CAMPTO 20 mg/mL concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Irinotecan hydrochloride trihydrate

Available from:

Pfizer Healthcare Ireland

ATC code:

L01XX; L01XX19

INN (International Name):

Irinotecan hydrochloride trihydrate

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antineoplastic agents; irinotecan

Authorization status:

Marketed

Authorization date:

2008-02-15

Patient Information leaflet

Page 1 of 11
2021-0069540, 2020-0063524
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAMPTO® 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
irinotecan hydrochloride, trihydrate
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN 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 anticancer medicine containing the active substance
irinotecan hydrochloride,
trihydrate.
Irinotecan hydrochloride trihydrate interferes with the growth and
spread of cancer cells in the
body.
CAMPTO is indicated in combination with other medicines for the
treatment of patients with
advanced or metastatic cancer of the colon or rectum.
CAMPTO may be used alone in patients with metastatic cancer of the
colon or rectum whose
disease has recurred or progressed following initial
fluorouracil-based therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CAMPTO
DO NOT USE CAMPTO:

if you have chronic inflammatory bowel disease and/or bowel
obstruction

if you are allergic to irinotecan hydrochloride trihydrate or any of
the other
ingredients of this medicine (listed in section 6 “What CAMPTO
contains”)

if you are a breast-feeding woman (see section 2)

if your
bilirubin level is higher than 3 times the upper limit of the normal
range

if you have severe bone marrow failure

if you are in poor general condition (WHO performance status higher
than 2)

if you are taking or have recently taken St John’s Wort
(a herbal extract containing
Hypericum)


Summary of Product characteristics

Health Products Regulatory Authority
09 May 2022
CRN00CXRL
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CAMPTO 20 mg/mL concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate contains 20 mg/mL irinotecan hydrochloride, trihydrate
(equivalent to 17.33 mg/mL irinotecan).
One vial of 2 mL contains 34.66 mg of irinotecan as 40 mg of
irinotecan hydrochloride, trihydrate (40 mg/2 mL).
One vial of 5 mL contains 86.65 mg of irinotecan as 100 mg of
irinotecan hydrochloride, trihydrate (100 mg/5 mL).
One vial of 15 mL contains 259.95 mg of irinotecan as 300 mg of
irinotecan hydrochloride, trihydrate (300 mg/15 mL).
Excipient(s) with known effect
Sorbitol
CAMPTO 20 mg/mL concentrate for solution for infusion contains 90 mg
of sorbitol (E420) in each 2 mL of solution, which is
equivalent to 90 mg/2 mL.
CAMPTO 20 mg/mL concentrate for solution for infusion contains 225 mg
of sorbitol (E420) in each 5 mL of solution, which is
equivalent to 225 mg/5 mL.
CAMPTO 20 mg/mL concentrate for solution for infusion contains 675 mg
of sorbitol (E420) in each 15 mL of solution, which is
equivalent to 675 mg/15 mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CAMPTO is indicated for the treatment of patients with advanced
colorectal cancer:
• in combination with 5-fluorouracil and folinic acid in patients
without prior chemotherapy for advanced disease,
• as a single agent in patients who have failed an established
5-fluorouracil containing treatment regimen.
CAMPTO in combination with cetuximab is indicated for the treatment of
patients with epidermal growth factor receptor
(EGFR)-expressing RAS wild-type metastatic colorectal cancer, who had
not received prior treatment for metastatic disease or
after failure of irinotecan-including cytotoxic therapy (see section
5.1).
CAMPTO in combination with 5-fluorouracil, folinic acid and
bevacizumab is