Irinotecan Injection is a topoisomerase I inhibitor that is typically administered, alone or together with other agents, to treat certain types of colorectal cancer.





Dabur, Fresenius Kabi India


40 mg, 100 mg



I. Introduction

Brief Overview of Irinotecan

Irinotecan is a drug used in chemotherapy to treat specific forms of cancer, especially colorectal cancer. It belongs to a group of medications called topoisomerase inhibitors.

Importance in Cancer Treatment

Irinotecan holds significance in the field of cancer treatment. It has played a role in offering relief to patients who haven't experienced positive outcomes with alternative therapeutic approaches. Its high effectiveness, ability to work well with chemotherapy drugs and contribution to enhancing overall survival rates cannot be emphasized enough.

Objectives of the Article

The main aim of this article is to offer a grasp of Irinotecan. We will explore its chemical makeup, applications, recommended dosage, and other pertinent information.

II. What is Irinotecan?

Chemical Structure and Composition

Irinotecan is an intricate chemical composition that includes an alkaloid extracted from Camptotheca acuminata, a plant native to China. The molecular formula of this compound is C33H38N4O6.

Mechanism of Action: How Irinotecan Works

It works by blocking an enzyme called topoisomerase 1, which is crucial, for the replication of DNA. By interfering with this enzyme, Irinotecan stops the unwinding of DNA effectively stopping cancer cells from multiplying.

FDA Approval Status

Irinotecan was granted FDA approval in 1996 for treating patients with colon or rectum carcinoma.

III. Uses of Irinotecan

Approved Uses

Irinotecan is a chemotherapy drug commonly used as a second-line therapy option for colorectal cancer 1It has also received FDA approval for the treatment of gastrointestinal cancer 2.

Here are some references that support these claims:

Experimental Uses and Clinical Trials

Irinotecan is a chemotherapy drug that has been used to treat various types of cancers, including colorectal, pancreatic, and lung cancers 1Recent experimental explorations have shown that irinotecan may also be effective in the management of breast and cervical cancer 2.

Here are some references that support these claims:

Role in Combination Therapies

Irinotecan is a chemotherapy drug that is commonly used in combination with other chemotherapy drugs such as 5 Fluorouracil to maximize the effectiveness of treatment. It helps increase the effects of these drugs thereby enhancing their overall efficacy 1.

Here are some references that support this statement:

  1. 1Irinotecan and 5-FU/Leucovorin in Metastatic Colorectal Cancer: Balancing Efficacy, Toxicity, and Logistics
  2. 2Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly bolus therapy for metastatic colorectal cancer: a phase II trial
  3. 3Safety and efficacy of irinotecan, oxaliplatin, and capecitabine (XELOXIRI) regimen with or without targeted drugs in patients with metastatic colorectal cancer: a retrospective cohort study

IV. Off-Label Uses

Lung Cancer

Irinotecan is a chemotherapy drug not officially approved for lung cancer treatment, but it has been used off-label for this purpose 1.

Here are some references that support this statement:

  1. 1Irinotecan Monograph for Professionals -
  2. 2Low-dose Irinotecan as a Second-line Chemotherapy for Recurrent Small …
  3. 3Case Report: Combination of Olaparib With Chemotherapy in a Patient With ATM-Deficient Colorectal Cancer

Ovarian Cancer

Irinotecan is a chemotherapy drug that is currently being investigated for its effectiveness in treating cancer, although it has not yet received formal approval 1.

Here are some references that support this statement:

  1. 1Irinotecan Monograph for Professionals -
  2. 2 Irinotecan: A Review of Its Use in the Treatment of Colorectal and Other Cancers
  3. 3Irinotecan (Campto) | Cancer information | Cancer Research UK

Pancreatic Cancer

Irinotecan is a chemotherapy drug that belongs to the class of topoisomerase I inhibitors. It works by causing breaks in the DNA of cells that cannot be repaired, thereby stopping the growth of cancer cells and other rapidly dividing cells and causing them to die 1Irinotecan hydrochloride is approved to be used alone or with other drugs to treat colorectal cancer that has metastasized (spread to other parts of the body), including metastatic cancer that has recurred (come back) or has not gotten better with other chemotherapy 1It is also being studied in the treatment of other types of cancer 1.

Clinical trials are being conducted to determine the efficacy of irinotecan in the treatment of various types of cancer. For example, a retrospective cohort study conducted in China evaluated the efficacy and safety of capecitabine, oxaliplatin, and irinotecan (XELOXIRI) regimen use with or without targeted drugs in Chinese patients with metastatic colorectal cancer 2Another study reviewed the individualization of irinotecan treatment for solid tumors such as colorectal, pancreatic, and lung cancer 3.

Learn more:

Rationale and Controversies

While professionals have differing viewpoints regarding the safety and effectiveness of using it for nonapproved purposes, some studies argue in favor of its off-label applications.

V. Composition of Irinotecan

Active Ingredients

Irinotecan hydrochloride trihydrate is the compound that serves as the ingredient in Irinotecan.

Inactive Ingredients

Inactive ingredients frequently consist of mannitol and sorbitol, stabilizing agents.

Formulations Available

Irinotecan is primarily offered as a medication that is administered intravenously.

VI. Dosage and Administration

Standard Dosage Guidelines

The usual recommended dose for adults, is 350 mg/m2 to be given once every three weeks.

Method of Administration

To minimize the occurrence of responses, it is essential to administer Irinotecan through an intravenous infusion that lasts for approximately 90 minutes.

Dosage Adjustment Factors

Dosage adjustments might be necessary depending on the functioning of your kidneys and liver.

VII. Common Side Effects

Gastrointestinal Side Effects

Some symptoms to watch out for are feeling queasy, throwing up, and experiencing intense bouts of diarrhea.

Hematological Side Effects

Patients might encounter conditions such as white blood cell count, low red blood cell count, and low platelet count.

Neurological Side Effects

Peripheral neuropathy is not something that most people experience. It tends to be relatively uncommon.

VIII. Interaction with Other Drugs

Common Drug Interactions

Taking medications such, as ketoconazole and St. Johns Wort at the time can impact how Irinotecan is processed in the body, so it's essential to keep a close eye on it.

Potentially Dangerous Interactions

There is a risk of interactions between live vaccines and anticoagulants such as warfarin.

Drugs to Avoid While Taking Irinotecan

Patients should refrain from consuming alcohol and using over-the-counter medications unless specifically recommended by a doctor.

IX. Warnings and Contraindications

Known Contraindications

People with a confirmed sensitivity to Irinotecan or its ingredients should avoid using it. The drug should also not be used by individuals with liver problems. Hypersensitivity and severe hepatic impairment are conditions in which this drug is not recommended.

Warnings for Special Populations

People who have preexisting kidney or liver conditions should be careful. These patients need medical supervision to reduce the chances of experiencing severe side effects.

Risk of Secondary Cancer

Long-term use of Irinotecan has been linked to a chance of developing secondary cancers, particularly leukemia. Healthcare providers must consider this risk in comparison to the advantages carefully.

X. Careful Administration and Important Precautions

Handling and Disposal

It is essential to exercise caution when dealing with Irinotecan, including gloves and eye protection. Make sure to dispose of it according to the regulations for cytotoxic waste.

Measures to Minimize Side Effects

Using medications like antiemetics can help reduce the occurrence of side effects. It is also advisable to ensure hydration to counteract any potential harm to the kidneys. Anti-nausea medication and staying hydrated are considerations.

Monitoring During Treatment

It is essential to monitor hematologic profiles, liver and renal function tests.

XI. Administration to Specific Groups

Administration to Elderly Patients

Elderly individuals often need to adjust their medication doses because their bodies undergo physiological changes as they age, which can affect their kidney function.

Administration to Pregnant Women and Nursing Mothers

Irinotecan falls into Category D for pregnancy medications, which carries risks for the fetus. Therefore it is not recommended for use in women or nursing mothers.

Administration to Children

The effectiveness and safety of using Irinotecan in populations have not been definitively proven. As a result, it is generally advised against using it in children.

XII. Overdosage and its Management

Symptoms of Overdose

Taking an amount of this substance can lead to a condition known as acute toxicity, which can cause severe diarrhea, neutropenia (a decrease in white blood cells), and, in some cases, sepsis.

Urgent medical attention is crucial. Admitting the patient to a hospital and providing care and support may be necessary.

Antidotes and Treatment Options

Currently, there is no remedy for an excessive dosage of Irinotecan. The approach to managing this situation revolves around addressing the symptoms. It could involve procedures like administering fluids intravenously and prescribing antibiotics, among other interventions.

XIII. Storage Guidelines

Optimal Storage Conditions

Irinotecan should ideally be stored within 20 to 25 degrees Celsius, equivalent to 68 to 77 degrees Fahrenheit.

Shelf Life

The usual timeframe for a product's expiration is two years from when it was produced, as long as it is stored properly.

Precautions for Safe Storage

Keep the product in a place where it is not exposed to sunlight and keep it out of children's reach.

XIV. Handling Precautions

Personal Protective Equipment

Healthcare professionals who are administering the medication should make sure to wear personal protective equipment, such as gloves and eye shields.

Disposal Guidelines

Disposing of the waste should follow the biohazard waste disposal protocols set by the institution. Adhere to all applicable local, state, and federal regulations.

Steps in Case of Spillage or Leakage

If there is a spill or leak, it's essential to contain the liquid clean the affected area using suitable cleaning products and dispose of the cleaning materials properly.

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