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

Irinotecan Hydrochloride Seacross Pharmaceuticals

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Hydrochloride Seacross Pharmaceuticals (Irinotecan Hydrochloride Trihydrate)

Irinotecan hydrochloride, the active ingredient in Irinotecan Hydrochloride Seacross Pharmaceuticals, is a topoisomerase I inhibitor presented as a sterile powder for intravenous use. It is employed in the treatment of colorectal cancer, including metastatic disease, and is administered under the supervision of oncology specialists.

GNH India supplies Irinotecan Hydrochloride Seacross Pharmaceuticals as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Seacross Pharmaceuticals Limited

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Indications & Clinical Uses

  • Irinotecan hydrochloride is used in chemotherapy regimens targeting colorectal malignancies.
  • Colorectal cancer: administered as part of combination chemotherapy to inhibit tumor growth.
  • Metastatic colorectal cancer: used to improve survival in patients with metastatic disease.
  • Advanced colorectal carcinoma: employed when disease has progressed after first‑line therapy.

How It Works

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

Side Effects

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

Common Side Effects

  • Nausea and vomiting: frequent gastrointestinal upset.
  • Diarrhea: may be severe and require supportive care.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Fatigue: general tiredness and weakness.
  • Alopecia: hair loss during treatment.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent medical attention.
  • Severe colitis: intense inflammation of the colon.
  • Allergic reactions: rash, itching, or anaphylaxis.
  • Hepatic toxicity: elevated liver enzymes or liver dysfunction.
  • Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.

Precautions & Warnings

  • Prior to initiating therapy, clinicians should evaluate patient-specific risk factors and monitor for toxicity.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: adjust dosing in hepatic impairment.
  • Hydration: ensure adequate fluid intake to mitigate diarrhea.
  • Pregnancy: avoid use unless potential benefit justifies risk.
  • Drug interactions: review concomitant medications for CYP3A4 inhibitors.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan can interact with several drug classes, influencing its safety and efficacy.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase irinotecan exposure and toxicity.
  • UGT1A1*28 homozygous genotype: heightened risk of severe neutropenia and diarrhea.
  • Concurrent myelosuppressive agents: can exacerbate bone marrow suppression.

Moderate Interactions (Monitor Closely)

  • Antiemetics such as ondansetron: may affect metabolism of irinotecan.
  • Warfarin: monitor INR for potential anticoagulation changes.
  • Fluoropyrimidines: increased risk of gastrointestinal toxicity.

Frequently Asked Questions

Irinotecan Hydrochloride is an antineoplastic agent indicated for the treatment of colorectal cancer, including metastatic disease. It is administered intravenously as part of combination chemotherapy regimens designed to inhibit tumor growth and improve patient survival.

Irinotecan is a prodrug that is metabolized to SN‑38, which inhibits topoisomerase I. This enzyme normally relieves torsional strain during DNA replication. By blocking topoisomerase I, SN‑38 prevents DNA strand re‑ligation, causing DNA breaks that lead to cancer cell death.

The specific dose of Irinotecan Hydrochloride is determined by the prescribing oncologist based on factors such as cancer type, disease stage, patient weight, and overall health. Dosage regimens are individualized and should follow the prescriber’s instructions.

Irinotecan’s safety in pregnancy and lactation is not well established. It is generally avoided unless the potential therapeutic benefit outweighs the possible risks to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

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 necessary 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. Compared with monotherapy, Irinotecan‑based combinations typically provide higher response rates but may increase the risk of specific toxicities such as diarrhea and neutropenia.

Irinotecan Hydrochloride for injection should be stored at 2‑8 °C in a refrigerator. Keep the product in its original packaging, protect it from light, and avoid freezing or shaking. Follow aseptic techniques when reconstituting and administering the medication.

Irinotecan is given intravenously, typically as an infusion over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare professionals in a clinical setting, with monitoring for infusion‑related reactions and supportive care as needed.

The most serious risks include severe neutropenia, febrile neutropenia, and life‑threatening diarrhea (colitis). Patients should be monitored closely for signs of infection, fever, or persistent gastrointestinal symptoms, and prompt medical intervention is required if these events occur.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its components. It should also be avoided in individuals with severe hepatic impairment, uncontrolled infections, or those who are pregnant unless the potential benefit justifies the risk.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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