Leaflet: information for the user

Oxaliplatino Kabi 5 mg/ml

Concentrate for infusion solution EFG

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

• 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, consult your doctor, pharmacist or nurse even if they are not listed in this leaflet. See section 4.

1.What is Oxaliplatino and what it is used for

2.What you need to know before starting to use Oxaliplatino

3.How to use Oxaliplatino

4.Possible side effects

5.Storage of Oxaliplatino

6.Contents of the pack and additional information

The active substance of Oxaliplatino Kabi 5mg/ml concentrated solution for infusion is oxaliplatino.

Oxaliplatino is used for the treatment of colorectal cancer (treatment of colon cancer in stage III after complete resection of the primary tumor, metastatic colon cancer, and rectal cancer). Oxaliplatino is used in combination with other anticancer medications called 5-fluorouracil and folinic acid.

Oxaliplatino is an antineoplastic or anticancer medication that contains platinum.

Do not use Oxaliplatino if:

• You are allergic to oxaliplatino or any of the other components of the medication (listed in section 6).
• You are breastfeeding.
• You have low levels of red or white blood cells.
• You have a sensation of numbness or tingling in your fingers and/or toes, or have difficulty performing delicate tasks such as buttoning your clothes.
• You have severe kidney problems.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use oxaliplatino:

• If you have ever had an allergic reaction to medications containing platinum, such as carboplatino, cisplatino. You may experience allergic reactions during any oxaliplatino infusion.
• If you have mild or moderate kidney problems.
• If you have liver disorders or abnormal liver function tests during your treatment.
• If you have cardiac disorders such as an abnormal electrical signal, known as prolonged QT interval, irregular heartbeat, or a family history of cardiac problems.
• If you have recently received or plan to receive any vaccine. During treatment with oxaliplatino, do not receive live or attenuated vaccines, such as the yellow fever vaccine.

If any of the following happens, inform your doctor immediately. Your doctor may need to treat you for these events. Your doctor may need to reduce the dose of oxaliplatino, or delay or stop treatment with Oxaliplatino.

• If you have an unpleasant sensation in your throat, particularly when swallowing, and feel like you are short of breath, during treatment, inform your doctor.
• If you have nerve problems in your hands or feet, such as numbness or tingling, or decreased sensation in your hands or feet, inform your doctor.
• If you have headaches, mental function alterations, seizures, and abnormal vision, from blurred vision to loss of vision, inform your doctor.
• If you do not feel well (nausea or vomiting), inform your doctor.
• If you have severe diarrhea, inform your doctor.
• If you have mouth pain or ulcers (mucositis/stomatitis), inform your doctor.
• If you have diarrhea or a reduction in white blood cells or platelets, inform your doctor. Your doctor may need to reduce the dose of Oxaliplatino or postpone your treatment with Oxaliplatino.
• If you have unexplained respiratory symptoms, such as coughing, or difficulty breathing, inform your doctor. Your doctor may suspend your treatment with oxaliplatino.
• If you experience extreme fatigue, shortness of breath, or kidney problems, which cause you to urinate little or not at all (acute renal insufficiency symptoms), inform your doctor.
• If you have a fever (temperature of 38°C or higher) or chills, which could be signs of infection, inform your doctor immediately. You may be at risk of developing blood infection.
• If you have a temperature > 38°C, inform your doctor. Your doctor may determine that you also have a reduction in white blood cells.
• If you unexpectedly experience bleeding or bruising (disseminated intravascular coagulation), inform your doctor, as this may be a sign of blood clots throughout your body's small blood vessels.
• If you feel dizzy (lose consciousness) or have an irregular heartbeat while taking Oxaliplatino, inform your doctor immediately, as this may be a sign of a serious cardiac condition.
• If you experience muscle pain and swelling, combined with weakness, fever, or brownish-red urine, inform your doctor. These may be signs of muscle damage (rhabdomyolysis) and may lead to kidney problems or other complications.
• If you have abdominal pain, nausea, vomiting like coffee grounds, dark stools that may be signs of intestinal ulcer (gastrointestinal ulcer with potential hemorrhage or perforation), consult your doctor.
• If you have abdominal pain (stomach), diarrhea with blood, and nausea and/or vomiting, which may be caused by reduced blood flow to the intestinal wall (intestinal ischemia), inform your doctor.

Use of oxaliplatino with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Pregnancy

• Do not become pregnant during treatment and, therefore, use an effective contraceptive method during treatment. It is recommended to use an appropriate contraceptive method for 15 months after stopping treatment.
• It is recommended that male patients not father children during treatment and for 12 months after treatment and use appropriate contraceptive methods during this period.
• 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, inform your doctor immediately.

Breastfeeding

• Do not breastfeed while on treatment with oxaliplatino.

Fertility

• Oxaliplatino may cause anti-fertility effects that may be irreversible. It is recommended that men seek advice on sperm preservation before treatment.
• After treatment with oxaliplatino, it is recommended that patients planning a pregnancy seek genetic counseling.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

Only used in adult patients.

For single use only.

Dose

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

The normal dose for adults, including the elderly, is 85 mg/m2of body surface area.

The dose administered will also depend on the results of blood tests and if you have previously experienced side effects as a result of oxaliplatino administration.

Method and route of administration

• Oxaliplatino prescription will be made by a cancer treatment specialist.
• You will be treated under the supervision of a healthcare professional, who will administer the appropriate dose of oxaliplatino.
• Oxaliplatino is administered through a slow injection into a vein (intravenous infusion) over a period of 2 to 6 hours.
• Oxaliplatino will be administered at the same time as folinic acid and before the infusion of 5-fluorouracil.

Administration frequency

You will normally receive treatment once every 2 weeks.

Treatment duration

The duration of treatment will be established by your doctor. Treatment lasts a maximum of 6 months after surgery to remove your cancer.

If you use more Oxaliplatino than you should

As this medication is administered by a healthcare professional, it is unlikely that you will receive a dose of medication higher or lower than the prescribed amount. In case of overdose, you may experience an increase in side effects. Your doctor will administer appropriate treatment for these effects.

If you have any other questions about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, it is essential to inform your doctor before starting the next treatment.

The following side effects may occur.

Inform your doctor immediately if you experience any of the following:

• Signs of an allergic reaction or anaphylaxis, such as sudden onset of rash, itching, or hives on the skin, difficulty swallowing, swelling in the face, lips, tongue, or other parts of the body, shortness of breath, wheezing, or difficulty breathing, extreme fatigue (feeling like you are going to faint).Most of the time, these symptoms occurred during infusion or immediately after, but delayed allergic reactions have also been observed hours or even days after infusion.

• Abnormal cardinals, bleeding, or signs of infection, such as sore throat and high temperature.
• Persistent and severe diarrhea and vomiting.
• Presence of blood or dark brown coffee-colored particles in your vomit.
• Stomatitis/mucositis (painful lips or mouth ulcers).
• Unexplained respiratory symptoms, such as dry or productive cough, difficulty breathing, or wheezing, shortness of breath, and wheezing, which may indicate a severe lung disease that can be fatal.
• A group of symptoms, including headache, altered mental function, seizures, and abnormal vision, ranging from blurred vision to loss of vision (posterior reversible encephalopathy syndrome, a rare neurological disorder).
• Stroke symptoms, which include severe and sudden headache, confusion, difficulty seeing with 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 fatigue with decreased red blood cell count and difficulty breathing (hemolytic anemia), alone or combined with low platelet count, abnormal bleeding (thrombocytopenia), and kidney problems that cause you to urinate little or not at all (symptoms of acute uremic hemolytic syndrome).

Other known side effects of oxaliplatin are:

Very common: may affect more than 1 in 10 patients

Oxaliplatin can affect the nerves (peripheral neuropathy). You may feel tingling and/or numbness in your fingers, toes, around your mouth, or in your throat, which may be associated with cramps. These effects can occur frequently with exposure to cold, for example, opening a refrigerator or handling a cold drink. You may also experience difficulty with fine motor tasks, such as buttoning your shirt. Although in most cases, these symptoms resolve completely on their own, it is possible that peripheral neuropathy symptoms may persist after treatment is completed.Some people have experienced tingling, a sensation of shock that passes through their arms or torso when their neck is flexed.

• Oxaliplatin can cause an unpleasant sensation in the throat, particularly when swallowing and giving the sensation of shortness of breath. This sensation, if it occurs, usually happens during or in the hours following infusion and may be triggered by exposure to cold. Although it is unpleasant, it does not last long and resolves without the need for treatment. Your doctor may decide to alter your treatment as a result of this.

• Oxaliplatin can cause diarrhea, mild nausea (feeling of dizziness), and vomiting (feeling unwell); However, your doctor will usually treat you to prevent this discomfort before starting treatment, and it should be continued after treatment.
• Oxaliplatin causes a temporary reduction in the number of blood cells. The reduction in red blood cells can cause anemia (a reduction in red blood cells), abnormal bleeding, or hematomas (due to a reduction in platelets). The reduction in white blood cell count can make you more prone to infections.
• Your doctor will take blood samples to verify that you have enough blood cells before starting treatment and after each subsequent cycle.
• Sensation of discomfort near or at the site of administration during infusion.
• Fever, chills, moderate or extreme fatigue, body aches.
• Weight changes, loss of appetite, taste disturbances, constipation.
• Headache, back pain.
• Muscle inflammation, neck stiffness, unusual sensation of the tongue that may affect speech, stomatitis/mucositis (painful lips or mouth ulcers).
• Abdominal pain.
• Abnormal bleeding, including nosebleeds.
• Cough, difficulty breathing.
• Allergic reactions, skin rash that may be red or itchy, moderate hair loss (alopecia).
• Changes in blood test results, including those showing changes in liver function.

Common: may affect up to 1 in 10 patients

• Infection due to a reduction in white blood cell count.

• Severe blood infection, in addition to a reduction in white blood cell count (neutropenic sepsis), which can be fatal.
• Reduction in white blood cell count accompanied by a temperature > 38.3°C or prolonged temperature > 38°C for more than an hour (febrile neutropenia).
• Indigestion and heartburn, hiccups, dizziness.
• Increased sweating and nail problems, skin peeling.
• Chest pain.
• Pulmonary problems and coughing.
• Joint and bone pain.
• Urination pain and changes in kidney function, changes in urination frequency, dehydration.
• Blood in urine/stool, vein swelling, pulmonary embolism.
• High blood pressure.
• Depression and insomnia.
• Conjunctivitis and vision problems.
• Decreased calcium levels in the blood.
• Falling.

Rare: may affect up to 1 in 1,000 patients

• Severe blood infection (sepsis), which can be fatal.
• Intestinal blockage or inflammation.
• Nervousness.

Very rare: may affect up to 1 in 10,000 patients

• Blood or dark brown coffee-colored particles in vomit.
• Kidney problems that cause you to urinate little or not at all (symptoms of acute renal failure).
• Liver vascular problems.

Unknown frequency(frequency cannot be estimated from available data)

• Allergic vasculitis (inflammation of blood vessels).
• Autoimmune reaction that causes a reduction in all blood cell lines (autoimmune pancytopenia, pancytopenia).
• Severe blood infection and low blood pressure (septic shock), which can be fatal.
• Seizures (uncontrolled body agitation).
• Throat spasm that can cause difficulty breathing.
• Extreme fatigue with decreased red blood cell count and shortness of breath (hemolytic anemia), alone or combined with low platelet count and kidney problems that cause you to urinate little or not at all (symptoms of acute uremic hemolytic syndrome), which can be fatal.
• Abnormal heart rhythm (prolonged QT) that can be seenin an electrocardiogram (ECG) that can be fatal.
• Muscle pain and swelling, along with weakness, fever, or reddish-brown urine (symptoms of muscle damage called rhabdomyolysis) that can be fatal.
• Abdominal pain, nausea, vomiting with blood or coffee grounds-like vomit, dark stools (symptoms of gastrointestinal ulcer with potential hemorrhage or perforation), which can be fatal.
• Decreased blood flow to the intestine (intestinal ischemia) that can be fatal.
• Risk of new cancers. Leukemia, a type of blood cancer, has been reported in patients after using oxaliplatin in combination with certain medications. Consult your doctor about the potential increased risk of this type of cancer when oxaliplatin is used with certain medications.
• Myocardial infarction (heart attack), angina (chest pain or discomfort).
• Esophageal inflammation (inflammation of the inner lining of the esophagus - the tube that connects the mouth to the stomach - causing pain and difficulty swallowing).

Focal nodular hyperplasia of the liver (non-cancerous abnormal liver nodules).

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

Store the vial in the outer packaging to protect it from light. Store at a temperature below 25°C. Do not freeze.

Do not use oxaliplatino if you observe that the solution is not transparent and is not free of particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of oxaliplatin

• The active substance is oxaliplatin. One ml of concentrate for infusion solution contains 5 mg of oxaliplatin.

• 10 ml of concentrate for infusion solution contain 50 mg of oxaliplatin.

• 20 ml of concentrate for infusion solution contain 100 mg of oxaliplatin.

• 40 ml of concentrate for infusion solution contain 200 mg of oxaliplatin.

• The other components are water for injection.

Appearance of the product and contents of the package

This medicine is a concentrate for infusion solution. The concentrate is a transparent and colorless infusion solution free of visible particles.

Each vial contains 50mg, 100mg or 200mg of oxaliplatin. The concentrate is presented in type I glass vials of 10 ml, 20 ml and 40 ml with a rubber stopper of chlorobutyl or bromobutyl with an aluminum cap with a plastic "flip-off" cap. Each vial may be supplied with a retractable wrapper and may be supplied or not supplied in a plastic container.

The vials are supplied in cardboard boxes of one vial.

Not all package sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi España S.A.U

C/Marina 16-18

08005 – Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Deutschland GmbH

Pfingstweide 53

61169 Friedberg

Germany

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Republic of CzechOxaliplatin Kabi 5 mg/ml concentrate for infusion solution

DenmarkOxaliplatin “Fresenius Kabi”, concentrate for infusion solution, solution

GermanyOxaliplatin Kabi 5 mg/ml concentrate for the preparation of an infusion solution

HungaryOxaliplatin Kabi 5 mg/ml concentrate for infusion solution

ItalyOxaliplatino Kabi

IrelandOxaliplatin 5 mg/ml concentrate for solution for infusion

NetherlandsOxaliplatine Kabi 5 mg/ml concentrate for infusion solution

NorwayOxaliplatin Kabi 5 mg/ml concentrate for infusion solution

PolandOxaliplatin Kabi

PortugalOxaliplatina Kabi 5 mg/ml concentrate for infusion solution

Slovak RepublicOxaliplatin Kabi 5 mg/ml infusion concentrate

SpainOxaliplatino Kabi 5 mg/ml concentrate for infusion solution EFG

United KingdomOxaliplatin 5 mg/ml concentrate for solution for infusion

(Northern Ireland)

Last review date of this leaflet: June 2024

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This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

As with any potentially toxic compound, precautions should be taken when handling and preparing oxaliplatin solutions.

Handling instructions

The handling of this cytotoxic agent by healthcare personnel requires caution to ensure the protection of the handler and the surroundings.

The preparation of injectable solutions of cytotoxic agents should be performed by specialized personnel trained in the handling of this class of medications, in conditions that ensure the integrity of the medication, environmental protection, and in particular the protection of personnel handling these drugs, in accordance with hospital policy. Preparation should be carried out in a designated area. Smoking, eating, or drinking is prohibited in this area.

Specialized personnel should be provided with appropriate materials for handling, long-sleeved gowns, masks, caps, glasses, sterile gloves for single use, protective clothing for the work area, containers, and bags for collecting waste.

Feces and vomit should be handled with care.

Pregnant women should avoid handling cytotoxic agents.

Any broken container should be treated with the same precautions and considerations as contaminated waste. Contaminated waste should be incinerated in suitable, rigid, and labeled containers. See the "Waste Disposal" section below.

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

If the oxaliplatin concentrate or infusion solution comes into contact with mucous membranes, wash immediately and abundantly with water.

Special precautions for administration

• DO NOT use equipment with aluminum.
• DO NOT administer without dilution.
• Only use the recommended diluents (see below).
• DO NOT mix other drugs in the same infusion bag or administer simultaneously through the same infusion route.
• DO NOT mix with alkaline drugs or solutions, particularly 5-fluorouracil, preparations of folic acid that contain trometamol as an excipient, and trometamol salts of other active principles. Alkaline drugs or solutions may adversely affect the stability of oxaliplatin.

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

The intravenous infusion of oxaliplatin 85 mg/m2in 250-500 ml of 5% glucose solution is administered at the same time as an intravenous infusion of folic acid in 5% glucose solution, over2 to6 hours, using a Y-connector located immediately before the infusion point. These two drugs should not be combined in the same infusion bag. Folic acid (AF) should not contain trometamol as an excipient and should only be diluted using isotonic glucose 5% solution, never in alkaline solutions or sodium chloride solutions or solutions containing chlorides.

Instructions for use with 5-fluorouracil (5 FU)

Oxaliplatin should always be administered before fluoropyrimidines, such as 5-fluorouracil (5-FU). After administering oxaliplatin, clean the line and then administer 5-fluorouracil (5 FU).

For additional information on the combination of drugs with oxaliplatin, see the corresponding Technical Dossier.

• USE ONLY the recommended diluents (see below).

• Any concentrate showing evidence of precipitation should not be used and should be destroyed in accordance with local regulations for the disposal of hazardous waste (see below).

Concentrate for infusion solution

Visually inspect before use. Only solutions that are transparent and free of particles should be used. The medicinal product is for single use only. Any unused infusion solution should be discarded.

Dilution before intravenous infusion

Remove the required amount of concentrate from the vial(s) and then dilute with250 to500 ml of a 5% glucose solution to administer a concentration of oxaliplatin between 0.2 mg/ml and 0.7 mg/ml. The concentration range in which the physical-chemical stability of oxaliplatin has been demonstrated is 0.2 mg/ml to 2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5% glucose solution, the chemical and physical stability of oxaliplatin has been demonstrated in use for 24 hours at room temperature (15°C-25°C) and in the refrigerator (2°C-8°C).

From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the time and conditions of storage before use are the responsibility of the user and should not normally exceed 24 hours at a temperature between2°Cand8°Cunless the dilution has taken place in controlled and validated aseptic conditions.

Visually inspect before use. Only solutions that are transparent and free of particles should be used. The medicinal product is for single use only. Any unused infusion solution should be discarded.

DO NOT use sodium chloride solutions or solutions containing chlorides for dilution.

The compatibility of Oxaliplatine infusion solution has been analyzed with representative administration equipment based on PVC.

Infusion

Oxaliplatin administration does not require prehydration.

Oxaliplatin diluted in 250 ml or 500 ml of 5% glucose solution to administer a concentration not less than 0.2 mg/ml should be infused via a peripheral or central vein over2 to6 hours. When oxaliplatin is administered with 5-fluorouracil, the infusion of oxaliplatin should precede the administration of 5-fluorouracil.

Disposal

Any remaining material or unused medication should be disposed of in accordance with local regulations.