Oxaliplatin Accord 5 mg/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxaliplatin Accord 5 mg/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Oxaliplatin Accord is and what it is used for
2. What you need to know before using Oxaliplatin Accord
3. How to use Oxaliplatin Accord
4. Possible side effects
5. How to store Oxaliplatin Accord
6. Contents of the pack and other information

1. What Oxaliplatino Accord is and what it is used for

Oxaliplatino Accord contains the active substance oxaliplatino.

Oxaliplatino is used to treat cancer of the large intestine (treatment of stage III colon cancer after complete resection of the primary tumour, metastatic colon and rectal cancer). Oxaliplatino is used in combination with other anticancer medicines called 5-fluorouracil and folinic acid.

Oxaliplatino must be dissolved in a solution before it can be injected into a vein.

Oxaliplatino is an antineoplastic or antitumour agent and contains platinum.

2. What you need to know before using Oxaliplatin Accord

Do not use Oxaliplatin Accord

• if you are allergic to oxaliplatin or to any of the other components of Oxaliplatin Accord,
• if you are breastfeeding,
• if you already have reduced blood cell counts,
• if you already suffer from tingling or numbness in the fingers of your hands or feet and have difficulty performing delicate tasks, such as buttoning clothes,
• if you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Oxaliplatin Accord

• if you have ever had an allergic reaction to medicines containing platinum, such as carboplatin or cisplatin. Allergic reactions may occur during infusion of any platinum compound.

• if you have moderate or mild kidney problems,

• if you have any liver problems or abnormal liver function tests during treatment,

• if you have or have had heart problems such as an abnormal electrical signal known as QT interval prolongation, irregular heartbeat, or a family history of heart problems,

• if you have received or are scheduled to receive any vaccine. During treatment with oxaliplatin, you must not be vaccinated with live or live attenuated vaccines, such as the yellow fever vaccine.

If any of the following occur at any time, inform your doctor immediately. Your doctor may need to treat these events and may need to reduce the dose of Oxaliplatin Accord, or delay or interrupt treatment with Oxaliplatin Accord.

• If you experience an unpleasant sensation in your throat, especially when swallowing, and feel short of breath during treatment.
• If you develop nerve problems in your hands or feet such as tingling and numbness, or decreased sensation in your hands or feet.
• If you have headache, altered mental function, seizures, or abnormal vision, ranging from blurred vision to loss of vision.
• If you feel unwell (nausea and vomiting).
• If you have severe diarrhoea.
• If you have pain in the lips or mouth ulcers (mucositis/stomatitis).
• If you have diarrhoea or a decrease in white blood cells or platelets. Your doctor may need to reduce the dose of Oxaliplatin Accord or postpone your treatment with Oxaliplatin Accord.
• If you develop unexplained respiratory symptoms such as cough or difficulty breathing. Your doctor may stop your treatment with Oxaliplatin Accord.
• If you develop extreme tiredness, shortness of breath, or kidney problems causing you to pass little or no urine (symptoms of acute renal failure).
• If you have fever (temperature greater than or equal to 38°C) or chills, which may be signs of infection. You may be at risk of developing a blood infection.
• If you have a fever > 38°C. Your doctor may determine whether you also have a decrease in white blood cells.
• If you unexpectedly experience bleeding or bruising (disseminated intravascular coagulation). These may be signs of blood clots forming throughout the small blood vessels in your body.
• If you feel dizzy (loss of consciousness) or have an irregular heartbeat while taking Oxaliplatin Accord. This may be a sign of a serious heart disorder.
• If you develop muscle pain and swelling, along with weakness, fever, and red-brown urine. These could be signs of muscle damage (rhabdomyolysis) and could lead to kidney problems or other complications.
• If you have abdominal pain, nausea, vomiting blood or coffee-ground-like vomit, or dark stools, which may be signs of an intestinal ulcer (gastrointestinal ulcer with potential for bleeding or perforation).
• If you have abdominal pain (around the navel), bloody diarrhoea, nausea and/or vomiting, which may be caused by reduced blood flow to the walls of your intestine (intestinal ischaemia).

Children and adolescents

Oxaliplatin must not be used in children and adolescents under 18 years of age.

Use of other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• 5-fluorouracil (a cancer medicine)
• Erythromycin (an antibiotic)
• Salicylates (medicines for pain relief)
• Granisetron (a medicine to prevent vomiting)
• Paclitaxel (a cancer medicine)
• Sodium valproate (a medicine for epilepsy)

Pregnancy and breastfeeding and fertility

Pregnancy

• You are advised not to become pregnant during treatment with oxaliplatin and should use an effective method of contraception. Female patients should use adequate contraceptive measures during treatment and continue them for 15 months after completion of treatment.
• Male patients are advised not to father a child during treatment and for 12 months after completion of treatment, and should use appropriate contraceptive measures during this period.
• If you are pregnant or planning to become pregnant, it is very important that you speak with your doctor before receiving any treatment.
• If you become pregnant during treatment, you must inform your doctor immediately.

Breastfeeding

• You must not breastfeed while being treated with oxaliplatin.

Fertility

• Oxaliplatin may have an anti-fertility effect which may be irreversible. Male patients should seek advice regarding sperm preservation before treatment.
• If you are planning a pregnancy after treatment with oxaliplatin, genetic counselling is recommended.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines

Treatment with oxaliplatin may increase the risk of dizziness, nausea and vomiting, and other neurological symptoms affecting gait and balance. If this occurs, you should not drive or operate machinery. If you experience vision problems while receiving Oxaliplatin Accord, do not drive, operate heavy machinery, or perform hazardous activities.

3. How to use Oxaliplatin Accord

Oxaliplatin is for adults only.

For single use only.

Posology

The oxaliplatin dose is based on body surface area. It is calculated from your height and weight.

The usual dose for adults, including elderly patients, is 85 mg/m² body surface area. The dose you receive may also depend on the results of your blood tests and whether you have previously experienced side effects with oxaliplatin.

Method and route of administration

• Oxaliplatin will be prescribed by a cancer treatment specialist.

• You will be treated by a healthcare professional, who will have prepared the required oxaliplatin dose.

• Oxaliplatin is administered as a slow injection into a vein (intravenous infusion) over a period of 2 to 6 hours.

• Oxaliplatin will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.

Frequency of administration

You will usually receive the infusion every two weeks.

Duration of treatment

Your doctor will determine the duration of treatment.

Your treatment will last up to a maximum of 6 months when used after complete resection of the tumour.

If you use more Oxaliplatin Accord than you should

Since this medicine will be administered by a healthcare professional, it is highly unlikely that you will receive too much or too little.

In case of overdose, you may experience more side effects. Your doctor will provide appropriate treatment for these side effects.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any adverse effect, it is important to inform your doctor before the next treatment.

The side effects you may experience are described below.

Tell your doctor immediately if you notice any of the following:

• Allergic or anaphylactic reaction with sudden signs such as rash, itching or hives on the skin, difficulty swallowing, swelling of the face, lips, tongue or other body parts, difficulty breathing, wheezing or shortness of breath, extreme tiredness (you may feel like fainting).
• Unusual bruising, bleeding or signs of infection such as sore throat and high fever.
• Persistent or severe diarrhoea or vomiting.
• Blood or dark coffee-ground-like particles in vomit.
• Stomatitis/mucositis (sore lips or mouth ulcers).
• Respiratory symptoms such as dry or wet cough, difficulty breathing or crackling sounds, shortness of breath and wheezing.
• A group of symptoms such as headache, altered mental function, seizures and abnormal vision ranging from blurred vision to vision loss (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder).
• Symptoms of stroke (such as sudden severe headache, confusion, vision problems in one or both eyes, numbness or weakness of the face, arm or leg usually on one side, facial drooping, difficulty walking, dizziness, loss of balance, and difficulty speaking).
• Extreme tiredness with reduced number of red blood cells (haemolytic anaemia), alone or combined with low platelet count, unusual bruising (thrombocytopenia), and kidney disease with little or no urine output (symptoms of haemolytic-uremic syndrome).

Other known adverse effects of Oxaliplatin Accord are:

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

• Tingling or numbness in fingers or toes, around the mouth or throat, sometimes accompanied by muscle cramps.
• Feeling of discomfort near or at the injection site during infusion.
• Fever, chills (shivering), mild to severe fatigue, body pain.
• Weight changes, weight loss or lack of appetite, taste disturbances, constipation.
• Stomach pain.
• Abnormal bleeding, including nosebleeds.
• Mild hair loss (alopecia).

Common (may affect up to 1 in 10 people)

• Infection due to a reduction in white blood cells.
• Severe blood infection along with a reduction in white blood cells (neutropenic sepsis), which may be fatal.
• Reduction in white blood cells accompanied by fever > 38.3°C or prolonged fever > 38°C for more than one hour (febrile neutropenia).
• Indigestion and heartburn, hiccups, flushing, dizziness.
• Increased sweating and nail abnormalities, skin peeling.
• Chest pain.
• Pulmonary disorders and nasal congestion.
• Joint and bone pain.
• Pain when urinating and changes in kidney function, changes in urinary frequency, dehydration.
• Blood in urine/stool, inflammation of veins.
• Increased blood pressure.
• Depression and insomnia.
• Conjunctivitis and visual disturbances.
• Reduced levels of calcium in blood.
• Falls.

Uncommon (may affect up to 1 in 100 people)

• Severe blood infection (septicaemia), which may be fatal.
• Intestinal obstruction or inflammation.
• Nervousness.

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

• Hearing loss.
• Scarring and thickening of the lungs causing breathing difficulties, sometimes fatal (interstitial lung disease).
• Short-term reversible vision loss.
• Unexpected bleeding or bruising due to widespread blood clots in small blood vessels throughout the body (disseminated intravascular coagulation), which may be fatal.

Very rare (may affect up to 1 in 10,000 people)

• Vascular disorders of the liver (symptoms include abdominal pain and swelling, weight gain, and tissue swelling of feet, ankles or other body parts).

Not known (cannot be estimated from available data)

• Allergic vasculitis (inflammation of blood vessels).
• Autoimmune reaction leading to reduction in all blood cell lines (autoimmune pancytopenia), pancytopenia.
• Seizures (uncontrolled body shaking).
• Throat spasm causing difficulty breathing.
• Abnormal heart rhythm (QT prolongation), which may be seen on electrocardiogram (ECG), and which can be fatal.
• Muscle pain and swelling, together with weakness, fever or brownish-red urine (symptoms of muscle damage known as rhabdomyolysis), which may be fatal.
• Black or tarry stools (symptoms of gastrointestinal ulcer, with possible bleeding or perforation), which may be fatal.
• Reduced blood flow to the intestine (intestinal ischaemia), which may be fatal.
• Myocardial infarction (heart attack), angina pectoris (chest pain or discomfort).
• Oesophagitis (inflammation of the oesophagus, the tube connecting your mouth to your stomach, causing pain and difficulty swallowing).
• Risk of new cancers such as leukaemia, when taken in combination with certain other medicines.
• Non-cancerous abnormal liver nodules (focal nodular hyperplasia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxaliplatin Accord

Keep out of the sight and reach of children.

Keep the vial in the outer packaging to protect it from light. Do not freeze.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Chemical and physical in-use stability has been demonstrated for 48 hours between 2°C and 8°C and for 24 hours at 25°C. From a microbiological standpoint, this infusion preparation should be used immediately. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

Do not use this medicine if the solution is not clear and free from particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

Oxaliplatin Accord must not come into contact with the eyes or skin. In case of accidental spillage, inform the doctor or nurse immediately.

After completion of the infusion, the doctor or nurse will carefully dispose of Oxaliplatin Accord.

6. Contents of the pack and other information

Composition of Oxaliplatin Accord

The active substance is oxaliplatin.

The other component is water for injections.

Appearance of the product and contents of the container

Each ml of concentrate for solution for infusion contains 5 mg of oxaliplatin.

Oxaliplatin Accord is a clear, colourless solution free from visible particles.

Each glass vial contains 50 mg, 100 mg or 200 mg of oxaliplatin and is individually packaged in a carton.

10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin.

20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin.

40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200

Pabianice,

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicinal product is authorized in the European Economic Area member states under the following names

Member State name	Medicinal product name
United Kingdom	Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion
Austria	Oxaliplatin Accord 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium	Oxaliplatin Accord Healthcare 5 mg/ml solution à diluer pour perfusion / concentraat voor oplossing voor infusie / Konzentrat zur Herstellung einer Infusionslösung
Bulgaria	Oxaliplatin Accord 5 mg/ml Concentrate for Solution for Infusion
Czech Republic	Oxaliplatin Accord 5 mg/ml Koncentrát pro Přípravu Infuzního Roztoku
Germany	Oxaliplatin Accord 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Denmark	Oxaliplatin Accord Healthcare
Estonia	Oxaliplatin Accord 5 mg/ml
Spain	Oxaliplatino Accord 5 mg/ml concentrado para solución para perfusión EFG
Finland	Oxaliplatin Accord 5 mg/ml Infuusiokonsentraatti, Liuosta Varten / koncentrat till infusionsvätska, lösning
France	Oxaliplatin Accord 5 mg/ml Solution à Diluer pour Perfusion
Hungary	Oxaliplatin Accord 5 mg/ml koncentrátum oldatos infúzióhoz
Ireland	Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion
Italy	Oxaliplatin AHCL 5 mg/ml Concentrate for Solution for Infusion
Latvia	Oxaliplatin Accord 5 mg/ml koncentrats infūzijas šķīduma pagatavošanai
Lithuania	Oxaliplatin Accord 5 mg/ml koncentratas infuziniam tirpalui
Malta	Oxaliplatin 5 mg/ml Concentrate for Solution for Infusion
Netherlands	Oxaliplatin Accord 5 mg/ml Concentraat voor Oplossing voor Infusie
Poland	Oxaliplatinum AHCL
Portugal	Oxaliplatin Accord
Romania	Oxaliplatin Accord 5 mg/ml concentrat pentru solutie perfuzabilă
Sweden	Oxaliplatin Accord 5 mg/ml Koncentrat till Infusionsvätska, Lösning

Date of last review of this leaflet: October 2024

This information is intended for medical or healthcare professionals only.

PREPARATION GUIDE FOR USE OF OXALIPLATIN ACCORD 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

It is important to read the entire content of this procedure before preparing OXALIPLATIN ACCORD 5 mg/ml CONCENTRATE FOR SOLUTION FOR INFUSION

1. COMPOSITION

Oxaliplatin Accord 5 mg/ml concentrate for solution for infusion is a colourless, transparent solution containing 5 mg/ml of oxaliplatin.

2. PRESENTATION

Supplied in single-dose vials. 1 vial per carton.

For 10 ml:

The concentrate for solution for infusion is packaged in a 10 ml capacity, clear type I tubular glass vial, closed with a 20 mm chlorobutyl rubber stopper and a 20 mm lavender-coloured aluminium crimp cap.

For 20 ml:

The concentrate for solution for infusion is packaged in a 20 ml capacity, clear type I molded glass vial, closed with a 20 mm chlorobutyl rubber stopper and a 20 mm lavender-coloured aluminium crimp cap.

For 40 ml:

The concentrate for solution for infusion is packaged in a 50 ml capacity, clear type I molded glass vial, closed with either a 20 mm chlorobutyl rubber stopper or a silicone-coated rubber stopper with a Teflon-coated contact surface, and a 20 mm lavender-coloured aluminium crimp cap.

Expiry date and storage:

2 years.

After dilution in 5% glucose solution, chemical and physical in-use stability has been demonstrated for up to 48 hours between 2°C and 8°C and for 24 hours at 25°C.

From a microbiological standpoint, the infusion preparation should be used immediately.

If not used immediately, the storage conditions and duration prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

Store the vial in the outer packaging to protect from light. Do not freeze.

Visually inspect before use. Only clear solutions without particles should be used.

This medicinal product is for single use only. Any unused solution must be discarded.

3. RECOMMENDATIONS FOR SAFE HANDLING

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.

Handling instructions

Handling of this cytotoxic agent by healthcare personnel requires maximum precautions to ensure the safety of the handler and the surrounding environment.

Preparation of injectable cytotoxic solutions must be performed by trained specialist personnel familiar with the drugs used, under conditions that ensure the integrity of the medicinal product, protection of the environment, and especially protection of personnel handling the drugs, in accordance with hospital policy. A dedicated preparation area is required. Eating, drinking, or smoking in this area is prohibited.

Appropriate handling materials should be provided to personnel, including long-sleeved gowns, protective masks, caps, protective goggles, sterile disposable gloves, protective covers for the work area, and containers and bags for waste collection.

Excreta and vomit should be handled with care.

Pregnant women should be advised to avoid handling cytotoxic products.

Broken containers should be handled with the same precautions and considered as contaminated waste. Contaminated waste should be incinerated in properly labeled rigid containers. See section “Disposal” below.

If Oxaliplatin Accord 5 mg/ml concentrate for solution for infusion comes into contact with the skin, wash immediately and thoroughly with water.

If Oxaliplatin Accord 5 mg/ml concentrate for solution for infusion comes into contact with mucous membranes, wash immediately and thoroughly with water.

4. PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special administration precautions

• DO NOT use infusion equipment containing aluminium.

• DO NOT administer undiluted.

• Only 5% glucose solution for infusion should be used as diluent. DO NOT dilute the infusion with solutions containing sodium chloride or chloride.

• DO NOT mix with any other medicinal product in the same infusion bag or administer simultaneously through the same infusion line.

• DO NOT mix with alkaline drugs or solutions, especially 5-fluorouracil, leucovorin preparations containing trometamol as excipient, or trometamol salts of other active substances. Alkaline drugs or solutions may adversely affect the stability of oxaliplatin.

Instructions for use with folic acid (as calcium folinate or disodium folinate)

Oxaliplatin 85 mg/m² administered as an intravenous infusion in 250 to 500 ml of 5% glucose solution is given simultaneously with intravenous infusion of folic acid in 5% glucose solution, over 2 to 6 hours, using a Y-line placed immediately before the infusion site.

These two medicinal products must not be combined in the same infusion bag. Folic acid must not contain trometamol as excipient and must only be diluted using 5% isotonic glucose solution, never in alkaline solutions or solutions containing sodium chloride or chloride.

Instructions for use with 5-fluorouracil

Oxaliplatin must always be administered before fluoropyrimidines, i.e., 5-fluorouracil.

After administration of oxaliplatin, the infusion line should be flushed before administering 5-fluorouracil.

For further information on the drug combined with oxaliplatin, refer to the corresponding Summary of Product Characteristics provided by the manufacturer.

• USE ONLY the recommended solvents (see below).
• Only clear, particle-free solutions should be used.

4.1 Preparation of the infusion solution

Withdraw the required amount of concentrate solution from the vial(s) and dilute with 250 ml to 500 ml of 5% glucose solution to achieve an oxaliplatin concentration between not less than 0.2 mg/ml and 0.7 mg/ml. The concentration range for which physicochemical stability has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5% glucose, chemical and physical in-use stability has been demonstrated for up to 48 hours between 2°C and 8°C and for 24 hours at 25°C.

From a microbiological standpoint, this infusion preparation should be used immediately.

If not used immediately, the storage conditions and duration prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

Visually inspect before use. Only clear, particle-free solutions should be used.

This medicinal product is for single use only. Any unused infusion solution must be discarded (see section “Disposal” below).

NEVER use solutions containing sodium chloride or chloride for dilution.

Compatibility of the oxaliplatin infusion solution with representative PVC administration sets has been studied.

4.2 Infusion of the solution

Administration of oxaliplatin does not require prior hydration.

Diluted oxaliplatin in 250 to 500 ml of 5% glucose solution to achieve a concentration of not less than 0.2 mg/ml must be administered by intravenous infusion via a peripheral vein or central venous access over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede the administration of 5-fluorouracil.

4.3 Disposal

Any unused medicinal product and all materials used for dilution and administration must be destroyed in accordance with the hospital's standard procedures applicable to cytotoxic agents, in line with local requirements for disposal of hazardous waste.