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Irobenz 40/100 Liquid Injection

Generic Name- Irinotecan

Drug Class- Antineoplastic agent

Irinotecan is a DNA topoisomerase I inhibitor which is used as a chemotherapy agent against a variety of solid tumors, such as colorectal, pancreatic, ovarian, and lung cancers. It is also used in combination with other therapeutic agents against colorectal cancer as a first- or second-line treatment. It acts by inhibiting DNA topoisomerase I, an enzyme essential for relaxation of the DNA double helix during replication and transcription. Inhibition of topoisomerase I activity leads to disruption of DNA and RNA synthesis, which ultimately results in cell cycle arrest, apoptosis and cell death.

Product Description

Irobenz 40/100 (Irinotecan for injection) is a liquid injection containing active drug concentrate for intravenous infusion.

Indications and Usage

Irinotecan is indicated for:

  • Treatment of metastatic carcinoma of colon or rectum as a first line therapy in combination with 5-fluorouracil and leucovorin
  • Treatment of metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy

Dosage and Administration

  • Dosage Regimens for Metastatic carcinoma of Colon or Rectum
Irinotecan, 5-Fluorouracil and Leucovorin (IFL) Regimen2
Irinotecan 125 mg/m2 IV over 90 minutes on days 1, 8,15, 22
Leucovorin 20 mg/m2 IV infusion on days 1, 8, 15, 22
5-fluorouracil IV infusion on days 1, 8, 15, 22 every 6 weeks
Irinotecan, 5-fluorouracil and Leucovorin (FOLFIRI) Regimen
Irinotecan 180 mg/m2 IV over 90 minutes on days 1, 15, 29
Leucovorin 200 mg/m2 IV over 2 hours on days 1, 2, 15, 16, 29, 30
5-fluorouracil 400 mg/m2 IV infusion on days 1, 2, 15, 16, 29, 30 and 600 mg/m2 IV infusion over 22 hours on days 1, 2, 15, 16, 29, 30
Irinotecan Monotherapy2
Irinotecan 125 mg/m2 IV over 90 minutes on days 1, 8, 15, 22 then 2-week rest


350 mg/m2 IV over 90 minutes on day 1 every 3 weeks

Dosage Form and Strengths

  • Supplied as a single use vial containing aqueous solution for intravenous infusion
  • Available as 40 mg and 100mg for injection

Clinical Efficacy

  • Increases survival by 30 months when used in combination with other chemotherapeutic agents such as 5-fluorouracil and oxaliplatin in patients with advanced colorectal cancer3
  • Offers response rates of 10%-35% when used as a single agent in treatment of metastatic colorectal cancer3
  • Effective for the second-line treatment of patients with advanced colorectal cancer who fail to respond to or relapse after fluorouracil therapy4

Adverse Reactions

  • The most common adverse reactions which are observed in patients treated with combination therapy are nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia
  • The common adverse reactions events associated with use of irinotecan as a single agent are nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia


  • It is contraindicated in patients with a known hypersensitivity to irinotecan

Special Precautions

  • Monitor electrolytes and consider fluid replacement or prophylactic administration of 0.25 mg to 1 mg of intravenous or subcutaneous atropine in patients developing early diarrheal symptoms
  • Irinotecan treatment should be delayed in patients until return of pretreatment bowel function for at least 24 hours without anti-diarrhea medication
  • Consider dose reduction in patients reporting infections related to myelosuppression
  • Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for developing neutropenia following initiation of irinotecan treatment, so diagnose and treat accordingly
  • Discontinue treatment if severe hypersensitivity reactions including severe anaphylactic or anaphylactic reactions occurs
  • Do not use irinotecan in combination with a regimen of 5-FU/LV administered for 4-5 consecutive days every 4 weeks
  • Patients with risk factors including pre-existing lung disease, use of pneumotoxic drugs, radiation therapy, and colony stimulating factors. should be closely monitored for respiratory symptoms before and during therapy
  • Patients with hepatic and renal impairment should be monitored closely and caution should be used while treating these patients with irinotecan
  • Do not administer strong CYP3A4 inducers with irinotecan due to risk of potential drug interactions
  • It is not recommended for use in pregnant and breast feeding women due to potential risk of toxicity to fetus
Irinotecan 40/100mg Liquid Injection Manufacturer | ADMAC