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

Irinotecan Actavis

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Actavis (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Actavis, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It is employed in oncology to treat metastatic colorectal cancer, as adjuvant therapy for colon cancer, and in combination regimens for small cell lung cancer.

GNH India supplies Irinotecan Actavis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide. The company adheres to EU quality standards and provides regulatory documentation for global distribution.

Manufacturer / TM Owner

Actavis Group Ptc Ehf.

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Indications & Clinical Uses

  • Irinotecan is used in chemotherapy protocols targeting cancers that rely on rapid DNA replication.
  • Metastatic colorectal cancer: combined with other agents to improve overall survival in patients with advanced disease.
  • Adjuvant colon cancer: administered after surgical resection to reduce recurrence risk.
  • Small cell lung cancer: incorporated into multi‑drug regimens to enhance response rates in extensive‑stage disease.

How It Works

  • Irinotecan is a pro‑drug converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the transient DNA‑topoisomerase I complex, it prevents relegation of single‑strand breaks, leading to accumulation of DNA damage during replication and ultimately triggering apoptosis in rapidly dividing tumor cells. The conversion is mediated by carboxylesterases, and SN‑38 exhibits markedly higher potency than the parent compound.

Side Effects

Irinotecan may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: often severe and may require supportive care.
  • Nausea and vomiting: typical chemotherapy‑related symptoms.
  • Alopecia: hair loss during treatment cycles.
  • Fatigue: generalized tiredness affecting daily activities.
  • Decreased appetite: reduced food intake during therapy.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical attention.
  • Severe colitis or watery diarrhea leading to dehydration.
  • Hepatic dysfunction: elevated liver enzymes or jaundice.
  • Allergic reactions: rash, bronchospasm, or anaphylaxis.
  • Severe abdominal pain: may indicate intestinal toxicity.
  • Electrolyte disturbances: especially hypokalemia and hypomagnesemia.

Precautions & Warnings

  • Before initiating Irinotecan therapy, clinicians should observe several safety measures.
  • Monitor blood counts: perform regular complete blood count tests to detect neutropenia.
  • Assess liver function: evaluate hepatic enzymes because metabolism occurs in the liver.
  • Avoid use in patients with known hypersensitivity to irinotecan or its excipients.
  • Use caution in patients with bowel obstruction or pre‑existing diarrhea.
  • Adjust dose in renal impairment: consider reduced dosing for decreased clearance.
  • Store at ambient temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Irinotecan can interact with other medicines, influencing its efficacy or toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce SN‑38 exposure.
  • Concurrent myelosuppressive chemotherapy (e.g., cyclophosphamide): increases risk of severe bone‑marrow suppression.
  • High‑dose loperamide or other antidiarrheals that alter gut motility: can exacerbate irinotecan‑induced diarrhea.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may increase SN‑38 levels.
  • Warfarin: potential for altered anticoagulation parameters.
  • NSAIDs: may increase risk of gastrointestinal toxicity.
  • UGT1A1 polymorphism affecting SN‑38 glucuronidation: monitor for increased toxicity.

Frequently Asked Questions

Irinotecan Actavis is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer, as adjuvant therapy following surgery for colon cancer, and as part of combination regimens for small cell lung cancer. It is used in adult patients where a topoisomerase I inhibitor is appropriate to target rapidly dividing tumor cells.

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 and prevents the re‑ligation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage, triggering apoptosis in rapidly proliferating cancer cells.

The dose of Irinotecan Actavis is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, type and stage of cancer, renal and hepatic function, and prior treatment history. No fixed dosing schedule can be provided without a medical prescription.

Safety data for Irinotecan in pregnancy and lactation are limited, and the drug is generally contraindicated because of potential fetal toxicity and excretion in breast milk. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternative treatment options with their healthcare provider.

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

Irinotecan and topotecan are the two main topoisomerase I inhibitors used in oncology. Irinotecan is typically administered intravenously and is preferred for colorectal and certain lung cancers, while topotecan is available in both intravenous and oral forms and is often used for ovarian and small‑cell lung cancers. Differences in pharmacokinetics, toxicity profiles, and approved indications guide the choice between them.

Irinotecan Actavis should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. The solution must be prepared in a sterile environment and used within the time frame recommended by the manufacturer. Personnel handling the product should wear appropriate protective equipment to avoid accidental exposure.

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

The most serious adverse events associated with Irinotecan include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare but severe allergic reactions such as anaphylaxis. Patients should be educated to report fever, persistent diarrhea, abdominal pain, jaundice, or any signs of an allergic response immediately.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its excipients. It should be avoided in individuals with uncontrolled infections, severe bone‑marrow suppression, or active bowel obstruction. Caution is also advised for patients with significant hepatic impairment or those taking strong CYP3A4 inducers that may reduce drug efficacy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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