Campto

Package leaflet: Information for the user

CAMPTO 20 mg/mL, concentrate for solution for infusion

irinotecan hydrochloride trihydrate
Please read this leaflet carefully before 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, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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. Contents of the pack and other information

1. WHAT CAMPTO IS AND WHAT IT IS USED FOR

CAMPTO is an antineoplastic medicinal product containing the active substance irinotecan hydrochloride trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and spread of tumour cells in the body.
CAMPTO is indicated in combination with other medicinal products for the treatment of patients with advanced or metastatic carcinoma of the colon or rectum.
CAMPTO may be used alone in patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed after initial fluorouracil-based therapy.

2. WHAT YOU SHOULD KNOW BEFORE USING CAMPTO

Do not use CAMPTO:

• 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 “Contents of the pack and other information”)
• if you are breastfeeding (see section 2)
• if your bilirubin level is 3 times higher than the upper limit of normal range
• if you have severe bone marrow insufficiency
• 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 extract containing hypericum)
• if you are due to receive or have recently received live attenuated vaccines (vaccines against yellow fever, varicella, herpes zoster, mumps, measles, rubella, tuberculosis, rotavirus, influenza) and during the 6 months following discontinuation of chemotherapy.

If you receive CAMPTO in combination with other medicines, make sure to read the package leaflet of the other medicines for additional contraindications.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using CAMPTO

• If you have Gilbert’s syndrome, an inherited condition that may cause elevated bilirubin levels and jaundice (yellowing of the skin and eyes)

Exercise particular caution with CAMPTO. The use of CAMPTO should be restricted to specialized units experienced in administering cytotoxic chemotherapy and must be administered only under the supervision of a physician experienced in antineoplastic chemotherapy.
Diarrhea
CAMPTO can cause diarrhea, which in some cases may be severe. It may occur a few hours or a couple of days after infusion of the medicine. If left untreated, it could lead to dehydration and serious chemical imbalances, which may be life-threatening. Your doctor will prescribe medications to help you prevent or manage this side effect. Make sure to obtain the medication promptly so that you have it at home when needed.

• Take the prescribed medication at the first sign of frequent bowel movements or the first loose stool.
• Drink large amounts of water and/or salty fluids (sparkling water, soda, or soup).
• Contact your doctor or nurse if you continue to have diarrhea, especially if it lasts more than 24 hours, or if you feel dizzy, lightheaded, or faint.

Neutropenia (reduction in certain white blood cells)
This medicine may reduce the number of white blood cells, especially in the weeks following administration. This may increase the risk of developing an infection. Make sure to inform your doctor or nurse immediately if you develop signs of infection, such as fever (38°C or higher), chills, pain when urinating, new cough, or increased sputum production. 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. Based on test results, additional medications may be required to manage side effects. Your doctor may also need to reduce or delay the next dose of this medicine, or even discontinue treatment altogether. Keep all scheduled medical appointments and laboratory tests.
This medicine may reduce platelet count 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 aspirin or aspirin-containing products, warfarin, or vitamin E. Inform your doctor immediately if you experience 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 you receive this medicine or in the first few days afterward. Your doctor may give you a medicine before treatment to help prevent nausea and vomiting. Your doctor will likely prescribe anti-nausea medications for you to take at home. Keep these medications readily available for when you need them. Contact your doctor if you are unable to take fluids orally due to nausea and vomiting.
Acute cholinergic syndrome
This medicine may affect a part of the nervous system that controls body secretions, leading to what is known as 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 there are medications available to help control them.
Respiratory disorders
Rarely, patients receiving this medicine may develop serious lung problems. Inform your doctor immediately if you develop cough or worsening of existing cough, difficulty breathing, or fever. Your doctor may need to discontinue treatment to manage this condition.
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, shortness of breath, or swelling, pain, redness, or warmth in one arm or leg.
Chronic intestinal inflammation and/or intestinal obstruction
Inform your doctor if you have abdominal pain and are unable to pass stool, especially if accompanied by bloating and loss of appetite.
Radiation therapy
If you have recently received pelvic or abdominal radiotherapy, you may have an increased risk of developing bone marrow suppression. Inform your doctor before starting CAMPTO.
Renal function
Cases of renal dysfunction have been reported.
Cardiac disorders
Inform your doctor if you have or have had heart disease or if you have previously received antineoplastic 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
CAMPTO is rarely associated with blood flow disorders (blood clots in blood 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 few weeks after starting treatment. This may lead to mouth pain, bleeding, or even difficulty eating. Your doctor or nurse may suggest ways to reduce this effect, such as modifying eating habits or oral hygiene. If necessary, your doctor may prescribe medications to relieve pain.
For information on contraception, pregnancy, breastfeeding, and fertility, 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 considering undergoing surgery or any medical procedure.
If used in combination with other antineoplastic medicines for your condition, make sure to read the package leaflets of those medicines as well.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Other medicines and CAMPTO
CAMPTO may interact with various medicines and supplements, which may increase or decrease the level of the medicine in the blood. Inform your doctor or pharmacist if you are using, have recently used, or might 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 muscles during general anesthesia and surgery (suxamethonium)
• 5-fluorouracil/folinic acid
• Bevacizumab (an inhibitor of blood vessel growth)
• 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 receiving CAMPTO without first talking to your doctor.
This medicine may 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, pharmacist, or nurse about other medicines, herbs, 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 effective contraceptive measures during treatment and for 6 months after stopping treatment.
If you are a man, you must use effective contraceptive measures during treatment and for 3 months after stopping treatment. It is important to consult your doctor about which types of contraceptive methods may be used with this medicine.
Pregnancy
This medicine may harm the fetus if taken at the time of conception or during pregnancy. Before starting treatment, your doctor will confirm that you are not pregnant. If you are pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Irinotecan and its metabolite have been detected in breast milk. Breastfeeding must be discontinued throughout the duration of treatment with this medicine.
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility
No studies have been conducted; however, this medicine may affect fertility. Before taking this medicine, discuss with your doctor the potential risk this medicine may pose and options that may preserve your ability to have children.
Driving and use of machines
You may experience dizziness and/or vision problems within the first 24 hours after taking this medicine. Do not drive or operate machinery if you experience this side effect.
CAMPTO contains sorbitol
This medicine contains a sugar (sorbitol).
Sorbitol is a source of fructose. If you (or your child) have been diagnosed with hereditary fructose intolerance, a rare genetic disorder, you (or your child) must not take this medicine. Patients with hereditary fructose intolerance cannot properly metabolize fructose, and its accumulation may cause serious adverse effects.
Before taking this medicine, inform your doctor if you (or your child) have hereditary fructose intolerance or if your child becomes unwell, vomits, or has unpleasant reactions such as bloating, stomach cramps, or diarrhea after consuming sweet foods or drinks.
This medicine contains 45 mg of sorbitol per mL, equivalent to 90 mg/2 mL, 225 mg/5 mL, and 675 mg/15 mL.
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 exactly as directed by your doctor. 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 this medicine.
The amount of CAMPTO you will receive depends on several factors, including height and weight, general health status, other medical conditions, and the type of cancer or condition being treated. Your doctor will determine the dose and schedule.
CAMPTO is injected into a vein through an intravenous (i.v.) line. You will receive this injection at a clinic or hospital. CAMPTO must be administered slowly, and the intravenous infusion may take up to 90 minutes to complete.
During treatment with CAMPTO, you may be given other medicines to prevent nausea, vomiting, diarrhoea, and other side effects. You may need to continue taking these medicines for at least one day after the CAMPTO injection.
Inform the healthcare staff if you feel burning, pain, or swelling around the needle during the CAMPTO infusion. If the medicine leaks out of the vein, it may cause tissue damage. If you experience pain or notice redness or swelling at the infusion site while receiving CAMPTO, inform your healthcare provider immediately.
There are currently several recommended treatment regimens for CAMPTO. It is generally administered once every 3 weeks (CAMPTO given alone), or once every 2 weeks (CAMPTO given in combination chemotherapy with 5FU/AF). The dose will depend on various factors, including the treatment regimen, body size, age, general health, blood counts, liver function, whether you have received prior radiation to the abdomen/pelvis, and whether you have experienced side effects such as diarrhoea.
Only your doctor can assess the appropriate duration of treatment.
If you use more CAMPTO than you should
Seek urgent medical advice. Symptoms of overdose may include some of the serious side effects listed in this medicine's instruction leaflet.
If you forget to use CAMPTO
If you miss an appointment for a CAMPTO injection, contact your doctor for instructions.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious. You must contact your doctor immediately if any of the following serious adverse reactions occur (see section 2).
Seek urgent medical advice if you experience any of the following signs of an allergic reaction:
hives, difficulty breathing, swelling of the face, lips, tongue or throat.

• Diarrhoea (see section 2)

• Early diarrhoea: Occurs within 24 hours of administration of the medicine, accompanied by symptoms such as runny nose, increased salivation, tearing, sweating, hot flushes, and abdominal cramps (This may occur during administration of the medicine. If so, inform the healthcare professional immediately. Medicines may be administered to stop and/or reduce this initial adverse reaction.)

• Delayed diarrhoea: Occurs more than 24 hours after administration of the medicine. Due to dehydration and electrolyte imbalances caused by diarrhoea, it is important to stay in contact with healthcare professionals for monitoring and advice on medications and dietary adjustments.

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 from the available data

• Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever) caused by bacteria called Clostridium difficile
• Blood infection
• Dehydration (caused by diarrhoea and vomiting)
• Dizziness, rapid heartbeat and paleness (a condition called hypovolemia)
• Allergic reaction
• Temporary speech disturbances 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
• Intestinal blockage
• Enlarged colon
• Bleeding from the intestine
• Inflammation of the large intestine
• Abnormal laboratory results
• Intestinal perforation
• Fatty liver disease
• Skin reactions
• Reactions at the site where the medicine was administered
• Low potassium levels in the blood
• Low sodium levels in the blood, mostly related to diarrhoea and vomiting
• Muscle cramps
• Kidney problems*
• Low blood pressure*
• Fungal infections
• Viral infections

Uncommon cases of these events have been observed in patients with episodes of dehydration associated with diarrhoea and/or vomiting, or blood infections.
Reporting of adverse reactions
If you get any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, 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 stated on the carton. The expiry date refers to the last day of that month. Your doctor will monitor this for you.
Storage conditions
Store below 25°C.
Keep in the original packaging to protect the medicine from light.
Shelf life
Before dilution: 2 years (40 mg in 2 mL presentation) or 3 years (100 mg in 5 mL and 300 mg in 15 mL presentations).
After dilution: The medicine will be administered within 24 hours of dilution. The diluted solution may be stored at 2°C-8°C in the refrigerator.

6. Package contents and other information

What CAMPTO contains
The active substance is
irinotecan hydrochloride trihydrate 20 mg/mL equivalent to irinotecan 17.33 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 section 2), lactic acid, sodium hydroxide (see section 2), hydrochloric acid,
and water for injections.

Description of the appearance of CAMPTO and contents of the pack
This medicinal product is supplied as a concentrate for solution for infusion in amber glass Onco-Tain vials of 2 mL, 5 mL or 15 mL.
The vials are coated with a protective plastic layer which reduces the risk of leakage in case of breakage – these are known as 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 European Economic Area Member States under the following names:
Belgium Campto 20 mg/mL, solution to be diluted for infusion
France Campto 20 mg/mL, solution to be diluted for perfusion (IV)
Greece Campto 20 mg/mL, concentrate for solution for infusion
Ireland Campto 20 mg/mL, concentrate for solution for infusion
Italy Campto 20 mg/mL, concentrate for solution for infusion
Luxembourg Campto, solution to be diluted for perfusion
Netherlands Campto 20 mg/mL, concentraat voor oplossing voor infusie
United Kingdom (Northern Ireland) Campto, 20 mg/mL, concentrate for solution for infusion

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) http://www.agenziafarmaco.gov.it/.

The following information is intended exclusively for physicians and healthcare professionals:
Instructions for healthcare personnel on safe handling of CAMPTO
As with all antineoplastic agents, irinotecan must be prepared and handled carefully. Protective goggles, masks and gloves must be used.
If CAMPTO comes into contact with the skin, wash immediately and thoroughly with soap and water. If CAMPTO comes into contact with mucous membranes, rinse immediately and thoroughly with water.
Like all injectable medicines, CAMPTO must be prepared under aseptic conditions.
If cloudiness or condensation is visible in the vial or after dilution of the concentrate, the medicinal product must not be used and should be disposed of.

Preparation of the infusion solution
As with any other injectable medicine, CAMPTO infusion solution must be prepared aseptically.
If a precipitate is observed in the vial or in the infusion solution, discard the product according to standard procedures for cytotoxic agents.
Aseptically withdraw the calculated amount of CAMPTO concentrate for infusion solution from the vial into a syringe and transfer it into a 250 mL infusion bag or bottle containing 0.9% (w/v) sodium chloride solution or 5% (w/v) glucose solution. Mix the solution in the infusion bag or bottle thoroughly by gentle manual rotation.
Do not mix with other medicinal products.

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

Warnings regarding 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 discarded according to standard hospital procedures applicable to cytotoxic waste.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Administration
For information on administration, please refer to the Summary of Product Characteristics of CAMPTO.

Disposal
Unused medicine and waste materials resulting from its use must be disposed of in accordance with local regulations.