IRINOTECAN 20 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. Irinotecan Mylan Generics
   1. What is Irinotecan Mylan Generics and what is it used for
   2. What you need to know before you are given Irinotecan Mylan Generics
   3. How Irinotecan Mylan Generics will be administered to you
   4. Possible side effects
   5. How to store Irinotecan Mylan Generics
   6. Contents of the pack and other information

Irinotecan Mylan Generics

20 mg/ml concentrate for solution for infusion
Irinotecan hydrochloride trihydrate
Generic medicine

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is Irinotecan Mylan Generics and what it is used for
• 2. What you need to know before you are given Irinotecan Mylan Generics
• 3. How you will be given Irinotecan Mylan Generics
• 4. Possible side effects
• 5. How to store Irinotecan Mylan Generics
• 6. Contents of the pack and other information

1. What is Irinotecan Mylan Generics and what is it used for

IRINOTECAN is an antineoplastic medicine containing the active substance irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and spread of tumor cells in the body.
IRINOTECAN is indicated in combination with other medicines for the treatment of patients with
advanced or metastatic colon or rectal carcinoma.
IRINOTECAN can be used as monotherapy in patients with metastatic colon or
rectal carcinoma whose disease has recurred or progressed following initial therapy based on fluorouracil.

2. What you need to know before you are given Irinotecan Mylan Generics

You must not be given Irinotecan Mylan Generics

• if you suffer from a chronic inflammatory bowel disease and/or intestinal obstruction
• if you are allergic to irinotecan hydrochloride trihydrate or to any of the other components of this medicine (listed in section 6 “What Irinotecan Mylan Generics contains”) if you are breastfeeding (see section 2)
• if your bilirubin level is more than 3 times the upper limit of the normal range
• if you suffer from severe bone marrow failure
• if your general health condition is moderate (determined according to the WHO scale greater than 2)
• if you are taking or have recently taken the natural remedy St. John's Wort (a herbal product containing hypericum).
• if you are to be given or have recently been given live attenuated vaccines (vaccines against yellow fever, chickenpox, herpes zoster, mumps, measles, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following the interruption of chemotherapy.

If you are given IRINOTECAN in combination with other medicines, please also read

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using IRINOTECAN.
Take special care with IRINOTECAN. The use of IRINOTECAN should be limited to units
specialized in the administration of cytotoxic chemotherapy and should only be administered under the
supervision of a doctor qualified for the use of antitumor chemotherapy.
Diarrhea
IRINOTECAN can cause diarrhea, which in some cases can be severe. It may start a few hours or a couple
of days after the infusion of the drug. If left untreated, it could lead to dehydration and severe chemical
imbalances, which can be life-threatening. The doctor will prescribe a medicine to help
prevent or control this side effect. Make sure you have the medicine available immediately, so you can take it when you need it.

• Take the medicine as prescribed at the first sign of slow or frequent bowel movements.
• Drink plenty of water and/or saline beverages (sparkling water, fizzy drinks or soup).
• Tell your doctor or nurse if you still have diarrhea, especially if it lasts more than 24 hours, or if you experience dizziness, lightheadedness or fainting.

Neutropenia (decrease in a certain type of white blood cells)
This medicine can reduce the count of white blood cells, mainly in the weeks following
administration of the medicine. This can increase the risk of contracting an infection. Make sure you
immediately inform your doctor or nurse if you notice any signs of infection, such as fever (38
°C or higher), chills, pain during urination, new onset cough or expectoration. Avoid staying
near sick people or those with infections. Immediately inform your doctor if you develop signs of
infection.
Blood monitoring
The doctor will probably perform a blood test before and during treatment, to check the
effects of the drug on the blood count or blood composition. Based on the results of the test,
you may need to take medicines to treat the effects. The doctor may also need to reduce or delay the next dose of this medicine, or even stop it completely. Do not
cancel your appointments for medical visits and laboratory tests.
This medicine can reduce the platelet count in the weeks following administration, with
consequent increase of the risk of bleeding. Talk to your doctor before taking any
medicine or supplement that could affect your body's ability to stop bleeding, such as aspirin or medicines containing aspirin, warfarin or vitamin E. Immediately inform your
doctor if you notice unusual bruising or bleeding such as nosebleeds, bleeding gums when brushing your
teeth or black and tarry stools.
Nausea and vomiting
You may experience nausea and vomiting on the day of administration of this medicine or in the first few
days afterwards. The doctor may prescribe you medicines before treatment to prevent nausea and
vomiting. The doctor will probably prescribe anti-nausea medicines that you can take home. Keep these
medicines handy when you need them. Call your doctor if you are unable to take
liquids orally due to nausea and vomiting.
Acute cholinergic syndrome
This medicine can affect part of the nervous system that controls body secretions,
causing a condition known as cholinergic syndrome. Symptoms may include runny nose,
excessive salivation, excessive tearing, sweating, flushing, abdominal cramps and diarrhea.
Immediately inform your doctor or nurse if you notice any of these symptoms, as there are
medicines that can help control them.
Pulmonary disorders
Rarely, people taking this medicine have serious lung problems. Immediately inform
your doctor if you notice a new onset or worsening cough, breathing problems and fever. The doctor may interrupt treatment to manage this problem.
This medicine can increase the risk of developing significant blood clots in the veins of the
legs or lungs, which can move to other parts of the body such as the lungs or brain. Immediately inform
your doctor if you notice chest pain, shortness of breath or swelling, pain, redness or
warmth in an arm or leg.
Chronic inflammatory bowel disease and/or intestinal blockage
Consult your doctor if you notice abdominal pain and constipation, especially if you also experience bloating and
loss of appetite.
Radiation therapy
If you have recently received radiation therapy to the pelvis or abdomen, you may be
increased risk of developing bone marrow suppression. Talk to your doctor before starting
IRINOTECAN.
Kidney function
Renal dysfunction has been reported.
Heart disorders
Inform your doctor if you suffer/have suffered from heart disease or if you have previously received antitumor drugs. The doctor will monitor you carefully and discuss with you how to reduce the risk factors (e.g. smoking, hypertension and high fat content).
Vascular disorders
IRINOTECAN is rarely associated with disorders of blood flow (blood clots in the vessels of legs
and lungs) and may rarely occur in patients with multiple risk factors.
Other
This medicine can cause ulcers in the mouth or on the lips, often in the first few weeks after starting
treatment. This can cause mouth pain, bleeding or even difficulty eating. The
doctor or nurse may suggest ways to reduce this problem, such as changing the
way you eat or how you brush your teeth. If necessary, the doctor may prescribe medicines to relieve the
pain.
Inform your doctor or dentist that you are taking this medicine if you are planning surgery
or any other type of operation.
If used in combination with other antitumor medicines to treat your condition, make sure you have
also read the package leaflets of the other medicines.
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking
this medicine.

Children and adolescents
Not applicable

Other medicines and Irinotecan Mylan Generics
IRINOTECAN can interact with a number of medicines and supplements that can increase or decrease
the level of the medicine in the blood. Tell your doctor or pharmacist if you are using, have recently
used or may use any of the following medicines:

• 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 the body's immune system to prevent transplant rejection (cyclosporine and tacrolimus)
• Medicines used to treat cancer (regorafenib, crizotinib and idelalisib)
• Vitamin K antagonists (common anticoagulants such as warfarin)
• Medicines used to relax the muscles used during surgery under general anesthesia (suxamethonium)
• 5-fluorouracil/folinic acid
• Bevacizumab (a growth inhibitor of blood vessels)
• Cetuximab (an EGF receptor inhibitor)

Do not start or stop taking any medicine while you are on therapy with IRINOTECAN without
first consulting your doctor.
This drug can cause severe diarrhea. Try to avoid laxatives and emollients while taking
this medicine.
There are also other drugs that have shown interactions with IRINOTECAN. Check with your
doctor, pharmacist or nurse about other medicines, herbal remedies and supplements you are taking and whether alcohol
can cause problems with this medicine.

Pregnancy, breastfeeding and fertility

Women of childbearing potential / Contraception in males and females
Women of childbearing potential and men must use an effective method of contraception during
treatment and respectively up to one month and three months after the end of treatment.
Pregnancy
This medicine can cause problems with the fetus if taken at the time of conception or during
pregnancy. Men and women taking this medicine must use a reliable method of birth control during treatment. It is important to check with your doctor which types of birth control methods 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
risks to the fetus.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Studies have not been conducted, however, this medicine may pass into breast milk and have effects on
the child. Breastfeeding should be discontinued throughout the duration of treatment with this
medicine.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
Studies have not been conducted, however, this medicine may affect fertility. Talk to your
doctor about the possible risk with this medicine and the options for improving the chances of having
children in the future.

Driving and operating machinery
You may experience dizziness and/or visual disturbances within approximately 24 hours of taking this medicine. Do not
drive or operate machinery if you experience any adverse effects.

Irinotecan Mylan Generics contains sorbitol and sodium.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with hereditary fructose intolerance, a rare genetic disease, you (or the child) should not take this medicine. Patients with hereditary fructose intolerance are unable to metabolize fructose, the accumulation of which can cause serious side effects.
Before taking this medicine, tell your doctor if you (or your child) suffer from hereditary
fructose intolerance or if the child feels unwell, vomits or has unpleasant reactions such as bloating and
stomach cramps or diarrhea when taking sweet foods or drinks.
This medicinal product contains less than 1 mmol (23 mg) of sodium per vial, i.e.
essentially sodium-free.

3. How Irinotecan Mylan Generics will be administered to you

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
IRINOTECAN will be administered by healthcare professionals.
Your doctor may request a DNA test before administering the first dose of IRINOTECAN.
Some people are genetically more predisposed to develop certain side effects of the medicine.
The amount of IRINOTECAN to be infused depends on many factors, including height and weight, general
medical conditions or other health problems, and the type of cancer or condition to be treated. The doctor
will determine the dose and schedule.
IRINOTECAN is injected into a vein intravenously (IV). This injection will be performed in a clinic
or in a hospital. IRINOTECAN must be administered slowly and the intravenous infusion may
take up to 90 minutes.
You may receive other medications to prevent nausea, vomiting, diarrhea and other side effects while you are
taking IRINOTECAN. You may need to continue using these medicines for
at least one day after the IRINOTECAN injection.
Inform healthcare professionals if you experience pain, burning or swelling around the injection needle when IRINOTECAN
is injected. If the medicine leaks out of the vein it can cause tissue damage. If you experience pain or notice
redness or swelling at the injection site during the IRINOTECAN infusion, notify
your doctor immediately.
Currently, several treatment regimens are recommended for IRINOTECAN. It is usually
administered once every 3 weeks (IRINOTECAN as monotherapy) or once every 2 weeks
(IRINOTECAN administered in combination with the chemotherapeutic agent 5FU//FA). The dose will depend on
a number of factors, including the treatment schedule, body size, age and general health,
blood count, good liver function, whether you have had radiation therapy to the abdomen/pelvis and whether
you experience side effects such as diarrhea.
Only your doctor can assess the duration of treatment.

If you use more IRINOTECAN than you should
Seek emergency medical assistance. Symptoms of overdose may include some of the

If you forget to use IRINOTECAN
Ask your doctor for instructions if you miss a IRINOTECAN administration session.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious. You should contact your doctor immediately if you
experience any of the following serious side effects (see section 2).
Seek emergency medical assistance if you experience any of these signs of an allergic reaction: hives;
difficulty breathing; swelling of the face, lips, tongue, or throat.
Diarrhea (see section 2)

• early diarrhea: occurs within 24 hours of administering the medicine, accompanied by symptoms such as runny nose, increased salivation, tearing, sweating, flushing, abdominal cramps. (These may occur while the medicine is being administered, in which case, promptly inform the healthcare staff. Medicines may be administered to stop and/or reduce these early side effects)
• delayed diarrhea: occurs more than 24 hours after administering the medicine. Following problems due to dehydration and electrolyte imbalances caused by diarrhea, it is important to consult healthcare professionals for monitoring and advice on medications and dietary changes.

Talk to 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
Not known: frequency cannot be estimated based on available data

• Severe, persistent, or bloody diarrhea that may be associated with stomach pain or fever associated with the bacterium Clostridium difficile
• Blood infection
• Fungal infections
• Viral infections
• Dehydration (due to diarrhea and vomiting)
• Dizziness, rapid heartbeat, and pale skin (a condition called hypovolemia)
• Allergic reaction
• Transient speech disorders during or immediately after treatment
• Tingling
• High blood pressure (during or after infusion)
• Heart problems*
• Lung disease causing wheezing and shortness of breath (see section 2)
• Hiccups
• Bowel obstruction
• Enlarged colon
• Intestinal bleeding
• Inflammation of the large intestine
• Abnormal laboratory test results
• Perforation of the intestine
• Fatty liver
• Skin reactions
• Reactions at the infusion site
• Low potassium levels in the blood
• Low salt levels in the blood mainly related to diarrhea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*

* Infrequent cases of these events have been observed in patients who have experienced episodes of
dehydration associated with diarrhea and/or vomiting or blood infections.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the website http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Irinotecan Mylan Generics

Store at a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date which is reported on the package or vial after
EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer packaging to protect the medicine from light.
After dilution in 0.9% sodium chloride solution (9 mg/ml) or 5% glucose solution (50
mg/ml), chemical and physical in-use stability has been demonstrated for 24 hours from 2 °C to 8 °C and at 25°C, protected
from light.
From a microbiological point of view, unless the opening/dilution method precludes the risk of
microbial contamination, the product must be used immediately. If not used
immediately, the storage times and conditions in-use are under the responsibility
of the user.
Do not use the medicine if you notice precipitate in the vials or after dilution, the product must be
disposed of according to standard procedures for cytotoxic agents.
Do not dispose of any medicine in the wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Irinotecan Mylan Generics contains

• The active ingredient is irinotecan hydrochloride trihydrate. Each 2 ml vial contains 40 mg of irinotecan hydrochloride trihydrate equivalent to 34.66 mg of irinotecan. Each 5 ml vial contains 100 mg of irinotecan hydrochloride trihydrate equivalent to 86.65 mg of irinotecan. Each 15 ml vial contains 300 mg of irinotecan hydrochloride trihydrate equivalent to 259.95 mg of irinotecan. Each 25 ml vial contains 500 mg of irinotecan hydrochloride trihydrate equivalent to 433.25 mg of irinotecan.

1 ml of concentrate for solution for infusion contains 20 mg of irinotecan hydrochloride trihydrate
equivalent to 17.33 mg of irinotecan.
The other ingredients are: sorbitol E420, lactic acid, sodium hydroxide (for pH adjustment) and water for
injections.

Description of the appearance of Irinotecan Mylan Genericsand contents of the pack
This medicine is presented as a concentrate for solution for infusion. It is a clear
solution.
Vials (Type I amber glass) of 2 ml, 5 ml, 15 ml, or 25 ml solution with a rubber
chlorobutylated stopper and a cap (flip-off type). Packs of 1, 5, 10 and 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan SpA
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer and batch release
GP Pharm
Pol. Ind. Els Vinyets-Els Fogars, Sector 2 Carretera Comarcal C-244, Km. 22-08777 Sant Quinti de
Mediona
(Barcelona) Spain
Mylan S.A.S
117 Allée des Parcs
69800 Saint-Priest
France
Vianex S.A,
Plant C, 16th Km. Marathonos Ave.,
15351 Pallini Attiki, Athens,
Greece
Mylan Spa
Viale dell’Innovazione 3
20126 Milan, Italy

This leaflet was last updated on
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The following information is intended exclusively for medical or healthcare professionals:
Instructions for use / handling, guidance for preparation and disposal for use with Irinotecan
Mylan Generics concentrate for solution for infusion
USE/HANDLING
As with other antineoplastic drugs, Irinotecan Mylan Generics must be prepared and handled with
caution. The use of goggles, mask and gloves is necessary.
If Irinotecan solution or the solution prepared for infusion comes into contact with the
skin, wash IMMEDIATELY and thoroughly with water and soap. If Irinotecan solution or
the solution prepared for infusion comes into contact with mucous membranes, wash
IMMEDIATELY with water.
Preparation of the intravenous solution.
As with all injectable drugs, irinotecan solution must be prepared under aseptic conditions.
If a precipitate is observed in the vials or after dilution, the product must be
disposed of following standard procedures for cytotoxic drugs.

Do not use Irinotecan Mylan Genericsif you notice any visible signs of deterioration.
Under aseptic conditions, withdraw the required amount of Irinotecan solution from the vial
using a graduated syringe and inject it into a 250 ml bag or vial containing
0.9% sodium chloride solution or 5% glucose solution. The infusion must then be
thoroughly mixed by manual rotation.
After dilution in 0.9% sodium chloride solution (9 mg /ml) or 5% glucose solution (50
mg/ml), chemical and physical stability in-use has been demonstrated for 24 hours at 2 ° C to 8 ° C and at 25 ° C, protected from light.
From a microbiological point of view, unless the opening/dilution method precludes the risk of
microbial contamination, the product must be used immediately. If not used
immediately, the storage times and conditions in-use are the responsibility
of the user.
Irinotecan Mylan Generics must be infused into a central or peripheral vein.
Irinotecan Mylan Generics must not be administered as an intravenous bolus or as an intravenous
infusion for a period of less than 30 minutes or more than 90 minutes.
Disposal
All materials used for dilution and administration must be disposed of according to
standard hospital procedures for cytotoxic drugs.