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

Irinotesin

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotesin (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotesin, is a topoisomerase I inhibitor presented as a sterile powder for reconstitution for intravenous use. It is employed in the treatment of colorectal cancer in adult patients. It is indicated for patients with metastatic or locally advanced disease and is administered under the supervision of qualified oncology specialists.

GNH India supplies Irinotesin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to EU GMP standards and provides reliable cold‑chain logistics where required.

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

  • Irinotesin (irinotecan) is used in the management of colorectal cancer, a malignancy of the large intestine.
  • Colorectal cancer: improves survival when combined with fluoropyrimidine‑based chemotherapy.
  • Metastatic colorectal cancer: reduces tumor burden in patients with advanced disease.
  • Adjuvant colorectal cancer: used after surgical resection to lower recurrence risk.

How It Works

  • Irinotecan is a prodrug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By binding to the enzyme‑DNA complex, it prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately cell death in rapidly dividing tumor cells.

Side Effects

Irinotecan therapy is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting
  • Diarrhea, which may be severe
  • Neutropenia (low white blood cell count)
  • Fatigue and weakness
  • Alopecia (hair loss)
  • Anemia

Serious or Rare Side Effects

  • Febrile neutropenia (infection with fever)
  • Severe colitis or intestinal perforation
  • Allergic reactions including anaphylaxis
  • Hepatotoxicity (liver enzyme elevation)
  • Pulmonary toxicity such as interstitial pneumonitis
  • Hemorrhagic events

Precautions & Warnings

  • Prior to and during treatment with Irinotesin, several safety measures should be observed.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: evaluate hepatic enzymes before and during therapy.
  • Hydration: ensure adequate fluid intake to mitigate diarrhea.
  • Avoid concurrent myelosuppressive agents: reduce risk of severe bone marrow suppression.
  • Pregnancy and lactation: contraindicated unless benefits outweigh risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Concurrent use with other topoisomerase I inhibitors: additive toxicity.
  • Strong CYP3A4 inducers (e.g., rifampin): may markedly reduce irinotecan exposure.
  • Live vaccines: increased risk of infection due to immunosuppression.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may increase drug exposure.
  • Anticoagulants such as warfarin: monitor INR for bleeding risk.
  • Nephrotoxic agents (e.g., cisplatin): may enhance renal toxicity.

Frequently Asked Questions

Irinotesin is the brand name for the intravenous formulation of irinotecan, a chemotherapy agent used primarily in the treatment of colorectal cancer. It is employed both in metastatic settings and as part of adjuvant therapy after surgical resection to improve disease‑free survival.

Irinotecan is a pro‑drug that is metabolised inside cancer cells to SN‑38, which binds to topoisomerase I. This prevents the re‑ligation of single‑strand DNA breaks during replication, causing accumulation of DNA damage and triggering apoptosis of rapidly dividing tumour cells.

The dose of Irinotesin is individualized and set by the treating oncologist based on factors such as disease stage, patient weight, performance status and prior therapies. Specific dosing regimens are not disclosed publicly and must follow the prescriber’s written order.

Irinotecan is classified as contraindicated during pregnancy and lactation unless the potential benefit to the mother outweighs the risk to the fetus or infant. Animal studies have shown embryotoxic effects, and limited human data suggest potential harm, so it should be avoided in these situations.

To request Irinotesin, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and any necessary import documentation.

The most common alternative to irinotecan is topotecan, another topoisomerase I inhibitor, which is generally used for ovarian and small‑cell lung cancers. Compared with topotecan, irinotecan has a broader evidence base in colorectal cancer and is often combined with fluoropyrimidines, whereas topotecan is administered on a different schedule and has a distinct toxicity profile.

Irinotesin should be stored at 2‑8 °C in a refrigerator, protected from light. The vial must not be frozen or shaken. Before reconstitution, inspect the product for particulate matter and discoloration, and use aseptic technique to prepare the sterile solution for intravenous infusion.

Irinotesin is administered by intravenous infusion. After reconstitution, the solution is diluted in an appropriate IV fluid and infused over a period defined by the prescribing oncologist, typically ranging from 30 minutes to several hours, depending on the treatment protocol.

The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea that can lead to colitis or intestinal perforation, and hypersensitivity reactions such as anaphylaxis. Prompt medical evaluation is essential if any of these symptoms develop.

Irinotesin should not be used in patients with known hypersensitivity to irinotecan or any of its excipients, in those with uncontrolled infections, or in individuals who are pregnant or breastfeeding unless absolutely necessary. Caution is also advised for patients with severe hepatic impairment or pre‑existing bone‑marrow suppression.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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