GNH USA

Europe — EMA

Irinotecan Hikma

GNH USA supplies Irinotecan Hikma (Irinotecan Hydrochloride Trihydrate), a Topoisomerase I inhibitor for metastatic colorectal cancer.

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 injection solution for intravenous use. It is used in the treatment of metastatic colorectal cancer in adult patients.

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

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan Hikma is a Topoisomerase I inhibitor indicated for colorectal cancer therapy.

Metastatic colorectal cancer: used as part of combination chemotherapy to improve overall survival. Advanced colorectal cancer: administered intravenously to inhibit tumor cell replication. Colorectal adenocarcinoma with disease progression: employed in regimens for patients who have failed prior therapy.

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 medical management. - Nausea and vomiting: typical during and after infusion. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: temporary hair loss. - Fatigue: generalized tiredness. - Abdominal cramping: discomfort in the stomach area.

Serious or Rare Side Effects: - Severe neutropenic infection: febrile neutropenia requiring hospitalization. - Acute cholinergic syndrome: sweating, salivation, bronchospasm. - Hepatotoxicity: elevated liver enzymes. - Severe mucositis: painful inflammation of the mouth lining. - Hypersensitivity reactions: rash, dyspnea, anaphylaxis. - Tumor lysis syndrome: metabolic disturbances from rapid tumor cell death.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Before initiating therapy, clinicians should assess patient health status and monitor laboratory parameters.

Baseline blood counts: obtain complete blood count and differential. Liver function: evaluate hepatic enzymes and bilirubin. Renal function: assess creatinine clearance for dose adjustments. Concurrent medications: review for agents that may increase toxicity. Pregnancy and lactation: avoid use unless benefits outweigh potential risks. 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 several drugs that affect its metabolism or toxicity profile.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin): may reduce efficacy. - Anticholinesterase agents (e.g., neostigmine): increase risk of cholinergic syndrome. - High‑dose corticosteroids: may exacerbate neutropenia.

Moderate Interactions (Monitor Closely): - UGT1A1 inhibitors (e.g., atazanavir): may raise SN‑38 levels. - Antiemetics containing serotonin antagonists: potential additive nausea control. - Warfarin: monitor INR for altered anticoagulation. - Fluoropyrimidines: increased myelosuppression risk. - Proton pump inhibitors: may affect gastric pH and absorption of oral supportive meds.

Frequently asked questions

What is Irinotecan Hikma used for?+
Irinotecan Hikma is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer in adult patients. It is typically used in combination with other chemotherapeutic drugs to improve survival outcomes.
How does Irinotecan Hydrochloride Trihydrate work?+
The drug is converted inside cells 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 permanent DNA damage and cancer cell death.
What is the usual dose of Irinotecan Hikma?+
The specific dose and schedule are determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Dosing is individualized and should follow the approved prescribing information.
Is Irinotecan Hikma safe during pregnancy or breastfeeding?+
The safety of Irinotecan Hikma in pregnancy or while nursing has not been established. It is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant, and decisions should be made by a qualified healthcare professional.
How do I order Irinotecan Hikma from GNH USA?+
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 necessary import documentation.
How does Irinotecan compare with other colorectal cancer drugs?+
Irinotecan belongs to the Topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or fluoropyrimidines. It offers a distinct mechanism of action and is often combined with these drugs to achieve synergistic anti‑tumor effects, especially in patients with disease progression.
What are the storage and handling requirements for Irinotecan Hikma?+
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 recommended by the manufacturer.
How is Irinotecan Hikma administered?+
Irinotecan Hikma is supplied as an injectable solution for intravenous infusion. It is administered by a qualified healthcare professional, typically over a period of 30‑90 minutes, according to the treatment protocol established by the oncologist.
What are the most serious risks associated with Irinotecan Hikma?+
Serious risks include severe neutropenia leading to infection, life‑threatening diarrhea, acute cholinergic syndrome, and rare but severe hypersensitivity reactions. Patients should be closely monitored for signs of infection, gastrointestinal toxicity, and any allergic responses during therapy.
Who should not receive Irinotecan Hikma?+
Patients with known hypersensitivity to Irinotecan or any component of the formulation should avoid the drug. It is also contraindicated in individuals with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment without dose adjustment.
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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