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

Irinotecan Onkovis

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Onkovis (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Onkovis, is a topoisomerase I inhibitor presented as an injection for intravenous use. It is employed in the treatment of colorectal cancer and metastatic colorectal cancer in adult patients, often as part of combination chemotherapy regimens designed to improve response rates and survival outcomes.

GNH India supplies Irinotecan Onkovis as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, ensuring quality‑assured product delivery across regulated markets through reliable logistics.

Manufacturer / TM Owner

Onkovis Gmbh

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Indications & Clinical Uses

  • Irinotecan, a topoisomerase I inhibitor, is used in colorectal cancer treatment pathways.
  • Colorectal cancer: used as part of combination chemotherapy to reduce tumor size and improve survival.
  • Metastatic colorectal cancer: administered to control disease spread and prolong life in patients with advanced disease.
  • Advanced colorectal cancer: employed when disease is not resectable to lessen tumor burden and alleviate symptoms.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This stabilizes the transient single‑strand breaks created during DNA replication, preventing religation and leading to accumulation of DNA damage, replication arrest, and ultimately apoptotic cell death in rapidly dividing tumor cells. The drug is administered intravenously, and hepatic carboxylesterases mediate the conversion. SN‑38 is further inactivated by glucuronidation, a process that can be influenced by genetic polymorphisms, affecting both efficacy and toxicity.

Side Effects

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

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: frequent loose stools that may become severe.
  • Nausea and vomiting: gastrointestinal upset common during treatment.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent care.
  • Severe colitis: intense inflammation of the colon causing dehydration.
  • Allergic reactions: rash, itching, or anaphylaxis in rare cases.

Precautions & Warnings

When using Irinotecan, clinicians should observe several precautionary measures to minimize risks.

  • Monitor blood counts: perform complete blood count regularly to detect neutropenia early.
  • Assess liver function: check hepatic enzymes before and during therapy to adjust dosing if needed.
  • Maintain hydration: ensure adequate fluid intake to reduce severity of diarrhea.
  • Avoid strong CYP3A4 inhibitors: concurrent use may increase irinotecan exposure and toxicity.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise irinotecan levels and increase toxicity.
  • Carboplatin: combined use can intensify myelosuppression.
  • Live vaccines: immunosuppression may raise infection risk.

Moderate Interactions (Monitor Closely)

  • Warfarin: irinotecan may affect INR and bleeding risk.
  • Anticholinergic agents: can exacerbate cholinergic syndrome symptoms.
  • Other myelosuppressive drugs: additive bone marrow suppression requires dose adjustments.

Frequently Asked Questions

Irinotecan Onkovis is an intravenous anticancer medication indicated for the treatment of colorectal cancer and metastatic colorectal cancer in adult patients. It is typically used as part of combination chemotherapy regimens aimed at reducing tumor burden and extending survival.

Irinotecan is a pro‑drug that is converted inside cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the re‑ligation of single‑strand DNA breaks that occur during replication. This leads to accumulation of DNA damage, replication arrest, and ultimately apoptosis of rapidly dividing cancer cells.

The dosing regimen for Irinotecan Onkovis is individualized by the prescribing oncologist based on factors such as the patient’s weight, disease stage, treatment protocol, and renal or hepatic function. Specific dose amounts and infusion schedules should be determined by a qualified healthcare professional.

Safety data for Irinotecan use in pregnancy or while breastfeeding are limited. Because the drug may pose risks to the fetus or infant, it is generally avoided unless the potential benefit justifies the potential harm. Patients should discuss reproductive plans with their physician before starting therapy.

To order Irinotecan Onkovis, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, and will request verification of trade or institutional credentials. The sales team then provides pricing, availability, shipping details (including cold‑chain handling if needed) and assists with import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class and is often used when disease has progressed after fluoropyrimidine‑based regimens. Compared with agents such as oxaliplatin, irinotecan offers a different mechanism of action and toxicity profile, making it a valuable option in combination protocols or as a second‑line therapy for metastatic colorectal cancer.

Irinotecan Onkovis should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking. Before administration, allow the product to reach room temperature if required, and follow aseptic techniques for preparation and infusion.

Irinotecan Onkovis is given by intravenous infusion, usually over 30 to 90 minutes depending on the treatment protocol. The infusion is performed in a clinical setting by qualified healthcare personnel, with monitoring for infusion‑related reactions and supportive care measures such as anti‑emetics and hydration as needed.

The most serious adverse events include severe neutropenia, febrile neutropenia, life‑threatening diarrhea (often referred to as irinotecan‑induced colitis), cholinergic syndrome, and rare allergic reactions such as anaphylaxis. Prompt recognition and medical intervention are essential to manage these potentially life‑threatening conditions.

Irinotecan Onkovis is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, and in individuals with severe hepatic impairment where drug clearance is markedly reduced. Caution is also advised for patients with pre‑existing bone‑marrow suppression or uncontrolled infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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