Topoisomerase Inhibitors

Topoisomerase Inhibitor

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Colonic Neoplasms

Leukemia

Lymphoma

Neoplasm Metastasis

Pancreatic Neoplasms

Rectal Neoplasms

Stomach Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">ONIVYDE is formulated with irinotecan hydrochloride trihydrate, a topoisomerase inhibitor, into a liposomal dispersion for intravenous use. The chemical name of irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4'bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate. The empirical formula is C<span class="Sub">33</span>H<span class="Sub">38</span>N<span class="Sub">4</span>O<span class="Sub">6</span>∙HCl∙3H<span class="Sub">2</span>O and the molecular weight is 677.19 g/mole. The molecular structure is:</p><div class="Figure"><img alt="Chemical Structure" src="onivyde-01.jpg"/></div><p>ONIVYDE is a sterile, white to slightly yellow opaque isotonic liposomal dispersion. Each 10 mL single-dose vial contains 43 mg irinotecan free base at a concentration of 4.3 mg/mL. The liposome is a unilamellar lipid bilayer vesicle, approximately 110 nm in diameter, which encapsulates an aqueous space containing irinotecan in a gelated or precipitated state as the sucrose octasulfate salt. The vesicle is composed of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 6.81 mg/mL, cholesterol 2.22 mg/mL, and methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE) 0.12 mg/mL. Each mL also contains 2-[4-(2-hydroxyethyl) piperazin-1-yl]ethanesulfonic acid (HEPES) as a buffer 4.05 mg/mL and sodium chloride as an isotonicity reagent 8.42 mg/mL.</p></section>

Onivyde

irinotecan hydrochloride liposome

10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection

10 ML irinotecan hydrochloride liposome 4.3 MG/ML Injection [Onivyde]

irinotecan

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information

Submit MSL Request 

Pharmacy List 

Reimbursement Information

Coverage Authorization Request 

Coverage Authorization Appeals

Letter of Medical Necessity 

Medicare Part D Letter of Tier Change Request

Ipsen Cares Program Enrollment

Ipsen Cares Program Enrollment - Online 

Ipsen Cares Patient Assistance Program Application

Enroll in Patient Savings Program 

Other HCP Resources 

Reimbursement Guide

Patient Brochure

Ipsen Cares Patient Support Program 

About Onivyde

Receiving Onivyde

Side Effects 

Tips To Manage Diarrhea

Patient Resources 

Instructions For Use: Metastatic Pancreatic Cancer