IRINOTECAN 20 mg /Ml Концентрат Для Кожного Раствора

Содержание инструкции

1. Irinotecan Accord 20 mg/ml concentrate for infusion solution
   1. What is Irinotecan Accord and what it is used for
   2. What you need to know before you are given Irinotecan Accord
   3. How Irinotecan Accord will be administered to you
   4. Possible side effects
   5. How to store Irinotecan Accord
   6. Package contents and other information

Irinotecan Accord 20 mg/ml concentrate for infusion solution

Equivalent medicine
The name of this medicine is “Irinotecan Accord 20 mg/ml concentrate for solution
Read this leaflet carefully before using this medicine.

• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be dangerous.
• If any undesirable effects occur, including any not listed in this leaflet, tell your doctor.

Contents of this leaflet:

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

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

Irinotecan Accord belongs to a group of medicines called cytostatic agents (anti-cancer drugs).
Irinotecan Accord can be used alone or in combination with a number of other drugs used
for the treatment of advanced colon and rectal cancer in adults.
The doctor may use a combination of Irinotecan Accord with 5-fluorouracil/folinic acid
(5FU/FA)and bevacizumabto treat colorectal cancer (colon or rectum).
The doctor may use a combination of Irinotecan Accord with capecitabine, with or without

bevacizumab,to treat colon and rectal cancer.
The doctor may use a combination of Irinotecan Accord with cetuximabfor the treatment of
a particular type of colorectal cancer (KRAS wildtype)that expresses a protein
called EGFR.

2. What you need to know before you are given Irinotecan Accord

Irinotecan Accord will not be given to you if

• you are allergic to irinotecan or any of the other ingredients of this medicine(listed in section 6)
• you have or have previously had chronic inflammatory bowel disease or an intestinal obstruction
• you are breastfeeding
• you have severe liver disease
• you have severe bone marrow failure
• you are in poor general health (according to international standards)
• you are taking a herbal remedy St John's Wort (hypericum perforatum)

Warnings and precautions
Particular care is also required in elderly patients.
Because Irinotecan Accord is an anticancer drug, it will be given to you in a special department and
under the supervision of a doctor qualified in the use of anticancer drugs. The staff in the
department will explain what you need to do to take special measures during and after treatment.
This leaflet will help you to remember.
Before treatment with Irinotecan Accord, tell your doctor if any of the following applies to you:
You have liver problems or jaundice
You have kidney problems
You have asthma
You have ever received radiotherapy
You have had severe diarrhoea or fever after receiving Irinotecan Accord
treatment previously
You have heart problems
You smoke, have high blood pressure or high cholesterol, because these can increase the
risk of heart problems during treatment with Irinotecan Accord
You have received or are to receive any vaccination
You are taking any other medicine. See the paragraph below “Other medicines and irinotecan”.

• 1) The first 24 hours after the administration of Irinotecan AccordDuring the administration of Irinotecan Accord (30–90 minutes) and immediately after the administration you may experience some of the following symptoms:
• Diarrhoea
• Watering eyes
• Sweating
• Vision disturbance
• Abdominal pain
• Excessive salivation

The medical term for these symptoms is acute cholinergic syndrome, which can be treated (with
atropine). If you have any of these symptoms, tell your doctor immediately who will
administer the necessary treatment.

• 2) From the day after treatment with Irinotecan Accord until the next treatment.During this period you may experience various symptoms, which may be serious and require immediate treatment and careful supervision.

Diarrhoea
If diarrhoea starts more than 24 hours after the administration of Irinotecan Accord (“delayed diarrhoea”)
it may be serious. It is often observed about 5 days after administration. Diarrhoea
must be treated immediately and kept under close control. Immediately after the first liquid bowel movement proceed as follows:

• 1. Take any antidiarrheal treatment that your doctor has prescribed, exactly as directed by your doctor. The treatment must not be changed without consulting your doctor. The recommended antidiarrheal treatment is loperamide (4 mg for the first dose and then 2 mg every 2 hours, even at night). This treatment should be continued for at least 12 hours

before the first liquid bowel movement. The recommended dose of loperamide should not be
taken for more than 48 hours.

• 2. Immediately drink large amounts of water and rehydrating fluids (e.g. water, sparkling water, fizzy drinks, broth or oral rehydration therapy).
• 3. Immediately inform the doctor responsible for monitoring your treatment of the onset of diarrhoea. If you cannot reach the doctor, contact the hospital department responsible for Irinotecan Accord treatment. It is very important that they are aware of the onset of diarrhoea.

You must immediately inform your doctor or the department responsible for treatment if

• you have nausea, vomiting or fever, in addition to diarrhoea
• you still have diarrhoea 48 hours after starting antidiarrheal treatment

Note:do not take antidiarrheal treatments other than those prescribed by your doctor and the fluids
described above. Follow your doctor's instructions. Antidiarrheal treatment should not be used
to prevent further episodes of diarrhoea, even if you have had delayed diarrhoea in previous cycles.

Fever
If your body temperature rises above 38°C, it may indicate an infection,
especially if you have diarrhoea. If you have a fever (above 38°C) contact your doctor or the
department immediately so they can give you any necessary treatment.

Nausea and vomiting
If you have nausea and/or vomiting contact your doctor or the department immediately.

Neutropenia
Irinotecan Accord can cause a reduction in the number of some white blood cells, which play an
important role in fighting infections. This reduction is called neutropenia, it is often observed during treatment with Irinotecan Accord and is reversible. Your doctor will need to
arrange for you to have regular blood tests to check your white blood cells. Neutropenia is serious, must be treated immediately and monitored carefully.

Breathing difficulties
If you have any difficulty breathing contact your doctor immediately.

Impaired liver function
Before you start treatment with Irinotecan Accord and before each subsequent treatment cycle,
your liver function must be checked (with blood tests).

Other medicines and irinotecan
Tell your doctor if you are taking or have recently taken any other medicines, including
those available without a prescription, including herbal medicines, vitamin and
mineral supplements.
If you receive Irinotecan Accord in combination with capecitabine, cetuximab or bevacizumab, make sure
Some medicines can change the effects of Irinotecan Accord, e.g. ketoconazole (for the
treatment of fungal infections), rifampicin (for the treatment of tuberculosis), warfarin
(an anticoagulant used to thin the blood), atazanavir (used to treat the human immunodeficiency virus, HIV), cyclosporine or tacrolimus (used to suppress the body's immune system) and some medicines for the treatment of epilepsy (carbamazepine,
phenobarbital and phenytoin).
The herbal remedy St John's Wort (Hypericum Perforatum) must not be used
simultaneously with Irinotecan Accord or between treatment cycles, because it can reduce the effect of
Irinotecan Accord.
If you are to undergo surgery, tell your doctor or anaesthetist that you are being treated
with irinotecan, as it may change the effect of some medicines used during surgery.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Irinotecan Accord must not be used during pregnancy. Irinotecan Accord can cause
birth defects.
Women of childbearing potential must avoid pregnancy. Contraceptive measures must be taken
by both male and female patients during and for at least three months (men) and one month (women) after the end of therapy. If you become pregnant during this period, you should inform
your doctor immediately.
Breastfeeding must be stopped for the entire duration of therapy with Irinotecan Accord.
Ask your doctor for advice before taking any medicine.

Driving and operating machinery
In some cases Irinotecan Accord can cause side effects that affect your ability to
drive and operate tools and machinery. If in doubt, contact your doctor.
During the first 24 hours after the administration of Irinotecan Accord, you may experience dizziness or
vision disturbances. In this case, do not drive and do not operate tools or machinery.

Important information about some of the excipients of Irinotecan Accord
Irinotecan Accord contains sorbitol. If you are affected by intolerance to certain sugars, tell your
doctor before you are given this medicine.
This medicine contains less than 1 mmol of sodium per dose, i.e. it is essentially “sodium-free”.

3. How Irinotecan Accord will be administered to you

Irinotecan Accord will be administered as an intravenous infusion over a period of 30-90
minutes.
The amount of the infusion that you receive will depend on your age, size and general
medical condition. It will also depend on any other therapy you may have received for cancer.
The doctor will calculate your body surface area in square meters (m²).

• If you have previously been treated with 5-fluorouracil, you will normally be treated with Irinotecan Accord alone, starting from a dose of 350 mg/m² every 3 weeks.
• If you have not received previous chemotherapy, you will normally receive 180 mg/m² of Irinotecan Accord every two weeks. This will be followed by folinic acid and 5-fluorouracil.
• If you are treated with irinotecan in combination with cetuximab, you will normally receive the same dose of irinotecan administered in the last cycles of the previous regimen containing irinotecan. Irinotecan Accord should not be administered less than 1 hour after the end of the cetuximab infusion.

These doses may be adjusted by your doctor, depending on your condition and any
undesirable effects you may experience.

If you receive more Irinotecan Accord than you should
It is unlikely that you will receive an excessive amount of Irinotecan Accord. However, if
this occurs, you may experience severe blood disorders and diarrhea. Maximum supportive care should be applied to prevent dehydration caused by diarrhea and to treat
any infectious complications. Consult the doctor administering the medication.

If you forget to take Irinotecan Accord
It is very important that you receive all scheduled doses. If you do not receive a dose, contact
your doctor immediately.

4. Possible side effects

Like all medicines, Irinotecan Accord can cause side effects, although not everybody gets them.
Your doctor will discuss side effects with you and explain the risks and benefits of treatment.
Some of these side effects need to be treated immediately.
See also the information in the “ Warnings and precautions”section.
If you experience any of the listed side effects after you have been given the medicine, tell your doctor immediately. If you are not in hospital, you MUST go to hospital immediately.

• Allergic reactions. If you have shortness of breath, difficulty breathing, rash or itching (affecting the whole body) contact your doctor or pharmacist immediately.
• Severe allergic reactions (anaphylactic/anaphylactoid reactions) can occur more frequently in the minutes following injection of the product: rash, including red, itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing or breathing) and you may feel symptoms of fainting.

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

• Blood disorders: neutropenia (decreased number of some white blood cells), thrombocytopenia (decreased number of platelets in the blood), anemia
• Delayed diarrhea
• Nausea and vomiting
• Hair loss (hair grows back after the end of treatment)
• In combination therapy, transiently increased levels of some enzymes (ALT, AST, alkaline phosphatase) or bilirubin in the serum

Common (may affect up to 1 in 10 people)

• Acute cholinergic syndrome: the main symptoms are early diarrhea and other symptoms such as abdominal pain, red, sore, itchy and watery eyes (conjunctivitis); runny nose (rhinitis); low blood pressure; widening of blood vessels; sweating, chills; a feeling of discomfort and general malaise, dizziness; visual disturbances, constricted pupils; watery eyes and increased salivation, which occur during or within the first 24 hours after the infusion of Irinotecan Accord
• Fever, infections (including sepsis)
• Fever associated with a severe decrease in the number of white blood cells
• Dehydration, commonly associated with diarrhea and/or vomiting
• Constipation
• Fatigue
• Increased levels of liver enzymes and creatinine in the blood

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions. If you have shortness of breath, difficulty breathing, rash or itching (affecting the whole body) contact your doctor or nurse immediately.
• Mild skin reactions; mild reactions at the infusion administration site
• Difficulty breathing
• Lung disease (interstitial lung disease)
• Bowel obstruction
• Pain and inflammation of the abdomen, causing diarrhea (a condition called pseudomembranous colitis)
• Infrequent cases of renal failure, low blood pressure or circulatory failure have been observed in patients who have had episodes of dehydration associated with diarrhea and/or vomiting or sepsis.

Rare (may affect up to 1 in 1000 people)

• Severe allergic reactions (anaphylactic/anaphylactoid reactions) can occur more frequently in the minutes following injection of the product: rash, including red, itchy skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing or breathing) and you may feel symptoms of fainting. In this case, tell your doctor immediately.
• Early effects such as muscle contraction or cramps and numbness (paresthesia).
• Gastrointestinal bleeding and inflammation of the colon, including the appendix.
• Intestinal perforation, anorexia, abdominal pain, inflammation of the mucous membranes.
• Inflammation of the pancreas.
• Increased blood pressure during and after administration.
• Decreased levels of potassium and sodium in the blood, mostly in relation to diarrhea and vomiting.

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

• Transient speech disorders
• Increased levels of some digestive enzymes that break down sugars and fats.

Not known (frequency cannot be estimated from the available data)

• Inflammation of the liver with concomitant accumulation of fat in the liver.

If you receive Irinotecan Accord in combination with cetuximab, some of the side effects you may experience may also be related to this combination. These side effects may include acne-like rash. Therefore, be sure to also read the leaflet for cetuximab.
If you receive Irinotecan Accord in combination with capecitabine, some of the side effects you may experience may also be related to this combination. These side effects may include: very common blood clots, common allergic reactions, heart attack and fever in patients with low white blood cell count. Therefore, be sure to also read the leaflet for capecitabine.
If you receive Irinotecan Accord in combination with capecitabineand bevacizumab, some of the side effects you may experience may also be related to this combination. These side effects include: low white blood cell count, blood clots, high blood pressure bevacizumab.
If any of these side effects get worse, or if you notice any side effect

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/conte nt/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 Accord

Keep this medicine out of the sight and reach of children.
Do not freeze.
For single use only.
This medicine does not require any particular storage temperature conditions.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the carton and vial
after Exp. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irinotecan Accord contains:

• The active ingredient is irinotecan hydrochloride trihydrate.
• 1 ml of concentrate contains 20 mg of irinotecan hydrochloride trihydrate equivalent to 17.33 mg of irinotecan.
• One vial of 2 ml contains 40 mg of irinotecan hydrochloride trihydrate
• One vial of 5 ml contains 100 mg of irinotecan hydrochloride trihydrate
• One vial of 15 ml contains 300 mg of irinotecan hydrochloride trihydrate
• One vial of 25 ml contains 500 mg of irinotecan hydrochloride trihydrate
• The other excipients are sorbitol (E420), lactic acid, sodium hydroxide, hydrochloric acid and water for injections.

Description of the appearance of Irinotecan Accord and package contents:
Irinotecan Accord 20 mg/ml Concentrate for solution for infusion is a transparent solution of
pale yellow colour.
Packages:
2 ml
5 ml
15 ml
25 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow
Middlesex HA1 4HF
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

Irinotecan Accord 20 mg/ml concentrate for solution for infusion
The following information is intended for healthcare professionals only:
Instructions for use - CYTOTOXIC
Handling of Irinotecan Accord
As with other antineoplastic agents, Irinotecan Accord must be handled with care.
Dilution must be carried out under aseptic conditions by adequately trained personnel in a dedicated area. Take appropriate precautions to avoid contact with skin and
mucous membranes.
Protection instructions for preparing irinotecan solution for infusion

• 1. The use of a safety cabinet is necessary and protective gloves and clothing must be worn. If a safety cabinet is not available, eye protection and a mask must be used.
• 2. Open containers, such as injection vials, infusion bottles, used cannulae, syringes, catheters, tubing and cytotoxic waste must be considered hazardous waste and disposed of in accordance with local regulations for the handling of HAZARDOUS WASTE.
• 3. Follow the following instructions in case of spillage:
• wear protective clothing
• collect broken glass and place it in the HAZARDOUS WASTE container
• thoroughly wash contaminated surfaces with cold water
• thoroughly dry the washed surfaces and dispose of the used materials as HAZARDOUS WASTE
• 4. In case of contact of Irinotecan Accord with the skin, rinse the area with running water and then wash with water and soap. In case of contact with the mucous membranes, wash the affected area thoroughly with water. If you feel unwell, contact a doctor.
• 5. If irinotecan comes into contact with the eyes, rinse them copiously with water. Contact an ophthalmologist immediately.

Preparation of the solution for infusion
Irinotecan concentrate for solution for infusion is intended for administration by intravenous
infusion only after dilution with the recommended diluents, a 0.9% sodium chloride solution or a 5% glucose solution. Aseptically
draw up the required amount of irinotecan concentrate for solution from the vial with a graduated syringe
and inject it into a 250 ml bag or bottle for infusion. The infusion must then be
thoroughly mixed by manual rotation.
The product must be diluted and used immediately after opening.
Irinotecan Accord solution is physically and chemically stable with infusion solutions (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) for up to
28 days if stored in LDPE or PVC containers at a temperature of 5°C or
25°C and protected from light. When the solution is exposed to light, a physical and chemical stability of up to a maximum of 3 days is indicated.
From a microbiological point of view, the diluted solution must be used immediately. If not
used immediately, the storage times in use and conditions before use are
the responsibility of the user and normally should not exceed 24 hours at 2°C-8°C, unless
the reconstitution/dilution has been carried out under controlled and validated aseptic conditions.
If precipitate is observed in the vials or after reconstitution, the medicine must be discarded
in accordance with standard procedures for cytotoxic agents.
Irinotecan Accord must not be administered as a bolus or as an intravenous infusion with
a duration of less than 30 minutes or more than 90 minutes.

Disposal:
All materials used for preparation, administration or that have come into contact
with Irinotecan Accord must be disposed of in accordance with local regulations on
the handling of cytotoxic drugs.