Product image of Irinotecan Mylan Generics (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Mylan Generics

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Mylan Generics (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 India 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.

Manufacturer / TM Owner

Mylan S.P.A.

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Indications & Clinical Uses

  • 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.

How It Works

  • After intravenous administration, irinotecan is converted by hepatic carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, stabilizing the transient single‑strand break complex and preventing relegation of DNA. This inhibition blocks DNA replication and transcription, leading to accumulation of DNA damage and ultimately cancer cell death. The effect is most pronounced in rapidly proliferating tumor cells, while normal tissues with lower proliferation are less affected.

Side Effects

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

Precautions & Warnings

  • 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.

Avoid Interactions

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

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.

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.

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.

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.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India 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.

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.

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.

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.

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.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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