Pfizer Irinotecan

Pfizer Irinotecan



Zydus Hospira Oncology


Concise Prescribing Info
Irinotecan HCl
1st-line therapy for patients w/ metastatic carcinoma of the colon or rectum. Patients w/ metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.
Dosage/Direction for Use
Combination therapy in 1st-line treatment of metastatic colorectal cancer Regimen 1 (6-wk cycle treatment resumes on day 43): Irinotecan HCl 125 mg/m2 IV over 90 min in combination w/ leucovorin (LV) 20 mg/m2 IV bolus inj & fluorouracil 500 mg/m2 IV bolus inj. Administered on days 1, 8, 15, 22 then 2 wk rest. Regimen 2 (6-wk cycle treatment resumes on day 43): Irinotecan HCl 180 mg/m2 IV over 90 min on days 1, 15, 29 then 1 wk rest, in combination w/ LV 200 mg/m2 IV over 2 hr, fluorouracil bolus 400 mg/m2 IV & fluorouracil infusion 600 mg/m2 IV over 22 hr which are administered on days 1, 2, 15, 16, 29, 30 then 1 wk rest. Single agent therapy in recurrent or progressive metastatic colorectal cancer Wkly regimen (6-wk cycle treatment resumes day 43): 125 mg/m2 IV over 90 min days 1, 8, 15, 22 then 2 wk rest. Once every 3 wk regimen: 350 mg/m2 IV over 90 min once every 3 wk. Patient w/ hepatic impairment Starting dose as single agent wkly: Serum total bilirubin conc 1.5-3.0 x IULN 60 mg/m2, 3.1-5.0 x IULN 50 mg/m2, <1.5 x IULN 60 mg/m2, 1.5-5.0 x IULN 40 mg/m2. Starting dose as single agent once every 3 wk: 1.5-3.0 x IULN 200 mg/m2.
Hypersensitivity. Women who intend to become pregnant. Pregnancy & lactation.
Special Precautions
Avoid extravasation & the infusion site should be monitored for signs of inflammation. Do not use in combination w/ the Mayo Clinic regimen of fluorouracil/LV (administration for 4-5 consecutive days every 4 wk); in patients w/ severe bone marrow failure. Avoid vaccination w/ a live vaccine. Can induce both early & late form of diarrhea. Colitis/ileus. Chronic inflammatory bowel disease &/or bowel obstruction. Patients w/ reduced UGT1A1 activity (eg, Crigler-Najjar & Gilbert's syndrome), known to be homozygous for UGT1A1*28. Patients w/ poor performance status increased risk of irinotecan-related adverse events. Not recommended for use in patients on dialysis; previously received pelvic/abdominal irradiation. Patients w/ asthma or CV disease; mechanical intestinal or urinary obstruction. Monitor for resp symptoms before & during therapy; WBC count w/ differential, Hb & platelet count before each dose; liver function before initiation of treatment & mthly or as clinically indicated. Fructose intolerance. Premedication w/ anti-emetic agents is recommended. Potential for dizziness or visual disturbances which may occur 24 hr following the administration, do not drive or operate machinery. Impaired renal function. Hepatic insufficiency. Childn. Elderly >65 yr.
Adverse Reactions
Combination therapy: Diarrhea, nausea, vomiting, neutropenia & alopecia. Neutropenia, neutropenic fever & mucositis in irinotecan/fluorouracil/LV therapy. Single agent therapy: Nausea, vomiting, diarrhea; neutropenia, leucopenia (including lymphocytopenia), anemia; cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing & intestinal hyperperistalsis; dehydration; hepatic events eg, ascites & jaundice; acute renal failure; alopecia, rashes; insomnia, dizziness; vasodilation.
Drug Interactions
Increased systemic exposure w/ CYP3A4 &/or UGT1A1 inhibitors. Reduced clearance w/ ketoconazole. Increased systemic exposure w/ atazanavir sulfate. Reduced exposure w/ CYP3A-inducing anticonvulsant drugs (eg, carbamazepine, phenobarb or phenytoin); St. John's wort. May prolong the neuromuscular blocking effects of suxamethonium & antagonize the neuromuscular blockade of non-depolarizing drugs. Exacerbated adverse effect (eg, myelosuppression & diarrhea) by other antineoplastic agents. Lymphocytopenia & hyperglycemia w/ dexamethasone. Akathisia w/ prochlorperazine. Worsened incidence or severity of diarrhea w/ laxative. Risk of dehydration secondary to vomiting &/or diarrhea w/ diuretics.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Pfizer Irinotecan conc soln for IV infusion 20 mg/mL
5 mL x 1's
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