Europe — EMA
Irinotekan Accord (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Irinotekan Accord (Irinotecan), a topoisomerase I inhibitor for colorectal cancer and metastatic colorectal cancer.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotekan Accord, is a topoisomerase I inhibitor presented as a sterile intravenous solution for intravenous use. It is employed in the treatment of colorectal cancer and metastatic colorectal cancer in adult patients.
GNH USA supplies Irinotekan Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Irinotecan Hydrochloride Trihydrate used for?
Irinotecan is a chemotherapy agent that targets the topoisomerase I pathway in colorectal malignancies. It is indicated for the following conditions: - Colorectal cancer: used as part of combination regimens to reduce tumor burden and improve response rates. - Metastatic colorectal cancer: administered to extend survival and control disease progression in advanced stages.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Irinotecan may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: may be severe and require supportive care. - Nausea and vomiting: often managed with anti‑emetics. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: hair loss during treatment cycles. - Fatigue: generalized tiredness. - Abdominal cramping.
Serious or Rare Side Effects: - Severe neutropenia with fever (febrile neutropenia). - Life‑threatening colitis or severe diarrhea. - Elevated liver enzymes indicating hepatic injury. - Allergic reactions including anaphylaxis. - Pulmonary toxicity such as interstitial pneumonitis. - Hemorrhagic events due to thrombocytopenia.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Before initiating therapy, clinicians should assess baseline health status and monitor patients closely for known risks. - Blood count monitoring: regular CBC to detect neutropenia. - Liver function assessment: evaluate transaminases before and during treatment. - Renal function evaluation: adjust dosing if renal impairment is present. - Hypersensitivity avoidance: discontinue if severe allergic reaction occurs. - Anti‑diarrheal prophylaxis: consider loperamide to mitigate severe diarrhea. - Store at ambient temperature: keep in original packaging, protect from moisture and light.
What does Irinotecan Hydrochloride Trihydrate interact with?
Irinotecan can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin) may markedly reduce irinotecan exposure. - Concurrent myelosuppressive agents increase risk of severe bone‑marrow suppression. - Anticholinergic drugs can exacerbate irinotecan‑induced diarrhea. - Live vaccines are contraindicated during treatment. - High‑dose warfarin may potentiate bleeding risk.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole) may increase SN‑38 levels. - UGT1A1 inhibitors can raise toxicity risk; dose adjustments may be needed. - Other chemotherapy agents may require schedule coordination to avoid overlapping toxicities. - Radiotherapy combined with irinotecan may heighten tissue damage. - Use of growth‑factor support (e.g., G‑CSF) should be monitored for synergistic effects.



