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

Irinotecan Medicus

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Medicus (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Medicus, is a Topoisomerase I inhibitor presented as a solution for injection for intravenous use. It treats metastatic colorectal cancer and other solid tumors in adult patients.

GNH India supplies Irinotecan Medicus as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Medicus A.E

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Indications & Clinical Uses

  • Irinotecan Medicus is employed in oncology protocols targeting DNA replication pathways in malignant disease.
  • Metastatic colorectal cancer: improves overall survival when used in combination chemotherapy regimens.
  • Colorectal adenocarcinoma: provides tumor control in advanced disease stages.
  • Other solid tumors: may be incorporated into approved treatment protocols for selected tumor types.

How It Works

  • Irinotecan Hydrochloride Trihydrate is a pro‑drug converted intracellularly to SN‑38, which binds to the DNA‑topoisomerase I complex. This binding prevents the religation step of DNA replication, resulting in permanent single‑strand breaks, replication arrest, and ultimately apoptosis of rapidly dividing cancer cells.

Side Effects

Irinotecan may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: may be managed with antiemetics.
  • Alopecia: temporary hair loss during treatment.
  • Fatigue: generalized tiredness affecting daily activities.
  • Abdominal cramping: discomfort in the gastrointestinal tract.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis (including ileitis): inflammation of the colon that can be life‑threatening.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis in rare cases.

Precautions & Warnings

Before initiating therapy, clinicians should assess patient suitability and monitor for known risks.

  • Baseline blood counts: obtain complete blood count to detect pre‑existing cytopenias.
  • Liver function: evaluate hepatic enzymes as irinotecan metabolism is hepatic.
  • UGT1A1 genotype: consider testing for reduced enzyme activity that may increase toxicity.
  • Concomitant myelosuppressive agents: adjust dosing or schedule to avoid excessive bone‑marrow suppression.
  • Pregnancy and lactation: avoid use due to unknown fetal risk; discontinue if pregnancy occurs.
  • Store at ambient temperature: keep in original container, protect from light and moisture, and do not freeze.

Avoid Interactions

Irinotecan interacts with several drug classes that may alter its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): can raise SN‑38 levels and toxicity.
  • Concurrent high‑dose irinotecan formulations: risk of cumulative toxicity.

Moderate Interactions (Monitor Closely)

  • Other myelosuppressive agents (e.g., carboplatin): monitor blood counts closely.
  • Anticoagulants (e.g., warfarin): increased bleeding risk with mucosal injury.
  • Antidiarrheal agents (e.g., loperamide): may mask early signs of severe diarrhea.
  • CYP3A4 inducers (e.g., rifampin): may reduce therapeutic effect.
  • Herbal supplements affecting liver enzymes (e.g., St. John’s wort): monitor for altered drug levels.

Frequently Asked Questions

Irinotecan Medicus is indicated for the treatment of metastatic colorectal cancer, colorectal adenocarcinoma, and selected solid tumors. It is used as part of combination chemotherapy regimens to improve tumor control and overall survival in adult patients with advanced disease.

The drug 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 religation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage, cell‑cycle arrest, and apoptosis of rapidly dividing cancer cells.

The dosing regimen for Irinotecan Medicus is individualized by the prescribing oncologist based on factors such as cancer type, treatment protocol, patient weight, renal and hepatic function, and prior therapy. Clinicians determine the appropriate dose and schedule for each patient.

The safety of Irinotecan Medicus in pregnancy and lactation has not been established. It is generally contraindicated in pregnant women because of potential fetal toxicity, and breastfeeding is not recommended while receiving treatment due to possible drug excretion in milk.

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 if needed), and import documentation.

Irinotecan is a widely used topoisomerase I inhibitor with a well‑characterized efficacy profile in colorectal and other solid tumors. Compared with alternatives such as topotecan, irinotecan generally offers broader activity in gastrointestinal cancers but may have a higher incidence of diarrhea and neutropenia, requiring specific supportive care measures.

Store at ambient temperature: keep the solution for injection in its original packaging, protect from light, moisture, and extreme temperatures, and do not freeze. Follow any additional handling instructions provided on the label to maintain product stability.

Irinotecan Medicus is supplied as a sterile solution for injection and is administered intravenously by a qualified healthcare professional. The infusion rate and duration are determined by the treating physician according to the prescribed regimen and patient tolerance.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare hypersensitivity reactions. Patients should be monitored closely for signs of infection, gastrointestinal complications, and liver function abnormalities throughout therapy.

Irinotecan Medicus should be avoided in patients with known hypersensitivity to irinotecan or its excipients, those with severe uncontrolled infections, significant hepatic impairment, or a documented deficiency in the UGT1A1 enzyme that predisposes to excessive toxicity. Pregnant women should also not receive the drug.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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