سعر ارينوتيكان ميلان 40 مجم / 2 مل فيال 2025

Irinotecan Mylan 40 mg/2 ml vial: irinotecan 40 mg/2 ml (20 mg/ml) concentrate for intravenous infusion, single vial. For use under the supervision of a physician experienced in cancer chemotherapy.

• Metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.Population: AdultsDailyMed (U.S. National Library of Medicine)

• Common adverse reactions (at least 30%) in single-agent studies: nausea, vomiting, abdominal pain, diarrhoea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anaemia, asthenia, fever, weight loss and alopecia.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Known hypersensitivity to irinotecan or to any of the excipients.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Boxed warning - diarrhoea and myelosuppression: early diarrhoea (during or shortly after infusion) may come with cholinergic symptoms and can be prevented or treated with atropine 0.25-1 mg IV/SC; late diarrhoea (more than 24 hours after dosing) can be life-threatening and must be treated promptly with loperamide, fluids and electrolytes, with antibiotics for ileus, fever or severe neutropenia. Interrupt and reduce subsequent doses for severe diarrhoea.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)
• Severe myelosuppression and deaths from sepsis after severe neutropenia have occurred; hold the drug for neutropenic fever or an absolute neutrophil count below 1,000/mm3 and reduce subsequent doses. Patients homozygous for UGT1A1*28 have a higher risk of neutropenia.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)
• Other warnings: hypersensitivity including anaphylaxis (discontinue); renal impairment or acute renal failure, usually after volume depletion from vomiting/diarrhoea; interstitial pulmonary disease-like events including deaths; do not combine with a 5-day 5-FU/leucovorin regimen outside clinical studies; embryo-fetal toxicity.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Strong CYP3A4 inducers (e.g. phenytoin, phenobarbital, carbamazepine, rifampin, rifabutin, St John's wort)These substantially reduce exposure to irinotecan and SN-38; consider non-inducing alternatives at least 2 weeks before starting and do not co-administer unless there is no alternative.DailyMed (U.S. National Library of Medicine)
• Strong CYP3A4 or UGT1A1 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, voriconazole, ritonavir, atazanavir, gemfibrozil)These may increase exposure to irinotecan or SN-38; stop strong CYP3A4 inhibitors at least 1 week before starting and do not co-administer unless there is no alternative.DailyMed (U.S. National Library of Medicine)

• Based on animal studies and its mechanism of action, irinotecan can cause fetal harm; IV dosing in rats and rabbits during organogenesis caused embryofetal death and malformations at exposures below the human clinical exposure. Verify pregnancy status before starting; females of reproductive potential should use effective contraception and male patients with female partners should use condoms.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)
• Irinotecan and its metabolites are present in human milk; advise women not to breastfeed during treatment and for 7 days after the final dose.International label, equivalent formulation · DailyMed (U.S. National Library of Medicine)

• Irinotecan: Irinotecan and its active metabolite SN-38 bind the topoisomerase I-DNA complex and prevent religation of single-strand DNA breaks, causing lethal double-strand damage during DNA synthesis.