Irinotecan Sun 1.5 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irinotecan SUN 1.5 mg/ml solution for infusion

Irinotecan hydrochloride trihydrate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Irinotecan SUN is and what it is used for

Irinotecan SUN is an anticancer medicine that contains as its active substance irinotecan hydrochloride trihydrate.

Irinotecan hydrochloride trihydrate interferes with the growth and spread of cancer cells in the body.

Irinotecan is indicated in combination with other medicines for the treatment of patients with advanced or metastatic colorectal cancer.

Irinotecan may be used as monotherapy in patients with metastatic colorectal cancer whose disease has recurred or progressed after initial treatment with fluorouracil.

2. What you need to know before using Irinotecan SUN

Tell your doctor and DO NOT use Irinotecan SUN in any of the following cases

• if you have chronic inflammatory bowel disease and/or intestinal obstruction
• if you are allergic to irinotecan hydrochloride trihydrate or to any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding (see section 2)
• if you have elevated levels of bilirubin in the blood (more than 3 times the upper limit of normal)
• if you have severe bone marrow failure
• if your general health condition prevents you from carrying out daily activities normally (WHO performance status greater than 2)
• if you are taking or have recently taken St. John’s wort (a herbal extract containing Hypericum).
• if you are due to receive or have recently received live attenuated vaccines (vaccines against yellow fever, varicella, herpes zoster, measles, mumps, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following discontinuation of chemotherapy.

If you receive irinotecan in combination with other medicines, make sure to also read the package leaflet of the other medicines regarding additional contraindications.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with irinotecan.

• if you have Gilbert’s syndrome, a hereditary condition that may cause high bilirubin levels and jaundice (yellowing of the skin and eyes).

As irinotecan is an anticancer medicine, it will be administered in a specialized unit and under the supervision of a doctor experienced in the use of such medicines. The staff will explain the special care you need during and after treatment. This leaflet may help you remember.

Children

This medicine is intended for adults only. Consult your doctor if this medicine has been prescribed for a child.

Elderly patients

Special caution is required in elderly patients.

Diarrhea

Irinotecan may cause diarrhea, which in some cases can be severe. This may begin a few hours or a couple of days after the infusion. If not treated, it may lead to dehydration and serious chemical imbalances, which may be fatal. Your doctor will prescribe a medicine to help prevent or control this side effect. Make sure to obtain the medicine immediately so you have it at home when needed.

• take the medicine as prescribed by your doctor at the first sign of loose or frequent stools
• drink plenty of water and/or electrolyte-containing fluids (mineral water, soda, or soup)
• contact your doctor or nurse if you still have diarrhea, especially if it lasts more than 24 hours, or if you feel confused, dizzy, or faint.

Neutropenia (reduction in certain white blood cells)

This medicine may reduce white blood cell counts, mainly in the weeks following administration. This may increase the risk of infection. Inform your doctor or nurse immediately if you have any signs of infection, such as fever (38°C or higher), chills, painful urination, new cough, or sputum. Avoid close contact with people who are ill or have infections. Inform your doctor immediately if you develop signs of infection.

Blood monitoring

Your doctor will likely perform blood tests before and during treatment to monitor the medicine’s effects on blood counts or blood chemistry. Depending on test results, you may need additional medicines to manage side effects. Your doctor may also reduce or delay your next dose, or even discontinue treatment completely. Keep all scheduled appointments for medical visits and 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 medicine or supplement that may affect your body’s ability to stop bleeding, such as acetylsalicylic acid or medicines containing acetylsalicylic acid, 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.

Nausea and vomiting

You may experience nausea and vomiting on the day of treatment or in the first few days afterward. Your doctor may give you anti-nausea medicines before treatment. You will likely be prescribed anti-nausea medicines for use at home. Keep these medicines available for when needed. Contact your doctor if you are unable to take fluids orally due to nausea and vomiting.

Acute cholinergic syndrome

This medicine may affect the part of your nervous system that controls bodily secretions, leading to a condition called acute cholinergic syndrome. Symptoms may include runny nose, increased salivation, excessive tearing, sweating, flushing, abdominal cramps, and diarrhea. Inform your doctor or nurse immediately if you experience any of these symptoms, as medicines are available to help control them.

Lung disorders

Rarely, people taking this medicine may develop serious lung problems. Inform your doctor immediately if you develop cough or worsening cough, difficulty breathing, or fever. Your doctor may need to stop treatment to manage this issue. This medicine may increase the risk of serious 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, difficulty breathing, or swelling, pain, redness, or warmth in one arm or leg.

Chronic intestinal inflammation and/or intestinal obstruction

Contact your doctor if you have abdominal pain and constipation, especially if accompanied by bloating and loss of appetite.

Radiation therapy

If you have recently received pelvic or abdominal radiation therapy, you may have an increased risk of bone marrow suppression. Discuss with your doctor before starting irinotecan treatment.

Kidney function

Cases of kidney dysfunction have been reported.

Heart disorders

Inform your doctor if you have or have had heart disease or if you previously received cancer medicines. Your doctor will monitor you closely and discuss ways to reduce risk factors (e.g., smoking, high blood pressure, high fat levels).

Vascular disorders

Irinotecan is rarely associated with circulatory disorders (blood clots in the vessels of the legs and lungs), which may rarely occur in patients with multiple risk factors.

Other

This medicine may cause mouth or lip sores, often in the first weeks after starting treatment. This may lead to mouth pain, bleeding, or difficulty eating. Your doctor or nurse may suggest ways to reduce this, such as changing how you eat or brush your teeth. If needed, your doctor may prescribe pain medicines.

For information on contraception, pregnancy, breastfeeding, and fertility, see the information provided below in the section Contraception, pregnancy, breastfeeding, and fertility.

Inform your doctor or dentist that you are being treated with this medicine if you are planning surgery or any medical procedure.

If used in combination with other anticancer medicines for your condition, make sure to also read the package leaflet of the other medicines.

Use of Irinotecan SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Irinotecan SUN may interact with several medicines and supplements, which may increase or decrease the level of the medicine in your blood.

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any of the following:

• medicines used to treat epilepsy (carbamazepine, phenobarbital, phenytoin, and fosphenytoin)
• medicines used to treat fungal infections (ketoconazole, itraconazole, voriconazole, and posaconazole)
• medicines used to treat bacterial infections (clarithromycin, erythromycin, and telithromycin)
• medicines used to treat tuberculosis (rifampicin and rifabutin)
• St. John’s wort (a herbal dietary supplement)
• live attenuated vaccines
• medicines used to treat HIV (indinavir, ritonavir, amprenavir, fosamprenavir, nelfinavir, atazanavir, and others)
• medicines used to suppress your immune system to prevent transplant rejection (cyclosporine and tacrolimus)
• medicines used to treat cancer (regorafenib, crizotinib, idelalisib, and apalutamide)
• vitamin K antagonists (an anticoagulant used to thin the blood, such as warfarin)
• medicines used to relax muscles during general anesthesia and surgery (suxamethonium)
• 5-Fluorouracil/folinic acid
• bevacizumab (a blood vessel growth inhibitor)
• cetuximab (an epidermal growth factor receptor inhibitor)

Inform your doctor, pharmacist, or nurse before receiving Irinotecan SUN if you are already receiving or have recently received chemotherapy (and radiotherapy).

While being treated with irinotecan, do not start or stop taking any medicine without first consulting your doctor.

This medicine may cause severe diarrhea. Try to avoid using laxatives and stool softeners while using this medicine.

There may be other medicines that interact with irinotecan.

Consult your doctor, pharmacist, or nurse about the use of other medicines, herbal products, and supplements, and whether alcohol could cause problems with this medicine.

Contraception, pregnancy, breastfeeding, and fertility

Contraception

If you are a woman of childbearing potential, you must use an effective method of contraception during treatment and for 6 months after stopping treatment.

If you are a male, you must use an effective method of contraception during treatment and for 3 months after stopping treatment. It is important to consult your doctor about which types of contraceptives can be used with this medicine.

Pregnancy

This medicine may cause problems in the fetus if used at the time of conception or during pregnancy. Before starting treatment, your doctor will ensure that you are not pregnant. Men and women using this medicine must use reliable contraceptive methods during treatment. It is important to consult your doctor about which types of contraceptives can be used with this medicine. In pregnant women, treatment with this medicine should only be used if the potential benefit to the mother outweighs the risk to the fetus.

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

Breastfeeding

Irinotecan and its metabolite were measured in breast milk. Breastfeeding should be discontinued during treatment with this medication.

If you are breastfeeding, consult your doctor or pharmacist before using this medicine.

Fertility

No studies have been conducted; however, this medication may affect fertility. Speak with your doctor about the potential risk associated with this medication and the options that may preserve your ability to have children.

Driving and use of machines

In some cases, irinotecan may cause adverse effects that could impair the ability to drive or operate tools and machinery. Contact your doctor or pharmacist if you are unsure.

During the first 24 hours after administration of irinotecan, you may experience dizziness or vision disturbances. If this occurs, do not drive or operate machinery until symptoms resolve.

Irinotecan SUN contains sorbitol

This medicinal product contains sugar (sorbitol).

This medicinal product contains 607.50 mg of sorbitol in each 180 ml infusion bag, equivalent to 3.375 mg/ml.

This medicinal product contains 675.00 mg of sorbitol in each 200 ml infusion bag, equivalent to 3.375 mg/ml.

This medicinal product contains 742.50 mg of sorbitol in each 220 ml infusion bag, equivalent to 3.375 mg/ml.

This medicinal product contains 810.00 mg of sorbitol in each 240 ml infusion bag, equivalent to 3.375 mg/ml. Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be administered. Patients with HFI are unable to metabolize fructose, which may lead to serious adverse effects. Consult your doctor before receiving this medicine if you (or your child) have HFI or cannot consume sweet foods or drinks because they cause dizziness, vomiting, or symptoms such as bloating, stomach cramps, or diarrhea.

Irinotecan SUN contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially "sodium-free".

Irinotecan SUN contains glucose

This medicinal product contains glucose. Patients with diabetes mellitus should be aware that this medicinal product contains 8.325 g of glucose per 180 ml infusion bag; 9.250 g of glucose per 200 ml infusion bag; 10.175 g of glucose per 220 ml infusion bag; and 11.100 g of glucose per 240 ml infusion bag.

If your doctor has advised you of intolerance to certain sugars, consult him or her before taking this medicine.

3. How to use Irinotecan SUN

If you are prescribed irinotecan, it will only be administered by doctors or nurses experienced in chemotherapy administration.

Method of administration

Irinotecan is administered as an intravenous infusion (drip) over a period of 30 to 90 minutes.

You may be given other medications to prevent nausea, vomiting, diarrhea, and other side effects while receiving irinotecan. You may need to continue taking these medications for at least one day after your irinotecan infusion.

Inform your healthcare providers if you experience burning, pain, or swelling around the needle site during irinotecan administration. If the medication leaks from the vein, it may cause tissue damage. If you feel pain or notice redness or swelling at the infusion site while receiving irinotecan, inform your healthcare professional immediately.

Dosage of irinotecan

The dose will depend on several factors, including the treatment regimen, your body size, age, and general health, your blood counts, liver function, whether you have received prior radiation to the abdomen or pelvis, and whether you are experiencing any side effects such as diarrhea. Your doctor will calculate your body surface area in square meters (m²).

• If you have previously been treated with 5-fluorouracil, you will normally be given irinotecan alone, starting at a dose of 350 mg/m² every three weeks.
  • If you have not previously received chemotherapy, you will normally be given 180 mg/m² of irinotecan every two weeks, followed by leucovorin and 5-fluorouracil.

If you are receiving irinotecan in combination with cetuximab, irinotecan must not be administered until at least 1 hour has passed after the end of the cetuximab infusion.

Only your doctor can determine the duration of treatment.

The number of infusions you will receive depends on your response to treatment. Your doctor will explain this to you.

If you receive more Irinotecan SUN than you should

Seek urgent medical attention if you think you have received too much irinotecan. Overdose worsens adverse effects such as diarrhea or neutropenia (a decrease in the number of white blood cells in the blood). If this occurs, you will receive treatment to prevent dehydration. Your white blood cell count will be monitored and any infection treated appropriately.

If you forget to use Irinotecan SUN

Consult your doctor for instructions if you miss an appointment for your irinotecan infusion.

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 may cause adverse effects, although not everyone will experience them. Your doctor will discuss these adverse effects with you and explain the risks and benefits of your treatment.

Some adverse effects could be serious. Contact your doctor immediately if you experience any of the following serious adverse effects (see section 2).

Seek urgent medical attention if you have any of these symptoms of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

• Diarrhea (see section 2).
• Early diarrhea: begins within 24 hours after receiving this medicine, and is accompanied by symptoms such as runny nose, increased salivation, watery eyes, sweating, flushing, abdominal cramps (this may occur while the medicine is being administered. In this case, notify the healthcare professional immediately. Medicines can be given to stop and/or reduce this early adverse effect).
• Late diarrhea: begins more than 24 hours after receiving this medicine. Because of the risks of dehydration and electrolyte imbalance associated with diarrhea, it is important to stay in contact with healthcare professionals for monitoring and to receive recommendations regarding medications and dietary changes.

Tell your doctor or nurse if you experience any of the following symptoms.

• Very common: may affect more than 1 in 10 people.

† Common: may affect up to 1 in 10 people.

Frequency not known (cannot be estimated from available data)

• severe, persistent, 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, and paleness (a condition called hypovolemia)

• allergic reaction

• temporary speech disorders during or shortly after treatment

• tingling

• high blood pressure (during or after infusion)

• heart problems*

• lung disease causing wheezing and difficulty breathing (see section 2)

• hiccups

• intestinal obstruction

• colon enlargement

• intestinal bleeding

• inflammation of the large intestine

• abnormal laboratory test results

• intestinal perforation

• fatty liver

• skin reactions

• reactions at the site where the medicine is administered

• low potassium levels in the blood

• low blood salt levels, mainly related to diarrhoea and vomiting

• muscle cramps

• kidney problems*

• low blood pressure*

• fungal infections

• viral infections.

• These events have been observed infrequently in patients who experienced episodes of dehydration associated with diarrhoea and/or vomiting, or blood infections.

If you are receiving Irinotecan SUN in combination with cetuximab, some of the possible adverse effects may be related to this combination. These adverse effects may include acne-like skin rashes. Therefore, make sure to also read the cetuximab package leaflet.

If you are receiving Irinotecan SUN in combination with capecitabine, some of the possible adverse effects may be related to this combination. These adverse effects may include very common blood clots, frequent allergic reactions, heart attack, and fever in patients with low white blood cell counts. Therefore, make sure to also read the capecitabine package leaflet.

If you are receiving Irinotecan SUN in combination with capecitabine and bevacizumab, some of the possible adverse effects may be related to this combination. These adverse effects may include low white blood cell count, blood clots, high blood pressure, and heart attack. Therefore, make sure to also read the package leaflets of capecitabine and bevacizumab.

Reporting of adverse reactions

If you experience any adverse reaction, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse reaction 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of Irinotecan SUN

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the infusion bag and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Keep in the original packaging to protect from light.

Once opened, the infusion bag should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Irinotecan SUN

• The active substance is irinotecan (as hydrochloride, trihydrate).
• The other components are: glucose (E620), sorbitol (E420), (S-)lactic acid (E270), sodium hydroxide (for pH adjustment) (E524), hydrochloric acid, concentrated (for pH adjustment) (E507), and water.

An 180 ml perfusion bag contains 270 mg of irinotecan hydrochloride trihydrate (equivalent to 234 mg of irinotecan).

A 200 ml perfusion bag contains 300 mg of irinotecan hydrochloride trihydrate (equivalent to 260 mg of irinotecan).

A 220 ml perfusion bag contains 330 mg of irinotecan hydrochloride trihydrate (equivalent to 286 mg of irinotecan).

A 240 ml perfusion bag contains 360 mg of irinotecan hydrochloride trihydrate (equivalent to 312 mg of irinotecan).

One ml of the infusion solution contains 1.5 mg of irinotecan hydrochloride trihydrate (equivalent to 1.3 mg/ml of irinotecan).

Appearance of the product and contents of the container

Irinotecan SUN infusion solution is a sterile, clear, pale yellow to yellow solution, free from visible particles.

Irinotecan SUN infusion solution is available in packaging containing 1, 5, or 10 single-dose perfusion bags of 180 ml, 200 ml, 220 ml, or 240 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

or

Terapia S.A.

124 Fabricii Street

400632, Cluj-Napoca

Romania

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

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

Germany: Irinotecan SUN
Denmark: Irinotecan SUN
Spain: Irinotecán SUN
Finland: Irinotecan SUN
France: Irinotecan SUN
Italy: Irinotecan SUN
Romania: Irinotecan SUN
Sweden: Irinotecan SUN
United Kingdom (Northern Ireland): Irinotecan

Date of the most recent review of this summary: May 2024

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

This information is intended for healthcare professionals only:

Handling

• Calculate the dose and determine which size of Irinotecan SUN perfusion bag is required.
• Inspect the product packaging for any defects. Do not use if there are signs of tampering.
• Apply the patient-specific label to the packaging.

Extraction of the perfusion bag from the packaging and inspection of the bag

• Tear the wrapper at the notch. Do not use the medicinal product if the wrapper is open or damaged.
• Remove the perfusion bag from the packaging.
• Use only if the perfusion bag and seal are intact. Before administration, check for small leaks by firmly squeezing the bag. If leaks are detected, discard the bag and solution, as sterility may be compromised.
• Parenteral medicinal products should be visually inspected for particulate matter or discoloration prior to administration. Do not administer if particles or discoloration are observed.

Administration

• Break the seal of the closure by applying pressure to one side with the hand.
• Connect the sterile administration set using aseptic technique.
• Refer to the instructions for use provided with the administration set.

Precautions

• Do not use in-line mixing.
• Do not add any additives to the perfusion bag.
• The infusion solution is ready for use and must not be mixed with other medicinal products.
• Irinotecan SUN infusion solution is for single use only.

Appropriate handling materials, such as long-sleeved gowns, protective masks, caps, safety goggles, single-use sterile gloves, protective covers for the work area, and waste collection bags, must be provided to personnel.

Pregnant women must not handle cytotoxic preparations.

If the product comes into contact with the eyes, it may cause severe irritation. In such cases, immediately rinse the eyes thoroughly with abundant water. Consult a physician if irritation persists. If the solution contacts the skin, rinse the affected area thoroughly with abundant water. Vomitus and excreta should be handled with caution.

Disposal

Disposal of unused medicinal product and materials that have come into contact with it must be carried out in accordance with local regulations regarding cytotoxic medicinal products.