In combination w/ oxaliplatin, 5-fluorouracil (5-FU) & leucovorin (LV) for 1st-line treatment of metastatic pancreatic adenocarcinoma; w/ 5-FU & LV for metastatic pancreatic adenocarcinoma in adult patients who have progressed following gemcitabine-based therapy.
In combination w/ oxaliplatin, 5-FU & LV 50 mg/m2 IV over 90 min, followed by oxaliplatin 60 mg/m2 IV over 120 min, followed by LV 400 mg/m2 IV over 30 min & 5-FU 2,400 mg/m2 IV over 46 hr every 2 wk. In combination w/ 5-FU & LV 70 mg/m2 IV over 90 min, followed by LV 400 mg/m2 IV over 30 min & 5-FU 2,400 mg/m2 IV over 46 hr every 2 wk. Patient known to be UGT1A1*28 allele homozygous Reduce starting dose to 50 mg/m2, may be increased to 70 mg/m2 if tolerated in subsequent cycles. Patient who starts treatment w/ 50 mg/m2 1st dose reduction: 43 mg/m2 & 2nd dose reduction: 35 mg/m2.
Hypersensitivity reactions including acute infusion-related reactions. Discontinue use if ILD is confirmed. Not to be used in patients w/ severe bone marrow failure, bowel obstruction & chronic inflammatory bowel disease. Patients w/ deficient bilirubin glucuronidation eg, Gilbert's syndrome. Cholinergic reactions; history of Whipple procedure; thromboembolic events eg, pulmonary embolism, venous thrombosis & arterial thromboembolism; preexisting lung disease. Monitor CBC during treatment; signs of infection. Not to be administered w/ strong CYP3A4 inducers, CYP3A4 & UGT1A1 inhibitors. Avoid use of live or live-attenuated vaccines. Concurrent use w/ irradiation. Concomitant use w/ pneumotoxic medicinal products, colony stimulating factors or prior RT; other hepatotoxic medicinal products. Underwt patients (BMI <18.5 kg/m2). May affect ability to drive & use machines. Not recommended in severe renal impairment (CrCl <30 mL/min). Avoid use in patients w/ bilirubin >2 mg/dL, AST & ALT >2.5 times ULN or >5 times ULN if liver metastasis is present. Preexisting hepatic impairment. Males should use effective contraception during treatment & 4 mth thereafter. Women of childbearing potential should use effective contraception during treatment & 7 mth thereafter. Not to be used during pregnancy. Not to be used during lactation until 1 mth after last dose. Childn & adolescents ≤18 yr.
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 4.3 mg_mLbbd8dd63-db3f-4555-9ccb-b0910083f361.GIF)
