GNH USA

Europe — EMA

Irinotecan Mylan

GNH USA supplies Irinotecan Mylan (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer and solid tumors. Request a quote for supply.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Mylan, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It treats metastatic colorectal cancer and advanced solid tumors in adult patients.

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

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan Mylan is a topoisomerase I inhibitor used in oncology for several cancer types.

- Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based regimens. - Advanced solid tumors: provides antitumor activity in a range of refractory solid malignancies. - Colorectal cancer (adjuvant setting): used as part of combination therapy to reduce recurrence risk after surgical resection.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

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

Common Side Effects: - Nausea and vomiting: gastrointestinal upset common during infusion. - Diarrhea: may be severe and require antidiarrheal therapy. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: temporary hair loss during treatment. - Fatigue: general tiredness and weakness. - Anemia: decreased red blood cell levels causing fatigue.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils requiring urgent care. - Severe colitis: inflammation of the colon that can be life‑threatening. - Hepatotoxicity: liver enzyme elevations indicating liver injury. - Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis during infusion. - Cardiac toxicity: rare arrhythmias or ischemic events. - Secondary malignancies: very rare risk of new cancers after prolonged exposure.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Before initiating therapy, clinicians should assess patient health status and monitor for specific risks.

- Baseline blood counts: obtain CBC to detect pre‑existing neutropenia or anemia. - Liver function: evaluate hepatic enzymes as irinotecan metabolism is hepatic. - Renal function: adjust monitoring if creatinine clearance is impaired. - Concomitant medications: review for drugs that may increase toxicity, especially CYP3A4 inhibitors. - Pregnancy and lactation: avoid use unless benefits clearly outweigh potential fetal or infant risks. - Store at ambient temperature: keep in original container, protect from light and moisture, and do not freeze.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan can interact with several drug classes, altering efficacy or toxicity.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase SN‑38 exposure and toxicity. - CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect. - Anticholinergic agents: can exacerbate irinotecan‑induced diarrhea.

Moderate Interactions (Monitor Closely): - Warfarin: may enhance anticoagulant effect, requiring INR monitoring. - UGT1A1 inhibitors (e.g., atazanavir): can raise SN‑38 levels, increasing risk of neutropenia. - Other myelosuppressive chemotherapy: may compound bone‑marrow suppression, necessitating frequent blood count checks.

Frequently asked questions

What is Irinotecan Mylan used for?+
Irinotecan Mylan is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and for patients with advanced solid tumors. It is used as part of combination regimens to improve survival and disease control in adult oncology patients.
How does Irinotecan work?+
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 replication, leading to accumulation of DNA strand breaks, disruption of tumor cell replication, and ultimately cell death.
What is the usual dose of Irinotecan Mylan?+
The dosing regimen for Irinotecan Mylan is individualized by the prescribing oncologist based on the specific cancer type, treatment protocol, patient weight, renal and hepatic function, and prior therapy. Clinicians determine the dose and schedule according to approved guidelines.
Is Irinotecan safe during pregnancy or breastfeeding?+
The safety of Irinotecan in pregnancy and lactation has not been established. It is classified as contraindicated unless the potential benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment and for a period after the last dose.
How do I order Irinotecan Mylan from GNH USA?+
To order Irinotecan Mylan, 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 import documentation.
How does Irinotecan compare with the main alternative drug or class?+
Irinotecan belongs to the topoisomerase I inhibitor class, with topotecan being a closely related alternative. Compared with topotecan, irinotecan generally has a broader indication spectrum, especially in colorectal cancer, and is often combined with fluoropyrimidines. Toxicity profiles differ, with irinotecan more commonly causing severe diarrhea, while topotecan is associated with greater myelosuppression.
What are the storage and handling requirements for Irinotecan Mylan?+
Irinotecan Mylan should be stored at controlled room temperature, below 25 °C, in its original packaging to protect from moisture and light. The solution must be inspected for particulate matter and discoloration before preparation, and it should not be frozen or shaken vigorously.
How is Irinotecan administered?+
Irinotecan is administered as an intravenous infusion by a qualified healthcare professional. The infusion is typically given over 30 to 90 minutes, depending on the prescribed regimen, and may be followed by hydration and anti‑emetic pre‑medication to reduce infusion‑related side effects.
What are the most serious risks to watch for while receiving Irinotecan?+
The most serious risks include febrile neutropenia, severe diarrhea that can lead to dehydration, hepatic toxicity, and rare hypersensitivity reactions such as anaphylaxis. Patients should be monitored closely for fever, persistent vomiting, abdominal pain, and changes in liver function tests throughout therapy.
Who should not use Irinotecan Mylan?+
Irinotecan is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, in those with severe uncontrolled infections, and in individuals with significant bone‑marrow suppression (e.g., neutrophil count <1500 µL) unless dose adjustments are made. Caution is also advised for patients with impaired hepatic function.
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
Viatris Limited
Origin
EU

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