Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - oncaspar

Document Subject

Generated Narrative: MedicinalProductDefinition mp214e72709936235d4c7554be3fb82817

identifier: http://ema.europa.eu/identifier/EU/1/15/1070/002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Oncaspar 750 U/ml powder for solution for injection/infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-214e72709936235d4c7554be3fb82817

identifier: http://ema.europa.eu/identifier/EU/1/15/1070/002

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - oncaspar

Attesters

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

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.

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. 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.

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 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 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 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 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.

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 inbreast 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 .

Before administration, you might receive combination of medicines to help reduce your chances of getting allergic reactions. Your doctor will decide whether such premedication 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 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.

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)

• 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;
• Blood clots;
• Fever with low counts of white blood cells.

Common (may affect up to 1 in 10 people)

• Severe bleeding or bruising;
• Violent shaking (seizures) and loss of consciousness;
• Severe infection with 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).

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;
• 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 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:

Belgi /Belgique/Belgien S.A. Servier Benelux N.V. T l/Tel: +32 (0)2 529 43 Lietuva UAB SERVIER PHARMA
Tel: +370 (5) 2 63 86

.: +359 2 921 57 Luxembourg/Luxemburg S.A. Servier Benelux N.V. Tel: +32 (0)2 529 43 esk republika Servier s.r.o. Tel: +420 222 118 Magyarorsz g Servier Hungaria Kft. Tel: +36 1 238 7Danmark Servier Danmark A/S Tlf: +45 36 44 22 Malta V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 Deutschland Servier Deutschland GmbH Tel: +49 (0)89 57095 Nederland Servier Nederland Farma B.V. Tel: + 31 (0)71 5246Eesti Servier Laboratories O
Tel:+ 372 664 5Norge Servier Danmark A/S Tlf: +45 36 44 22 E

: + 30 210 939 1 sterreich Servier Austria GmbH Tel: +43 (1) 524 39 Espa a Laboratorios Servier S.L. Tel: + 34 91 748 96 Polska Servier Polska Sp. z o.o. Tel: + 48 (0) 22 594 90 France Les Laboratoires Servier T l: + 33 (0)1 55 72 60 Portugal Servier Portugal, Lda Tel: + 351 21 312 20 Hrvatska Servier Pharma, d. o. o. Tel: + 385 (0)1 3016 Rom nia Servier Pharma SRL Tel: + 4 021 528 52 Ireland Servier Laboratories (Ireland) Ltd. Tel: + 353 (0)1 663 8Slovenija Servier Pharma d. o. o.
Tel: + 386 (0)1 563 48 sland Servier Laboratories c/o Icepharma hf S mi: + 354 540 8Slovensk republika Servier Slovensko spol. s r.o. Tel: + 421 2 5920 41 Italia Servier Italia S.p.A. Tel: + 39 (06) 669Suomi/Finland Servier Finland Oy P. /Tel: +358 (0)9 279 80
CA Papaellinas Ltd. : + 357 22 741 Sverige Servier Sverige AB Tel : +46 (0)8 522 508 Latvija SIA Servier Latvia Tel: + 371 67502United Kingdom (Northern Ireland) Servier Laboratories (Ireland) Ltd.Tel: +(0)1753 666This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: