Oxaliplatin Qilu 5 mg/ml concentrate for infusion solution EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

oxaliplatin

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

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

What Oxaliplatin Qilu is and what it is used for
What you need to know before you are given Oxaliplatin Qilu
How Oxaliplatin Qilu is administered
Possible side effects
How to store Oxaliplatin Qilu
Contents of the pack and other information

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

The active substance of Oxaliplatin Qilu is oxaliplatin.

This medicine is used in the treatment of cancer of the large intestine (treatment of stage III colon cancer after complete resection of the primary tumour, and metastatic carcinoma of the colon and rectum). Oxaliplatin Qilu is used in combination with other anticancer medicines called 5-fluorouracil (5-FU) and folinic acid.

Oxaliplatin Qilu is an antineoplastic or anticancer medicine containing platinum.

2. What you need to know before using Oxaliplatin Qilu

Do not use Oxaliplatin Qilu:

if you are allergic to oxaliplatin or any of the other ingredients of this medicine (listed in section 6).
if you are breastfeeding.
if you already have a low number of blood cells.
if you already suffer from tingling or numbness in your fingers and toes and have difficulty performing delicate tasks, such as buttoning clothes.
if you have a severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Oxaliplatin Qilu:

If you have ever had an allergic reaction to medicines containing platinum, such as carboplatin and cisplatin. Allergic reactions may occur during oxaliplatin infusion.
If you have a mild or moderate kidney disorder.
If you have liver problems or abnormal liver function test results during your treatment.
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 received or are scheduled to receive any vaccine. During treatment with oxaliplatin, you must not be vaccinated with live or live attenuated vaccines, such as the yellow fever vaccine.

If you experience any of the following symptoms at any time, inform your doctor immediately. Your doctor may need to treat these symptoms and reduce the dose of Oxaliplatin Qilu, delay treatment with this medicine, or stop it:

If you experience an unpleasant sensation in your throat, especially when swallowing, and feel short of breath during treatment, inform your doctor.
If you have nerve problems in your hands or feet, such as tingling or numbness, or reduced sensitivity in your hands or feet, inform your doctor.
If you have headache, changes in mental function, seizures, or vision disturbances (ranging from blurred vision to loss of vision), inform your doctor.
If you feel dizzy (nausea and vomiting), inform your doctor.
If you have severe diarrhea, inform your doctor.
If your lips are painful or you have mouth ulcers (mucositis/stomatitis), inform your doctor.
If you have diarrhea or a decrease in white blood cell or platelet count, inform your doctor. Your doctor may reduce the dose of Oxaliplatin Qilu or delay your treatment with this medicine.
If you experience respiratory symptoms without an apparent cause, such as cough or difficulty breathing, inform your doctor. Your doctor may discontinue your treatment with Oxaliplatin Qilu.
If you experience extreme fatigue, shortness of breath, or kidney problems with little or no urine output (symptoms of acute renal failure), inform your doctor.
If you have fever (temperature ≥ 38°C) or chills, inform your doctor immediately, as these could be signs of infection. You may be at risk of developing a blood infection.
If you have a fever with a temperature > 38°C, inform your doctor. The doctor will determine whether you also have a low white blood cell count.
If you experience unexpected bleeding or bruising (disseminated intravascular coagulation), inform your doctor, as these could be signs of blood clot formation in small blood vessels of the body.
If you faint (lose consciousness) or have an irregular heartbeat while taking Oxaliplatin Qilu, inform your doctor immediately, as this could be a sign of a serious heart condition.
If you experience muscle pain and swelling accompanied by weakness, fever, or dark-colored urine, inform your doctor, as these symptoms could indicate muscle injury (rhabdomyolysis) and may lead to kidney problems or other complications.
If you experience abdominal pain, nausea, bloody vomiting, or vomiting that looks like "coffee grounds," or dark or black stools with blood, which could be signs of an intestinal ulcer (gastroduodenal ulcer, possibly with hemorrhage or perforation), inform your doctor.
If you have abdominal pain (stomach ache), bloody diarrhea, and nausea or vomiting, which could be caused by reduced blood flow to the intestinal wall (intestinal ischemia), inform your doctor.

Children and adolescents

Oxaliplatin Qilu is only indicated for use in adults.

Other medicines and Oxaliplatin Qilu

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not advisable to become pregnant during treatment with oxaliplatin; therefore, you must use an effective method of contraception during treatment. Adequate contraceptive measures are recommended for 15 months after completion of treatment.
Male patients are advised not to father a child during treatment and for 12 months after its completion, and to use adequate contraceptive measures 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, you must inform your doctor immediately.

Breastfeeding

Breastfeeding must be discontinued during treatment with Oxaliplatin Qilu.

Fertility in men and women

Oxaliplatin may cause infertility, which may be irreversible. Male patients should seek advice on sperm preservation before treatment.

After treatment with oxaliplatin, female patients who wish to become pregnant are advised to seek genetic counseling.

Consult your doctor or pharmacist before taking any medicine.

Driving and use of machines

Treatment with oxaliplatin may increase the risk of dizziness, nausea, and vomiting, as well as other neurological symptoms that may affect walking and balance.

If you are affected by any of these symptoms, you must not drive or operate machinery.

If you experience vision problems while being treated with Oxaliplatin Qilu, do not drive, operate heavy machinery, or perform hazardous activities.

3. How to use Oxaliplatino Qilu

Oxaliplatino Qilu is indicated only for use in adults.

For single use only.

Dosage

The dose of Oxaliplatino Qilu depends on your body surface area, which is calculated based on your height and weight.

The usual dose in adults (including elderly patients) is 85 mg/m2 of body surface area. The dose you receive may also depend on the results of blood tests and whether you have previously experienced adverse effects with this medicine.

Method and route of administration

Oxaliplatino Qilu will be prescribed by a physician specialized in cancer treatment.
You will be treated by a healthcare professional, who will calculate the dose of medication you require.
Oxaliplatino Qilu is administered as a slow injection into a vein (intravenous infusion) over a period of 2–6 hours.
This medicine is administered at the same time as folinic acid and prior to the infusion of 5-fluorouracil.

Frequency of administration

In general, you will 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 use more Oxaliplatino Qilu than you should

Since this medicine will be administered by a healthcare professional, it is unlikely that you will receive too much or too little medication. In the event of an overdose, you may experience an increase in adverse effects. Your doctor can provide appropriate treatment for these adverse effects.

If you have any further questions about the use of this medicine, ask your doctor, nurse, 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 very important that you inform your doctor before starting the next treatment.

Below are the effects you may experience.

Contact your doctor immediately if you experience any of the following symptoms:

Signs of an allergic or anaphylactic reaction, accompanied by sudden symptoms such as rash, itching or hives, difficulty swallowing, swelling of the face, lips, tongue or other body parts, difficulty breathing, wheezing or trouble breathing, extreme tiredness (you may feel like fainting). These symptoms usually occur during or immediately after the infusion, but delayed allergic reactions have also been observed hours or even days after the infusion.
Unusual bruising, bleeding, or signs of infection such as sore throat and fever.
Persistent or severe diarrhea or vomiting.
Presence of blood or dark brown coffee-ground-like particles in vomit.
Stomatitis/mucositis (sores on the lips and mouth ulcers).
Respiratory symptoms such as dry or productive cough, difficulty breathing, breathing noises, shortness of breath, or wheezing, as these may indicate a serious lung disease that could be fatal.
A combination of symptoms such as headache, altered mental activity, seizures, and abnormal vision (from blurred vision to vision loss) (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder).
Symptoms of stroke (including sudden severe headache, confusion, vision problems in one or both eyes, numbness or weakness in the face, arm, or leg usually on one side, drooping face, difficulty walking, dizziness, loss of balance, and difficulty speaking).
Extreme tiredness, accompanied by a decrease in red blood cells and shortness of breath (hemolytic anemia), alone or together with a decrease in platelet count, unusual bruising (thrombocytopenia), and kidney problems resulting in little or no urine output (symptoms of hemolytic uremic syndrome).

Other adverse effects of Oxaliplatin Qilu are:

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

Tingling or numbness in fingers, toes, around the mouth or throat, sometimes accompanied by cramps (peripheral neuropathy).

These adverse effects are often triggered by exposure to cold, such as opening a refrigerator or holding a cold drink. You may also have difficulty performing fine motor tasks, such as buttoning clothes. Although in most cases these symptoms resolve completely on their own, sensory peripheral neuropathy symptoms may persist after treatment has ended. Some people have experienced a sudden tingling sensation in the arms or trunk when bending the neck.

An unpleasant sensation in the throat, particularly when swallowing, which may feel like difficulty breathing.
If this occurs, it usually happens during or shortly after the infusion and may be triggered by exposure to cold. Although unpleasant, it does not last long and resolves without treatment.
Your doctor may decide to modify your treatment as a result.
Diarrhea, mild nausea (feeling of queasiness), and vomiting (feeling unwell). However, your doctor will provide you with treatment to prevent this discomfort before starting therapy, which should continue afterward.
Temporary reduction in blood cell counts.
A decrease in red blood cells may cause anemia (reduced number of red blood cells), abnormal bleeding, or bruising (due to reduced platelet count). A decrease in white blood cells may increase the risk of 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.

Discomfort around or at the injection site during infusion.
Fever, chills (shivering), mild or extreme fatigue, body pain.
Weight changes, weight loss, or loss of appetite, taste disturbances, constipation.
Headache, back pain.
Inflammation of muscular nerves, neck stiffness, abnormal sensation in the tongue that may impair speech, stomatitis/mucositis (sores on the lips and mouth ulcers).
Stomach pain.
Unusual bleeding, including nosebleeds.
Cough, difficulty breathing.
Allergic reactions, skin rash (which may be red and itchy), moderate hair loss (alopecia).
Abnormal blood test results, including those related to changes in liver function.

Common (may affect up to 1 in 10 people)

Infection due to a decrease in white blood cells.
Severe blood infection, in addition to decreased white blood cells (neutropenic sepsis), which may be fatal.
Decreased white blood cell count accompanied by fever >38.3°C or prolonged fever >38°C for more than one hour (febrile neutropenia).
Indigestion and heartburn, hiccups, hot flashes, dizziness.
Increased sweating and nail changes, skin peeling.
Chest pain.
Pulmonary disorders and runny nose.
Joint pain and bone pain.
Pain when urinating and kidney function disturbances, changes in urination frequency, dehydration.
Blood in urine or stools, vein inflammation, blood clots in the lung.
High blood pressure.
Depression and insomnia.
Conjunctivitis and vision problems.
Decreased blood calcium levels.
Falls.

Uncommon (may affect up to 1 in 100 people)

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

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

Hearing loss.
Scarring and thickening of the lungs, accompanied by difficulty breathing, sometimes fatal (interstitial lung disease).
Reversible, temporary vision loss.
Unexpected bleeding or bruising due to widespread blood clotting in small blood vessels (disseminated intravascular coagulation), which may be fatal.

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

Presence of blood or dark brown coffee-ground-like particles in vomit.
Kidney problems resulting in very little or no urine output (symptoms of acute renal failure).
Liver vascular disorders.

Frequency not known (cannot be estimated from available data)

Allergic vasculitis (inflammation of blood vessels).
Autoimmune reaction causing a decrease in all blood cell lines (autoimmune pancytopenia), pancytopenia.
Severe blood infection or low blood pressure (septic shock), which may be fatal.
Seizures (uncontrolled body shaking).
Throat spasm that may cause difficulty breathing.
Cases of extreme tiredness, accompanied by a decrease in red blood cells and shortness of breath (hemolytic anemia), alone or together with a decrease in platelet count and kidney problems resulting in little or no urine output (symptoms of hemolytic uremic syndrome), which may be fatal, have been reported.
Abnormal heart rhythm (QT interval prolongation), which may be seen on an electrocardiogram (ECG) and may be fatal.
Myocardial infarction (heart attack), angina (chest pain or discomfort).
Muscle pain and swelling, accompanied by weakness, fever, or reddish-brown urine (symptoms of muscle damage known as rhabdomyolysis), which may be fatal.
Esophagitis (inflammation of the inner lining of the esophagus—the tube connecting the mouth to the stomach—causing pain and difficulty swallowing).
Abdominal pain, nausea, vomiting with blood or "coffee-ground" vomit, dark or black stools with blood (symptoms of gastrointestinal ulcer, possibly with bleeding or perforation), which may be fatal.
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 certain medicines. Consult your doctor about the potential 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 or pharmacist, 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 Qilu

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

Prior to mixing, this medicine should be stored in its original container to protect it from light, and it must not be frozen.

Do not use this medicine after the expiry date stated on the carton and on the label of the vial following EXP. The expiry date refers to the last day of the month indicated.

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

After completion of the infusion, the doctor or nurse will dispose of this medicine using appropriate safety measures.

Medicines must 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 Qilu

The active substance of Oxaliplatin Qilu is oxaliplatin.

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

Each 10 ml vial contains 50 mg of oxaliplatin.

Each 20 ml vial contains 100 mg of oxaliplatin.

Each 40 ml vial contains 200 mg of oxaliplatin.

The other component is water for injections.

Appearance of the product and contents of the container

Oxaliplatin Qilu vials contain a concentrate for solution for infusion (a concentrated solution which must be diluted to form a solution suitable for slow intravenous infusion via an infusion set).

The solution is clear, colourless and free from visible particles in suspension, contained in glass containers known as vials, each containing 50 mg (10 ml), 100 mg (20 ml) or 200 mg (40 ml) of oxaliplatin.

The vials are supplied in cartons containing a single vial.

Marketing Authorisation Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, Madrid, 28046,

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parc Tecnològic del Vallès),

Cerdanyola del Vallès, 08290

Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom (Northern Ireland)	Oxaliplatin 5mg/ml concentrate for solution for infusion
Spain	Oxaliplatin Qilu 5 mg/ml concentrate for solution for infusion EFG

Date of last review of this summary: August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended solely for healthcare professionals:

PREPARATION GUIDE FOR THE USE OF OXALIPLATIN QILU 5 MG/ML CONCENTRATE FOR INFUSION SOLUTION EFG

It is very important that you read the entire content of this procedure before preparing Oxaliplatin Qilu infusion solution EFG.

COMPOSITION

Oxaliplatin Qilu 5 mg/ml concentrate for infusion solution EFG is a clear, colourless liquid containing 5 mg/ml of oxaliplatin in water for injectable preparations.

PRESENTATION

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

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

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

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

Oxaliplatin Qilu packaging for sale:

This medicine must be stored in its original packaging to protect it from light and must not be frozen.

Infusion solution:

After dilution of the concentrate for infusion solution in 5% glucose solution (50 mg/ml), the physical and chemical stability during use is 48 hours at a temperature between 2°C and 8°C and 24 hours at 25°C.

From a microbiological standpoint, the infusion preparation should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2–8°C, unless dilution has taken place under controlled and validated aseptic conditions.

Inspect the vial visually before use. Only clear solutions free from suspended particles should be used. This medicine is for single use only. Any unused solution must be discarded.

RECOMMENDATIONS FOR SAFE HANDLING

As with other medicines containing potentially toxic compounds, extreme caution must be exercised during handling and preparation of solutions containing oxaliplatin.

Handling instructions

Handling of this cytotoxic agent by healthcare personnel requires precautions to ensure protection of the handler and the working area.

Preparation of injectable solutions of cytotoxic agents must be carried out by appropriately trained and qualified personnel, under conditions that guarantee product integrity, environmental protection, and particularly the protection of personnel handling the medicines, in accordance with hospital regulations. A dedicated preparation area is required for this purpose. Smoking, eating or drinking in this area is prohibited.

Personnel must wear appropriate protective equipment for handling the medicine, such as sleeves, protective mask, cap, protective goggles, sterile disposable gloves, protective gown for the work area, and waste collection containers and bags.

Faeces and vomit must be handled carefully.

Pregnant women should avoid handling cytotoxic agents.

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

If the concentrate for infusion solution or the diluted oxaliplatin infusion solution comes into contact with the skin, immediately wash the affected area thoroughly with plenty of water.

If the concentrate for infusion solution or the diluted oxaliplatin infusion solution comes into contact with mucous membranes, immediately wash the affected area thoroughly with plenty of water.

PREPARATION FOR INTRAVENOUS ADMINISTRATION

Special administration precautions

Do NOT use injection equipment containing aluminium.
Do NOT administer undiluted.
Only 5% glucose solution (50 mg/ml) should be used as diluent.

Do NOT dilute with infusion solutions containing sodium chloride or chloride.

Do NOT mix with other medicines in the same infusion bag or administer simultaneously through the same infusion line.
Must not be mixed with alkaline solutions or medicines, particularly 5-fluorouracil or leucovorin preparations containing trometamol as excipient and trometamol salts of other medicines. Alkaline solutions or medicines will negatively affect the stability of oxaliplatin.

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

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

Instructions for use with 5-fluorouracil

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

Refer to the detailed information on concomitant administration of medicines provided in the corresponding Summary of Product Characteristics.

USE ONLY the recommended solvents (see below).
Only clear solutions free from suspended particles should be used.

Preparation of the infusion solution

Withdraw the required volume of concentrate from the vials and then dilute it with 250–500 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 in which the physico-chemical stability of oxaliplatin has been demonstrated is 0.2–2.0 mg/ml.

Administer by intravenous infusion.

After dilution in 5% glucose solution (50 mg/ml), the physical and chemical stability during use is 48 hours at a temperature between 2°C and 8°C and 24 hours at 25°C.

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

If not used immediately, the storage time and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2–8°C, unless dilution has been performed under controlled and validated aseptic conditions.

Visually inspect the vial before use. Only clear solutions free from suspended particles should be used.

This medicine is for single use only. Any unused infusion solution must be discarded (see Disposal section).

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

Compatibility of the oxaliplatin infusion solution has been confirmed with administration sets containing PVC components.

Infusion of the solution

Administration of oxaliplatin does not require prehydration.

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

Disposal

Any unused medicine residue and all materials that have come into contact with it during dilution and administration must be disposed of in accordance with local regulations for cytotoxic agents and in compliance with local legal requirements for disposal of hazardous waste.