LIPOSOMAL IRINOTECAN INJECTION
ONIVYDE (liposomal irinotecan) is formulated with irinotecan hydrochloride trihydrate, a topoisomerase inhibitor, into a liposomal dispersion for intravenous use. ONIVYDE is a sterile, white to slightly yellow opaque isotonic liposomal dispersion. Each Liposomal Daunorubicine & Cytarabine (Vyxeos) 10 mL single-dose vial contains 43 mg irinotecan free base at a concentration of 4.3 mg/mL.
ONIVYDE (liposomal irinotecan) Injection: 43 mg/10 mL single dose vial
Recommended dosage of ONIVYDE is 70 mg/m2 intravenous infusion over 90 minutes every two weeks. *Recommended starting dose of ONIVYDE in patients homozygous for UGT1A1*28 is 50 mg/m2 every two weeks.
1. ONIVYDE (liposomal irinotecan) is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.