GNH USA

Europe — EMA

Irinotecan Hikma

GNH USA supplies Irinotecan Hikma (Irinotecan Hydrochloride Trihydrate), a topoisomerase I inhibitor for metastatic colorectal cancer and adjuvant colon

Irinotecan Hydrochloride Trihydrate

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

What is Irinotecan Hydrochloride Trihydrate used for?

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.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

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

What precautions apply to Irinotecan Hydrochloride Trihydrate?

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.

What does Irinotecan Hydrochloride Trihydrate interact with?

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

What is Irinotecan Hikma used for?+
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.
How does Irinotecan Hydrochloride Trihydrate work?+
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.
What is the usual dose of Irinotecan Hikma?+
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.
Is Irinotecan safe during pregnancy or breastfeeding?+
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.
How do I order Irinotecan Hikma from GNH USA?+
To order, submit an enquiry on the Irinotecan Hikma product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Irinotecan compare with other topoisomerase I inhibitors?+
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.
What are the storage and handling requirements for Irinotecan Hikma?+
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.
How is Irinotecan Hikma administered?+
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.
What are the most serious risks associated with Irinotecan Hikma?+
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.
Who should not use Irinotecan Hikma?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Irinotecan Hydrochloride Trihydrate
Route
Intravenous Use
Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Origin
EU

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