GNH USA

Europe — EMA

Irinotecano Hikma

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

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, the active ingredient in Irinotecano 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, targeting rapidly dividing tumor cells.

GNH USA supplies Irinotecano Hikma as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide. The company adheres to EU GMP standards and provides cold‑chain logistics where required, ensuring product integrity from manufacturing to the point of care. All shipments are tracked and documented in accordance with international regulatory requirements.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is a topoisomerase I inhibitor used in the management of colorectal cancer.

- Metastatic colorectal cancer: used as a single agent or in combination regimens to achieve tumor shrinkage and prolong survival. - Colorectal cancer refractory to fluoropyrimidine therapy: provides an alternative mechanism of action after failure of standard chemotherapy. - Colorectal cancer in combination with 5‑fluorouracil and leucovorin (FOLFIRI): forms part of a standard regimen to enhance response rates.

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: - Neutropenia: reduced white blood cell count increasing infection risk. - Diarrhea: often severe and may require supportive care. - Nausea and vomiting: typical chemotherapy‑related symptoms. - Fatigue: generalized tiredness affecting daily activities. - Alopecia: hair loss that is usually reversible.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent treatment. - Severe colitis or intestinal perforation: life‑threatening gastrointestinal complications. - Hepatic toxicity: elevated liver enzymes or bilirubin. - Allergic reactions: anaphylaxis or severe hypersensitivity. - Pulmonary toxicity: interstitial lung disease or pneumonitis.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Before initiating therapy, clinicians should assess patient suitability and monitor for potential complications.

- Monitor blood counts: regular CBCs to detect neutropenia early. - Assess liver function: baseline and periodic LFTs due to hepatic metabolism. - Evaluate gastrointestinal status: avoid use in patients with active bowel obstruction. - Avoid in patients with known hypersensitivity to irinotecan or its excipients. - Adjust dose in renal or hepatic impairment: follow prescribing guidelines. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan's efficacy and safety can be altered by concomitant medications.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin): may reduce SN‑38 formation and therapeutic effect. - Concurrent myelosuppressive agents: increase risk of severe neutropenia and infection. - Potent UGT1A1 inhibitors: elevate SN‑38 levels, heightening toxicity.

Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): may increase irinotecan exposure. - Anticholinergic drugs: can exacerbate diarrhea. - Warfarin: may require INR monitoring due to potential interaction.

Frequently asked questions

What is Irinotecano Hikma used for?+
Irinotecano Hikma contains irinotecan, a topoisomerase I inhibitor indicated for the treatment of metastatic colorectal cancer in adult patients. It is administered intravenously, often as part of combination chemotherapy regimens, to help control tumor growth and extend survival.
How does irinotecan work in cancer therapy?+
After infusion, irinotecan is converted to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately causing cancer cell death.
What is the usual dose of Irinotecano Hikma?+
The dosing regimen for Irinotecano Hikma is determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Specific dose calculations and schedules are individualized and should follow approved oncology guidelines.
Is Irinotecano Hikma safe during pregnancy or breastfeeding?+
The safety of irinotecan in pregnancy and lactation has not been established. It is generally contraindicated in pregnant or nursing women unless the potential benefit outweighs the potential risk, and this decision must be made by the treating physician.
How do I order Irinotecano Hikma from GNH USA?+
To place an order, submit an enquiry on the Irinotecano 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 Irinotecano Hikma compare with other colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines or oxaliplatin. It is often used after failure of first‑line therapies or in combination regimens such as FOLFIRI, providing an alternative for patients who need a different cytotoxic approach.
What are the storage and handling requirements for Irinotecano Hikma?+
Irinotecano Hikma 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 by the manufacturer.
How is Irinotecano Hikma administered to patients?+
The product is supplied as an injectable solution for intravenous infusion. Administration is performed by qualified healthcare professionals in a clinical setting, following aseptic technique and the infusion rate recommended in the prescribing information.
What are the most serious risks associated with Irinotecano Hikma?+
The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare but severe allergic reactions. Patients should be monitored closely for signs of infection, gastrointestinal complications, and liver function abnormalities.
Who should not receive Irinotecano Hikma?+
Irinotecano Hikma is contraindicated in patients with known hypersensitivity to irinotecan or any formulation component. Caution is advised for individuals with pre‑existing severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment, and the drug should be avoided in such cases.
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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