ONCASPAR 750 U/ML POWDER FOR SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

Oncaspar 750 U/ml

pegaspargase

Read al of this leaflet carefully before you are given th medicine because it contains bn porta nt Information for you.

• - Keep ttfc leaflet. You may need tn read It again.

• - If you have any further questions, ask you doctor.

- If you get any side effects, talk tn your doctor. This todudes any possible side effects not feted In this leaflet. See section 4.

What Is In this leaflet

1. What Oncaspar Is and what It Is used for

• 2. Whatyou need to knew 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 toformation

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 swviw. Normal cels can make asparagine for themselves, while some cancer ceils cannot. Oncaspar lowers asperajflie level In blood cancer cells and stops the cancer cels growing.

Oncaspar Is used to treat acute lymphoblastic leukaemia (ALL) to chlltflen from bkth to 1B years and In addts. ALL Is a white blood cel cancer type In which certato knmature white cells (named lymphoblasts) start growing out of control thus preventtog the production of fimctional Mood cells. Oncaspar is used together with other medetoes.

2. what you need to know before you are given oncaspar

Do not um Oiicuper

• - If you are alerglc to pegaspargase or to any of the other Inpedlents of this medicine (listed In section 6).

  
  
  
  

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• - if you have over had swere blasting following asparapnase therapy.

• - if you have ever had blood clots folowing asparaginase therapy.

Tel 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 tel the doctor if any of them apply to your child.

Wamtogt and precautions

Tafc to ywr doctor before you are given Oncaspar. This medicine may not be statable for you: – if you have had serious allergic reactions to other forms of asparaginase, for example itching, flushtog or swelling of the always, because major allergic reactions to Oncaspar can occur.

• - If you suffer from a bleeding dsottfer or have had serious blood dots.

• - If you get a fever. This medetoe may malra you more susceptible to tofeeflons.

• - If you have had poor Itver function or are using other medetoes which may harm the liver.

When Oncaspar Is used In combtootion with other cancer treatments, Itver and central nervous system damage can occur.

• - If you suffer abdominal pato. Inflammation of the pancreas, that In some cases caused death, can occur with Oncaspar treatment

This meddle can lead to fluctuations In clotting factors and may tocrease the risk of Needing and/or clotting.

If you are the parent of a chid being treated with Oncaspar, tell the doctor if any of the above conations apply to you chid.

During treatment with Oncaspar

During Oncaspar adminetration you will be closely watched for an hour after the start of treatment tor any signs of serious allergic reactions.

Medcal equipment to treat allergic reactions will be available nearby.

Addtional monitoraw tests

Blood and urine sugar levels, liver and pancreas fincton and other tests wfl be carried out regularly to monitor you1 health during and after treatment because this medcine can affect your Mood and other organs.

Other medicines and Oncaspar

Tel you doctor if you are uang, have recently used or might use any other medicines.

Thia Is Important as Oncaspar may Increase the side effects of other medicines throujpi Its effect on the liver which plays an Important role In remwtog meddnes from the body, to addition, It Is especially Important to tell your doctor If you are also ustog any of the folowing medicines: – Immunisation with live vaccines wtthto three months of completing your leukaemia treatment.

• - vlncristtoe, another cancer medicine. If used at the same tkne as Oncaspar there Is an Increased

• - medicines which reduce the blood s ability to clot such as anttcoagNante (e.g., counarin/wariarin and heparin), dipyridamole, acetylsalicylic add or non-steroidal anti-inflammatory medetoes (such as ibuprofen or naproxen). If used at the same ttoie as Oncaspar, there is a hi^ier risk of Meecflig disorders.

• - medicines which require cell division tor their effect, tor example, methotrexate (a mettidne used for cancer as well as arthritis treatment) may have a decrease in its effect

• - prednisone, a steroid medictoe. If used at the same time as Oncaspar, the effects on the clotting

• - cytarabtoe, a medldne which can be used to cancar treatment and could Interfere with the effects of Oncaspar.

Oncaspar can also cause changes In Itver function which can affect the way other meddnes work.

Pregnancy and breut-faedng

If you are pre^iant or breast-feeding, think you may be prejyiant or are ptanntog to have a baby, ask your doctor fer advice before using this medldne.

You should not use Oncaspar if you are pregnant because Its effects durtog pregnancy have not been studed. Your physician will decide whether your disease reqifles treatment. Women who are able to get pregnant must use reliable contraception diaing treatment, and for at least 6 months after Oncaspartreatment has been dscontinued. Oral contraception Is notan effective method of contraception while on treatment with Oncaspar. Ask your doctor fer advice on the best contraceptive method that you can use. Men must also use effective contraception whle they orthet partners are betog treated with Oncaspar.

It Is not known whether pegaspargase Is excreted In breast mfle As a precautionary measure, breast-feerfcig should be discontinued during treatment with Oncaspar and should not be re-started untl after treatment with Oncaspar has been dsconttoued.

Driving and us tog machines

Do not ttovs or use machines when using this medldne because It may make you feel drowsy, tired or confused.

Oncaspar contains sodwn

This medetoe contains less than 1 mmd sodium per dose, that Is to say essentially sodum-fre

• 3. How Oncaspar Is ghran

Your treatment wttii Oncaspar has been presafoed by a doctor experienced to medicines used to treat cancer. Yoir doctor wfl decide what dose of the meddne Is needed and how often, based on yoir age and body surface area which Is calculated from your height and wel^it The medldne Is given as a solution by Injection Into a muscle or, If more sdtebie, tote a veto.

If you are given too much Oncaspar

As your doctor will administer the medldne, It Is very unlikely you will be given more than you need.

In the unflreiy event of accidental overdose, you wfl be monitored carefully by medical staff and treated appropriately.

If you have any firther questions on the use of this meddne, ask yoir doctor.

4. possible side effects

Like all medicines, this meddne can causa side effects, affhou^i not everybody gets them.

Serious side effects

Tel you doctor Immediately if you get any of the fellawing side effects:

Very common gmay affect more than 1 to 10 people)

• - Inflammation or other dsordere of the pancreas (pancreatitis) causing severe stomach pain which may spread to jmr back, vomiting, increase in Mood sugar levels;

• - Serious allergic reactions with symptoms such as rash, Itching, swefeig, hives, shortness of breath, fast heart beat and drop to blood pressire;

• - Blood dots;

• - Fever wttii low courts of white Mood cels.

Common (may affect up fol In 10 people)

• - Severe Meerfeg or bruising;

• - Violent shaking (seizures) and loss of consciousness;

• - Severe Infection wttii very high fever;

• - ProMems with your Itver (e^„ change In colour of yoir skto or wtoe or stod and laboratory results of elevated liver enzymes or blllrubto).

Rare (may affect upto 11n 1,000 peopfe)

• - Uverfalure;

• - Jaimdlce;

• - Blocked Nie flow from the liver (cholestasis);

• - Destruction of Itver cels (Iver cells necrosis).

Not known (frequency camot be astfanated from the nrelabte data)

• - Severe skto reaction called toxic epidermal necrolysis;

• - Loss of kittoey 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-threatentog (anaphylactic shock).

Other side offsets

Tak to your doctor if you pet any of the fellwitog:

Very common (may affect more thin 1 to 10 people)

• - Changes to 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 Nood dots in the lungs, caled pulmonary embolism);

• - Loss of appetite, general weakness, vomiting, diarrhoea, nausea;

• - Increased Mood sugar levels.

Common (may affect up to 11n 10 people)

• - Decreased number of red blood cells;

• - Build-up of fluid In the stomach (ascites);

• - Fever and flu-llke symptoms;

• - Mouth sores;

• - Back, Jdntorabdomtoal pain;

• - High levels of fat and cholesterol to your Nood; low potasslisn to your Nood.

Rare (may affect up to 11n 1,000 peopfe)

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

Not known (frequency camot be eitknatod from the mlabte feta)

• - Decreased number of white blood cellsand platelets;

• - Palpitations;

• - Fever;

• - Cysts In your pancreas, swelling of the salivary glands;

• - High levels of urea to your Nood; antibodies agatost Oncaspar; high levels of ammonia to your Nood; decreased blood sugar levels;

• - Sleepiness, confusion, mild twitching of the fingers.

Reporttog of skfe effects

If you get any aids effects you think mljflrt be related to you chemotherapy, talk to your doctor.

This Includes any possiile side effects not listed to this leaflet.

You can also report side effects (fleetly via the Yellow Card Scheme at or search for MHRA Yellow Card In the Google Play or Apple App Store. By reporttog side effects, you can help pnwide more Information on the safety of this medldne.

5. how to store oncaspar

Keep this medicine out of the sight and reach of Chilian.

Do not use this medicine after 1he expiry date which Is stated on the label and carton after EXP.

The expiry data refers to the last day of that month.

Store to a refrigerator (2°C-fl*C).

Do not freeze.

After the medetoe has been reconstituted and diluted, the solution shodd be used Immediately. If Immediate use Is not posslde, the (fluted sotatkxi can be stored at 2C-8C for ip to 4B 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 tiie pharmacist how to depose of mused medetoes. These measures will help protect the envtonment.

6. contents of the pack and other information

What Oncaspar contains

The active substance Is pegaspargase. Each vtai contains 3,750 U of pegaspargase.

After reconstitution, 1 ml of solution contains 750 U pegaspargase (750 li/mi).

The other In^edlents are: dsodlum phosphate heptahydate, sodum dlhydrogen phosphate monohyttoate, sodium chloride, sucrose, sodum hyttowlde (for pH aflustment), hyttoochtarfc add (for pH adjustment) (see section 2 „Oncaspar contains sodlun“).

WhatOncaspar took* like and contents of the pack

Oncaspar Is a white to off-white powder. After reconstitution, the solution Is clear, cdonless and free from visible forelfai particles.

Each pack contains 1 glass vial with 3,750 U pegas­pargase.

MarkMtog Authorisation Holder

L wirier

50, rue Camot

92284 Swesnes cedex – France

Manufactmr

Los LaboratNres Senrier Industrie

905, route de Saren

45520 Gldy-France

For any toformation about this medcine, please contact the local representative of the Marketing Authorisation Holder:

United Ktogdom

Sender Laboratories Ltd

Tet +44 (0)1753 666409

life Mist was test revised In 11/2020

Deleted Information on this medetoe Is avallaMe on the European Medicines Agency web site: httrrJ7wwwtama­.europa.eu .

The following m is intended for healthcare professionals only:

It is strong recommended that every time Oncaspar is attaiinistered to a patient, the name and lot number of the product are recoded in order to link the patient and the lot of the product

In view of the impredictability of adverse reactions, Oncaspar shold be attaiinistered only by health care personnel experienced in the use of cancer diemotherapeutic medicinal products.

Particularly in patients with known hyperse nativity 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 restecitation equipment and other items required for the treatment of anaphylaxis in readiness (epinephrine, oxygen, intravenous steroids etc.).

Patients should be Informed about possible hypersanstttvtty reactions to Oncaspar, Including Immedate anaphylaxis. Patients who receive Oncaspar are at tocreasod risk of deeding and thrombotic disorders. It should be explained to patients that Oncaspar should not be used at the same ttane as other medicines associated with an Increased risk of blseckig (sae section 2 ‘Other meddnes and Oncaspar').

This medicinal product can cause Irritation on contact. The powder must therefore be handled and attaiinistered with particular care. Inhalation of the vapour and contact wtth the skin and mucosa, particularly that of the eyes, must be awlded; If the product comes In contact wtth eyes, skta, or mucous membranes, rinse taimedately with plenty of waterfor st least 15 minutes.

Any unused medlctaal product or waste material should be disposed of In accordance wtth local reqiiements.

Instruction* on ht» to prepir… store and rlxposa of ir

Instructions for handling

• 1. Staff shodd be trained to howto handle and transferthe medlctaal product (pregnant staff shold be excluded from writing wtth this medicinal product).

• 2. Aseptic technique must be used.

• 3. ProcetUes for proper handling of antineoplastic agents should be observed.

• 4. The use of disposable gloves and protective garments is recommended when handling Oncaspar.

• 5. All items for administration or cleaning, induing gloves, ahould be placed in high-risk waste disposal bags tor high-temperature incineration.

Reconstitution

1.5.2 mi water for Injections are tojected Into the vtai using a syringe and 21 gauge neede.

• 2. The vtai ahold be gently swirled unll the powder Is reconstituted.

• 3. After reconstitution, the solution shold be clear, colouiess and free from visible foreign particles. Do not use If the reconstituted solution Is doudy or If a precipitate has formed. Do not shake.

• 4. The solution shold be used wttiiln 24 hours after reconstitution, when stored below 25*0.

Artailnlstration

• 1. Parenteral medicinal products should be Inspected for particulate matter prior to attoilnlstration, only a dear, colourless solution free from visible foreign particles should be used.

• 2. The medlctaal product should be admHstered Intravenously or Intramuscularly.