Chapters Transcript Video Onivyde Formulation Video indication and important safety Information. Indication on a Vied aeronautic and Liposome injection is indicated in combination with floral yourself five f u and locavore in l V for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following Jim site of being based therapy. Limitation of use on a vine is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas warning severe neutropenia and severe diarrhea. Fatal neutral Penick sepsis occurred in 0.8% of patients receiving on a vied severe life threatening neutral Penick fever. Sepsis occurred in 3% and severe or life threatening neutropenia occurred in 20% of patients receiving ANA vied in combination with five f u and l V Withhold ANA vied for absolute neutrophils count below 1500 per millimeter cube or neutral Penick Fever monitor. Blood cell counts periodically during treatment. Severe diarrhea occurred in 13% of patients receiving on Abide in combination with five f u l v. Do not administer ANA vied to patients with bowel obstruction with hold on, Abide for diarrhea of great 2 to 4 severity administer lo Para might for late diarrhea of any severity. Administer atropine, if not contra indicated for early diarrhea of any severity. Please see additional important safety information below and full prescribing information, including box warnings. Metastatic pancreatic cancer is considered to be one of the most challenging types of cancer to treat. Three tumors have dense troma, which can hinder the delivery of some therapeutic agents. On divide represents a technological advance and drug delivery. It is a unique liposome, a formulation of Iran ot can that was designed to address the challenge of the dense Troma this unique design helps on of I'd stay in the fight way on a vied Aeronautic and Liposome injection is indicated in combination with floral your Ozil and locavore for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following Jim, site of being based therapy, please note that on a vibe has a boxed warning regarding severe neutropenia and severe diarrhea. The Ana Vied Liposome is a lipid bi layer vesicles that shelters and acquia space containing Iran ot can. This liposomes encapsulation helps protect aeronautic can from early conversion to a more active metabolite sn 38. The Ana Vied Liposome is stabilized through the addition of a hydro filic polymer coating. Polyethylene glycol or peg peg Elation helps protect the ANA vied liposomes from being rapidly cleared by the body while in circulation following administration of on divide by intravenous infusion, The half life of total Iren O T can in the body is 25.8 hours, which is longer than the half life of non liposomes aeronautic can. In addition, direct measurement of the undivided liposomes showed that 95% of aeronautic can remains liposome encapsulated in circulation, and the ratio between total and encapsulated forms did not change from zero toe 169.5 hours post dose. By having a prolonged circulation time like Osama Encapsulation allows, ANA vied to deliver its site a toxic payload to the tumor. Tumors often have leaky vasculature and defective lymphatic drainage, which allows larger particles such as macro molecules and liposomes to gain access and be retained. This effect is known as the enhanced permeability and retention, or E. P. R. Effect. Thes e PR effect is believed to enable the ANA Vied Liposome to exit circulation and reach the tumor. Theo Tumor environment contains a high concentration of macrophages. Thes tumor associated macrophages engulf the ANA vied liposomes through Figo psychosis and unpacked the liposomes. Facilitating the release of Aaron ot Can Theo here in o. T. Can is then converted by car box. Celeste raises into sn 38 its active metabolite. Both are n ot can and sn 38 are topo ice armories inhibitors, which work by overwhelming the DNA repair mechanisms and cells. However, SN 38 is more potent than Iran ot can. Pre clinical data suggests that DNA damage and apoptosis are time dependent and exposure to s and 38 correlates with anti tumor activity on a bright eyes. A unique life Isobel formulation of Iran OT can specifically designed to protect its payload while in circulation so it can reach the metastatic pancreatic tumor and stay in the fight. Selected important safety information. Severe life threatening or fatal neutral Penick fever or sepsis has been reported in patients receiving on a vied monitor, blood cell counts and with hold on a vied for N C below 1500 per millimeter. Cubed or neutral Penick fever. Severe diarrhea has occurred in patients receiving on of I'd do not administer ANA vied to patients with bowel obstruction with hold on a vied for grades 2 to 4. Diarrhea administer lo para meid for late diarrhea and a drop in for early diarrhea, if not contra indicated on a vied is contra indicated in patients who have had a severe hypersensitivity reaction toe on a vied or Aaron OT can on a vied should be permanently discontinued if a severe hypersensitivity reaction occurs, fatal interstitial lung disease or I L. D has occurred in patients receiving Iren o T. Can discontinue Ana Vied if I. L D is diagnosed on a vied can cause fetal harm. Females of reproductive potential should use effective contraception. The most common adverse reactions, greater than or equal to 20% include diarrhea, fatigue or s tenia vomiting, nausea, decreased appetite. Still, mastitis and Pyrex CIA. The most common severe laboratory abnormalities greater than or equal to 10% or limp a pina and neutropenia. The use of strong C Y. P. Three, a four inducers and three A four inhibitors should be avoided. Please see additional important safety information below and full prescribing information, including box warnings Published Created by
