Irinotraz 40mg Belongs to antineoplastic enzyme inhibitor mainly necessary in the treatment of colorectal cancer. It is a derivative of camptothecin that prohibits the action of topoisomerase I.
Irinotraz 40mg commonly administering with other chemotherapy medicines in a combination chemotherapy.
Irinotraz 40mg is a prescription drugs which is used under supervision by medical physician.


Irinotraz 40mg is mainly indicated for the treatment in patients with metastatic colon or rectal cancer.

Mechanism Of Action

Irinotecan prevents the action of topoisomerase I. Irinotecan prohibits relocation of the DNA strand by binding to topoisomerase I-DNA complex. The formation of this ternary complex prohibits the moving multiplication fork, which activate multiplication arrest and lethal double-stranded cuts in DNA. Hence, DNA loss is not efficiently repaired and apoptosis (programmed cell death) occurs.

Dosage and administration

Colorectal cancer :
Monotherapy dosage :
Premediate the patients with antiemetic agents
For experience cholinergic symptoms in patient’s atropine treatment should be considered
Dose 1: 125mg/m2 IV infusion over 90 minutes on days 1,8,15,22, then 2 weeks off then repeat administrated weekly
Dose 2: 350mg/sq. meter IV Infusion over 30-90 minutes q3weeks administrated once every 3 weeks.
Combination therapy :
Premediate the patients with antiemetic agents
For experience cholinergic symptoms in patient’s atropine treatment should be considered
Dose 1: 180mg/m2 IV infusion over 30-90 minutes once on days 1,15, and 29, then followed by infusion with leucovorin and 5- fluorouracil; next cycle begins on day 43
Dose 2: 125mg/sq. meter on days 1,8,15 and 22 IV Infusion over 90 minutes then followed by bolus doses of leucovorin and 5-fluorouracil


Peak Plasma Concentration of Irinotraz 40mg is 1660 ng/mL; SN-38 26.3 ng/mL
Irinotraz 40mg has Protein Bound: 30-68%; SN-38 95% and Vd: 110-234 L/m²
Irinotraz 40mg is mainly metabolized in hepatic, to SN-38; SN-38 is further metabolized by UGT1A1 and metabolites are metabolized to SN-38
Excretion of Irinotraz 40mg through urine, feces
Half-Life of Irinotraz: 6-12 hr; SN-38 10-20 hr


• While on Irinotraz treatment interstitial pulmonary disease (IPD)-like events, contains fatalities, have been resulted (in combination and as monotherapy) for treatment of colorectal cancer and other advanced solid tumors
• Risk of both early and late forms of diarrhea will occurs on treatment with Irinotraz
• When treatment will cause Hyperbilirubinemia, elderly, receiving radiation therapy, abdominal/pelvic radiation history
• Not for use in concomitant with a regimen of 5-FU/LV administered for 4-5 consecutive days every 4 weeks outside of a clinical study

Drug Interaction

• When Irinotraz 40mg concomitant use with 5-fluorouracil and leucovorin (LV), the disposition of irinotecan was not substantially altered.
Irinotraz 40mg concomitant use with strong CYP34A inducers do not administer unless there are no therapeutic alternatives
• When Irinotraz 40mg concomitant use with strong CYP34A inhibitors may increase systemic exposure to irinotecan or SN-38

Side Effects

Common side effects of Irinotraz 40mg :
Loss of appetite
Feeling sick
Loss of Hair
Mouth ulcers
Tummy pain
Increased risk of getting an infection
Breathlessness and looking pale
Serious side effects of Irinotraz 40mg :
Liver changes
Swelling around the drip site
Skin rash
Blood clots.

Missed Dose

If dose is failed to take, then have the dose immediately before reach of next dose time or leave the missed dose and follow the normal schedule. Avoid have extra dose which leads to over dosage Consult the doctor about missed dose and overdose


Irinotraz 40mg is Store at 20o C to 25o C Protect from light
Keep in its original vial until the time of use


Pregnancy category is D
The drug Irinotraz 40mg may causes risk to fetus when administered to pregnant women. Advice the women about the potential hazard to the fetus


The drug Irinotraz 40mg has no data on the excretion into human milk. Advice the breastfeed mother potential risk to the infants. So, discontinue nursing when getting treatment with Irinotraz


Known hypersensitivity to the drug or its excipients

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