Oxaliplatin Fosun Pharma

Leaflet accompanying the packaging: information for the user

Oxaliplatin Fosun Pharma, 5 mg/mL, concentrate for solution for infusion

Oxaliplatinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Oxaliplatin Fosun Pharma and what is it used for
• 2. Important information before using Oxaliplatin Fosun Pharma
• 3. How to use Oxaliplatin Fosun Pharma
• 4. Possible side effects
• 5. How to store Oxaliplatin Fosun Pharma
• 6. Contents of the packaging and other information

1. What is Oxaliplatin Fosun Pharma and what is it used for

The active substance of Oxaliplatin Fosun Pharma, concentrate for solution for infusion, is oxaliplatin.
Oxaliplatin Fosun Pharma is used to treat colorectal cancer (adjuvant treatment of stage III colon cancer after complete resection of the primary tumor, colon and rectal cancer with metastases).
Oxaliplatin Fosun Pharma is used in combination with other anticancer medicines such as 5-fluorouracil and folinic acid.
Oxaliplatin Fosun Pharma is a medicine with anticancer effects and contains platinum.

2. Important information before using Oxaliplatin Fosun Pharma

When not to use Oxaliplatin Fosun Pharma

• during breastfeeding;

Warnings and precautions

Before starting treatment with Oxaliplatin Fosun Pharma, discuss with your doctor, pharmacist, or nurse:

If at any time any of the following statements apply to the patient, inform the doctor immediately. The doctor may decide to initiate appropriate treatment and also reduce the dose of Oxaliplatin Fosun Pharma or delay or discontinue treatment.

• If during treatment the patient experiences an unpleasant sensation in the throat (especially when swallowing) and shortness of breath, inform the doctor.
• If the patient experiences nerve disorders in the hands or feet, such as numbness or tingling or decreased sensation in the hands or feet, inform the doctor.
• If the patient experiences headache, mental disorders, seizures, and vision disturbances from blurred vision to loss of vision, inform the doctor.
• If the patient experiences nausea or vomiting, inform the doctor.
• If the patient experiences severe diarrhea, inform the doctor.
• If the patient experiences lip or oral mucosa ulcers (mucositis and/or stomatitis), inform the doctor.
• If the patient experiences diarrhea or a decreased number of white blood cells or platelets, inform the doctor. The doctor may reduce the dose of Oxaliplatin Fosun Pharma or delay its administration.
• If the patient experiences unexplained respiratory symptoms, such as cough or difficulty breathing, inform the doctor. The doctor may decide to discontinue the use of Oxaliplatin Fosun Pharma.
• If the patient experiences extreme fatigue, shortness of breath, or kidney disease and passes a small amount of urine or does not pass it at all (symptoms of acute kidney failure), inform the doctor.
• If the patient has a fever (38°C or higher) or chills, which may indicate an infection, inform the doctor immediately due to the risk of developing a blood infection.
• If the patient has a fever > 38°C, inform the doctor. The doctor may check if there is also a decrease in the number of white blood cells.
• If the patient experiences unexpected bleeding or bruising (disseminated intravascular coagulation), inform the doctor, as these may be symptoms of blood clots in small blood vessels.
• If the patient faints (loses consciousness) or experiences irregular heart rhythm during treatment with Oxaliplatin Fosun Pharma, inform the doctor immediately, as these may be symptoms of severe heart problems.
• If the patient experiences muscle pain and swelling along with weakness, fever, or reddish-brown urine color, inform the doctor, as these may be symptoms of muscle damage (rhabdomyolysis) that can lead to kidney function disorders or other complications.
• If the patient experiences abdominal pain, nausea, bloody vomiting, or dark (tarry) stools, which may indicate a stomach ulcer (gastric or intestinal ulcer with possible bleeding or perforation), inform the doctor.
• If the patient experiences abdominal pain, bloody diarrhea, and nausea and/or vomiting, which may be caused by reduced blood flow to the intestinal wall (intestinal ischemia), inform the doctor.

Oxaliplatin Fosun Pharma and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

• Pregnancy is not recommended during treatment with oxaliplatin. Effective methods of preventing pregnancy should be used. Women should use appropriate contraception during treatment and for 15 months after its completion.
• If the patient is pregnant or plans to become pregnant, it is very important to discuss this with the doctor before starting treatment.
• In case of pregnancy during treatment, inform the doctor immediately.

Breastfeeding

• Breastfeeding is not allowed during treatment with oxaliplatin.

Fertility

• Oxaliplatin may have an irreversible effect on fertility. Before starting treatment, men should consult about the possibility of storing sperm.
• Men are advised not to conceive a child during treatment and for 12 months after its completion. During this time, appropriate contraception should be used.

Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

Treatment with oxaliplatin may increase the risk of dizziness, nausea, and vomiting, as well as other neurological symptoms that can affect gait and balance.
In case of their occurrence, do not drive vehicles or operate machines. If the patient experiences vision disturbances during treatment with Oxaliplatin Fosun Pharma, they should not drive vehicles, operate machines, or perform hazardous activities.

3. How to use Oxaliplatin Fosun Pharma

Oxaliplatin Fosun Pharma is intended for adults only. For single use only.

Dosage

The dose of Oxaliplatin Fosun Pharma is determined based on body surface area. It is calculated based on the patient's height and weight.
The usual dose for adults, including elderly patients, is 85 mg/m² of body surface area. The dose the patient receives also depends on blood test results and whether the patient has previously experienced side effects related to the use of Oxaliplatin Fosun Pharma.

Method and route of administration

• Oxaliplatin Fosun Pharma is prescribed by a doctor specializing in cancer treatment.
• The patient will be treated by medical staff who will prepare the required dose of oxaliplatin.
• Oxaliplatin Fosun Pharma is administered by slow intravenous injection into one of the patient's veins (intravenous infusion) lasting from 2 to 6 hours.
• Oxaliplatin Fosun Pharma is administered at the same time as folinic acid, and before the infusion of 5-fluorouracil.

Frequency of administration

The patient usually receives an intravenous infusion every 2 weeks.

Duration of treatment

The doctor will decide on the duration of treatment.
Treatment will last for a maximum of 6 months in the case of adjuvant treatment with oxaliplatin after complete tumor resection.

Use of a higher than recommended dose of Oxaliplatin Fosun Pharma

Since the medicine is administered by medical staff, it is highly unlikely that the patient will receive too little or too much of the medicine.
In case of overdose, side effects may worsen. The doctor may apply appropriate treatment for side effects.
If you have any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, it is important to inform the doctor before the next treatment cycle.
The following side effects may occur.

Immediately consult a doctor if the following symptoms occur:

• allergy symptoms or anaphylactic reaction with sudden symptoms such as rash, itching or hives, swallowing difficulties, facial, lip, tongue, or other body part swelling, shortness of breath, wheezing, or breathing difficulties, extreme fatigue (the patient may feel like fainting); in most cases, these symptoms occur during or immediately after infusion, but delayed allergic reactions have also been observed several hours or even days after infusion; very common (may occur in more than 1 in 10 people);
• unusual bruising, bleeding, or signs of infection, such as sore throat and high fever; very common (may occur in more than 1 in 10 people);
• persistent or severe diarrhea, or vomiting; very common (may occur in more than 1 in 10 people);
• blood or dark brown particles (resembling coffee grounds) in vomit; very rare (may occur in fewer than 1 in 10,000 people);
• mouth or oral mucosa ulcers (mouth or lip pain or mouth ulcers); very common (may occur in more than 1 in 10 people);
• respiratory symptoms, such as dry or wet cough, breathing difficulties, or wheezing, which may be signs of a severe lung disease that can lead to death; very common (may occur in more than 1 in 10 people);
• a group of symptoms such as headache, changes in mental state, seizures, and vision disturbances from blurred vision to loss of vision (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder); rare (may occur in fewer than 1 in 1,000 people);
• stroke symptoms (including 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, walking difficulties, dizziness, balance problems, and speech difficulties); frequency not known (frequency cannot be estimated from the available data);
• extreme fatigue with decreased red blood cell count and shortness of breath (hemolytic anemia) - rare (may occur in fewer than 1 in 1,000 people), occurring with decreased platelet count or without, and abnormal blood clotting (thrombocytopenia) and kidney disease, in which the patient passes a small amount of urine or does not pass it at all (symptoms of hemolytic-uremic syndrome) – frequency not known (frequency cannot be estimated from the available data)].

  Other known side effects of oxaliplatin are:

  Very common(may occur in more than 1 in 10 people):

  • Oxaliplatin Fosun Pharma affects the nerves (peripheral neuropathy). The patient may experience tingling and/or numbness of the fingers of the hands and feet, in the mouth or throat area, sometimes accompanied by cramps. This side effect is often caused when the patient is exposed to cold, e.g., when opening the refrigerator or holding a cold drink. The patient may also experience difficulties in performing precise actions, such as buttoning. Although in most cases these symptoms completely resolve, there is a possibility of persistent symptoms of peripheral sensory neuropathy after treatment completion. In some patients, a tingling sensation resembling an "electric shock" may occur along the arms or torso after neck flexion;
  • Oxaliplatin Fosun Pharma may sometimes cause unpleasant sensations in the throat, especially when swallowing, as well as shortness of breath. Such sensations, if they occur, usually appear during infusion or within a few hours after its completion and may be caused by exposure to low temperatures. They are unpleasant but do not last long and resolve without the need for any treatment. The doctor may decide to change the treatment;
  • Oxaliplatin Fosun Pharma may cause diarrhea, mild nausea, and vomiting. The doctor will administer an antiemetic, which is usually given before treatment and can be taken after the treatment cycle;
  • Oxaliplatin Fosun Pharma causes transient reduction in blood cell count: reduced red blood cell count may cause anemia, reduced platelet count may cause unusual bleeding or bruising, and reduced white blood cell count may increase the risk of infection. Before starting treatment and before each subsequent cycle, the doctor will order a blood test to check if the patient has a sufficient number of blood cells;
  • discomfort at the injection site or in its area during infusion
  • fever, chills, mild or moderate fatigue, body pain;
  • weight changes, decreased or absent appetite, taste disorders, constipation;
  • headache, back pain;
  • nerve swelling leading to muscle weakness, neck stiffness, unusual tongue sensation that may disrupt speech, mouth or oral mucosa ulcers (mouth or lip pain or mouth ulcers);
  • abdominal pain;
  • abnormal bleeding, including nosebleeds;
  • cough, breathing difficulties;
  • allergic reactions, skin rash, which may be red and itchy, mild hair loss (alopecia);
  • abnormal blood test results, including those indicating abnormal liver function.

  Common(may occur in fewer than 1 in 10 people):

  • infection due to reduced white blood cell count;
  • severe blood infection (septic neutropenia) that can lead to death;
  • reduced white blood cell count with fever > 38.3°C or prolonged fever > 38°C for more than an hour (febrile neutropenia);
  • indigestion and heartburn, hiccups, sudden facial flushing;
  • excessive sweating and nail disorders, skin peeling;
  • chest pain;
  • lung and respiratory tract diseases;
  • bone and joint pain;
  • urinary pain and kidney changes, changes in urine frequency, dehydration;
  • blood in urine and/or stool, blood vessel inflammation, blood clots in the lungs;
  • high blood pressure;
  • depression, insomnia;
  • conjunctivitis, vision disturbances;
  • reduced calcium levels in the blood;
  • falls.

  Uncommon(may occur in fewer than 1 in 100 people):

  • severe blood infection (sepsis) that can lead to death;
  • intestinal obstruction or swelling;
  • nervousness.

  Rare(may occur in fewer than 1 in 1,000 people):

  • hearing loss;
  • scarring and thickening of the lungs, with breathing difficulties, sometimes leading to death (interstitial lung disease);
  • transient, 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(less than 1 in 10,000 people):

  • blood or dark brown particles (resembling coffee grounds) in vomit;
  • kidney disease, in which the patient passes a small amount of urine or does not pass it at all (symptoms of acute kidney failure);
  • vascular liver disease.

  Frequency not known(frequency cannot be estimated from the available data):

  • allergic blood vessel inflammation (vasculitis);
  • an autoimmune reaction causing a reduction in all blood cell counts (autoimmune pancytopenia), pancytopenia;
  • severe blood infection with low blood pressure (septic shock) that can lead to death;
  • seizures (uncontrolled body shaking);
  • throat spasm causing breathing difficulties;
  • extreme fatigue with decreased red blood cell count and shortness of breath (hemolytic anemia), with decreased platelet count or without, and kidney disease, in which the patient passes a small amount of urine or does not pass it at all (symptoms of hemolytic-uremic syndrome), which can lead to death;
  • abnormal heart rhythm (QT interval prolongation), which can be detected in an electrocardiogram (ECG) - a condition that can lead to death;
  • muscle pain and swelling along with weakness, fever, or reddish-brown urine color (symptoms of muscle damage known as rhabdomyolysis) - a condition that can lead to death;
  • abdominal pain, nausea, bloody vomiting, or dark (tarry) stools, which may indicate a stomach ulcer (gastric or intestinal ulcer 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;
  • risk of developing new tumors. Cases of leukemia - a type of blood cancer - have been reported in patients treated with Oxaliplatin Fosun Pharma in combination with certain other medicines. Consult a doctor about the possibility of developing this type of tumor during treatment with Oxaliplatin Fosun Pharma and certain other medicines;

  heart attack (myocardial infarction), angina pectoris (chest pain or discomfort);

  • esophageal inflammation (inflammation of the mucous membrane of the esophagus, which connects the mouth to the stomach - resulting in pain and difficulty swallowing).

  Reporting side effects

  If side effects occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
  Reporting side effects will help gather more information on the safety of the medicine.

  5. How to store Oxaliplatin Fosun Pharma

  Store the medicine out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the label and carton after: Expiry date (EXP). The expiry date refers to the last day of the month.
  Store the vial in the outer packaging to protect from light.
  Store below 30°C.
  Stability after dilution:
  It has been demonstrated that the solution after dilution with 5% glucose solution retains chemical and physical stability for 96 hours at a temperature of 2°C to 8°C and for 24 hours at a temperature of 25°C.
  From a microbiological point of view, the infusion solution should be used immediately.
  If the solution is not used immediately, the in-use storage times and conditions are the responsibility of the user. The storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution is performed under controlled and validated aseptic conditions.
  Do not use Oxaliplatin Fosun Pharma if the solution is not clear and visible solid particles are present.
  Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Oxaliplatin Fosun Pharma contains

  • The active substance of Oxaliplatin Fosun Pharma is oxaliplatin. 1 mL of the concentrate for solution for infusion contains 5 mg of oxaliplatin. 10 mL of the concentrate for solution for infusion contains 50 mg of oxaliplatin. 20 mL of the concentrate for solution for infusion contains 100 mg of oxaliplatin.
  • The other ingredient is: water for injections.

  What Oxaliplatin Fosun Pharma looks like and contents of the pack

  This medicine is a concentrate for solution for infusion. It is a clear, colorless solution, without visible solid particles.
  Each vial contains 50 mg or 100 mg of oxaliplatin. The concentrate is supplied in vials with a capacity of 10 mL or 20 mL made of colorless glass type I with bromobutyl rubber or fluoropolymer stoppers and aluminum flip-off seals with yellow (50 mg/10 mL vial) or blue (100 mg/20 mL vial) caps.
  Pack sizes:
  50 mg/10 mL: 1 vial
  100 mg/20 mL: 1 vial
  The vials are supplied in cardboard boxes containing one vial.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Fosun Pharma Sp. z o.o.
  Zajęcza 15
  00-351 Warsaw
  Tel.: + 48 22 244 11 05

  This medicine is authorized in the Member States of the European Economic Area under the following names:

  Austria: Oxaliplatin Fosun Pharma
  France: Oxaliplatine Fosun Pharma
  Germany: Oxaliplatin Fosun Pharma 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
  Poland: Oxaliplatin Fosun Pharma
  Italy: Oxaliplatina Fosun Pharma

  Date of last revision of the leaflet:

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  Information intended for healthcare professionals only:

  SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINE FOR ADMINISTRATION

  As with other potentially toxic substances, special care should be taken when handling and preparing oxaliplatin solutions.

  Instructions for preparation

  Preparation of cytotoxic medicine solutions by healthcare professionals requires special precautions to ensure the safety of the preparer and their environment.
  Cytotoxic medicine solutions for injection must be prepared by appropriately trained personnel with knowledge of the medicines used, in conditions that ensure the integrity of the medicine, environmental protection, and in particular the safety of personnel preparing cytotoxic medicines, in accordance with hospital regulations.
  This requires the preparation of a dedicated area. Smoking, eating, and drinking are not allowed in the designated area.
  Personnel preparing cytotoxic medicines must be equipped with appropriate personal protective equipment, in particular long-sleeved gowns, protective masks, protective headgear, protective eyewear, single-use gloves, and appropriate protective covers for workstations, containers, and waste bags.
  Caution should be exercised when handling excreta and vomit.
  Pregnant women should be warned to avoid contact with cytotoxic medicines.
  Damaged packaging should be treated with the same caution as contaminated waste. Contaminated waste should be incinerated after being placed in appropriately labeled, rigid containers. See below "Disposal of residues".
  In case of contact of the concentrate for solution for infusion or infusion solution of oxaliplatin with the skin, the area should be rinsed immediately with plenty of water.
  In case of contact of the concentrate for solution for infusion or infusion solution of oxaliplatin with the mucous membranes, the area should be rinsed immediately with plenty of water.

  Special precautions for administration

  • DO NOT use injection equipment containing aluminum.
  • DO NOT administer undiluted solutions.
  • For dilution, use only 5% glucose solution for infusion. DO NOT dilute the infusion solution with sodium chloride solution or solutions containing chlorides.
  • DO NOT mix with other medicines in the same infusion bag and DO NOT administer simultaneously in the same infusion set.
  • DO NOT mix with medicines or solutions with an alkaline pH, in particular with 5-fluorouracil, folinic acid products containing trometamol as an excipient, and trometamol salts of other active substances. Medicines or solutions with an alkaline pH have a negative effect on the stability of oxaliplatin.

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

  Oxaliplatin at a dose of 85 mg/m² administered as an intravenous infusion in 250 mL to 500 mL of 5% glucose solution, so as to achieve a concentration of oxaliplatin solution in the range of 0.2 mg/mL to 2 mg/mL, is administered at the same time as folinic acid (FA) in 5% glucose solution, over 2 to 6 hours, using a Y-connector placed directly before the infusion site. The two medicines should not be mixed in the same infusion bag. Folinic acid should not contain trometamol as an excipient and should be diluted only with isotonic 5% glucose solution; never use alkaline solutions, sodium chloride solution, or solutions containing chlorides for dilution.

  Instructions for use with 5-fluorouracil (5-FU)

  Oxaliplatin should always be administered before fluoropyrimidines, e.g., 5-fluorouracil. After administration of oxaliplatin, the infusion set should be flushed, and then 5-fluorouracil should be administered.
  For additional information on medicines used in combination with oxaliplatin, see the relevant sections of the Summary of Product Characteristics.

  • USE ONLY the recommended solvents (see below).
  • Any concentrate that shows signs of precipitation should not be used and should be disposed of in accordance with the requirements for disposal of hazardous waste (see below).

  Concentrate for solution for infusion

  Before use, inspect the solution. Only clear solutions without visible solid particles should be used. The medicine is for single use only. Any unused solution should be disposed of (see "Disposal of residues" below).
  DO NOT use sodium chloride solutions or solutions containing chlorides for dilution.

  Dilution of the infusion solution

  Withdraw the required amount of concentrate from the vial(s) and then dilute with 250 mL to 500 mL of 5% glucose solution, to achieve a concentration of oxaliplatin solution in the range of 0.2 mg/mL to 2 mg/mL. This is the range of concentrations for which the physical and chemical stability of oxaliplatin has been demonstrated.
  Administer intravenously.
  It has been demonstrated that the solution after dilution with 5% glucose solution retains chemical and physical stability for 96 hours at a temperature of 2°C to 8°C and for 24 hours at a temperature of 25°C.
  From a microbiological point of view, the infusion solution should be used immediately.
  If the solution is not used immediately, the in-use storage times and conditions are the responsibility of the user. The storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution is performed under controlled and validated aseptic conditions.
  The solution before and after dilution should be practically free from visible solid particles.
  Before use, inspect the solution. Only clear solutions without visible solid particles should be used. The medicine is for single use only. Any unused solution should be disposed of (see "Disposal of residues" below).
  DO NOT use sodium chloride solutions or solutions containing chlorides for dilution.

  Infusion

  Administration of oxaliplatin does not require prior hydration of the patient.
  Oxaliplatin diluted in 250 mL to 500 mL of 5% glucose solution, so as to achieve a concentration of not less than 0.2 mg/mL, should be administered into a peripheral or central vein over 2 to 6 hours.
  When oxaliplatin is administered with 5-fluorouracil, the oxaliplatin infusion should precede the administration of 5-fluorouracil.

  Disposal of residues

  Residues of the medicine and all materials used for dilution and administration should be disposed of in accordance with standard hospital procedures for handling cytotoxic medicines and taking into account local requirements for disposal of hazardous waste.

  Method of administration

  ONLY FOR ADULTS
  The recommended dose of oxaliplatin for adjuvant treatment is 85 mg/m², administered intravenously every 2 weeks, for 12 cycles (6 months).
  The recommended dose of oxaliplatin for the treatment of colorectal cancer with metastases is 85 mg/m², administered intravenously every 2 weeks, until disease progression or unacceptable toxicity occurs.
  The administered dose should be adjusted according to tolerance (see section 4.4 "Special warnings and precautions for use" in the SmPC).
  Oxaliplatin should always be administered before fluoropyrimidines, e.g., 5-fluorouracil (5-FU).
  Oxaliplatin is administered as an intravenous infusion over 2 to 6 hours, diluted in 250 mL to 500 mL of 5% glucose solution (50 mg/mL), so as to achieve a concentration in the range of 0.2 mg/mL to 0.7 mg/mL.
  A concentration of 0.7 mg/mL is the highest concentration in clinical practice for a dose of oxaliplatin of 85 mg/m².
  Shelf life
  2 years
  Special precautions for storage
  Store the vial in the outer packaging to protect from light.
  Store below 30°C.