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

Irinotecan Hikma

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Hikma (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Hikma, is a topoisomerase I inhibitor presented as a sterile powder for intravenous infusion. It is used to treat metastatic colorectal cancer and as adjuvant therapy for colorectal cancer in adult patients.

GNH India supplies Irinotecan Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation for import and distribution. Clients benefit from reliable logistics, temperature‑controlled shipping where required, and dedicated technical support throughout the supply chain.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Irinotecan Hikma is employed in oncology regimens targeting colorectal malignancies.

  • Metastatic colorectal cancer: improves overall survival and disease control.
  • Adjuvant colorectal cancer: reduces risk of recurrence after surgical resection.
  • Palliative colorectal cancer: alleviates tumor burden and associated symptoms.

How It Works

  • Irinotecan is a prodrug converted intracellularly to SN‑38, which binds to the DNA‑topoisomerase I complex. This stabilizes the transient single‑strand breaks created during DNA replication, preventing relegation and leading to irreversible DNA damage, inhibition of transcription, and ultimately cancer cell death.

Side Effects

Irinotecan may cause a range of adverse reactions.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Nausea and vomiting: managed with standard antiemetics.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Fatigue: generalized tiredness during treatment.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, a medical emergency.
  • Severe colitis or intestinal perforation: life‑threatening gastrointestinal complications.
  • Hepatotoxicity: marked elevation of liver enzymes.
  • Hypersensitivity reactions: including rash, bronchospasm, or anaphylaxis.

Precautions & Warnings

Before initiating Irinotecan Hikma, consider the following safety measures.

  • Pregnancy: category D – avoid use unless potential benefits justify the risk.
  • Breastfeeding: not recommended as drug may be excreted in milk.
  • Renal impairment: assess renal function and adjust dosing if necessary.
  • Hepatic impairment: use with caution; monitor liver enzymes closely.
  • Concomitant myelosuppressive agents: increased risk of bone‑marrow suppression.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): may reduce irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): can increase SN‑38 levels and toxicity.
  • Concurrent myelosuppressive chemotherapy: heightened bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Antiemetics such as ondansetron: may affect drug metabolism.
  • Fluoroquinolone antibiotics: potential additive neutropenia.
  • Warfarin: monitor INR as irinotecan may influence anticoagulation.

Frequently Asked Questions

Irinotecan Hikma is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy following surgical resection of colorectal cancer in adult patients.

Irinotecan is converted inside cells to the active metabolite SN‑38, which binds to topoisomerase I-DNA complexes, preventing DNA strand re‑ligation during replication. This causes irreversible DNA breaks, halting tumor cell replication and leading to cell death.

The dosing regimen for Irinotecan Hikma is determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Specific dose and schedule should be obtained from the treating physician.

Irinotecan is classified as pregnancy category D, indicating evidence of risk to the fetus. It should be avoided unless the potential benefit justifies the risk. Breastfeeding is not recommended because the drug can be excreted in milk.

To place an order, submit an enquiry on the Irinotecan Hikma 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 belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines (e.g., 5‑FU) and oxaliplatin. It is often combined with these agents to enhance efficacy, and its toxicity profile differs, featuring notable diarrhea and neutropenia.

Irinotecan Hikma should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen. The product should be kept in its original packaging until preparation for intravenous infusion.

Irinotecan Hikma is supplied as a sterile powder for injection. It is reconstituted with the appropriate diluent and administered intravenously over a specified infusion period, as directed by the treating physician.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare but severe hypersensitivity reactions. Prompt medical attention is required if any of these occur.

Patients with known hypersensitivity to irinotecan or its excipients, those with uncontrolled infections, severe hepatic impairment, or who are pregnant without a compelling therapeutic indication should not receive Irinotecan Hikma.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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