Irinotecan Accord

Irinotecan hydrochloride trihydrate – Topoisomerase I inhibitor for cancer treatment

Prescription Only (Rx) Topoisomerase I Inhibitor
Active Ingredient
Irinotecan hydrochloride trihydrate
Dosage Form
Concentrate for solution for infusion
Available Strength
20 mg/ml
Administration Route
Intravenous infusion
Manufacturer
Accord Healthcare B.V.
✓ Medically reviewed | Last reviewed: | Evidence Level 1A

Irinotecan Accord is a chemotherapy medication belonging to a class of drugs called topoisomerase I inhibitors. It is used to treat advanced (metastatic) colorectal cancer in adults, either in combination with other anticancer drugs or as a single agent. Irinotecan works by interfering with the DNA replication process in cancer cells, thereby inhibiting their growth and spread. This medication is administered exclusively in hospital settings by trained healthcare professionals.

📅 Updated:
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⚕ iMedic Medical Team

Quick Facts

Active Ingredient
Irinotecan HCl
Drug Class
Topoisomerase I Inhibitor
Common Uses
Colorectal Cancer
Available Forms
20 mg/ml Solution
Prescription Status
Rx Only
Key Warning
Severe Diarrhea

Key Takeaways

  • Irinotecan Accord is a chemotherapy drug used to treat advanced colorectal cancer in adults, either alone or in combination with 5-fluorouracil/folinic acid, bevacizumab, capecitabine, or cetuximab.
  • The most critical side effects are severe delayed diarrhea (occurring more than 24 hours after infusion) and neutropenia (low white blood cell count), both of which can be life-threatening if not treated promptly.
  • Genetic testing for UGT1A1 polymorphisms may be recommended before treatment, as certain genetic variants increase the risk of severe side effects.
  • Patients must not use St. John’s wort (Hypericum perforatum) or receive live vaccines during treatment and for 6 months after completion of chemotherapy.
  • Effective contraception is mandatory during treatment and for 6 months (women) or 3 months (men) after the last dose; breastfeeding must be discontinued.

What Is Irinotecan Accord and What Is It Used For?

Irinotecan Accord is a cytotoxic (cell-killing) chemotherapy medication that belongs to the topoisomerase I inhibitor class. It is used for the treatment of advanced cancer of the colon and rectum (colorectal cancer) in adults, either as part of combination chemotherapy regimens or as a single agent in patients who have failed prior treatment.

Irinotecan is a semisynthetic derivative of camptothecin, a natural alkaloid originally isolated from the bark and stem of the Chinese tree Camptotheca acuminata. Camptothecin was first identified in the 1960s for its anticancer properties, and irinotecan was developed as a water-soluble analogue to improve its clinical utility. It was first approved for clinical use in Japan in 1994 and subsequently gained regulatory approval in Europe and the United States.

The active ingredient, irinotecan hydrochloride trihydrate, is a prodrug that is converted in the body to its active metabolite SN-38, which is approximately 100 to 1000 times more potent than the parent compound. SN-38 inhibits topoisomerase I, an enzyme that is essential for DNA replication and transcription. By stabilizing the complex formed between topoisomerase I and DNA, irinotecan prevents the religation of DNA strands, resulting in lethal double-strand DNA breaks during the S-phase of the cell cycle. This mechanism is particularly effective against rapidly dividing cancer cells.

Irinotecan is listed on the WHO Model List of Essential Medicines, reflecting its importance as a cornerstone of colorectal cancer treatment worldwide. Colorectal cancer is the third most commonly diagnosed cancer globally and the second leading cause of cancer-related death, according to the World Health Organization.

Approved Indications and Combination Regimens

Irinotecan Accord is approved for the treatment of advanced colorectal cancer in adults in the following settings:

  • Combination with 5-fluorouracil/folinic acid (FOLFIRI) – This is one of the most widely used first-line regimens for metastatic colorectal cancer. The FOLFIRI protocol combines irinotecan with infusional 5-fluorouracil and leucovorin (folinic acid), and has demonstrated significant improvements in overall survival and progression-free survival compared to 5-fluorouracil alone.
  • Combination with 5-fluorouracil/folinic acid and bevacizumab – Adding bevacizumab (a monoclonal antibody that inhibits vascular endothelial growth factor) to FOLFIRI further improves treatment outcomes, particularly in first-line therapy for metastatic disease.
  • Combination with capecitabine with or without bevacizumab – Capecitabine is an oral fluoropyrimidine that may be used as a substitute for intravenous 5-fluorouracil in combination with irinotecan.
  • Combination with cetuximab – For patients with RAS wild-type metastatic colorectal cancer that expresses the epidermal growth factor receptor (EGFR), irinotecan can be combined with cetuximab, a monoclonal antibody targeting EGFR. This combination is typically used after failure of prior irinotecan-containing chemotherapy.
  • Monotherapy – Irinotecan may be used as a single agent in patients who have failed established 5-fluorouracil-containing treatment regimens.

The choice of treatment regimen depends on several factors, including the stage and molecular profile of the cancer (particularly RAS and BRAF mutation status), the patient’s overall health and performance status, prior treatments received, and the goals of therapy (curative vs. palliative). Treatment decisions are made by the oncologist in consultation with a multidisciplinary team, following international guidelines such as those from ESMO (European Society for Medical Oncology) and NCCN (National Comprehensive Cancer Network).

What Should You Know Before Taking Irinotecan Accord?

Before receiving irinotecan, your oncologist will conduct a thorough assessment of your overall health, liver function, kidney function, blood counts, and medical history. There are several important contraindications, warnings, and precautions that must be considered to minimize the risk of serious adverse effects.

Contraindications

Irinotecan Accord must not be used in the following situations:

  • Known allergy to irinotecan – patients with a documented hypersensitivity to irinotecan hydrochloride trihydrate or any of the excipients must not receive this medication.
  • Chronic inflammatory bowel disease or bowel obstruction – patients with a current or historical diagnosis of chronic inflammatory bowel disease (such as Crohn’s disease or ulcerative colitis) or those with intestinal obstruction must not receive irinotecan, as the drug can significantly worsen these conditions.
  • Breastfeeding – irinotecan and its active metabolite SN-38 have been detected in breast milk. Breastfeeding must be discontinued during treatment.
  • Severe hepatic impairment – patients with bilirubin levels exceeding 3 times the upper limit of normal must not receive irinotecan, as impaired liver function significantly increases the risk of severe toxicity.
  • Severe bone marrow failure – patients with severely compromised bone marrow function are at unacceptably high risk of life-threatening myelosuppression.
  • Poor performance status – patients with WHO performance status greater than 2 (i.e., those who are confined to bed more than 50% of waking hours) should not receive irinotecan.
  • Concurrent use of St. John’s wort – Hypericum perforatum is a potent CYP3A4 inducer that significantly reduces irinotecan plasma levels, potentially compromising treatment efficacy.
  • Live attenuated vaccines – patients must not receive live vaccines (including yellow fever, varicella, measles, mumps, rubella, tuberculosis, rotavirus, and live attenuated influenza vaccines) during treatment and for 6 months after the last dose of chemotherapy.

Warnings and Precautions

Critical Warning: Severe Diarrhea

Irinotecan can cause two distinct forms of diarrhea. Early diarrhea (within 24 hours of infusion) is part of the acute cholinergic syndrome and is manageable with atropine. Delayed diarrhea (after 24 hours, typically around day 5) can be severe and life-threatening, potentially leading to dehydration, electrolyte imbalance, and death if not treated immediately with loperamide and aggressive fluid replacement. Contact your medical team immediately at the onset of delayed diarrhea.

Critical Warning: Neutropenia

Irinotecan frequently causes severe neutropenia (critically low white blood cell counts), increasing the risk of serious and potentially fatal infections. If you develop a fever of 38°C (100.4°F) or higher, chills, painful urination, new or worsening cough, or any signs of infection, contact your medical team or emergency services immediately.

Your doctor should be informed about the following conditions and risk factors before treatment begins:

  • Liver problems – irinotecan is extensively metabolized by the liver, and impaired hepatic function increases drug exposure and toxicity risk. Liver function tests will be performed before each treatment cycle.
  • Kidney problems – renal impairment may affect drug clearance and require dose adjustments. Kidney function deterioration has been reported during irinotecan treatment.
  • Asthma – patients with asthma should inform their medical team, as cholinergic symptoms during infusion may exacerbate respiratory issues.
  • Prior radiation therapy – patients who have received pelvic or abdominal radiation may be at increased risk of bone marrow suppression.
  • Heart disease or cardiovascular risk factors – smoking, high blood pressure, and elevated cholesterol increase the risk of cardiac events during treatment. Cardiac monitoring may be required.
  • Gilbert syndrome – this hereditary condition causes reduced UGT1A1 enzyme activity, leading to elevated bilirubin levels and increased risk of severe irinotecan toxicity. Dose adjustments may be necessary.
  • Hereditary fructose intolerance – Irinotecan Accord contains sorbitol (45 mg per ml), a source of fructose. Patients with hereditary fructose intolerance must not receive this formulation.

Acute Cholinergic Syndrome

During or shortly after the irinotecan infusion (within the first 24 hours), some patients experience an acute cholinergic syndrome. This syndrome is caused by the inhibition of acetylcholinesterase and can present with a constellation of symptoms including:

  • Acute-onset diarrhea
  • Excessive sweating
  • Increased salivation
  • Watery eyes (lacrimation)
  • Visual disturbances (miosis)
  • Abdominal cramping
  • Runny nose (rhinitis)

This syndrome is distinct from the delayed diarrhea that occurs days after treatment. The acute cholinergic syndrome can be effectively managed with atropine sulfate, which your medical team will administer if needed. Inform your healthcare providers immediately if you experience any of these symptoms during or shortly after the infusion.

Managing Delayed Diarrhea

Delayed diarrhea is the most clinically significant toxicity of irinotecan and typically occurs approximately 5 days after treatment, though it can occur at any time after the first 24 hours. If not treated promptly, it can lead to severe dehydration, electrolyte imbalance, and in rare cases, death. Follow these steps immediately at the first sign of loose stool occurring more than 24 hours after your infusion:

  • Take loperamide exactly as prescribed by your doctor: an initial dose of 4 mg followed by 2 mg every 2 hours (including during the night) until at least 12 hours after the last loose stool. The recommended duration of loperamide treatment should not exceed 48 hours at these doses.
  • Drink large volumes of fluids immediately, including water, oral rehydration solutions, clear broths, and electrolyte-containing beverages.
  • Contact your treating oncologist or the hospital ward immediately to report the diarrhea. If your doctor is unavailable, go to the emergency department.
  • Seek immediate medical attention if you also have nausea, vomiting, or fever alongside diarrhea, or if diarrhea persists after 48 hours of loperamide treatment.
Important: Ensure you have loperamide at home before starting treatment.

Your doctor will prescribe anti-diarrheal medication before your first infusion. Make sure you fill this prescription and have loperamide readily available at home so you can begin treatment immediately at the first sign of delayed diarrhea. Do not use any other anti-diarrheal medications without consulting your doctor.

Pregnancy, Breastfeeding, and Fertility

Irinotecan poses significant reproductive risks that must be carefully considered before treatment:

Contraception: Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose. Men must use effective contraception during treatment and for at least 3 months after the last dose. Discuss suitable contraceptive methods with your doctor, as some hormonal contraceptives may interact with chemotherapy drugs.

Pregnancy: Irinotecan may cause harm to the developing fetus if used at the time of conception or during pregnancy. A pregnancy test should be performed before starting treatment. If you become pregnant during treatment, inform your doctor immediately.

Breastfeeding: Irinotecan and its active metabolite SN-38 have been detected in breast milk. Breastfeeding must be discontinued during irinotecan treatment and should not be resumed until advised by your doctor.

Fertility: No formal fertility studies have been conducted with irinotecan. However, chemotherapy drugs in general may affect fertility in both men and women. Patients should discuss fertility preservation options (such as sperm banking or egg freezing) with their healthcare team before starting treatment.

Driving and Operating Machinery

Irinotecan can cause side effects that may impair your ability to drive or operate machinery safely. During the first 24 hours after treatment, you may experience dizziness, visual disturbances, or fatigue. Do not drive or operate heavy machinery if you experience any of these symptoms. Beyond the first 24 hours, assess your own fitness carefully, taking into account the cumulative effects of chemotherapy such as fatigue, nausea, and general malaise.

How Does Irinotecan Accord Interact with Other Drugs?

Irinotecan has clinically significant interactions with numerous medications. Because irinotecan is metabolized by CYP3A4 and UGT1A1 enzymes, drugs that inhibit or induce these enzymes can substantially alter irinotecan levels, potentially increasing toxicity or reducing efficacy. Always inform your oncologist about all medications, supplements, and herbal products you are taking.

Irinotecan undergoes complex metabolism involving multiple enzyme systems. The parent drug is converted to its active metabolite SN-38 by carboxylesterases. SN-38 is then inactivated by glucuronidation via UGT1A1 (UDP-glucuronosyltransferase 1A1). Additionally, irinotecan is oxidized by CYP3A4 to inactive metabolites. Drugs that affect any of these metabolic pathways can significantly alter irinotecan pharmacokinetics and toxicity.

Major Interactions (Contraindicated or Avoid)

Drugs with Major Interactions – Contraindicated or to Be Avoided
Drug/Class Interaction Mechanism Clinical Effect
St. John’s wort (Hypericum perforatum) Potent CYP3A4 inducer Significantly reduces irinotecan levels, compromising antitumor efficacy. Contraindicated.
Live attenuated vaccines Immunosuppression Risk of fatal generalized vaccine disease due to suppressed immune system. Contraindicated during treatment and for 6 months after.
Ketoconazole, itraconazole, voriconazole, posaconazole Strong CYP3A4 inhibitors Increases irinotecan and SN-38 exposure, raising risk of severe neutropenia and diarrhea.
Carbamazepine, phenytoin, phenobarbital CYP3A4 inducers Reduces irinotecan exposure, potentially decreasing treatment efficacy.
Rifampicin, rifabutin Potent CYP3A4 inducers Dramatically reduces irinotecan levels. Avoid concurrent use.
HIV protease inhibitors (atazanavir, ritonavir, indinavir, etc.) CYP3A4 inhibitors Increases irinotecan exposure and risk of severe toxicity.

Moderate Interactions (Use with Caution)

Drugs with Moderate Interactions – Use with Caution and Monitoring
Drug/Class Interaction Mechanism Clinical Effect
Warfarin and other vitamin K antagonists Altered coagulation Increased INR and bleeding risk. Close INR monitoring required.
Cyclosporine, tacrolimus Immunosuppression; CYP3A4 interaction Excessive immunosuppression; altered drug levels.
Clarithromycin, erythromycin, telithromycin CYP3A4 inhibitors May increase irinotecan exposure and toxicity risk.
Regorafenib, crizotinib, idelalisib, apalutamide CYP3A4/UGT interactions May alter irinotecan metabolism; close monitoring required.
Suxamethonium Cholinesterase interaction Prolonged neuromuscular blockade. Inform anesthesiologist before surgery.
Laxatives and stool softeners Additive bowel effects May worsen irinotecan-induced diarrhea. Avoid during treatment.

Combination Chemotherapy Partners

Irinotecan is commonly used in combination with the following anticancer agents, which are not “interactions” in the traditional sense but are deliberately combined under close medical supervision:

  • 5-Fluorouracil/folinic acid (leucovorin) – the backbone of the FOLFIRI regimen. Toxicity profiles are additive, particularly for diarrhea and myelosuppression.
  • Bevacizumab – a VEGF inhibitor that may increase the risk of thromboembolic events and hypertension when combined with irinotecan-based regimens.
  • Cetuximab – an EGFR inhibitor used in RAS wild-type tumors. Acne-like rash is a common additional side effect. Irinotecan should be administered no earlier than 1 hour after cetuximab infusion is completed.
  • Capecitabine – oral fluoropyrimidine that may increase the risk of blood clots, allergic reactions, and febrile neutropenia when combined with irinotecan.
Important: Always inform your medical team about ALL medications.

Before starting or stopping any medication during irinotecan treatment, consult your oncologist. This includes prescription drugs, over-the-counter medicines, vitamins, mineral supplements, and herbal or traditional remedies. If you need surgery, inform the surgeon and anesthesiologist that you are receiving irinotecan, as it may affect certain drugs used during anesthesia.

What Is the Correct Dosage of Irinotecan Accord?

Irinotecan is administered as an intravenous infusion over 30 to 90 minutes. The dose is calculated based on body surface area (BSA) in square meters (m²) and depends on whether irinotecan is given as monotherapy or in combination with other drugs. Only trained healthcare professionals should prepare and administer this medication.

Your oncologist will determine the appropriate dose and schedule based on your individual characteristics, including body surface area, organ function, performance status, and prior treatment history. Blood tests will be performed before each treatment cycle to ensure your blood counts and liver function are adequate to safely receive the next dose. Doses may be reduced, delayed, or treatment discontinued entirely based on your response and tolerance.

Adults

Standard Dosage Regimens for Adults
Regimen Dose Schedule Notes
Monotherapy (after prior 5-FU failure) 350 mg/m² Every 3 weeks 30–90 min IV infusion; dose adjustments based on toxicity
Combination therapy (FOLFIRI) 180 mg/m² Every 2 weeks Followed by folinic acid and 5-fluorouracil infusion
With cetuximab Same as prior irinotecan-containing regimen As per prior schedule Administered ≥1 hour after cetuximab infusion

Children

Irinotecan Accord is not recommended for use in children. There is insufficient evidence regarding the safety and efficacy of irinotecan in pediatric patients for colorectal cancer indications. Use of irinotecan in children should only be considered in the context of clinical trials for other tumor types.

Elderly Patients

Special caution is required when treating elderly patients with irinotecan. Older adults are more likely to experience severe diarrhea and may have reduced organ reserve. No specific dose adjustment based solely on age is mandated, but your oncologist will carefully evaluate your overall health, liver and kidney function, and performance status before determining the appropriate dose. Close monitoring is essential, particularly during the first treatment cycles.

Genetic Testing (UGT1A1)

Your doctor may recommend a DNA test (genotyping) before your first dose of irinotecan. The enzyme UGT1A1 plays a critical role in inactivating SN-38, the active metabolite of irinotecan. Patients who carry the UGT1A1*28 polymorphism (approximately 10% of Caucasian and African populations are homozygous) have reduced enzyme activity and are at significantly increased risk of severe neutropenia and diarrhea. For these patients, a reduced starting dose may be recommended.

Missed Dose

If you miss a scheduled treatment session, contact your oncologist immediately to reschedule. Do not attempt to “make up” a missed dose by receiving a double dose. Maintaining the treatment schedule is important for optimal outcomes, so attend all scheduled appointments.

Overdose

Overdose with irinotecan is unlikely in clinical practice as the drug is administered by healthcare professionals. However, if an overdose occurs, the main expected effects are severe neutropenia and severe diarrhea. There is no specific antidote for irinotecan overdose. Treatment is supportive, focusing on aggressive management of dehydration from diarrhea, prevention and treatment of infections resulting from neutropenia, and close monitoring of blood counts and organ function in an intensive care setting.

What Are the Side Effects of Irinotecan Accord?

Like all chemotherapy medications, irinotecan can cause side effects. The most clinically significant are severe delayed diarrhea and neutropenia, both of which require immediate medical attention. Not everyone will experience all side effects, and your medical team will monitor you closely and manage any that arise.

Side effects of irinotecan are dose-dependent and vary in severity. Your oncologist will weigh the benefits of treatment against the potential risks. Many side effects are manageable with appropriate supportive care, and some are temporary, resolving after treatment is completed. It is essential to report any new or worsening symptoms to your medical team promptly, as early intervention can prevent serious complications.

Seek immediate medical attention if you experience:

Allergic reactions (wheezing, difficulty breathing, swelling, rash, or itching affecting the whole body); severe or persistent diarrhea; fever of 38°C or higher; signs of infection (chills, painful urination, new cough); unusual bruising or bleeding; chest pain or sudden shortness of breath.

Very Common

May affect more than 1 in 10 patients
  • Neutropenia (decreased white blood cells)
  • Thrombocytopenia (decreased platelets)
  • Anemia (decreased red blood cells)
  • Delayed diarrhea (after 24 hours)
  • Nausea and vomiting
  • Hair loss (reversible after treatment ends)
  • Elevated liver enzymes (transient, with combination therapy)

Common

May affect up to 1 in 10 patients
  • Acute cholinergic syndrome (diarrhea, sweating, salivation, watery eyes, abdominal cramps, blurred vision, small pupils, rhinitis – during or within 24 hours of infusion)
  • Fever, infections including sepsis
  • Febrile neutropenia (fever with severely low white blood cells)
  • Dehydration (usually associated with diarrhea and/or vomiting)
  • Constipation
  • Fatigue
  • Elevated creatinine levels
  • Elevated liver enzymes (monotherapy)

Uncommon

May affect up to 1 in 100 patients
  • Allergic reactions (rash, itching, swelling, wheezing)
  • Mild skin reactions
  • Mild reactions at the infusion site
  • Breathing difficulties
  • Interstitial lung disease (inflammation of lung tissue)
  • Intestinal obstruction (ileus)
  • Pseudomembranous colitis (abdominal pain and inflammation causing diarrhea)
  • Renal failure, low blood pressure, cardiovascular failure (in patients with dehydration)

Rare

May affect up to 1 in 1,000 patients
  • Severe allergic reactions (anaphylaxis) – typically within minutes of infusion
  • Muscle cramps, numbness (paresthesia)
  • Gastrointestinal bleeding, colitis, typhlitis (inflammation of the appendix area)
  • Intestinal perforation (hole in the bowel wall)
  • Pancreatitis (inflammation of the pancreas)
  • Increased blood pressure during and after infusion
  • Decreased potassium or sodium levels (often related to diarrhea and vomiting)

Very Rare

May affect up to 1 in 10,000 patients
  • Transient speech disturbances
  • Elevated levels of digestive enzymes (amylase, lipase)

Frequency Not Known

Cannot be estimated from available data
  • Severe, persistent, or bloody diarrhea caused by Clostridioides difficile infection
  • Blood clots (deep vein thrombosis, pulmonary embolism)
  • Cardiac events (ischemia, myocardial infarction)
  • Hiccups
  • Enlargement of the colon (megacolon)
  • Fatty liver disease
  • Oral mucositis (mouth sores)
  • Kidney problems
  • Muscle cramps

Side Effects with Combination Regimens

When irinotecan is combined with other anticancer drugs, additional side effects may occur:

  • With cetuximab: Acne-like skin rash is very common and is often a marker of treatment response.
  • With capecitabine: Blood clots (very common), allergic reactions (common), myocardial infarction (common), and febrile neutropenia.
  • With capecitabine and bevacizumab: Low white blood cell count, blood clots, high blood pressure, and cardiac events.

Always read the patient information leaflets for all medications in your treatment regimen. Report any new or worsening symptoms to your healthcare team.

How Should You Store Irinotecan Accord?

Irinotecan Accord is stored and handled by healthcare professionals in hospital pharmacy settings. Patients do not typically store this medication at home, but understanding proper storage conditions supports safe treatment.

Irinotecan Accord concentrate for solution for infusion should be stored according to the following conditions:

  • No special temperature storage requirements – store at room temperature in the original packaging to protect from light.
  • Do not freeze.
  • Each vial is for single use only. Any unused solution must be discarded.
  • Do not use after the expiry date printed on the carton and vial (the expiry date refers to the last day of the stated month).
  • If any precipitation is observed in the vials or after reconstitution, the product must be discarded according to standard cytotoxic waste procedures.

After dilution in 0.9% sodium chloride or 5% glucose solution, the prepared infusion should be used immediately. If not used immediately, storage times and conditions before use are the responsibility of the hospital pharmacist and should normally not exceed 24 hours at 2–8°C, unless preparation was carried out under controlled and validated aseptic conditions.

Medicines should not be disposed of via household waste or wastewater. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment.

What Does Irinotecan Accord Contain?

The active substance is irinotecan hydrochloride trihydrate. Each milliliter of concentrate contains 20 mg of irinotecan hydrochloride trihydrate, equivalent to 17.33 mg of irinotecan free base.

Active Ingredient

Each vial contains irinotecan hydrochloride trihydrate at a concentration of 20 mg/ml. The medication is available in the following vial sizes:

  • 2 ml vial – containing 40 mg irinotecan hydrochloride trihydrate
  • 5 ml vial – containing 100 mg irinotecan hydrochloride trihydrate
  • 15 ml vial – containing 300 mg irinotecan hydrochloride trihydrate
  • 25 ml vial – containing 500 mg irinotecan hydrochloride trihydrate
  • 50 ml vial – containing 1,000 mg irinotecan hydrochloride trihydrate

Not all pack sizes may be available in all markets.

Inactive Ingredients (Excipients)

  • Sorbitol (E420) – 45 mg per ml. Sorbitol is a source of fructose; patients with hereditary fructose intolerance must not use this product.
  • Lactic acid
  • Sodium hydroxide (for pH adjustment)
  • Hydrochloric acid (for pH adjustment)
  • Water for injections
Sodium content:

This medicine contains less than 1 mmol sodium per dose, meaning it is essentially sodium-free.

Appearance

Irinotecan Accord 20 mg/ml concentrate for solution for infusion is a clear, pale yellow solution.

Known Brand Names

Irinotecan hydrochloride trihydrate is marketed under several brand names internationally, including Irinotecan Accord and Irinotecan Fresenius Kabi. The active substance and pharmacological properties are identical across these generic formulations, which have all received regulatory approval from the European Medicines Agency (EMA) or equivalent national authorities.

Frequently Asked Questions About Irinotecan Accord

Irinotecan Accord is a chemotherapy medication used to treat advanced (metastatic) colorectal cancer in adults. It can be administered as a single agent or in combination with other anticancer drugs, including 5-fluorouracil/folinic acid (FOLFIRI regimen), bevacizumab, capecitabine, and cetuximab. The specific treatment combination chosen depends on the type, stage, and genetic profile of the cancer, as well as the patient’s overall health and prior treatments.

Irinotecan is given as an intravenous infusion (drip) in a hospital or specialized cancer treatment center. The infusion typically takes 30 to 90 minutes. It must not be given as a rapid injection (bolus) or as an infusion shorter than 30 minutes or longer than 90 minutes. Treatment is administered by trained healthcare professionals who will monitor you throughout the infusion.

If diarrhea occurs more than 24 hours after your infusion (delayed diarrhea), start loperamide immediately as prescribed by your doctor (4 mg initially, then 2 mg every 2 hours, including overnight). Drink large amounts of fluids including water and oral rehydration solutions. Contact your medical team right away. If you also have nausea, vomiting, or fever, or if diarrhea continues after 48 hours of loperamide treatment, seek emergency medical attention. Do not take any other anti-diarrheal medications without consulting your doctor.

Your doctor may recommend genetic testing for the UGT1A1 enzyme before your first dose. Some people carry a genetic variation (UGT1A1*28) that reduces their ability to break down SN-38, the active metabolite of irinotecan. Patients with this variation are at significantly higher risk of severe side effects, particularly neutropenia and diarrhea. If you carry this genetic variant, your doctor may start you on a lower dose to reduce the risk of severe toxicity.

You must avoid St. John’s wort (Hypericum perforatum) completely during irinotecan treatment, as it significantly reduces the drug’s effectiveness by accelerating its metabolism. Other herbal supplements should also be discussed with your oncologist before use, as many herbal products can interact with chemotherapy drugs through effects on liver enzymes. Always inform your medical team about all supplements, vitamins, and traditional remedies you are taking or considering.

Yes. Hair loss (alopecia) is a very common side effect of irinotecan treatment, but it is reversible. Hair typically begins to regrow after treatment is completed. The rate and quality of regrowth can vary between individuals. Some patients may notice changes in hair texture or color when it grows back. Your medical team can advise you on managing hair loss during treatment.

References

  1. European Medicines Agency (EMA). Summary of Product Characteristics: Irinotecan Accord 20 mg/ml concentrate for solution for infusion. Last updated 2025. www.ema.europa.eu
  2. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. The Lancet. 2000;355(9209):1041-1047. doi:10.1016/S0140-6736(00)02034-1
  3. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Colon Cancer. Version 1.2024. www.nccn.org
  4. Cervantes A, Adam R, Rosello S, et al. Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Annals of Oncology. 2023;34(1):10-32. doi:10.1016/j.annonc.2022.10.003
  5. World Health Organization (WHO). Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023. www.who.int
  6. Innocenti F, Undevia SD, Iyer L, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. Journal of Clinical Oncology. 2004;22(8):1382-1388. doi:10.1200/JCO.2004.07.173
  7. British National Formulary (BNF). Irinotecan hydrochloride. bnf.nice.org.uk
  8. U.S. Food and Drug Administration (FDA). Irinotecan Hydrochloride Injection prescribing information. www.accessdata.fda.gov

Editorial Team

This article was written by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, clinical pharmacology, and internal medicine. All content is based on international medical guidelines (WHO, EMA, FDA, ESMO, NCCN) and peer-reviewed clinical evidence at Evidence Level 1A.

Our editorial process follows the GRADE evidence framework. All medical claims are verified against multiple authoritative sources and reviewed by independent medical experts. We declare no conflicts of interest and receive no pharmaceutical industry funding.

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