CAMPTO <20 mg/ml Concentrate for infusion solution

Зміст інструкції

1. CAMPTO 20 mg/mL, concentrate for solution for infusion
   1. WHAT CAMPTO IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING CAMPTO
   3. HOW TO USE CAMPTO
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CAMPTO
   6. Package Contents and Other Information

CAMPTO 20 mg/mL, concentrate for solution for infusion

irinotecan hydrochloride trihydrate

Read this leaflet carefully before you start 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, pharmacist or nurse.
• If you get any side effects, see section 4. If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

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

1. WHAT CAMPTO IS AND WHAT IT IS USED FOR

CAMPTO 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.
CAMPTO is indicated in combination with other medicines for the treatment of patients with advanced or metastatic carcinoma of the colon or rectum.
CAMPTO can be used alone in patients with metastatic carcinoma of the colon or rectum whose
disease has recurred or progressed after initial therapy based on fluorouracil.

2. WHAT YOU NEED TO KNOW BEFORE USING CAMPTO

Do not use CAMPTO:

• if you have a chronic inflammatory bowel disease and/or an intestinal obstruction
• if you are allergic to irinotecan hydrochloride trihydrate or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”)
• if you are breastfeeding (see section 2)
• if the bilirubin level is 3 times higher than the upper limit of the normal range
• if you have severe bone marrow failure
• if you have poor general condition (“WHO performance status” greater than 2)
• if you are taking or have recently taken St. John's Wort (a herbal remedy containing hypericum)
• if you have been or are about to receive live attenuated vaccines (vaccines against yellow fever, chickenpox, shingles, mumps, measles, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following the interruption of chemotherapy.

If you receive CAMPTO in combination with other medicines, make sure you also read the leaflet of the other medicines regarding further contraindications.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using CAMPTO

• If you have Gilbert's syndrome, a hereditary condition that can cause high levels of bilirubin and jaundice (yellowing of the skin and eyes)

Take special care with CAMPTO. The use of CAMPTO should be restricted to units
specialized in the administration of cytotoxic chemotherapy and should only be administered under
the supervision of a doctor qualified in the use of antineoplastic chemotherapy.

Diarrhea
CAMPTO can cause diarrhea, which in some cases can be severe. It may occur a few hours or a
couple of days after the infusion of the medicine. If left untreated, it could cause dehydration and serious
chemical imbalances, which can be life-threatening. Your doctor will prescribe you medicines to
help prevent or control this side effect. Make sure you take the medicine immediately,
so you have it at home when you need it.

• Take the medicine as prescribed at the first sign of frequent bowel movements or the first bowel movement of loose stools.
• Drink plenty of water and/or salty drinks (sparkling 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 dizzy, lightheaded or faint.

Neutropenia (decrease in some white blood cells)
This medicine can reduce the number of white blood cells, especially 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 experience signs of infection, such as fever (38 °C
or higher), chills, pain when urinating, new cough or increased sputum. Avoid being near people
who are sick or have infections. Immediately inform your doctor if you develop signs of
infection.

Blood monitoring
Your doctor will likely perform a blood test before and during treatment to monitor
the effects of the medicine on your blood count or blood chemistry. Based on the test results,
medicines may be needed to treat the effects. Your doctor may also need to reduce or delay the next dose of this medicine, or even stop it altogether.
Keep all appointments for medical visits and laboratory tests.
This medicine can reduce the platelet count in the weeks following administration, which can
increase the risk of bleeding. Consult 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 experience unusual bruising or bleeding such as nosebleeds, bleeding gums when brushing your
teeth or black, tarry stools.

Nausea and vomiting
You may experience nausea and vomiting on the day you receive this medicine or in the first few
days afterwards. Your doctor may give you a medicine before treatment to help prevent nausea and
vomiting. Your doctor will probably prescribe anti-nausea medicines that you can take at home. Keep
these medicines handy when you need them. Contact your doctor if you are unable to
take liquids by mouth due to nausea and vomiting.

Acute cholinergic syndrome
This medicine can affect a part of the nervous system that controls the body's secretions,
leading to what is known as cholinergic syndrome. Symptoms may include runny nose,
increased salivation, excessive tearing, sweating, hot flashes, 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.

Respiratory diseases
Rarely, those taking this medicine have serious lung problems. Immediately inform
your doctor if you develop a cough or if an existing cough worsens, and if you have difficulty
breathing and fever. Your doctor may need to stop treatment to manage this problem.
This medicine can increase the risk of serious 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 experience chest pain, shortness of breath, or swelling, pain,
redness or warmth in an arm or leg.

Chronic intestinal inflammation and/or intestinal obstruction
Inform your doctor if you experience abdominal pain and are unable to defecate, especially if you also have bloating
and loss of appetite.

Radiation therapy
If you have recently received radiation therapy to the pelvis or abdomen, you may have a
higher risk of developing bone marrow suppression. Before starting to take CAMPTO,
inform your doctor.

Kidney function
Cases of kidney dysfunction have been reported.

Heart diseases
Inform your doctor if you suffer from/have suffered from heart diseases or if you have previously received antineoplastic medicines. The doctor will monitor you carefully and analyze with you how to reduce the risk factors
(e.g. smoking, high blood pressure and high fat content).

Vascular diseases
CAMPTO is rarely associated with disturbances of blood flow (blood clots in the blood vessels
of the legs and lungs) which can occur rarely in patients with multiple risk factors.

Others
This medicine can cause sores in the mouth or on the lips, often in the first weeks after starting
treatment. This can cause pain in the mouth, bleeding or even difficulty eating
foods. Your doctor or nurse can suggest ways to reduce this consequence, such as changing
the way you eat or brush your teeth. If necessary, your doctor may prescribe medicines to relieve
the pain.

For information on contraception and breastfeeding, refer to the instructions provided
below in the section Contraception, pregnancy, breastfeeding and fertility.
Inform your doctor or dentist that you are taking this medicine if you are thinking of undergoing
surgery or any procedure.
If used in combination with other antineoplastic medicines for your condition, make sure you also read
the leaflets of those medicines.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

Other medicines and CAMPTO
CAMPTO can interact with several medicines and supplements, which can increase or decrease
the level of the medicine in the blood. Inform your doctor or pharmacist if you are using, have recently used
or may use any of the following medicines:

• Medicines used to treat seizures (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, idelalisib and apalutamide)
• Vitamin K antagonists (common anticoagulants such as warfarin)
• Medicines used to relax the muscles used during general anesthesia and surgical procedures (suxamethonium)
• 5-fluorouracil/folinic acid
• Bevacizumab (a growth inhibitor of blood vessels)
• Cetuximab (an EGF receptor inhibitor)

Inform your doctor, pharmacist or nurse before using CAMPTO if you are receiving or have
recently received chemotherapy (and radiotherapy).
Do not start or stop taking any medicine while taking CAMPTO without first
talking to your doctor.
This medicine can cause severe diarrhea. Try to avoid laxatives and stool softeners
while taking this medicine.
There may be other medicines that interact with CAMPTO. Check with your doctor, the
pharmacist or nurse about the existence of other medicines, herbs and supplements and whether alcohol can cause
problems with this medicine.

Contraception, pregnancy, breastfeeding and fertility

Contraception
If you are a woman of childbearing potential, you must use effective contraceptive measures during and up to 6 months after
stopping treatment.
If you are a man, you must use effective contraceptive measures during and up to 3 months after stopping
treatment. It is important to check with your doctor which types of contraceptive methods can be
used with this medicine.

Pregnancy
This medicine can cause problems with the fetus if taken at the time of conception or during
pregnancy. Before starting treatment, your doctor will make sure that you are not pregnant.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.

Breastfeeding
Irinotecan and its metabolite have been detected in breast milk. Breastfeeding must be
interrupted for the entire 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 have effects on fertility. Before
taking this medicine, talk to your doctor about the possible risk posed by this
medicine and the options that may preserve your ability to have children.

Driving and using machines
You may feel dizzy and/or have vision problems in the first 24 hours after taking this
medicine. Do not drive or use machines if you experience this side effect.

CAMPTO contains sorbitol
This medicine contains a sugar (sorbitol).
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, inform your doctor if you (or the child) suffer from hereditary
fructose intolerance or if the child feels unwell, vomits or has unpleasant reactions such as bloating and
cramps in the stomach or diarrhea when taking sweet foods or drinks.

This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. HOW TO USE CAMPTO

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor.
CAMPTO will be administered by healthcare professionals.
Your doctor may recommend a DNA test before the first dose of CAMPTO.
Some people are genetically more likely to experience certain side effects from the
medicine.
The amount of CAMPTO you will receive will depend on many factors, including your height and weight, your
general health status or other health problems, and the type of cancer or condition being treated. Your doctor
will determine the dose and timing.
CAMPTO is injected into a vein through an intravenous (i.v.) route. You will receive this injection in
a clinic or hospital. CAMPTO must be administered slowly and it may take up to 90 minutes to complete
the i.v. infusion.
While taking CAMPTO, you may be given other medicines to prevent
nausea, vomiting, diarrhea, and other side effects. You may need to continue using these
medicines for at least one day after the CAMPTO injection.
Tell the people assisting you if you experience burning, pain, or swelling around the needle during
the CAMPTO infusion. If the medicine leaks out of the vein, it can cause tissue damage. If you experience
pain or notice redness or swelling at the infusion site while taking CAMPTO, inform
the healthcare professional immediately.
Currently, there are several recommended treatment schedules for CAMPTO. It is generally
administered once every 3 weeks (CAMPTO administered alone), or once every 2
weeks (CAMPTO administered in chemotherapy in combination with 5FU/AF). The dose will depend
on several factors, including the treatment schedule, body size, age, and general health,
blood count, liver function, whether you have had radiation to the abdomen/pelvis, and whether you have
experienced side effects such as diarrhea.
Only your doctor can assess the duration of treatment.

If you use more CAMPTO than you should
Seek urgent medical attention. Symptoms of overdose may include some of the serious side effects
listed in this guide for the use of the medicine.

If you forget to use CAMPTO
If you miss an appointment for a CAMPTO injection, contact your doctor for instructions.
If you have any further questions on 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 immediately contact your doctor if you experience any of the following serious side effects (see section 2).
Seek urgent medical attention 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, hot flashes, abdominal cramps (This may occur during the administration of the medicine. If so, immediately inform the healthcare professional. Medicines may be administered to stop and/or reduce this initial side effect).

sanitary personnel. Medicines may be administered to stop and/or decrease this initial unwanted effect).

• Delayed diarrhea: Occurs more than 24 hours after administering the medicine. Due to the dehydration and electrolyte imbalances caused by diarrhea, it is important to be in contact with 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 (which may be associated with stomach pain or fever) caused by bacteria called Clostridium difficile
• Blood infection
• Dehydration (caused by diarrhea and vomiting)
• Dizziness, rapid heartbeat and paleness (a condition called hypovolemia)
• Allergic reaction
• Temporary 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 results
• Perforation of the intestine
• Fatty liver disease
• Skin reactions
• Reactions at the site where the medicine was administered
• Low level of potassium in the blood
• Low level of salt in the blood, mostly related to diarrhea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE CAMPTO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Your doctor will check it for you.

Storage conditions
Store at a temperature below 25°C.
Store in the original package, to protect the medicine from light.

Shelf life
Before dilution: 2 years (40 mg presentation in 2 mL) or 3 years (100 mg presentations in
5 mL and 300 mg in 15 mL).
After dilution: the medicine will be administered to you within 24 hours of dilution. The diluted
solution can be stored at 2°C-8°C in a refrigerator.

6. Package Contents and Other Information

What CAMPTO contains
The active ingredient is
irinotecan hydrochloride trihydrate 20 mg/mL equivalent to irinotecan17.33 mg/mL
A 2 mL vial contains 40 mg of irinotecan hydrochloride trihydrate (40 mg/2 mL).
A 5 mL vial contains 100 mg of irinotecan hydrochloride trihydrate (100 mg/5 mL)
A 15 mL vial contains 300 mg of irinotecan hydrochloride trihydrate (300 mg/15 mL)
The other components are:
sorbitol E420 (see paragraph 2), lactic acid, sodium hydroxide (see paragraph 2), hydrochloric acid
and water for injections.

Description of the appearance of CAMPTO and package contents
This medicine is provided as a concentrate for solution for infusion in Onco-Tain glass vials
in amber color of 2 mL, 5 mL or 15 mL.
The vials are coated with a protective plastic that reduces the risk of leakage in case of breakage
of the vials – these are called Onco-Tain vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem (Belgium)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Campto 20 mg/mL, solution for dilution for infusion
Campto 20 mg/mL, solution for dilution for infusion (IV)
Campto 20 mg/mL, concentrate for solution for infusion
Campto 20 mg/mL, concentrate for solution for infusion
Campto 20 mg/mL, concentrate for solution for
infusion
Luxembourg Campto, solution à diluer pour perfusion
Netherlands Campto 20 mg/mL, concentrate for solution for
infusion
United Kingdom (Northern Ireland) Campto, 20 mg/mL, concentrate for solution for infusion
More detailed information on this medicine is available on the website of the Italian Medicines Agency
(AIFA) http://www.agenziafarmaco.gov.it/.
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The following information is intended exclusively for doctors and healthcare professionals:
Instructions for personnel regarding the safe handling of CAMPTO
As with all antineoplastic substances, irinotecan must be prepared and handled with care. It is
necessary to use protective glasses, masks and gloves.
If CAMPTO comes into contact with the skin, wash it immediately and thoroughly with water and
soap. If CAMPTO comes into contact with the mucous membranes, wash immediately and thoroughly with
water.
Like all injectable medicines, CAMPTO must be prepared under aseptic conditions.
If opacity or condensation is visible in the vial or after dilution of the concentrate, the medicine
cannot be used and must be disposed of.

Preparation of the solution for infusion
As with any other injectable medicine, CAMPTO solution for infusion must be prepared
aseptically.
If you observe any precipitate in the vial or in the infusion solution, discard the product in
accordance with standard procedures for cytotoxic agents.
Aseptically draw up the calculated amount of CAMPTO concentrate for solution for infusion from
the vial into a syringe and transfer it into a 250 mL bag or bottle for infusion containing a
solution of 0.9% (w/v) sodium chloride or a 5% (w/v) glucose solution. Mix the
infusion solution in the bag or bottle thoroughly by manual rotation.
Do not mix with other medicines.
Belgium
France
Greece
Ireland
Italy

Shelf life
The diluted CAMPTO solution is physically and chemically stable for up to 28 days as a solution
for infusion (0.9% (w/v) sodium chloride solution and 5% (w/v) glucose solution) if
stored in containers made of LDPE or PVC at a temperature of 5°C or 30°C if protected from light.
When the diluted solution is not stored protected from light, it is physically and chemically
stable for a maximum of 3 days.
From a microbiological point of view, immediate use is recommended. If the product is not used
immediately after dilution, the storage times and conditions are the responsibility of the user and should not normally exceed 24 hours at 2°C-8°C, unless the dilution
takes place under controlled aseptic conditions.

Warnings against certain visible signs of deterioration
Do not use CAMPTO if you notice a precipitate in the vials or in the diluted solution. In this case, the
product must be disposed of according to standard hospital procedures applicable to cytotoxic waste.
Do not dispose of any medicine in the wastewater. Ask your pharmacist how to dispose of medicines
that you no longer use. This will help protect the environment.

Administration
For information on administration, read the Summary of Product Characteristics of
CAMPTO.

Disposal
Unused medicine and waste derived from this medicine must be disposed of in accordance with
current local regulations.