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  • Campto
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    Active Ingredient
    Irinotecan HCl 20 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    40 mg / 2 ml

    partial basket chart 10486 9349

    Vial

    100 mg / 5 ml

    partial basket chart 10487 3998

    Vial

    300 mg / 15 ml

    partial basket chart 16338 9365

    Related information


    Dosage

    For adults only. Irinotecan solution for infusion should be infused into a peripheral or central vein.
    Recommended dosage: In monotherapy (for previously treated patient): The recommended dosage of CAMPTO® is 350 mg/m² administered as an intravenous infusion over a 30- to 90- minute period every three weeks.
    In combination therapy (for previously untreated patient): Safety and efficacy of CAMPTO® in combination with 5-fluorouracil (5FU) and folinic acid (FA) have been assessed with the following schedule (See prescribing information for full details):
    – CAMPTO® plus 5FU/FA in every 2 weeks schedule: The recommended dose of CAMPTO® is 180 mg/m² administered once every 2 weeks as an
    intravenous infusion over a 30- to 90-minute period, followed by infusion with folinic acid and 5- fluorouracil.
    Dosage adjustments: Irinotecan should be administered after appropriate recovery of all adverse events to Grade 0 or 1 NCI-CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhoea is fully resolved. At the start of a subsequent infusion of therapy, the dose of Irinotecan, and 5FU when applicable, should be decreased according to the worst Grade of adverse events observed in the prior infusion. Treatment should be delayed by 1 to 2 weeks to allow recovery from treatment-related adverse events. With the following adverse events a dose reduction of 15 to 20% should be applied for Irinotecan and/or 5FU when applicable: Hematological toxicity (neutropenia Grade 4, febrile neutropenia (neutropenia Grade 3-4 and fever Grade 2-4), thrombocytopenia and leukopenia (Grade 4), Non -haematological toxicity (Grade 3-4).
    Treatment duration: Treatment should be continued until there is an objective progression of the disease or an unacceptable toxicity.
    Patients with impaired hepatic function: In monotherapy: Blood bilirubin levels (up to 3 times the upper limit of the normal range (ULN)) in patients with performance status  2, should determine the starting dose of Irinotecan. In these patients with hyperbilirubinemia and prothrombin time greater than 50%, the clearance of irinotecan is decreased and therefore the risk of hepatotoxicity is increased. Thus, weekly monitoring of complete blood counts should be conducted in this patient population. In patients with bilirubin up to 1.5 times the upper limit of the normal range (ULN), the recommended dosage of Irinotecan is 350 mg/m², In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of Irinotecan is 200 mg/m², Patients with bilirubin beyond to 3 times the ULN should not be treated with Irinotecan No data are available in patients with hepatic impairment treated by Irinotecan in combination.
    Patients with impaired renal function: Irinotecan is not recommended for use in patients with impaired renal function, as studies in this population have not been conducted.
    Elderly: No specific pharmacokinetic studies have been performed in elderly. However, the dose should be chosen carefully in this population due to their greater frequency of decreased biological functions. This population should require more intense surveillance.


    Indications

    Irinotecan  is indicated for the 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. For the treatment of patients with small cell lung cancer. For the treatment of patients with gastric cancer. Irinotecan in combination with leucovorin, oxaliplatin and 5-fluorouracil for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.


    Contra-Indications

    Chronic inflammatory bowel disease and/or bowel obstruction. Hypersensitivity to the active substance(s) or to any of the excipients. Lactation. Bilirubin > 3 times the upper limit of the normal range. Severe bone marrow failure. WHO performance status > 2. Concomitant use with St John’s Wort. Live attenuated vaccines.


    Special Precautions

    Given the nature and incidence of adverse events, Irinotecan will only be prescribed in the following cases after the expected benefits have been weighted against the possible therapeutic risks: In patients presenting a risk factor, particularly those with a WHO performance status = 2. In the few rare instances where patients are deemed unlikely to observe recommendations regarding management of adverse events (need for immediate and prolonged antidiarrhoeal treatment combined with high fluid intake at onset of delayed diarrhoea). Strict hospital supervision is recommended for such patients. When Irinotecan is used in monotherapy, it is usually prescribed with the every-3-weekdosage schedule. However, the weekly-dosage schedule (see section 5) may be considered in patients who may need a closer follow-up or who are at particular risk of severe neutropenia.
    See prescribing information for full details.


    Side Effects

    Decreased appetite, alopecia, vomiting, nausea, diarrhea, constipation, abdominal pain, pyrexia.
    See prescribing information for full details.


    Drug interactions

    Yellow fever vaccine: Risk of fatal generalised reaction to vaccines
    Saint John’s Wort: Decrease in the active metabolite of irinotecan, SN-38, plasma levels.
    Live attenuated vaccines: Risk of generalised reaction to vaccines, possibly fatal. Concomitant use is contraindicated during treatment with irinotecan and for 6 months following discontinuation of chemotherapy. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
    See prescribing information for full details. 


    Pregnancy and Lactation

    Pregnancy: There is no data from the use of irinotecan in pregnant women. Irinotecan has been shown to be embryotoxic and teratogenic in animals.
    Lactation: In lactating rats, 14C-irinotecan was detected in milk. It is not known whether irinotecan is excreted in human milk. Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding should be discontinued for the duration of therapy.
    See prescribing information for full details.


    Overdose

    Symptoms: There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia and severe diarrhoea.
    Management: There is no known antidote for CAMPTO®. Maximum supportive care should be instituted to prevent dehydration due to diarrhoea and to treat any infectious complications.


    Important notes

    Storage: Store below 30°C. Store in the original package in order to protect from light.
    Compatibility: None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


    Manufacturer
    Pfizer (Perth) Pty Limited, Australia
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