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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if the side effect is not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Oxaliplatin Aurovit is and what it is used for

Oxaliplatin Aurovit contains the active substance oxaliplatin, which belongs to a group of medicines known as platinum-based agents used to treat cancer.

Oxaliplatin is used for the treatment of advanced colorectal cancer (particularly after complete resection of the primary tumor), and metastatic (cancer cells that have spread to other parts of the body) colon and rectal cancer. Oxaliplatin is used in combination with other anticancer medicines called 5-fluorouracil and folinic acid.

2. What you need to know before using Oxaliplatin Aurovit

Do not use Oxaliplatin Aurovit if

• you are allergic to oxaliplatin.
• you are breastfeeding.
• you already have a low blood cell count.
• you already have tingling and numbness in your fingers and/or toes and have difficulty performing delicate tasks, such as buttoning clothes.
• you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting oxaliplatin:

• If you have ever had an allergic reaction to medicines containing platinum, such as carboplatin or cisplatin. Allergic reactions may occur during any oxaliplatin infusion.
• If you have mild or moderate kidney problems.
• If you have low blood values after previous treatment with oxaliplatin. Your doctor will need to perform tests to check whether your blood values are sufficient before starting treatment.
• If you have symptoms of nerve damage, such as weakness, numbness, altered taste, or abnormal sensations after previous treatment with oxaliplatin. These symptoms may be triggered by cold exposure. Inform your doctor if you experience any of these symptoms, especially if they are bothersome and/or last longer than 7 days. Your doctor will perform neurological examinations before and during treatment, particularly if you are receiving other medicines that may cause nerve damage. Symptoms of nerve damage may persist after completion of treatment.
• If you are also receiving 5-fluorouracil, due to an increased risk of diarrhea, vomiting, mouth ulcers, and abnormal blood parameters.
• If you have liver problems.
• If you have or have had heart disorders, such as an abnormal electrical signal known as QT interval prolongation, irregular heartbeat, or a family history of heart problems.
• If you have recently received or plan to receive any vaccine. During treatment with oxaliplatin, you must not be vaccinated with "live" or "attenuated" vaccines, such as the yellow fever vaccine.
• If you are pregnant or planning to become pregnant (see Pregnancy, breastfeeding, and fertility).
• Read the section on fertility even if you are a man.

Other medicines and Oxaliplatin Aurovit

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

• It is not recommended that you become pregnant during treatment with oxaliplatin, and you must use an effective method of contraception. Female patients should use adequate contraceptive measures during treatment and for at least 4 months after its completion.
• If you are pregnant or planning to become pregnant, it is very important to discuss this 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 cause infertility, which could be irreversible. Male patients should seek advice about sperm preservation before treatment.
• Male patients are advised not to father a child during treatment and for 6 months after treatment, and to use appropriate contraceptive measures during this period.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Treatment with oxaliplatin may increase the risk of dizziness, nausea, vomiting, and other neurological symptoms that may affect walking and balance. If this occurs, you must not drive or operate machinery. If you experience vision problems while using oxaliplatin, do not drive or use heavy machinery, or engage in hazardous activities.

3. How to use Oxaliplatin Aurovit

Oxaliplatin is indicated only in adults.

Dosage

The dose of oxaliplatin depends on your body surface area. This is calculated based on your weight and height.

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

Method and route of administration

• Oxaliplatin will be prescribed by a specialist in cancer treatment.
• You will be treated by a healthcare professional who will have prepared the appropriate dose of oxaliplatin.
• Oxaliplatin is administered as a slow injection into a vein (intravenous infusion) over a period of 2 to 6 hours.
• This medicine will be given to you at the same time as folinic acid and before the infusion of 5-fluorouracil.

Frequency of administration

Generally, you should receive an infusion every 2 weeks.

Duration of treatment

Your doctor will determine the duration of treatment.

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

If you are given more Oxaliplatin Aurovit than you should

Since this medicine is administered by a healthcare professional, it is highly unlikely that you will receive a dose that is too low or too high.

In case of overdose, you may experience an increase in adverse effects. Your doctor may provide appropriate treatment for these adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

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

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 that you inform your doctor before the next treatment.

Seek immediate medical attention if you notice any of the following symptoms:

• Signs of an allergic reaction with sudden onset 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 breathing difficulties, extreme tiredness (you may feel you are going to faint). In most cases, these symptoms occurred during or immediately after the infusion, but delayed allergic reactions have also been observed hours or even days after infusion. Very common (may affect more than 1 in 10 people).
• Abnormal bruising or bleeding. Very common (may affect more than 1 in 10 people).
• Signs of infection, such as sore throat and high temperature. Common (may affect up to 1 in 10 people).
• Persistent or severe diarrhea or vomiting. Very common (may affect more than 1 in 10 people).
• Blood or dark brown coffee-ground-like particles in your vomit. Very rare (may affect up to 1 in 10,000 people).
• Pain in the lips or mouth ulcers. Very common (may affect more than 1 in 10 people).
• Unexplained respiratory symptoms such as dry or productive cough, difficulty breathing or noisy breathing, shortness of breath and wheezing. Very common (may affect more than 1 in 10 people).
• A group of symptoms such as headache, altered mental function, seizures and abnormal vision, ranging from blurred vision to loss of vision (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder). Rare (may affect up to 1 in 1,000 people).
• Extreme tiredness with a decrease in red blood cells and shortness of breath (hemolytic anemia), alone or in combination with low platelet count, abnormal bruising (thrombocytopenia), and kidney problems causing reduced urine output or no urine (symptoms of hemolytic uremic syndrome). Frequency not known (cannot be estimated from available data).

Other known adverse effects of oxaliplatin

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

• Oxaliplatin can affect the nerves (peripheral neuropathy). You may experience tingling and/or numbness in the fingers and toes, around the mouth or in the throat, which may sometimes be accompanied by muscle cramps.

These effects are often triggered by exposure to cold, for example, opening the refrigerator or holding a cold drink. You may also have difficulty performing delicate tasks such as buttoning clothes. Although in most cases these symptoms resolve completely on their own, there is a possibility that symptoms of peripheral sensory neuropathy may persist after treatment has ended.

• Some people have experienced a tingling sensation in the arms or trunk when bending the neck.
• Oxaliplatin may sometimes cause an unpleasant sensation in the throat, particularly when swallowing, and may give a feeling of difficulty breathing. If this occurs, it usually appears during or within hours after the infusion and may be triggered by exposure to cold. Although unpleasant, it does not last long and resolves without treatment. As a consequence, your doctor may decide to modify your treatment.
• Oxaliplatin may cause diarrhea, mild nausea and vomiting; however, your doctor will usually give you medications to prevent nausea before treatment, and these may continue to be used after treatment.
• Oxaliplatin causes a temporary reduction in blood cell counts. A decrease in red blood cells may cause anemia (reduction in red blood cells), abnormal bleeding or bruising (due to a reduction in platelet count). A decrease in white blood cells may increase susceptibility to infections. Before starting treatment and before each treatment cycle, your doctor will perform a blood test to ensure you have an adequate number of blood cells.
• Feeling of discomfort near or at the site of administration during infusion.
• Chills (shivering), mild to severe tiredness, body pain.
• Weight changes, loss of appetite or appetite changes, taste disturbances, constipation.
• Headache, back pain.
• Inflammation of muscular nerves, neck stiffness, abnormal sensation in the tongue that may impair speech.
• Stomach pain.
• Moderate hair loss (alopecia).
• Blood test abnormalities showing changes in liver function.

Common (may affect up to 1 in 10 people)

• Indigestion and heartburn, hiccups, hot flushes, dizziness.
• Increased sweating and nail changes, skin peeling.
• Chest pain.
• Runny nose.
• Joint pain and bone pain.
• Pain when urinating and changes in kidney function, changes in frequency of urination, dehydration.
• Blood in urine/stool, inflammation of veins, blood clots in the lung.
• High blood pressure.
• Depression and insomnia.
• Conjunctivitis, vision problems.
• Decreased levels of calcium in the blood.
• Falls.

Uncommon (may affect up to 1 in 100 people)

• Bowel 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, which may sometimes be fatal (interstitial lung disease).
• Reversible and temporary loss of vision.

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

• Kidney problems causing very little or no urine output (symptoms of acute renal failure).
• Vascular disorders of the liver.

Frequency not known (cannot be estimated from available data)

• Allergic vasculitis (inflammation of blood vessels).
• Seizures (uncontrolled shaking of the body).
• Throat spasm that may cause breathing difficulties.
• Abnormal heart rhythm (QT prolongation), which can be seen on an electrocardiogram (ECG) and may be life-threatening.
• Myocardial infarction (heart attack), angina (chest pain or discomfort).
• Esophagitis (inflammation of the inner lining of the esophagus – the tube connecting the mouth to the stomach – causing pain and difficulty swallowing).
• Reduced blood flow to the intestine (intestinal ischemia), which may be fatal.
• Risk of new cancers. Leukemia, a type of blood cancer, has been reported in patients after using oxaliplatin in combination with other medicines. Consult your doctor about the possible increased risk of this type of cancer when oxaliplatin is used with certain medicines.
• Abnormal, non-cancerous 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxaliplatin Aurovit

Keep this medicinal product out of the sight and reach of children.

Oxaliplatin 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, oxaliplatin must be handled and disposed of carefully by the doctor or nurse.

Do not use this medicinal product after the expiry date stated on the carton and vials after EXP. The expiry date refers to the last day of the month indicated.

This medicinal product does not require any special storage conditions.

After dilution in 5% glucose, chemical and physical stability in use has been demonstrated for 48 hours at 2–8°C and for 24 hours at 25°C. From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the dilution was carried out under validated and controlled aseptic conditions.

Do not use this medicinal product 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 containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Oxaliplatin Aurovit

• The active substance is oxaliplatin. Each vial contains 50 mg, 100 mg, or 200 mg of oxaliplatin.
• The other component is water for injections.

Nature of the product and contents of the container

Concentrate for solution for infusion.

A clear, colourless solution, essentially free from visible particles. Each vial contains 50 mg, 100 mg, or 200 mg of oxaliplatin in water for injections. Vials are supplied in packs containing one vial.

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

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

Germany: Oxaliplatin PUREN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium: Oxaliplatin Eugia 5 mg/ml concentraat voor oplossing voor infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung
Spain: Oxaliplatino Aurovit 5 mg/ml concentrado para solución para perfusión EFG
France: OXALIPLATINE ARROW LAB 5mg/ml, solution à diluer pour perfusion
Italy: Oxaliplatino Aurobindo Italia
Poland: Oxaliplatin Eugia
Portugal: Oxaliplatina Generis
Sweden: Oxaliplatin Eugia

Date of the most recent revision of this leaflet: January 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended solely for medical or healthcare professionals.

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

It is important to read the entire content of this procedure before preparing the oxaliplatin infusion solution.

1. FORMULATION

Oxaliplatin Aurovit 5 mg/ml concentrate for solution for infusion is a clear, colourless liquid containing 5 mg/ml of oxaliplatin in water for injections.

1. PRESENTATION

Oxaliplatin Aurovit is supplied as single-dose vials. Each carton contains one vial of oxaliplatin (50 mg, 100 mg, or 200 mg).

The 10 ml vial of Oxaliplatin Aurovit is made of clear type I glass and contains 50 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper.

The 20 ml vial of Oxaliplatin Aurovit is made of clear type I glass and contains 100 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper.

The 40 ml vial of Oxaliplatin Aurovit is made of clear type I glass and contains 200 mg of oxaliplatin concentrate for solution for infusion, with a bromobutyl rubber stopper.

Oxaliplatin Aurovit packaging for sale

This medicinal product does not require special storage conditions.

Solution for infusion

After dilution in 5% glucose, chemical and physical stability in use has been demonstrated for 48 hours at 2–8°C and for 24 hours at 25°C. From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated and controlled aseptic conditions (not exceeding 48 hours).

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

The medicine is for single use. Unused solution must be discarded.

1. SAFE HANDLING INSTRUCTIONS

As with other potentially toxic compounds, precautions must be taken when handling and preparing oxaliplatin solutions.

Handling instructions

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

Preparation of injectable solutions of cytotoxic agents should be performed by personnel specialised in handling such medicines, under conditions that guarantee product integrity, environmental protection, and, above all, the protection of personnel handling these medicines, in accordance with hospital regulations. A designated, dedicated area is required for this purpose. Eating, drinking, or smoking in this area is prohibited.

Personnel must be provided with appropriate handling materials, especially long-sleeved gowns, masks, caps, protective goggles, single-use sterile gloves, protective clothing for the work area, and containers and waste bags for disposal of contaminated materials.

Faeces and vomit must be handled with care.

Pregnant women should be warned to avoid handling cytotoxic agents.

Any broken container must be handled with the same precautions and considerations as contaminated waste. Contaminated waste must be incinerated in appropriate rigid containers, properly labelled. See section "Disposal" below.

If the concentrate for solution for infusion or the oxaliplatin infusion solution comes into contact with the skin, wash immediately with abundant water.

If the concentrate for solution for infusion or the oxaliplatin infusion solution comes into contact with mucous membranes, rinse immediately with abundant water.

1. PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special precautions for administration

• DO NOT use infusion devices containing aluminium.
• DO NOT administer undiluted.
• Only 5% glucose solution (50 mg/ml) may be used as diluent. DO NOT dilute for infusion with sodium chloride or chloride-containing solutions.
• DO NOT mix with other medicines in the same infusion bag or administer simultaneously through the same infusion line with other medicines.
• DO NOT mix with alkaline solutions or medicines, particularly 5-fluorouracil, folinic acid preparations containing trometamol as excipient, or trometamol salts of other medicines. Alkaline solutions or medicines may negatively affect the stability of oxaliplatin.

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

The intravenous infusion of 85 mg/m² of oxaliplatin in 250 to 500 ml of 5% glucose solution (50 mg/ml) is administered simultaneously with an intravenous infusion of folinic acid in 5% glucose solution (50 mg/ml), over 2 to 6 hours, using a Y-line placed immediately before the injection site. These two medicines must not be combined in the same infusion bag. Folinic acid must not contain trometamol as excipient and must be diluted only with 5% glucose isotonic solutions, never with alkaline solutions, sodium chloride solutions, or chloride-containing solutions.

Instructions for use with 5-fluorouracil

Oxaliplatin must always be administered before fluoropyrimidines, i.e., 5-fluorouracil. After oxaliplatin administration, flush the line and then administer 5-fluorouracil.

For additional information on combination therapies with oxaliplatin, refer to the corresponding summary of product characteristics.

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

4.1 Preparation of the infusion solution

Withdraw the required amount of concentrate from the vial(s) and dilute with 250 to 500 ml of 5% glucose solution (50 mg/ml) to achieve an oxaliplatin concentration between 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 solution (50 mg/ml), chemical and physical stability in use has been demonstrated for 48 hours at 2°C–8°C and for 24 hours at +25°C.

From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated and controlled aseptic conditions (not exceeding 48 hours).

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

The medicine is for single use. Unused solution must be discarded (see section "Disposal" below).

NEVER use sodium chloride or chloride-containing solutions for dilution.

Compatibility of the oxaliplatin solution has been verified for administration systems with PVC components.

4.2 Infusion of the solution

Administration of oxaliplatin does not require prehydration.

Oxaliplatin, diluted in 250 ml to 500 ml of 5% glucose solution (50 mg/ml) to achieve a concentration of not less than 0.2 mg/ml, should be infused via central or peripheral venous route over 2 to 6 hours. When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion must precede the 5-fluorouracil infusion.

4.3 Disposal

Disposal of unused medicine and materials used for dilution and administration must be carried out in accordance with hospital procedures for cytotoxic agents, taking into account local regulations for the disposal of hazardous waste.