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Europe — EMA

Irinotecanhydrochlorid 3 H2o Kelix Bio

GNH USA supplies Irinotecanhydrochlorid 3 H2O Kelix Bio (Irinotecan), a topoisomerase I inhibitor for colorectal and metastatic colorectal cancer.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecanhydrochlorid 3 H2O Kelix Bio, is a topoisomerase I inhibitor presented as an injectable solution for intravenous use. It treats colorectal cancer, including metastatic disease, in adult patients.

GNH USA supplies Irinotecanhydrochlorid 3 H2O Kelix Bio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

What is Irinotecan Hydrochloride Trihydrate used for?

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

- Colorectal cancer: improves overall survival when used in combination chemotherapy. - Metastatic colorectal cancer: part of standard first‑line regimens for advanced disease. - Recurrent colorectal cancer: employed after disease progression on prior therapies.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, from mild to severe.

Common Side Effects: - Neutropenia: reduced white blood cell count increasing infection risk. - Diarrhea: may be severe and require supportive care. - Nausea and vomiting: typical chemotherapy‑related symptoms. - Alopecia: hair loss during treatment cycles. - Fatigue: generalized weakness and reduced stamina. - Abdominal pain: discomfort in the gastrointestinal tract.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent medical attention. - Severe colitis: life‑threatening inflammation of the colon. - Allergic reactions: rash, itching, or anaphylaxis. - Hepatotoxicity: liver enzyme elevations indicating potential liver injury. - Pulmonary toxicity: rare lung inflammation or fibrosis. - Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Irinotecan requires careful monitoring and specific safety measures before and during therapy.

- 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: screen for obstruction or severe diarrhea risk. - Adjust dose in hepatic impairment: reduce dosage according to liver function tests. - Avoid use in severe neutropenia: postpone treatment if neutrophils are critically low. - 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 other medicines, affecting its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase SN‑38 exposure. - UGT1A1 inhibitors (e.g., atazanavir, indinavir): raise risk of severe neutropenia. - Concurrent myelosuppressive agents: additive bone‑marrow toxicity. - Live vaccines: heightened infection risk during immunosuppression. - Anticholinergic drugs: may exacerbate constipation and bowel complications.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce therapeutic effect. - Antacids containing magnesium or aluminum: may alter gastrointestinal absorption. - Warfarin: monitor INR as irinotecan can affect anticoagulation control.

Frequently asked questions

What is Irinotecanhydrochlorid 3 H2O Kelix Bio used for?+
Irinotecanhydrochlorid 3 H2O Kelix Bio contains the chemotherapy agent irinotecan, which is used to treat colorectal cancer, including metastatic disease. It is administered as part of combination regimens to improve survival and control tumor growth in adult patients.
How does Irinotecan work in the body?+
Irinotecan is converted to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, causing accumulation of DNA damage, cell‑cycle arrest, and ultimately death of rapidly dividing cancer cells.
What is the usual dose of Irinotecan?+
The dose of Irinotecan is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, and patient tolerance. Specific dosing regimens are determined by the treating physician and should follow established clinical guidelines.
Is Irinotecan safe during pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated in pregnancy because it can cause fetal harm. It is also not recommended during breastfeeding, as it may be excreted in milk and affect the infant. Women of child‑bearing potential should use effective contraception during treatment.
How do I order Irinotecanhydrochlorid 3 H2O Kelix Bio from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials and respond with 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, offering a different mechanism of action compared with fluoropyrimidines (e.g., 5‑FU) or oxaliplatin. It is often used in combination with these agents to enhance efficacy. Compared with newer targeted therapies, irinotecan provides a cytotoxic approach that remains a backbone of many standard regimens.
What are the storage requirements for Irinotecanhydrochlorid 3 H2O Kelix Bio?+
The product should be stored at 2‑8 °C in a refrigerator. Keep it in the original packaging, protect it from light, and avoid freezing or shaking the vial. Do not store at room temperature for extended periods.
How is Irinotecan administered to patients?+
Irinotecan is given as an intravenous infusion by a qualified healthcare professional. The infusion rate and duration are determined by the prescribing physician and may vary depending on the treatment protocol and patient tolerance.
What are the most serious risks associated with Irinotecan therapy?+
The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, allergic reactions such as anaphylaxis, and hepatic toxicity. Patients should be monitored closely for signs of infection, gastrointestinal distress, and liver function abnormalities.
Who should not receive Irinotecan?+
Irinotecan should not be used in patients with known hypersensitivity to the drug or its components, those with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment without dose adjustment. It is also contraindicated during pregnancy and breastfeeding.
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
Kelix Bio (Malta) Limited
Origin
EU

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