Onivyde

【】Functions and Indications】
The US FDA approved Onivyde (irinotecan liposome injection) as a new marketed drug for pancreatic cancer in combination with fluorouracil and folinic acid for the treatment of patients with advanced (metastatic) pancreatic cancer who have not responded well to gemcitabine chemotherapy.

[Models and specifications】
Injection: 43 mg/10 ml

[Usage and Dosage].=
Do not substitute Onivyde for medications containing irinotecan hydrochloride.
The recommended dose of Onivyde is 70 mg/m2 IV infusion over 90 minutes every two weeks.
The recommended starting dose*28 of OnivydeE for purist patients with UGT1A1 is 50 mg/m2 every two weeks.
There is no recommended dose of Onivyde for patients with serum bilirubin above the upper limit of normal.
Premedicate with the first 30 minutes Onivyde corticosteroids and antiemetics.

[Precautions】
1. Interstitial Lung Disease (ILD): Fatal ILD has occurred in patients receiving Irinotecan Hydrochloride please stop Onivyde if ILD is diagnosed.
2. Severe allergic reactions: Permanently stop Onivyde severe allergic reactions.
3. Embryo-fetal toxicity: can cause foetal harm remind women of the potential risk of reproductive potential and use effective contraception.

[Adverse Reactions】
Diarrhoea, fatigue/weakness, vomiting, nausea, the most common adverse reactions (≥20%), decreased appetite, stomatitis and fever the most common laboratory abnormalities (≥10% grade 3 or 4) were lymphocytopenia and neutropenia respectively.

[Contraindicated]
Severe allergic reactions to Onivyde or irinotecan HCl.

[Drug Interactions】
Irinotecan Liposome Injection is a topoisomerase 1 inhibitor encapsulated in lipid bilayer vesicles or liposomes. Topoisomerase 1 attenuates torsional deformation in DNA by inducing single-strand breaks. Irinotecan and its active metabolite, SN-38, bind reversible topoisomerase 1-DNA complexes and prevent religation of ligated single-strand breaks leading to exposure time-dependent double-stranded DNA damage and cell death. In mice bearing human tumour xenografts, irinotecan liposomes administered irinotecan hydrochloride equivalent doses 5-fold lower than irinotecan hydrochloride achieved similar intra-tumour irradiation as SN-38.