GNH USA

Europe — EMA

Irinotecan Hydrochloride Medac

GNH USA supplies Irinotecan Hydrochloride Medac (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer and colorectal adenocarcinoma.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, the active ingredient in Irinotecan Hydrochloride Medac, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer and colorectal adenocarcinoma in adult patients. The product conforms to European Union pharmacopeial standards and is indicated for use under specialist oncology supervision.

GNH USA supplies Irinotecan Hydrochloride Medac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, ensuring quality, regulatory compliance and reliable delivery.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is a topoisomerase I inhibitor used in the treatment of colorectal cancer and related metastatic disease.

Metastatic colorectal cancer: improves survival when incorporated into combination chemotherapy regimens. Colorectal adenocarcinoma: reduces tumor progression in advanced disease settings. Colorectal cancer (adjuvant setting): used post‑surgery to lower recurrence risk in eligible patients.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Nausea and vomiting: mild to moderate gastrointestinal upset. - Diarrhea: often early‑onset and may require antidiarrheal therapy. - Neutropenia: reduced white blood cell count increasing infection risk. - Fatigue: generalized tiredness during treatment cycles. - Alopecia: temporary hair loss. - Anorexia: decreased appetite.

Serious or Rare Side Effects: - Severe neutropenia or febrile neutropenia: requires immediate medical attention. - Severe diarrhea or colitis: can lead to dehydration and electrolyte imbalance. - Allergic reactions: rash, pruritus, or anaphylaxis in rare cases. - Hepatic toxicity: elevated liver enzymes or jaundice. - Pulmonary toxicity: interstitial pneumonitis or dyspnea. - Hemorrhagic cystitis: rare urinary tract irritation.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

When using Irinotecan, clinicians should observe several safety measures to minimize risks.

Monitor blood counts: perform regular CBC to detect neutropenia early. Assess liver function: adjust dosing in patients with hepatic impairment. Hydration: ensure adequate fluid intake to reduce risk of severe diarrhea. Pregnancy: avoid use unless potential benefits outweigh risks to the fetus. Drug‑specific monitoring: watch for signs of infection or severe gastrointestinal toxicity. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan can affect or be affected by other medicines; awareness of key interactions helps manage therapy safely.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase SN‑38 exposure and toxicity. - Concurrent myelosuppressive agents (e.g., carboplatin, cyclophosphamide): heighten risk of severe neutropenia. - Anticholinergic drugs (e.g., atropine) when used to manage diarrhea: may mask early signs of severe colitis.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, St. John’s wort): may reduce efficacy by lowering SN‑38 levels. - Warfarin: Irinotecan may alter INR; monitor coagulation parameters. - Other chemotherapeutic agents (e.g., 5‑FU, oxaliplatin): dose adjustments may be required based on combined toxicity profiles.

Frequently asked questions

What is Irinotecan Hydrochloride Medac used for?+
Irinotecan Hydrochloride Medac is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and colorectal adenocarcinoma in adult patients. It is typically administered as part of combination regimens under the supervision of an oncology specialist.
How does Irinotecan work in cancer therapy?+
Irinotecan is a prodrug that is converted inside cells to the active metabolite SN‑38. SN‑38 inhibits topoisomerase I, an enzyme required for DNA unwinding during replication. By stabilizing the DNA‑topoisomerase I complex, it prevents DNA strand re‑ligation, leading to DNA breaks, halted replication, and cancer cell death.
What is the usual dose of Irinotecan Hydrochloride Medac?+
The specific dose of Irinotecan Hydrochloride Medac is determined by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, and concurrent therapies. Dosing regimens are individualized and should follow the latest clinical guidelines and the product’s prescribing information.
Is Irinotecan safe to use during pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated in pregnancy unless the potential benefit justifies the risk to the fetus. It may be excreted in breast milk, so breastfeeding is generally not recommended during treatment. Decisions should be made in consultation with a healthcare professional familiar with the patient’s condition.
How do I order Irinotecan Hydrochloride Medac from GNH USA?+
To place an order, submit an enquiry on the 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 any required import documentation.
How does Irinotecan compare with other colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines (e.g., 5‑FU) and oxaliplatin, which target DNA synthesis and cross‑linking. It is often combined with these agents to enhance efficacy. Compared with some alternatives, Irinotecan may have a higher incidence of diarrhea but provides valuable benefit in resistant disease.
What are the storage and handling requirements for Irinotecan Hydrochloride Medac?+
The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to administration, the solution should be inspected for particulate matter and used within the time frame specified in the product label after dilution.
How is Irinotecan Hydrochloride Medac administered?+
Irinotecan Hydrochloride Medac is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions and supportive care measures.
What are the most serious risks associated with Irinotecan therapy?+
The most serious risks include severe neutropenia or febrile neutropenia, which can predispose to life‑threatening infections, and severe diarrhea or colitis that may lead to dehydration and electrolyte imbalance. Prompt recognition and management of these events are essential to reduce morbidity.
Who should not receive Irinotecan Hydrochloride Medac?+
Patients with known hypersensitivity to Irinotecan or any of its excipients, those with uncontrolled severe infections, or individuals with significant hepatic impairment where dose adjustment is not feasible should avoid this medication. Additionally, it is contraindicated in pregnant women unless the therapeutic benefit outweighs the potential fetal risk.
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
Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)
Origin
EU

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