Onivyde

Irinotecan

In combination w/ 5-fluorouracil (5-FU) & leucovorin (LV) for metastatic pancreatic adenocarcinoma in adult patients who have progressed following gemcitabine-based therapy.

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 start treatment w/ 50 mg/m² 1st dose reduction: 43 mg/m² & 2nd dose reduction: 35 mg/m².

Severe hypersensitivity. Lactation.

Hypersensitivity reactions. Discontinue use if ILD is confirmed. Not to be used in patients w/ severe bone marrow failure, bowel obstruction & chronic inflammatory bowel disease. Withhold treatment if neutropenic fever occurs or ANC drops <1,500 cells/mm³. 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. Asian patients; 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.

Neutropenia, leukopenia, anaemia, thrombocytopenia; hypokalaemia, hypomagnesaemia, dehydration, decreased appetite; dizziness; diarrhoea, vomiting, nausea, abdominal pain, stomatitis; alopecia; pyrexia, peripheral oedema, mucosal inflammation, fatigue, asthenia; decreased wt. Septic shock, sepsis, pneumonia, febrile neutropenia, gastroenteritis, oral candidiasis; lymphopenia; hypoglycaemia, hyponatraemia, hypophosphataemia; insomnia; cholinergic syndrome, dysgeusia; hypotension; pulmonary embolism, embolism, DVT; dyspnoea, dysphonia; colitis, haemorrhoids; hypoalbuminaemia; pruritus; acute renal failure; infusion-related reaction, oedema; increased bilirubin, ALT, AST & INR.

Reduced systemic exposure w/ strong CYP3A4 inducers eg, anticonvulsants, rifampin, rifabutin, St. John's wort. Increased systemic exposure w/ strong CYP3A4 (eg, grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) & UGT1A1 (eg, atazanavir, gemfibrozil, regorafenib) inhibitors. Exacerbated adverse effects by other antineoplastics including flucytosine.

Cytotoxic Chemotherapy

L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.

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