Irinotecan 40/100mg Liquid Injection Manufacturer

Product Description

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

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

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 OR 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

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

Contraindications

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