GNH USA

Europe — EMA

Irinotecan Mylan Generics

GNH USA supplies Irinotecan Mylan Generics (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer, adjuvant colon cancer and other solid

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Mylan Generics, is a topoisomerase I inhibitor presented as an injection solution for intravenous infusion use. It treats metastatic colorectal cancer and other solid tumors as part of combination chemotherapy regimens.

GNH USA supplies Irinotecan Mylan Generics as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The product complies with European Union marketing authorisation standards and is manufactured under GMP conditions. It is distributed through a regulated supply chain to ensure quality and traceability.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is used in oncology to target rapidly dividing cancer cells, particularly in colorectal and other solid tumor regimens.

Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy. Adjuvant therapy for colon cancer: reduces risk of disease recurrence after surgical resection. Small cell lung cancer (in combination regimens): contributes to tumor control as part of multi‑drug chemotherapy. Other solid tumors (as part of combination chemotherapy): provides antitumor activity in a variety of malignancies.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Nausea and vomiting - Diarrhea (often delayed) - Fatigue - Neutropenia (low white blood cell count) - Alopecia (hair loss) - Abdominal cramping

Serious or Rare Side Effects: - Severe neutropenia with fever (febrile neutropenia) - Severe diarrhea leading to dehydration and electrolyte imbalance - Hepatotoxicity (elevated liver enzymes) - Allergic reactions including anaphylaxis - Severe abdominal pain - Blood clotting abnormalities

What precautions apply to Irinotecan Hydrochloride Trihydrate?

When using Irinotecan, careful monitoring and specific precautions are required.

Dose adjustment: reduce dose in patients with hepatic impairment. Monitoring: perform regular complete blood counts to detect neutropenia. Diarrhea management: initiate antidiarrheal therapy promptly and consider dose delay if severe. Pregnancy: contraindicated in pregnancy; avoid use due to fetal risk. Drug interactions: avoid concurrent strong CYP3A4 inhibitors that may increase SN‑38 exposure. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan interacts with several medicines; some require avoidance while others need close monitoring.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may increase SN‑38 levels and toxicity. - UGT1A1*28 homozygous genotype: risk of severe neutropenia; consider alternative therapy. - Concurrent use with other myelosuppressive agents: heightened risk of bone marrow suppression.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin): may modestly raise exposure. - Anticholinergic agents (e.g., atropine): can mask early signs of cholinergic toxicity. - Warfarin: monitor INR as irinotecan may affect coagulation parameters.

Frequently asked questions

What is Irinotecan Mylan Generics used for?+
Irinotecan Mylan Generics is an intravenous chemotherapy agent used primarily to treat metastatic colorectal cancer, as adjuvant therapy for colon cancer, and in combination regimens for small cell lung cancer and other solid tumors. It is administered as part of multi‑drug protocols to improve survival and reduce disease recurrence.
How does Irinotecan work?+
After infusion, irinotecan is metabolised by liver enzymes into the active metabolite SN‑38. SN‑38 binds to DNA‑topoisomerase I, stabilising the enzyme‑DNA complex and preventing the re‑ligation of single‑strand DNA breaks. This blocks DNA replication and transcription, causing accumulation of DNA damage that leads to cancer cell death.
What is the usual dose of Irinotecan?+
The dose of Irinotecan is individualized by the prescribing oncologist based on factors such as cancer type, treatment regimen, patient weight, renal and hepatic function, and prior therapy. Specific dosing schedules are not provided here; clinicians determine the appropriate amount and frequency for each patient.
Is Irinotecan safe in pregnancy or breastfeeding?+
Irinotecan is classified as Pregnancy Category D, indicating evidence of fetal risk. It should not be used during pregnancy, and breastfeeding is contraindicated because the drug can be excreted in milk and may harm the infant. Women of child‑bearing potential should use effective contraception during treatment.
How do I order Irinotecan Mylan Generics from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if needed) and the necessary import documentation.
How does Irinotecan compare with other chemotherapy agents?+
Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or 5‑fluorouracil (a pyrimidine analogue). Its unique mechanism targets DNA‑topoisomerase I, offering efficacy in tumors resistant to other drugs, but it also has a distinct toxicity profile, notably delayed diarrhea and neutropenia.
How should Irinotecan be stored and handled?+
Irinotecan injection solution must be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and do not freeze or shake the product. Before administration, allow the solution to reach room temperature if required by the preparation protocol.
How is Irinotecan administered?+
Irinotecan is given as an intravenous infusion, usually over 30 to 90 minutes depending on the specific regimen. The infusion is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions and supportive care measures such as anti‑emetics and antidiarrheals.
What are the most serious risks to watch for with Irinotecan?+
The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea that can cause dehydration and electrolyte imbalance, and rare but severe allergic reactions such as anaphylaxis. Prompt recognition and medical intervention are essential to mitigate these risks.
Who should not use Irinotecan?+
Irinotecan should be avoided in patients with known hypersensitivity to the drug or its components, those with severe hepatic impairment, and individuals who are pregnant. Patients with a homozygous UGT1A1*28 genotype may also be at high risk for toxicity and should be evaluated carefully before treatment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Irinotecan Hydrochloride Trihydrate
Route
Intravenous Use
Manufacturer
Mylan S.P.A.
Origin
EU

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