GNH USA

Europe — EMA

Irinotecan Hikma

GNH USA supplies Irinotecan Hikma (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer. Request a quote for global supply to hospitals.

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 is employed in the treatment of metastatic colorectal cancer in adult patients, where it interferes with DNA replication in rapidly dividing tumor cells.

GNH USA supplies Irinotecan Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, providing reliable sourcing and regulatory‑aligned distribution for oncology therapeutics.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is a topoisomerase I inhibitor that forms a core component of chemotherapy protocols for colorectal cancer, addressing disease progression and tumor burden.

Metastatic colorectal cancer: improves overall survival and disease control when used in combination chemotherapy regimens. Colorectal adenocarcinoma (advanced): contributes to tumor shrinkage as part of FOLFIRI or similar protocols. Colorectal cancer after oxaliplatin failure: used as a second‑line option to target resistant disease.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

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

Common Side Effects: - Diarrhea: often severe and may require antidiarrheal therapy. - Neutropenia: reduced white‑blood‑cell count increasing infection risk. - Nausea and vomiting: may be managed with antiemetics. - Alopecia: hair loss that is usually reversible. - Fatigue: generalized tiredness during treatment. - Anemia: decreased red‑blood‑cell levels.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent care. - Severe colitis or bowel perforation due to intense diarrhea. - Cholinergic syndrome: abdominal cramping, sweating, and bradycardia. - Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis. - Hepatotoxicity: elevated liver enzymes or liver dysfunction.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Prior to initiating therapy, clinicians should evaluate patient‑specific factors and monitor for potential complications. - Monitor blood counts: perform regular complete blood count tests to detect neutropenia or anemia. - Assess liver function: check hepatic enzymes and bilirubin before each cycle. - Evaluate gastrointestinal status: avoid use in patients with recent bowel obstruction or inflammatory bowel disease. - Adjust dose in renal impairment: consider reduced dosing for patients with compromised kidney function. - Avoid in known hypersensitivity: discontinue if severe allergic reactions occur. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

What does Irinotecan Hydrochloride Trihydrate interact with?

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

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce irinotecan exposure. - UGT1A1 inhibitors (e.g., atazanavir, indinavir): can increase SN‑38 levels and toxicity. - Concurrent myelosuppressive agents: heighten risk of severe neutropenia and anemia.

Moderate Interactions (Monitor Closely): - Anticoagulants (warfarin, DOACs): increased bleeding risk due to mucosal injury. - Other antineoplastic drugs (e.g., oxaliplatin): may augment cumulative hematologic toxicity. - Drugs affecting electrolyte balance (e.g., diuretics): monitor for dehydration from diarrhea.

Frequently asked questions

What is Irinotecan Hikma used for?+
Irinotecan Hikma is used as an intravenous chemotherapy agent for the treatment of metastatic colorectal cancer in adult patients. It is typically administered as part of combination regimens such as FOLFIRI, where it helps to control tumor growth and improve survival outcomes.
How does Irinotecan work?+
Irinotecan is a pro‑drug that is converted inside cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, preventing the re‑ligation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage and triggers apoptosis of rapidly dividing cancer cells.
What is the usual dose of Irinotecan Hikma?+
The dose of Irinotecan Hikma is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, prior therapies, and organ function. No fixed regimen is provided here; the healthcare professional determines the appropriate dosing schedule.
Is Irinotecan safe in pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated during pregnancy and lactation because of potential fetal toxicity and the risk of serious adverse effects in the infant. Women of child‑bearing potential should use effective contraception, and breastfeeding is not recommended while receiving treatment.
How do I order Irinotecan Hikma from GNH USA?+
To place an 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 colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, whereas alternatives such as oxaliplatin are platinum‑based agents and capecitabine is an oral fluoropyrimidine. Irinotecan is often chosen for patients who have progressed after oxaliplatin‑based therapy, offering a different mechanism of action and a distinct toxicity profile.
How should Irinotecan be stored and handled?+
Irinotecan should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. The product should be kept in its original packaging until preparation for infusion to maintain stability and potency.
How is Irinotecan administered?+
Irinotecan is given by intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The infusion is performed in a clinical setting by qualified healthcare personnel, and patients are monitored for infusion‑related reactions and early signs of toxicity.
What are the most serious risks associated with Irinotecan?+
The most serious risks include severe neutropenia leading to infection, febrile neutropenia, life‑threatening diarrhea or colitis, cholinergic syndrome, and hypersensitivity reactions. Prompt medical attention is required if patients develop fever, persistent diarrhea, abdominal pain, or signs of an allergic response.
Who should not use Irinotecan?+
Irinotecan should be avoided in patients with known hypersensitivity to the drug or its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant bowel obstruction. Caution is also advised for individuals with impaired hepatic function or 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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