Package(a):
CONCENTRATE FOR INFUSION: 2 ml x 40 mg. Dosage(a):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil.
Dosage adjustment: See prescribing information for full details.
Treatment duration: Should be continued until there is an objective progression of an unacceptable toxicity. See prescribing information for full details. Prescribing Restrictions:
Package(b):
CONCENTRATE FOR INFUSION: 5 ml x 100 mg. Dosage(b):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil.
Dosage adjustment: See prescribing information for full details.
Treatment duration: Should be continued until there is an objective progression of an unacceptable toxicity. See prescribing information for full details. Prescribing Restrictions:
Package(c):
CONCENTRATE FOR INFUSION: 15 ml x 300 mg. Dosage(c):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil.
Dosage adjustment: See prescribing information for full details.
Treatment duration: Should be continued until there is an objective progression of an unacceptable toxicity. See prescribing information for full details. Prescribing Restrictions: None
Indications:
Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease; as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. Treatment of patients with small cell lung cancer. Treatment of patients with gastric cancer. Contra-Indications:
Chronic inflammatory bowel disease and/or bowel obstruction. Hypersensitivity to irinotecan or any of the excipients. Pregnancy and lactation. Bilirubin >3 times the upper limit of the normal range, severe bone marrow failure, WHO performance status > 2, concomitant use with St. John? Wort. Special Precautions:
Should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy.
Will only be prescribed in the following cases after the expected benefits have been weighed against the possible therapeutic risks: In patients presenting a risk factor, particularly those with a WHO performance status=2. Where patients are deemed unlikely to observe recommendations regarding the management of adverse events. Strict hospital supervision is recommended for such patients.
When used in monotherapy, it is usually prescribed using the 3 weekly dosage schedule. However, a weekly dosage schedule may be considered in patients who need a closer follow-up or who are at particular risk of severe neutropenia.
Vaccination with a live vaccine should be avoided.
Patients should be made aware of the risk of delayed diarrhea occurring more than 24 hours after the administration and at any time before the next cycle. Patients should quickly inform their physician of its occurrence and start appropriate therapy immediately. See prescribing information for full details. Hospitalization is recommended for management of the diarrhea, in the following cases: Diarrhea associated with fever; severe diarrhea (requiring I.V. hydration); diarrhea persisting beyond 48 hours following the initiation of high-dose loperamide therapy.
Should not be used in patients with severe bone marrow failure. In patients who experienced severe hematological events, a dose reduction is recommended for subsequent administration. There is an increased risk of infections and hematological toxicity in patients with severe diarrhea. In such patients, complete blood cell counts should be performed. Hypersensitivity reactions, including severe anaphylactic/anaphylactoid reactions, have been reported. Liver function tests should be performed at baseline and before each cycle.
A prophylactic treatment with antiemetics is recommended before each treatment. Nausea and vomiting have been frequently reported. Patients with vomiting associated with delayed ( i.e. late) diarrhea should be hospitalized as soon as possible for treatment. Caution should be exercised in patients with asthma. In patients who experienced an acute and severe cholinergic syndrome, the use of prophylactic atropine sulphate is recommended with subsequent doses of Campto. Interstitial pulmonary disease can be fatal .Risk factors possibly associated with the development of interstitial pulmonary disease include pre-existing lung disease , use of pneumotoxic drugs, radiation therapy and colony stimulating factors. Patients with risk factors should be closely monitored for respiratory symptoms before and during therapy. Elderly. Chronic inflammatory bowel disease and/or bowel obstruction. Campto is unsuitable in hereditary fructose intolerance. Contraceptive measures must be taken during and for at least three months after cessation of therapy.
Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration, and advised not to drive or operate machinery if these symptoms occur. Patients with underlying cardiac disease, other known risk factors for cardiac disease or previous cytotoxic chemotherapy. Side Effects:
Delayed diarrhea, nausea and vomiting, dehydration, infrequent cases of intestinal obstruction, ileus. Rare cases of symptomatic pancreatitis or asymptomatic elevated pancreatic enzymes have been observed. Neutropenia, anemia, thrombocytopenia. Severe transient acute cholinergic syndrome was observed in 9 % of patients treated in monotherapy and in 1.4 % of patients treated in combination therapy. Asthenia, fever in the absence of infection, and without concomitant severe neutropenia. Mild infusion site reactions, rare cases of hypertension. Interstitial pneumonia and pneumonitis presenting as pulmonary infiltrates have rarely been observed. Hypersensitivity reactions. Muscular contraction or cramps and paraesthesia. See prescribing information for full details. Drug Interactions:
Neuromuscular blocking agents. CYP3A-inducing anticonvulsant drugs (e.g., rifampicin, carbamazepine, phenobarbital or phenytoin). Consideration should be given to starting or substituting non-enzyme-inducing anticonvulsants at least one week prior to initiation of irinotecan therapy (e.g., ketoconazole) in patients requiring anticonvulsant treatment.
