Europe — EMA
Iritec (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Iritec (Irinotecan Hydrochloride Trihydrate), a topoisomerase I inhibitor for metastatic colorectal cancer.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Iritec, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer in adult patients, acting to disrupt tumor DNA replication and may be used as part of combination chemotherapy regimens under specialist oncology supervision.
GNH USA supplies Iritec as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide and clinical research institutions with reliable logistics and regulatory support ensuring timely delivery.
What is Irinotecan Hydrochloride Trihydrate used for?
Iritec (irinotecan) is used in oncologic regimens targeting cancers that rely on rapid DNA synthesis.
- Metastatic colorectal cancer: improves progression‑free survival when combined with fluoropyrimidine‑based chemotherapy. - Small cell lung cancer: contributes to tumor response as part of combination protocols. - Adjuvant colorectal cancer: used after surgery to reduce risk of disease recurrence.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Iritec may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Diarrhea: may be severe and require antidiarrheal therapy. - Neutropenia: reduced white blood cell count increasing infection risk. - Nausea: often managed with antiemetics. - Fatigue: general tiredness affecting daily activities.
Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils, a medical emergency. - Severe colitis: intense intestinal inflammation leading to dehydration. - Allergic reaction: includes rash, itching, and possible anaphylaxis.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Prior to initiating therapy, clinicians should evaluate patient‑specific factors and monitor for toxicity.
- Monitor blood counts: perform regular CBC to detect neutropenia. - Assess liver function: adjust dosing in hepatic impairment. - Evaluate bowel status: avoid use in patients with recent obstruction. - Use prophylactic antiemetics: to reduce nausea and vomiting. - Adjust dose for renal dysfunction: consider reduced exposure. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Irinotecan Hydrochloride Trihydrate interact with?
Iritec can interact with several medicines that affect its metabolism or increase toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): increase irinotecan exposure. - UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia. - Concurrent topoisomerase I inhibitors: additive toxicity.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin): may reduce efficacy. - Other myelosuppressive agents: enhance bone‑marrow suppression. - Drugs affecting electrolyte balance (e.g., diuretics): may worsen diarrhea.



