GNH USA

Europe — EMA

Irinomedac

GNH USA supplies Irinomedac (Irinotecan), an antineoplastic agent for metastatic colorectal cancer and adjuvant colon cancer.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, the active ingredient in Irinomedac, is a topoisomerase I inhibitor presented as an injection solution for intravenous use. It treats metastatic colorectal cancer, is used as adjuvant therapy for colon cancer, and has off‑label application in small cell lung cancer.

GNH USA supplies Irinomedac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is employed in oncology regimens targeting specific solid tumours.

Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy. Adjuvant treatment of colon cancer: reduces the risk of disease recurrence after surgical resection. Small cell lung cancer (off‑label): may be incorporated into combination chemotherapy protocols for disease control.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan is associated with a range of adverse reactions that vary 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: temporary hair loss. - Fatigue: generalized tiredness during treatment. - Anemia: decreased red blood cell levels.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils requiring urgent medical attention. - Severe colitis or intestinal perforation. - Hepatotoxicity: elevated liver enzymes or liver dysfunction. - Allergic reactions: rash, bronchospasm, or anaphylaxis. - Hand‑foot syndrome: painful redness and swelling of palms and soles. - Cardiotoxicity: rare cardiac rhythm disturbances.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Prior to initiating therapy, clinicians should assess patient‑specific risk factors and monitor relevant parameters.

Monitor blood counts: perform regular complete blood counts to detect neutropenia. Assess liver function: evaluate hepatic enzymes before and during treatment. Screen for bowel obstruction: consider baseline imaging in patients with prior abdominal surgery. Adjust dose in hepatic impairment: reduce dosage according to liver function test results. Avoid in known hypersensitivity: discontinue if severe allergic reaction occurs. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan may interact with other medicines, altering its efficacy or toxicity profile.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin): decrease irinotecan exposure. - UGT1A1 inhibitors (e.g., atazanavir): increase SN‑38 levels and toxicity. - Concurrent myelosuppressive agents: amplify risk of severe neutropenia. - Anticholinergic drugs: may exacerbate irinotecan‑induced diarrhea. - Live vaccines: immunosuppression may reduce vaccine effectiveness.

Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): raise irinotecan plasma concentrations. - Anticoagulants (e.g., warfarin): heightened bleeding risk. - Antidiarrheal agents (e.g., loperamide): may mask early signs of severe diarrhea. - Proton pump inhibitors: possible alteration of gastric pH affecting absorption of oral metabolites. - Herbal supplements (e.g., St. John’s wort): may induce metabolic enzymes.

Frequently asked questions

What conditions is Irinomedac used to treat?+
Irinomedac contains irinotecan, which is approved for metastatic colorectal cancer and for adjuvant therapy after surgical resection of colon cancer. It is also used off‑label in combination regimens for small cell lung cancer when clinicians deem it appropriate.
How does irinotecan work in the body?+
Irinotecan is a pro‑drug that is converted to SN‑38, a potent inhibitor of DNA‑topoisomerase I. By stabilising the enzyme‑DNA complex, SN‑38 prevents the re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage and ultimately causing cancer cell death.
What is the usual dose of Irinomedac?+
The specific dose of Irinomedac is determined by the prescribing oncologist based on the patient’s cancer type, body surface area, treatment protocol and clinical condition. Dosing regimens are individualized and should follow the approved prescribing information.
Is Irinomedac safe to use during pregnancy or breastfeeding?+
The safety of irinotecan in pregnancy and lactation has not been established. It is generally contraindicated in pregnant or nursing patients unless the potential benefit justifies the potential risk to the fetus or infant. Consultation with a specialist is essential.
How do I order Irinomedac from GNH USA?+
To place an order, submit an enquiry on the Irinomedac 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 Irinomedac compare with other topoisomerase I inhibitors?+
Irinotecan is one of the most widely used topoisomerase I inhibitors and differs from agents such as topotecan in its pro‑drug conversion to SN‑38 and its dosing schedule. Both share a similar mechanism, but irinotecan is primarily used for colorectal and certain lung cancers, whereas topotecan is often employed in ovarian and small cell lung cancer.
What are the storage requirements for Irinomedac?+
Irinomedac should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and do not freeze or shake the solution. If the product reaches room temperature, it should be used promptly and not re‑refrigerated.
How is Irinomedac administered to patients?+
Irinomedac is supplied as an injectable solution for intravenous infusion. It is typically administered by a qualified healthcare professional in a clinical setting, following a controlled infusion rate as specified in the treatment protocol.
What are the most serious risks associated with Irinomedac?+
The most serious risks 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 monitored closely for signs of infection, gastrointestinal distress and liver function abnormalities.
Who should not receive Irinomedac?+
Irinomedac is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients. It should also be avoided in individuals with uncontrolled infections, severe hepatic impairment, or pre‑existing bowel obstruction without careful risk assessment.
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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