Gonadotropin Releasing Hormone Receptor Agonists

Gonadotropin Releasing Hormone Receptor Agonist

Breast Neoplasms

Endometriosis

Infertility

Leiomyoma

Ovarian Neoplasms

Prostatic Hyperplasia

Prostatic Neoplasms

Puberty, Precocious

Endometrial Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="LINK_fbd16669-832d-42a1-8f2c-482d2a101b4d"></a><a name="section-10"></a><h1>11  DESCRIPTION </h1>ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection.  It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period.Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis.  The analog possesses greater potency than the natural hormone.  The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:<div class="Figure"><img alt="153d1272-figure-12" src="eligard-19.jpg"/></div>ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration.  The two syringes are joined and the single dose product is mixed until it is homogenous.  ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot.One syringe contains the ATRIGEL® Delivery System and the other contains leuprolide acetate.  ATRIGEL® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD® product.Table 6.  ELIGARD® Delivery System Composition and Reconstituted Product Formulation<table cellpadding="0" cellspacing="0" width="100%"><col width="1px"/><col width="1px"/><col width="1px"/><col width="1px"/><col width="1px"/><col/><tbody class="Headless"><tr class="First"><td class="Botrule Rrule Toprule" colspan="2">ELIGARD®</td><td class="Botrule Rrule Toprule">7.5 mg </td><td class="Botrule Rrule Toprule">22.5 mg </td><td class="Botrule Rrule Toprule">30 mg </td><td class="Botrule Toprule">45 mg </td></tr><tr><td class="Botrule Toprule" rowspan="3">ATRIGEL® Delivery System syringe          </td><td class="Botrule Lrule Rrule Toprule">Polymer</td><td class="Botrule Rrule Toprule">PLGH</td><td class="Botrule Rrule Toprule">PLG</td><td class="Botrule Rrule Toprule">PLG</td><td class="Botrule Toprule">PLG</td></tr><tr><td class="Botrule Lrule Rrule Toprule">Polymer description</td><td class="Botrule Rrule Toprule">Copolymer containing carboxyl endgroups</td><td class="Botrule Rrule Toprule">Copolymer with hexanediol</td><td class="Botrule Rrule Toprule">Copolymer with hexanediol</td><td class="Botrule Toprule">Copolymer with hexanediol</td></tr><tr><td class="Botrule Lrule Rrule Toprule">Polymer DL-lactide to glycolide molar ratio</td><td class="Botrule Rrule Toprule">50:50</td><td class="Botrule Rrule Toprule">75:25</td><td class="Botrule Rrule Toprule">75:25</td><td class="Botrule Toprule">85:15</td></tr><tr><td class="Botrule Toprule" rowspan="6">Reconstituted product          </td><td class="Botrule Lrule Rrule Toprule">Polymer delivered</td><td class="Botrule Rrule Toprule">82.5 mg</td><td class="Botrule Rrule Toprule">158.6 mg</td><td class="Botrule Rrule Toprule">211.5 mg</td><td class="Botrule Toprule">165 mg</td></tr><tr><td class="Botrule Lrule Rrule Toprule">NMP delivered</td><td class="Botrule Rrule Toprule">160.0 mg</td><td class="Botrule Rrule Toprule">193.9 mg</td><td class="Botrule Rrule Toprule">258.5 mg</td><td class="Botrule Toprule">165 mg</td></tr><tr><td class="Botrule Lrule Rrule Toprule">Leuprolide acetate delivered</td><td class="Botrule Rrule Toprule">7.5 mg</td><td class="Botrule Rrule Toprule">22.5 mg</td><td class="Botrule Rrule Toprule">30 mg</td><td class="Botrule Toprule">45 mg</td></tr><tr><td class="Botrule Lrule Rrule Toprule">Approximate Leuprolide free base equivalent</td><td class="Botrule Rrule Toprule">7.0 mg</td><td class="Botrule Rrule Toprule">21 mg</td><td class="Botrule Rrule Toprule">28 mg</td><td class="Botrule Toprule">42 mg</td></tr><tr><td class="Botrule Lrule Rrule Toprule">Approximate administered formulation weight</td><td class="Botrule Rrule Toprule">250 mg</td><td class="Botrule Rrule Toprule">375 mg</td><td class="Botrule Rrule Toprule">500 mg</td><td class="Botrule Toprule">375 mg</td></tr><tr class="Last"><td class="Botrule Lrule">Approximate injection volume</td><td class="Botrule Lrule Rrule Toprule">0.25 mL</td><td class="Botrule Rrule Toprule">0.375 mL</td><td class="Botrule Rrule Toprule">0.5 mL</td><td class="Botrule Toprule">0.375 mL</td></tr></tbody></table></section>

ELIGARD

leuprolide acetate

Fensolvi

0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Fensolvi]

Eligard

leuprolide

0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe

0.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe

0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe

0.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe

0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Eligard]

0.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]

0.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Eligard]

0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]

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 

Prescribing Information: Pre-Connected Syringe System

Pharmacy List

How To Order Eligard 

Coverage Authorization Request

Coverage Authorization Appeals

Enroll in Patient Savings Program 

Other HCP Resources 

Other HCP Resources - TolmarSync

Prostate Cancer 360 RoadMap Brochure

About Eligard 

Eligard Start Guide 

Managing Side Effects 

Doctor Discussion Guide 

Patient Resources 

Patient Brochure

Prostate Cancer & You Guide 

Patient Brochure: Spanish

Instructions For Use: Prostate Cancer

Prostate Cancer & You Guide - Spanish