (see section 2 “Other medicines and Oncaspar”).

This medicinal product can cause irritation on contact. The powder must therefore be handled and administered with particular care. Inhalation of the vapour and contact with the skin and mucosa, particularly that of the eyes, must be avoided ; if the product comes in contact with eyes, skin, or mucous membranes , rinse imm ediately with plenty of water for at least 15 minutes.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions on how to prepare, store and dispose of Oncaspar Instru ctions for handling 1. Staff should be trained in how to handle and transfer the medicinal product (pregnant staff should be excluded from working with this medicinal product).

2. Aseptic technique must be used.

3. Procedures for proper handling of antineoplastic agents should be observed.

4. The use of disposable gloves and protective garments is recommended when handlin g Oncaspar .

5. All items for administration or cleaning, including gloves, should be placed in high- risk waste disposal bags for high -temperature incineration.

Reconstitution 1. 5.2 ml water for injections are injected into the vial using a syringe and 21 gauge needle.

2. The vial should be g ently swirl ed until the powder is reconstit uted.

3. After reconstitution , the solution should be clear, colourless and free from visible foreign particles . Do not use if the reconstituted solution is cloudy or if a precipitate has formed. Do not shake.

4. The solution should be used within 24 hours after reconstitution , when stored below 25°C.

35 Administration 1. Parenteral medicinal products should be inspected for particulate matter prior to administration, only a clear, colourless solution free from visible foreign particles should be used.

2. The medicinal product should be a dminister ed intravenousl y or intramuscularly. The solution should be administered slowly.

For intramuscular injection, the volume should not exceed 2 ml in children and adolescents and 3 ml in adults.

For intravenous administration, the reconsti tuted solution should be diluted in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution.

The diluted solution can be given over 1 to 2 hours together with an already-running infusion of either sodium chloride 9 mg/ml (0.9%) solution or 5% glucose. Do not infuse other medicinal products through the same intravenous line during administration of Oncaspar .

After dilution, the solution should be used immediately. If immediate use is not possible, the diluted solution can be stored at 2°C -8°C f or up to 48 hours.

Disposal Oncaspar is for single use only. Any unused medicinal product or waste material should be disposed of in acco rdance with local requirements.

Further detailed information can be found in the SmPC.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Oncaspar (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/15/1070).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.