Oxaliplatinum Accord

Package Leaflet: Information for the Patient

Oxaliplatinum Accord, 5 mg/ml, Concentrate for Solution for Infusion

Oxaliplatinum
Read all of this leaflet carefully before using this medicine because it contains important information for you.
This leaflet is available in other formats, such as large print, audio, or Braille.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

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

The active substance of Oxaliplatinum Accord is oxaliplatin.
Oxaliplatinum Accord is an anti-cancer medicine and is used to treat colon cancer (treatment of stage III colon cancer after complete resection of primary tumor, metastatic colon and rectal cancer).
It is used in combination with other anti-cancer medicines called 5-fluorouracil (5-FU) and folinic acid (FA).
Before injection into a vein, the oxaliplatin concentrate for solution for infusion must be dissolved.
The oxaliplatin concentrate for solution for infusion is an anti-cancer medicine that contains platinum.

2. What you need to know before you are given Oxaliplatinum Accord

When not to use Oxaliplatinum Accord:

• if you are allergic to oxaliplatin or any of the other ingredients of Oxaliplatinum Accord
• if you are breast-feeding
• if you have a low blood cell count
• if you have tingling and/or numbness in your fingers and/or toes and difficulty performing precise movements, such as buttoning up a shirt
• if you have severe kidney problems

Warnings and precautions

Before starting treatment with Oxaliplatinum Accord, tell your doctor or pharmacist:

• if you have ever had an allergic reaction to platinum-containing medicines, such as carboplatin or cisplatin. Allergic reactions can occur during any infusion of oxaliplatin;
• if you have moderate or mild kidney problems;
• if you have liver problems or abnormal liver function tests during treatment;
• if you have had or have heart problems, such as abnormal heart rhythm, irregular heartbeat, or a family history of heart problems;
• if you have received or plan to receive any vaccines. You should not receive "live" or "attenuated" vaccines during treatment with oxaliplatin.

If any of the following apply to you, tell your doctor immediately. Your doctor may decide to give you appropriate treatment and may reduce the dose of Oxaliplatinum Accord or delay or stop treatment.
If you experience an unpleasant sensation in your throat, especially when swallowing, and shortness of breath, tell your doctor.
If you experience nerve problems in your hands or feet, such as numbness or tingling, or decreased sensation in your hands or feet, tell your doctor.
If you experience headache, mental changes, seizures, and vision disturbances from blurred vision to loss of vision, tell your doctor.
If you experience nausea or vomiting, tell your doctor.
If you experience severe diarrhea, tell your doctor.
If you experience mouth sores or mouth ulcers (mucositis and/or stomatitis), tell your doctor.
If you experience diarrhea or a decreased number of white blood cells or platelets, tell your doctor. Your doctor may reduce the dose of Oxaliplatinum Accord or delay administration.
If you experience unexplained respiratory symptoms, such as coughing or difficulty breathing, tell your doctor. Your doctor may decide to stop using Oxaliplatinum Accord.
If you experience extreme fatigue, shortness of breath, or kidney disease and pass a small amount of urine or do not pass urine at all (symptoms of acute kidney failure), tell your doctor.
If you have a fever (38°C or higher) or chills, which may indicate an infection, tell your doctor immediately due to the risk of developing a blood infection.
If you have a fever >38°C, tell your doctor. Your doctor may check if you have also had a decrease in white blood cells.
If you experience unexpected bleeding or bruising (disseminated intravascular coagulation), tell your doctor, as these may be signs of blood clots in small blood vessels.
If you have fainted (lost consciousness) or have an irregular heartbeat during treatment with Oxaliplatinum Accord, tell your doctor immediately, as these may be signs of severe heart problems.
If you experience muscle pain and swelling with weakness, fever, or brownish discoloration of urine (symptoms of muscle damage called rhabdomyolysis), which can lead to kidney problems or other complications, tell your doctor.
If you experience abdominal pain, nausea, vomiting blood or coffee ground-like vomit, or very dark (tarry) stools, which may indicate stomach or intestinal ulcers (symptoms of stomach or intestinal ulcers, with possible bleeding or perforation), tell your doctor.
If you experience abdominal pain, bloody diarrhea, and nausea and/or vomiting, which may be caused by reduced blood flow to the intestinal wall (intestinal ischemia), tell your doctor.

Children and Adolescents

Oxaliplatinum Accord should not be used in children and adolescents under 18 years of age.

Oxaliplatinum Accord and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• 5-fluorouracil (anti-cancer medicine)
• erythromycin (antibiotic)
• salicylates (pain-relieving medicines)
• granisetron (anti-emetic medicine)
• paclitaxel (anti-cancer medicine)
• sodium valproate (anti-epileptic medicine)

Pregnancy and Breast-feeding

Pregnancy

• Pregnancy should be avoided during treatment with oxaliplatin; women of childbearing potential must use effective contraception. Women should use appropriate contraceptive measures during therapy and for 15 months after the end of treatment.
• Men are advised not to father a child during and up to 12 months after treatment.
• If you are pregnant or planning to become pregnant, it is very important to discuss this with your doctor before starting any treatment.
• If you become pregnant during treatment, tell your doctor immediately.

Breast-feeding

Do not breast-feed during treatment with oxaliplatin.

Fertility

• Oxaliplatin may cause infertility, which may be irreversible. Men should seek advice on sperm preservation before starting treatment.
• If you plan to become pregnant after treatment with oxaliplatin, genetic counseling is recommended.

Before taking any medicine, consult your doctor or pharmacist.

Driving and Using Machines

Treatment with oxaliplatin increases the risk of dizziness, nausea, and vomiting, as well as other neurological symptoms that affect gait and balance and may have a mild or moderate effect on the ability to drive or operate machinery.
If you experience drowsiness and/or dizziness after taking oxaliplatin, do not drive or operate machinery or perform any tasks that may put you at risk due to reduced alertness.

3. How Oxaliplatinum Accord is Given

Oxaliplatinum Accord Concentrate for Solution for Infusion is for Adult Use Only

For single use only.

Dose

The dose of oxaliplatin depends on your body surface area. It is calculated based on your weight and height. The standard dose used in adults, including the elderly, is 85 mg/m² body surface area.
The dose of the medicine also depends on the results of your blood tests and whether you have had any side effects from Oxaliplatinum Accord in the past.

Method and Route of Administration

Oxaliplatinum Accord will be prescribed for you by a doctor specializing in cancer treatment.
You will be treated by a specialist who will prepare the required dose of oxaliplatin concentrate for solution for infusion.
Oxaliplatin is given as an infusion into one of your veins (intravenous infusion). The infusion time is 2 to 6 hours.
The oxaliplatin concentrate for solution for infusion is given at the same time as folinic acid and before intravenous administration of 5-fluorouracil.

Frequency of Administration

Usually, you receive an infusion every 2 weeks.

Duration of Treatment

Your doctor will decide on the duration of treatment. After tumor removal surgery, treatment with oxaliplatin is recommended for 6 months.

Overdose

The medicine will be administered by experienced personnel, usually in specialized oncology units, so the likelihood of the medicine being administered in too small or too large a quantity is low. In case of overdose, the risk of side effects may increase. In case of overdose, your doctor will decide on the treatment of symptoms.
If you have any questions about your treatment, ask your doctor, nurse, or pharmacist.

4. Possible Side Effects

Like all medicines, Oxaliplatinum Accord can cause side effects, although not everybody gets them.
If you experience any side effects, you must tell your doctor before taking the next dose of Oxaliplatinum Accord.
The following are possible side effects:

• allergic reactions or anaphylactic reactions with sudden symptoms such as rash, itching, or hives on the skin, difficulty swallowing, swelling of the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, extreme fatigue (you may feel like you are about to faint)
• unusual bruising, bleeding, or signs of infection, such as sore throat and high temperature
• persistent or severe diarrhea or vomiting
• blood in vomit or coffee ground-like vomit
• mouth sores or mouth ulcers (mucositis and/or stomatitis)
• respiratory symptoms, such as dry or wet cough, difficulty breathing, or wheezing
• symptoms such as headache, changes in mental status, seizures, and vision disturbances from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy 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, drooping of the face, difficulty walking, dizziness, loss of balance, and difficulty speaking)
• extreme fatigue with decreased red blood cells and shortness of breath (hemolytic anemia) occurring with decreased platelets and kidney disease, where you pass a small amount of urine or do not pass urine at all (symptoms of hemolytic-uremic syndrome)

Other Side Effects of Oxaliplatinum Accord:

Very Common(may affect more than 1 in 10 people):

• tingling or numbness in fingers and toes, around the mouth or throat, sometimes associated with spasms (peripheral neuropathy)
• discomfort at the injection site or at the site of administration during infusion
• fever, chills, mild or severe fatigue, loss of strength and/or weakness, body aches
• weight changes, loss of appetite, taste disturbances, constipation
• stomach pains
• abnormal bleeding, including nosebleeds
• mild hair loss (alopecia)

Common(may affect up to 1 in 10 people):

• infection caused by a low white blood cell count
• severe infection of the blood, associated with a low white blood cell count (febrile neutropenia), which can lead to death
• low white blood cell count, accompanied by fever >38.3°C or persistent fever >38°C for more than 1 hour (febrile neutropenia)
• indigestion and heartburn, hiccups, sudden flushing of the face, dizziness
• excessive sweating and nail disorders, skin peeling
• chest pain
• lung disorders and cough
• joint and bone pain
• urinary problems and changes in kidney function, as well as changes in urine frequency, dehydration
• blood in urine and stools, vein swelling, blood clots in the lungs
• high blood pressure
• depression, insomnia
• conjunctivitis, vision disturbances
• low calcium levels in the blood
• falls

Uncommon(may affect up to 1 in 100 people):

• severe blood infection (sepsis), which can lead to death
• intestinal obstruction or swelling
• feeling anxious or nervous

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

• deafness
• scarring and thickening in the lungs, with breathing difficulties, sometimes leading to death (interstitial lung disease)
• temporary, short-term loss of vision
• unexpected bleeding or bruising due to blood clots in small blood vessels (disseminated intravascular coagulation) - a condition that can lead to death

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 swelling of the feet, ankles, and other parts of the body)

Frequency Not Known(cannot be estimated from the available data):

• allergic vasculitis (inflammation of blood vessels)
• autoimmune reaction causing a decrease in all blood cell counts (autoimmune pancytopenia), pancytopenia
• seizures (uncontrolled seizures of the whole body)
• laryngospasm causing difficulty breathing
• abnormal heart rhythm (prolonged QT interval), which can be seen on an electrocardiogram (ECG) - a condition that can lead to death
• muscle pain and swelling with weakness, fever, or brownish discoloration of urine (symptoms of muscle damage called rhabdomyolysis) - a condition that can lead to death
• abdominal pain, nausea, vomiting blood or coffee ground-like vomit, or very dark (tarry) stools (symptoms of stomach or intestinal ulcers, with possible bleeding or perforation) - a condition that can lead to death
• reduced blood flow to the intestine (intestinal ischemia) - a condition that can lead to death
• heart attack (myocardial infarction), angina pectoris (chest pain or discomfort)
• esophagitis (inflammation of the esophagus, causing pain and difficulty swallowing)
• risk of developing new cancers, such as leukemia, when taking oxaliplatin and certain other medicines
• abnormal, non-cancerous liver tumors (focal nodular hyperplasia)

Reporting Side Effects

If you experience any side effects, tell your doctor or pharmacist. Side effects can also be reported directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to Store Oxaliplatinum Accord

Keep out of the sight and reach of children.
Store the vial in the outer carton to protect from light. Do not freeze.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.
After preparation, the infusion solution is chemically and physically stable for 48 hours at 2°C to 8°C and 24 hours at 25°C.
From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage time and conditions before administration are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless the solution has been diluted under controlled and validated aseptic conditions.
Before administration, the solution must be inspected. Only clear solutions without particles should be used.
This medicinal product is for single use only. Any unused solution should be disposed of (see section "Disposal" below).
Do not dispose of medicines in the sewage system or in household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Oxaliplatin Accord should not come into contact with the eyes. If the medicine accidentally gets into the eye, tell your doctor or nurse immediately.
After the infusion is complete, your doctor or nurse will dispose of any remaining medicine with caution.

6. Contents of the Pack and Other Information

What Oxaliplatinum Accord Contains

Oxaliplatinum Accord contains oxaliplatin as the active substance
The other ingredients are water for injections.

What Oxaliplatinum Accord Looks Like and Contents of the Pack

1 ml of concentrate for solution for infusion contains 5 mg of oxaliplatin.
Oxaliplatinum Accord is a clear, colorless solution, free from visible particles.
Each glass vial is packaged individually 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.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Leaflet: October 2024

The Following Information is Intended for Healthcare Professionals Only

Instructions for Use

Before Preparing the OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION, Read the Entire Procedure

1. Presentation

The oxaliplatin concentrate for solution for infusion is a colorless solution containing 5 mg/ml of oxaliplatin.

2. Presentation

The oxaliplatin concentrate for solution for infusion is supplied in single vials. 1 vial in a carton.
For 10 ml,
The oxaliplatin concentrate for solution for infusion is in a 15 ml glass vial (siliconized), closed with a 20 mm chlorobutyl rubber stopper type V9048 FM259/0 OMNIFLEX PLUS 2500/RF and a 20 mm lavender flip-off aluminum seal.
For 20 ml,
The oxaliplatin concentrate for solution for infusion is in a 20 ml glass vial (siliconized), closed with a 20 mm chlorobutyl rubber stopper type V9048 FM259/0 OMNIFLEX PLUS 2500/RF and a 20 mm lavender flip-off aluminum seal.
For 40 ml,
The oxaliplatin concentrate for solution for infusion is in a 50 ml glass vial (siliconized), closed with a 20 mm chlorobutyl rubber stopper type V9048 FM259/0 OMNIFLEX PLUS 2500/RF and a 20 mm lavender flip-off aluminum seal.
Shelf life and storage:
2 years
After dilution in 5% glucose solution, the chemical and physical stability of the solution has been demonstrated for 48 hours at 2°C to 8°C and 24 hours at 25°C.
From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage time and conditions before administration are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless the solution has been diluted under controlled and validated aseptic conditions.
Store the vial in the outer carton to protect from light. Do not freeze.
Before administration, the solution must be inspected. Only clear solutions without particles should be used.
This medicinal product is for single use only. Any unused solution should be disposed of (see section "Disposal" below).

3. Handling Precautions

As with other potentially toxic compounds, caution should be exercised when handling and preparing oxaliplatin solutions.
Instructions for Handling Cytotoxic Agents
Handling of this cytotoxic agent by healthcare personnel requires the use of all protective measures to minimize exposure to the user and the environment.
Preparation of solutions for injection of cytotoxic products must be performed by specially trained personnel with knowledge of the product, under conditions that ensure the integrity of the product, environmental protection, and in particular, the protection of personnel handling the product, in accordance with hospital procedures. This requires the designation of an area exclusively for these activities. Smoking, eating, and drinking are prohibited in these areas.
Personnel must be equipped with appropriate protective equipment, in particular, long-sleeved gowns, protective masks, head coverings, protective eyewear, sterile single-use gloves, protective covers for the work surface, and containers and bags for collecting waste.
Patient excreta and vomit must be treated with caution.
Pregnant women should be warned against contact with cytotoxic agents.
Any damaged or broken containers should be treated with the same precautions as contaminated waste. Contaminated waste should be incinerated in appropriately labeled rigid containers. See "Disposal" below.

4. Preparation for Administration

Special Precautions for Administration

• DO NOT use materials for injection or infusion containing aluminum.
• DO NOT administer undiluted.
• Only 5% glucose solution for infusion can be used as a diluent. DO NOT reconstitute or dilute with sodium chloride solution or solutions containing chlorides.
• DO NOT mix with other medicines in the same bag or bottle or administer simultaneously in the same infusion set.
• DO NOT mix with medicines with a basic pH or solutions containing bases, in particular, 5-fluorouracil, folinic acid preparations containing trometamol as an excipient, or other trometamol salt medicines. Medicines or solutions with a basic pH affect the stability of oxaliplatin.

Instructions for Use with Folinic Acid (FA) (as Calcium Folinic Acid or Disodium Folinic Acid)

Oxaliplatin at a dose of 85 mg/m² body surface area, administered as an intravenous infusion, in 250 to 500 ml of 5% glucose solution, is given at the same time as an intravenous infusion of folinic acid (FA) in 5% glucose solution, lasting more than 2 to 6 hours, using a Y-connector, placed immediately before the infusion site. The two medicines must not be mixed in the same infusion bag. Folinic acid (FA) must not contain trometamol as an excipient and must be diluted only with isotonic 5% glucose solution. Never use alkaline solutions or sodium chloride solution or solutions containing chlorides for dilution.

Instructions for Use with 5-Fluorouracil (5-FU)

Oxaliplatinum Accord must always be administered before fluoropyrimidine derivatives, such as 5-fluorouracil (5-FU).
After administration of Oxaliplatinum Accord, the infusion line must be flushed with 5-fluorouracil (5-FU).
For further information on medicines used in combination with Oxaliplatinum Accord, see the corresponding Summary of Product Characteristics.

• USE only the recommended diluents (see below).
• USE only clear solutions without visible particles.

4.1 Preparation of the Infusion Solution

Withdraw the required amount of the prepared solution from the vial (vials) and dilute in 250 to 500 ml of 5% glucose solution to achieve a concentration of not less than 0.2 mg/ml to 0.7 mg/ml. The range of concentrations for which the physico-chemical stability of oxaliplatin has been demonstrated is from 0.2 mg/ml to 2 mg/ml.
Administer only by intravenous infusion.
After dilution in 5% glucose solution, the chemical and physical stability of the solution has been demonstrated at 2°C to 8°C. From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the storage time and conditions before administration are the responsibility of the user. The storage period should not exceed 24 hours at 2°C to 8°C, unless the solution has been diluted under controlled and validated aseptic conditions.
Before administration, the solution must be inspected. Only clear solutions without particles should be used.
This medicinal product is for single use only. Any unused solution should be disposed of (see section "Disposal" below).
Never use sodium chloride solution or solutions containing chlorides for dilution or preparation of the infusion solution.

4.2 Infusion of the Solution

Before administration of Oxaliplatinum Accord, there is no need for prior hydration of the patient.
Oxaliplatin diluted in 250 to 500 ml of 5% glucose solution to achieve a concentration of not less than 0.2 mg/ml must be administered through a peripheral vein or central access over 2 to 6 hours. When administering oxaliplatin with 5-fluorouracil, the oxaliplatin infusion must be performed before 5-fluorouracil administration.

4.3 Disposal

Dispose of the medicinal product, as well as all materials used for preparation, dilution, and administration, in accordance with standard hospital procedures for the disposal of cytotoxic agents, taking into account local requirements for the disposal of hazardous waste.