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 an injectable solution for intravenous use. It treats metastatic colorectal cancer and is used as adjuvant therapy for colon cancer in adult patients.

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

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

Irinotecan Hikma is a topoisomerase I inhibitor used in colorectal cancer treatment pathways.

  • Metastatic colorectal cancer: improves overall survival when combined with other chemotherapeutic agents.
  • Adjuvant treatment of colon cancer: reduces the risk of disease recurrence after surgical resection.
  • Colorectal cancer (advanced setting): provides disease control as part of multi‑drug regimens.

How It Works

  • After intravenous administration, irinotecan is converted by hepatic carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing relegation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage, triggering apoptosis in rapidly dividing tumor cells.

Side Effects

Irinotecan may cause a range of adverse reactions, from mild to life‑threatening.

Common Side Effects

  • Nausea and vomiting
  • Diarrhea (often severe)
  • Neutropenia
  • Alopecia
  • Fatigue
  • Abdominal cramping

Serious or Rare Side Effects

  • Febrile neutropenia
  • Severe colitis or intestinal perforation
  • Hepatic toxicity (elevated transaminases)
  • Anaphylactic or severe infusion reactions
  • Hemorrhagic cystitis
  • Severe electrolyte disturbances

Precautions & Warnings

Before initiating therapy, clinicians should assess patient‑specific risk factors and monitor for toxicity.

  • Monitor blood counts: perform regular complete blood counts to detect neutropenia.
  • Assess liver function: check hepatic enzymes and bilirubin prior to each cycle.
  • Evaluate bowel status: avoid use in patients with recent bowel obstruction or inflammatory bowel disease.
  • Adjust for renal impairment: consider dose modification in patients with reduced renal clearance.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential risks, as safety data are limited.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) – may reduce SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir) – can increase SN‑38 levels and toxicity.
  • Concurrent myelosuppressive agents – heighten risk of severe neutropenia.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin) – monitor INR for bleeding risk.
  • Diuretics – watch for electrolyte imbalances, especially with diarrhea.
  • Antacids containing aluminum or magnesium – may affect absorption of oral supportive medications.

Frequently Asked Questions

Irinotecan Hikma is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy after surgical resection of colon cancer. It is used in adult patients as part of combination regimens to improve survival and reduce disease recurrence.

After infusion, irinotecan is metabolised to SN‑38, which binds to DNA‑topoisomerase I. This prevents the enzyme from resealing single‑strand DNA breaks that occur during replication, leading to accumulation of DNA damage and ultimately causing tumor cell death.

The dose of Irinotecan Hikma is individualized by the prescribing oncologist based on factors such as cancer type, treatment regimen, patient weight, liver function and prior therapy. Clinicians determine the exact amount, infusion rate and schedule for each patient.

Safety data for Irinotecan in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and breastfeeding is generally discouraged during treatment.

To 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 required import documentation.

Irinotecan and topotecan are the two main topoisomerase I inhibitors. Irinotecan is typically used for colorectal cancers and is administered intravenously, whereas topotecan is often used for ovarian and small‑cell lung cancers and can be given intravenously or orally. Irinotecan’s active metabolite SN‑38 has a longer half‑life, which may affect toxicity profiles.

Irinotecan Hikma should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. The product should be kept in its original container until use and handled in accordance with aseptic technique to maintain sterility.

Irinotecan Hikma is given as an intravenous infusion, usually over 30‑90 minutes depending on the protocol. The infusion is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring of vital signs and supportive care for potential side effects.

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

Irinotecan Hikma is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant bowel obstruction. Caution is also advised for patients with impaired hepatic function or known UGT1A1 deficiency.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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