Irinotecan Qilu 20 mg/ml concentrate for infusion solution EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Irinotecan Qilu 20 mg/ml concentrate for solution for infusion EFG
irinotecan hydrochloride trihydrate
Read this entire leaflet carefully before you start using this medicine, as 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.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, including possible side effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Irinotecan Qilu is and what it is used for
- What you need to know before being given Irinotecan Qilu
- How Irinotecan Qilu is given to you
- Possible side effects
- How to store Irinotecan Qilu
- Contents of the pack and other information
1. What Irinotecan Qilu is and what it is used for
It is an anticancer medicine whose active substance is irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.
It is used in the treatment of advanced or metastatic colon or rectal cancer in adults, in combination with other medicines (for example, 5-fluorouracil/folinic acid, bevacizumab, cetuximab, capecitabine).
Irinotecan may be used as monotherapy in patients with metastatic colon or rectal cancer whose disease has recurred or worsened after initial treatment with fluorouracil.
2. What you need to know before using Irinotecan Qilu
Do not use Irinotecan Qilu:
- if you are allergic to irinotecan hydrochloride trihydrate or to any of the other ingredients of this medicine (listed in section 6, "Contents of Irinotecan Qilu").
- if you have chronic inflammatory bowel disease and/or intestinal obstruction.
- if you are a breastfeeding woman (see section 2).
- if your bilirubin level is more than 3 times the upper limit of normal.
- if you have very low blood cell counts (severe bone marrow failure).
- if you are in poor general health (performance status greater than 2 according to WHO).
- if you are taking or have recently taken St. John’s wort (a herbal extract containing Hypericum).
- if you are receiving or have recently received live attenuated vaccines (vaccines against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following discontinuation of chemotherapy.
If irinotecan is administered to you in combination with other medicines, make sure to also read the package leaflet of each of these medicines, especially regarding additional contraindications.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting treatment with irinotecan. In elderly patients, closer monitoring is required.
Use special caution with Irinotecan Qilu. The use of irinotecan should be restricted to specialized units experienced in the administration of cytotoxic chemotherapy, and must only be administered under the supervision of a physician experienced in the use of antineoplastic chemotherapy.
If you have Gilbert’s syndrome, a hereditary condition causing elevated bilirubin levels and jaundice (yellowing of the skin and eyes).
Diarrhea
Irinotecan may cause diarrhea, which can be severe in some cases. It may begin a few hours or a few days after the infusion. Without treatment, it could lead to dehydration and serious electrolyte imbalances that may be life-threatening. Your doctor will prescribe a medication to help you prevent or manage this side effect. Make sure to obtain the medication immediately so it is available at home when needed.
- Take the medication as prescribed at the first sign of loose or more frequent stools.
- Drink large amounts of water and/or electrolyte-containing fluids (soda, sports drinks, or soup).
- Contact your doctor or nurse if diarrhea persists, especially if it lasts longer than 24 hours, or if you feel dizzy, lightheaded, or faint.
Nausea and vomiting
You may experience nausea or vomiting on the day of treatment or during the first few days after administration. Your doctor may give you medication before treatment to prevent nausea and vomiting. You may also be prescribed anti-nausea medication to take at home. Keep these medications on hand for when you need them. Contact your doctor if you are unable to keep fluids down due to nausea and vomiting.
Neutropenia (reduction in white blood cell count)
Irinotecan may reduce the number of certain types of white blood cells, particularly neutrophils, which play a key role in fighting infections. This is called neutropenia. Neutropenia is commonly observed during treatment with irinotecan and is usually reversible.
Inform your doctor or nurse immediately if you develop signs of infection such as fever (38°C or higher), chills, painful urination, a new cold, or production of phlegm. Avoid close contact with people who are ill or have infections. Report any signs of infection to your doctor immediately.
Inform your doctor immediately if you develop signs of infection.
Blood count monitoring
Your doctor will likely perform blood tests before and during treatment to monitor the effects of the medicine on blood cell counts and blood chemistry. Depending on the results, you may require additional medications to manage side effects. Your doctor may also need to reduce or delay your next dose, or even discontinue treatment. Do not miss any scheduled appointments or laboratory tests.
This medicine may reduce platelet counts in the weeks following administration, increasing the risk of bleeding. Talk to your doctor before taking any medication or supplement that may affect blood clotting, such as aspirin or aspirin-containing products, warfarin, or vitamin E. Inform your doctor immediately if you develop unusual bruising or bleeding, such as nosebleeds, bleeding gums when brushing teeth, or black, tarry stools.
Acute cholinergic syndrome
This medicine may affect the part of the nervous system that controls secretions, leading to what is known as acute cholinergic syndrome. Symptoms include runny nose, increased saliva, excessive tearing, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you experience any of these symptoms, as medications are available to help manage them.
Lung disorders
Patients receiving this medicine rarely develop serious lung problems. Inform your doctor immediately if you develop new or worsening cough, difficulty breathing, or fever. Your doctor may need to interrupt treatment to manage this condition.
This medicine may increase the risk of blood clots in the veins of the legs or lungs, which may travel to other parts of the body such as the lungs or brain. Inform your doctor immediately if you experience chest pain, shortness of breath, swelling, pain, redness, or warmth in one arm or leg.
Chronic intestinal inflammation and intestinal blockage
Contact your doctor if you have stomach pain and are unable to pass stool, especially if accompanied by bloating or loss of appetite.
Radiation treatment
If you have recently received pelvic or abdominal radiation therapy, you may have an increased risk of developing bone marrow suppression. Discuss this with your doctor before receiving Irinotecan Qilu.
Kidney problems
Kidney dysfunction has been reported.
Heart disorders
Inform your doctor if you have or have had heart disease or if you have previously received anticancer medicines. Your doctor will monitor you closely and discuss ways to reduce risk factors (e.g., smoking, high blood pressure, high lipid levels).
Vascular disorders
Irinotecan is rarely associated with blood flow disorders (blood clots in the vessels of the arms and legs), particularly in patients with multiple risk factors.
Other
This medicine may cause mouth or lip sores, often within the first few weeks after treatment. This may cause mouth pain and bleeding, and may make eating difficult. Your doctor or nurse may suggest ways to reduce discomfort, such as modifying your diet or oral hygiene routine. If needed, your doctor may prescribe pain medication.
For information on contraception and breastfeeding, refer to the information provided in the section "Contraception, pregnancy, breastfeeding, and fertility."
Inform your doctor or dentist that you are receiving this medicine if you are scheduled for surgery or a medical procedure.
If you are receiving irinotecan in combination with other anticancer medicines, make sure to also read the package leaflets of each of these medicines.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Other medicines and Irinotecan Qilu
Irinotecan may interact with a number of medicines and supplements, which could increase or decrease the level of the drug in the blood. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:
- carbamazepine, phenobarbital, phenytoin, or fosphenytoin (used to treat seizures and epilepsy)
- ketoconazole, itraconazole, voriconazole, and posaconazole (used to treat fungal infections)
- clarithromycin, erythromycin, and telithromycin (used to treat bacterial infections)
- rifampicin and rifabutin (used to treat tuberculosis)
- atazanavir, indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, and others (used to treat HIV infection)
- St. John’s wort (a herbal remedy)
- vitamin K antagonists (e.g., warfarin, used to reduce blood clot formation)
- live attenuated vaccines
- cyclosporine and tacrolimus (used to suppress the immune system, e.g., after organ transplantation to prevent rejection)
- regorafenib, crizotinib, idelalisib, and apalutamide (used to treat cancer)
- suxamethonium (used to relax muscles during general anesthesia and surgery)
- 5-fluorouracil/folinic acid
- bevacizumab (a blood vessel growth inhibitor)
- cetuximab (an EGFR inhibitor)
Talk to your doctor, pharmacist, or nurse before receiving irinotecan if you are currently undergoing or have recently undergone chemotherapy (and radiotherapy).
Do not start or stop any medication while receiving irinotecan without first consulting your doctor.
This medicine may cause severe diarrhea. Avoid taking laxatives or stool softeners while receiving this medicine.
There may be other medicines that interact with irinotecan. Consult your doctor, pharmacist, or nurse about all other medicines, herbs, and supplements, and whether alcohol could cause problems with this medicine.
Contraception, pregnancy, breastfeeding, and fertility
Contraception
Women of childbearing potential must use effective contraceptive methods during treatment and for 6 months after the end of treatment.
Men must use effective contraceptive methods during treatment and for 3 months after the end of treatment. It is important to discuss with your doctor the types of contraception suitable for use with this medicine.
Pregnancy
This medicine may harm the unborn baby if taken at the time of conception or during pregnancy. Before starting treatment, your doctor will confirm that you are not pregnant.
If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before receiving this medicine.
Breastfeeding
Irinotecan and its metabolites are excreted in breast milk. You must stop breastfeeding during treatment with this medicine.
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility
No studies have been conducted; however, this medicine may affect fertility. Discuss with your doctor before taking this medicine about potential risks and possible effects on your reproductive capacity.
Driving and using machines
During the first 24 hours after administration of irinotecan, you may feel dizzy or experience visual disturbances. If you experience these effects, avoid driving or operating machinery.
Irinotecan Qilu contains sorbitol
This medicine contains sugar (sorbitol). Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot metabolize fructose, which may lead to serious adverse effects.
Before receiving this medicine, inform your doctor if you (or your child) have HFI or if your child cannot consume sweet foods or drinks because they cause discomfort, vomiting, or unpleasant symptoms such as bloating, stomach cramps, or diarrhea.
This medicine contains 45 mg of sorbitol per mL, equivalent to 90 mg/2 mL, 225 mg/5 mL, 675 mg/15 mL, and 1,125 mg/25 mL.
Irinotecan Qilu contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, which is essentially "sodium-free".
3. How to use Irinotecan Qilu
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again.
Irinotecan will be administered to you by a doctor or nurse.
Your doctor may recommend a DNA test before you receive your first dose of irinotecan.
Some people are genetically more likely to experience certain adverse effects from the medicine.
The amount of irinotecan you receive depends on many factors, including your weight and height, your general health or other health problems, and the type of cancer or condition being treated. It will also depend on other treatments you may have received for your cancer. Your doctor will determine the dose and treatment schedule.
Irinotecan is injected into a vein intravenously (IV). You will receive the infusion at a clinic or hospital. It must be administered slowly, and the IV infusion may take up to 90 minutes to complete.
You may be given other medications to prevent nausea, vomiting, diarrhea, and other adverse effects during the irinotecan injection. You may need to continue taking these medications for at least one day after the irinotecan infusion.
Inform your caregivers if you feel burning, pain, or swelling around the needle during the irinotecan injection. The medicine can damage tissues if it leaks out of the vein. If you feel pain or notice redness or swelling at the administration site while receiving irinotecan, notify a healthcare professional immediately.
Several treatment schedules are currently recommended for irinotecan. Generally, it is administered every three weeks (irinotecan given alone) or once every two weeks (irinotecan given in combination with 5-fluorouracil/leucovorin chemotherapy). The dose will depend on a number of factors, including the treatment schedule, your body size, age, general health, blood counts, liver function, whether you have received radiation to the abdomen or pelvis, and whether you have any adverse effects such as diarrhea.
Your doctor may adjust these dosage schedules based on your condition and any adverse effects you may experience.
Only your doctor can assess the duration of treatment.
If you use more Irinotecan Qilu than you should
Irinotecan will be administered by a doctor or nurse familiar with this type of treatment, so the likelihood of receiving an overdose is very small.
If you missed a dose of Irinotecan
Call your doctor to find out what to do if you miss an appointment for an irinotecan injection.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Your doctor will inform you about these adverse effects and explain the risks and benefits of the treatment.
Some of these adverse effects must be treated immediately (see also section Warnings and precautions).
Seek urgent medical assistance if you experience any of the following signs of an allergic reaction: hives,
- Allergic reactions: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.
- Diarrhea (see section 2)
- Early diarrhea: within 24 hours after administration of the medicine, accompanied by symptoms such as runny nose, increased salivation, watery eyes, sweating, flushing, and abdominal cramps. (This may occur while the medicine is being administered. If so, inform the healthcare professional immediately. There are medicines available that can help stop or relieve this early adverse effect.)
- Late diarrhea: occurring more than 24 hours after receiving the medicine. Because of the risk of dehydration and electrolyte imbalance caused by diarrhea, it is important to stay in contact with healthcare professionals for monitoring and advice regarding possible medication and dietary changes.
Talk to your doctor or nurse if you experience any of the following symptoms:
Symptoms | Frequency* of occurrence in monotherapy | Frequency† of occurrence in combination therapy |
Abnormally low white blood cell count which may increase the risk of infection | Very common | Very common |
Abnormally low red blood cell count causing fatigue and shortness of breath | Very common | Very common |
Decreased appetite | Very common | Very common |
Cholinergic syndrome (see Special warnings with Irinotecan Qilu) | Very common | Very common |
Vomiting | Very common | Very common |
Nausea | Very common | Very common |
Abdominal pain | Very common | Common |
Loss of hair (reversible) | Very common | Very common |
Inflammation of mucous membranes | Very common | Very common |
Fever | Very common | Common |
Feeling of weakness and lack of energy | Very common | Very common |
Low platelet count (blood cells that help blood clotting), which may cause bruising or bleeding | Common | Very common |
Abnormal liver function values | Common | Very common |
Infection | Common | Common |
Low white blood cell count with fever | Common | Common |
Difficulty in defecation | Common | Common |
Abnormal renal function values | Common | No data |
- Very common: may affect more than 1 in 10 patients
† Common: may affect up to 1 in 10 people
Frequency not known: cannot be estimated from the available data
- Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever) caused by a bacterium called (Clostridium difficile)
- Blood infection
- Dehydration (due to diarrhoea and vomiting)
- Dizziness, rapid heartbeat, pale skin (a condition called hypovolemia)
- Allergic reaction
- Transient speech disturbances during or shortly after receiving the treatment
- Tingling sensations
- Increase in blood pressure during and after administration
- Heart problems*
- Lung disease presenting as difficulty breathing, dry cough or shortness of breath
- Hiccups
- Partial or complete intestinal obstruction (intestinal obstruction, ileus)
- Dilated colon
- Intestinal bleeding
- Inflammation of the large intestine
- Abnormal laboratory test results
- Perforation of the intestine
- Fatty liver disease
- Skin reactions
- Reactions at the site of drug administration
- Decreased blood concentrations of potassium and sodium, mostly related to diarrhoea and vomiting
- Muscle cramps or contractions and numbness (paraesthesia)
- Kidney problems (renal failure)*
- Low blood pressure*
- Fungal infections
- Viral infections
Uncommon cases of these events have been observed in patients who had experienced episodes of dehydration due to diarrhoea and/or vomiting or blood infection.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor, pharmacist or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Irinotecan Qilu
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "EXP". The expiry date is the last day of the month indicated.
Store below 25°C.
Keep in the original packaging to protect from light. Do not refrigerate or freeze.
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 Irinotecan Qilu
- The active substance is irinotecan hydrochloride trihydrate. Each millilitre of concentrate contains 20 mg of irinotecan hydrochloride trihydrate, equivalent to 17.33 mg of irinotecan.
Each 2 ml vial contains 40 mg of irinotecan hydrochloride trihydrate.
Each 5 ml vial contains 100 mg of irinotecan hydrochloride trihydrate.
Each 15 ml vial contains 300 mg of irinotecan hydrochloride trihydrate.
Each 25 ml vial contains 500 mg of irinotecan hydrochloride trihydrate.
- The other components are sorbitol (E-420), lactic acid, sodium hydroxide, hydrochloric acid and water for injections.
Appearance of the product and contents of the pack
Irinotecan concentrate for solution for infusion is a pale yellow, aqueous, clear solution.
Irinotecan 40 mg/2 ml, 100 mg/5 ml, 300 mg/15 ml and 500 mg/25 ml is available in single vials of brown glass packed in cartons.
Pack sizes:
1 vial of 2 ml
1 vial of 5 ml
1 vial of 15 ml
1 vial of 25 ml
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
QILU PHARMA SPAIN S.L.,
Paseo de la Castellana 40, Planta 8,
Madrid, 28046,
Spain
Manufacturer
KYMOS, S.L.
Ronda de Can Fatjó,
7B (Parc Tecnològic del Vallès),
Cerdanyola del Vallès, 08290
Barcelona, Spain
Local representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 – 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) | Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion |
Spain | Irinotecan Qilu 20 mg/ml concentrate for solution for infusion EFG |
Date of the most recent review of this leaflet: February 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
This information is intended solely for healthcare professionals:
Irinotecan Qilu 20 mg/ml concentrate for solution for infusion EFG
irinotecan hydrochloride trihydrate
Instructions for use. – Cytotoxic.
Handling of irinotecan
As with all antineoplastic agents, extreme caution should be exercised when handling irinotecan. Dilution must be performed by appropriately trained personnel under aseptic conditions and in an area designated for this purpose. Extreme care must be taken to avoid contact with skin and mucous membranes.
Protective instructions for the preparation of Irinotecan Qilu concentrate for solution for infusion EFG:
- A safety cabinet and protective gloves should be used, along with wearing a protective gown. If a safety cabinet is not available, a face mask and protective goggles must be worn.
- Empty containers, as well as injectable vials and infusion bottles, cannulae, syringes, catheters, used tubing, and waste from the cytostatic medicine must be treated as hazardous waste, and their disposal must comply with local guidelines for handling HAZARDOUS WASTE.
- In the event of a spill, follow the instructions below:
- Wear protective clothing.
- Broken glassware should be collected and placed in the HAZARDOUS WASTE container.
- Contaminated surfaces should be thoroughly rinsed with copious amounts of cold water.
- Subsequently, rinsed surfaces should be thoroughly cleaned, and all materials used in cleaning must be discarded as HAZARDOUS WASTE.
- If irinotecan comes into contact with the skin, rinse the affected area with large amounts of water and then wash with water and soap. If contact occurs with mucous membranes, rinse the exposed area with abundant water. If any discomfort occurs, contact a physician.
- If irinotecan comes into contact with the eyes, rinse thoroughly with abundant water and contact an ophthalmologist immediately.
Preparation of the infusion solution
Irinotecan concentrate for solution for infusion is intended for intravenous infusion only after prior dilution in the recommended diluents: 0.9% sodium chloride infusion solution or 5% glucose infusion solution. Withdraw the required amount of irinotecan concentrate from the vial using a calibrated syringe under aseptic conditions and inject it into a 250 ml infusion bag or bottle. Mix the infusion solution thoroughly by gently rotating the bag or bottle by hand.
If any precipitate is observed in the vials or after reconstitution, the product must be discarded following standard cytostatic waste disposal procedures.
Irinotecan must be administered as an intravenous bolus or intravenous infusion with a duration of no less than 30 minutes and no more than 90 minutes.
Disposal
All materials used in the preparation, administration, or that have otherwise come into contact with irinotecan must be disposed of in accordance with local regulations for handling cytotoxic compounds.