Iritero

Iritero

irinotecan

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
Advanced colorectal cancer in combination w/ 5-fluorouracil & folinic acid in patients w/o prior chemotherapy or as single agent in patients who have failed an established 5-fluorouracil-containing treatment regimen. Small cell lung cancer in combination w/ cisplatin.
Dosage/Direction for Use
Adult Monotherapy Previously untreated patient 350 mg/m2 as IV infusion over 30-90 min every 3 wk. Combination therapy Previously untreated patient 180 mg/m2 as IV infusion over 30-90 min once every 2 wk, followed by infusion w/ folinic acid & 5-fluorouracil. In combination w/ cisplatin Initially 65 mg/m2 as IV infusion over 30-90 min & cisplatin 30 mg/m2 in repeated 6-wk cycles on days 1 & 8 every 21 days. Patient w/ bilirubin up to 1.5x ULN 350 mg/m2, 1.5-3x ULN 200 mg/m2.
Contraindications
Hypersensitivity. Chronic inflammatory bowel disease &/or obstruction. Patients w/ bilirubin >3x ULN; severe bone marrow failure; risk factor particularly w/ WHO performance status >2. Pregnancy & lactation.
Special Precautions
Hypersensitivity. Temporarily discontinue if neutropenic fever occurs or absolute neutrophil counts <1,000/mm3. Not to be used in patients w/ severe bone marrow failure. Patients w/ gastric cancer; extensive irradiation; poor ECOG performance status; cholinergic symptoms; late diarrhea; chronic inflammatory bowel disease &/or obstruction; nausea & vomiting; dizziness; preexisting lung disease; WHO performance status = 2. Patients who received previous pelvic/abdominal irradiation; baseline serum total bilirubin levels ≥1 mg/dL; reduced UGT1A1 activity. Monitor infusion site for signs of inflammation. Avoid extravasation & vaccination w/ live vaccine. Concomitant use w/ pneumotoxic drugs, radiation therapy, colony-stimulating factors. Not to be used in hereditary fructose intolerance. May affect ability to drive & use machines. Monitor liver function before initiation & mthly thereafter. Not recommended in renal impairment. Women of childbearing potential should avoid pregnancy. Not to be used during pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Late &/or early diarrhea, nausea, vomiting, abdominal cramping/pain, anorexia, stomatitis, constipation, mucositis, rectal disorder, GI monilia; leukopenia, anemia, neutropenia, thrombocytopenia; asthenia, fever, pain, chills, malaise; alopecia, rash, cutaneous signs; infection, sepsis; decreased wt, dehydration, hypovolemia, hypokalemia, hypomagnesemia; thromboembolic events; bilirubinemia; dyspnea; abnormal gait, confusion, headache; hypotension, syncope, CV disorders; UTI; breast pain; increased creatinine, alkaline phosphatase, GGTP.
Drug Interactions
Increased systemic exposure w/ CYP3A4 &/or UGT1A1 inhibitors eg, atazanavir sulfate. Reduced clearance w/ ketoconazole. Reduced exposure w/ CYP3A-inducing anticonvulsants eg, carbamazepine, phenobarb or phenytoin; St. John's wort. Prolonged neuromuscular blocking effect of suxamethonium. Antagonized neuromuscular blockade of non-depolarizing drugs. Exacerbated adverse effects eg, myelosuppression & diarrhea w/ other antineoplastic agents. Contributed to hyperglycemia in patients w/ history of DM or evidence of glucose intolerance w/ dexamethasone. Worsened incidence or severity of diarrhea w/ laxatives. Induced dehydration secondary to vomiting &/or diarrhea w/ diuretics.
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Iritero infusion conc 20 mg/mL
Packing/Price
2 mL x 1's;5 mL x 1's
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