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Indications & Uses

Irotin 40 is indicated for:

Pharmacology

Irinotecan belongs to a family of anti-cancer compounds derived from camptothecin. These agents work by targeting topoisomerase I, an enzyme that normally relieves tension in the DNA strand by creating small, temporary breaks in it that are then resealed. Irinotecan, along with its active byproduct SN-38, attaches itself to the topoisomerase I-DNA complex and blocks this resealing process, leaving the breaks unrepaired.

Dosage Reference

Reference Information Only

Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.

Adults:

Colorectal cancer, combination regimen 1: Irinotecan 125 mg/m2 as an intravenous infusion over 90 minutes on days 1, 8, 15 and 22, together with LV 20 mg/m2 as an intravenous bolus infusion on the same days, followed by 5-FU as an intravenous bolus infusion on the same days. The cycle repeats every 6 weeks. The original text gives no 5-FU dose for this regimen.

Colorectal cancer, combination regimen 2: Irinotecan 180 mg/m2 as an intravenous infusion over 90 minutes on days 1, 15 and 29. LV 200 mg/m2 is given as an intravenous infusion over 2 hours on days 1, 2, 15, 16, 29 and 30. This is followed by 5-FU 400 mg/m2 as an intravenous bolus infusion and then 5-FU 600 mg/m2 as an intravenous infusion over 22 hours, both on days 1, 2, 15, 16, 29 and 30.

Colorectal cancer, single agent regimen 1: Irinotecan 125 mg/m2 as an intravenous infusion over 90 minutes on days 1, 8, 15 and 22, then a 2-week rest.

Colorectal cancer, single agent regimen 2: Irinotecan 350 mg/m2 as an intravenous infusion over 90 minutes on day 1, every 3 weeks.

Side Effects

In clinical studies of irinotecan used in combination therapy, the following side effects were common, affecting more than 30% of patients: nausea, vomiting, abdominal pain, diarrhoea, constipation, loss of appetite, mucositis (inflammation of the lining of the mouth and gut), neutropenia, leukopenia (including lymphocytopenia), anaemia, thrombocytopenia, weakness, pain, fever, infection, abnormal bilirubin levels, and hair loss.

Cautions & Contraindications

Warnings & Precautions

Diarrhoea and cholinergic reactions: Early diarrhoea, which occurs during or shortly after an infusion of Irotecan, is usually short lived and rarely severe. It may come with cholinergic symptoms such as a runny nose, increased salivation, constricted pupils, watery eyes, sweating, flushing and overactive bowel movement that can cause abdominal cramping. A slow heart rate may also occur. Early diarrhoea and the other cholinergic symptoms can be prevented or treated. Consider giving 0.25 mg to 1 mg of atropine by intravenous or subcutaneous injection, either as prevention or as treatment, unless it is clinically contraindicated. These symptoms are expected to occur more often with higher doses of Irotecan. Late diarrhoea, which generally begins more than 24 hours after Irotecan is given, can be life threatening because it may be prolonged and may lead to dehydration, electrolyte imbalance or sepsis. Grade 3 to 4 late diarrhoea occurred in 23 to 31 percent of patients on weekly dosing. Myelosuppression: Deaths from sepsis following severe neutropenia have been reported in patients treated with Irotecan. In the clinical studies of the weekly dosing schedule, neutropenic fever (NCI grade 4 neutropenia together with fever of grade 2 or higher) occurred in 3 percent of patients, and 6 percent of patients received G-CSF to treat neutropenia. Febrile neutropenia should be managed promptly with antibiotic support. Patients with reduced UGT1A1 activity: People who are homozygous for the UGT1A1*28 allele (UGT1A1 7/7 genotype) are at increased risk of neutropenia after starting Irotecan treatment.

Contraindications

Irinotecan Injection must not be given to patients who are known to be hypersensitive to irinotecan or to any of the other ingredients in the preparation.

Pregnancy & Breastfeeding

Pregnancy Category D. Irinotecan can cause fetal harm if given to a pregnant woman. In animal studies, radioactivity was detected in rat milk within 5 minutes of an intravenous dose of radiolabeled Irinotecan, reaching levels up to 65 times higher than plasma concentrations by 4 hours after dosing. Whether this drug passes into human breast milk is not known.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Use in Special Populations

Pediatric use

The effectiveness of Irinotecan Hydrochloride in pediatric patients has not been established.

Geriatric use

Patients older than 65 years should be monitored closely, because they have a greater risk of early and late diarrhea. For patients aged 70 years and older on the once-every-3-week schedule, the starting dose should be 300 mg/m2.

Renal impairment

The effect of renal impairment on Irinotecan Hydrochloride has not been evaluated, so use caution in patients with impaired renal function. The medicine is not recommended for patients on dialysis.

Hepatic impairment

In patients with hepatic impairment, clearance of irinotecan is lower. Exposure to the active metabolite SN-38 is higher than in patients with normal hepatic function.

Storage

Keep Irinotecan Hydrochloride at controlled room temperature, between 15° and 30°C. Protect it from light. Leave the vial in its carton until you are ready to use it.

Drug Interactions

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Common questions about Irotin 40 40 mg

What is Irotin 40 40 mg Injection?

Irotin 40 40 mg Injection is a medicine that contains Irinotecan Hydrochloride. It is made by Techno Drugs Ltd., Satipara, Narshingdi. It belongs to the Cytotoxic Chemotherapy group of medicines.

What is Irotin 40 used for?

Irotin 40 is used for: Cancer.

What are the side effects of Irotin 40?

In clinical studies of irinotecan used in combination therapy, the following side effects were common, affecting more than 30% of patients: nausea, vomiting, abdominal pain, diarrhoea, constipation, loss of appetite, mucositis (inflammation of the lining of the mouth and gut), neutropenia, leukopenia (including lymphocytopenia), anaemia, thrombocytopenia, weakness, pain, fever, infection, abnormal bilirubin levels, and hair loss.

Can I take Irotin 40 during pregnancy or while breastfeeding?

Pregnancy Category D. Irinotecan can cause fetal harm if given to a pregnant woman. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

How should I store Irotin 40?

Keep Irinotecan Hydrochloride at controlled room temperature, between 15° and 30°C. Protect it from light.

Can I take other medicines with Irotin 40?

Some medicines can interact with Irinotecan Hydrochloride, for example: Dexamethasone, Ketoconazole, Prochlorperazine Maleate. Tell your doctor or pharmacist about every medicine you take.

Do I need a prescription for Irotin 40?

Irotin 40 is a prescription (Rx) medicine. Take it as your doctor advises.

Last updated: 15 Aug 2026