Somatostatin Receptor Agonists

Somatostatin Analog

Cushing Syndrome

<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">SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt). Pasireotide is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. Pasireotide pamoate has a chemical name of (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester pamoic acid salt.       </p><p>The molecular formula of pasireotide pamoate is C<span class="Sub">58</span>H<span class="Sub">66</span>N<span class="Sub">10</span>O<span class="Sub">9</span> • C<span class="Sub">23</span>H<span class="Sub">16</span>O<span class="Sub">6</span> and the molecular weight is 1435.58 g/mol. </p><p>The structural formula is:</p><p><img alt="structural formula" src="signiforLAR-01.jpg"/></p><p>The drug product consists of pasireotide pamoate uniformly distributed within microspheres which are made of biodegradable copolymers of poly (D,L-lactide-co-glycolide) acids (PLGA).</p><p>SIGNIFOR LAR is available in a vial containing the sterile pasireotide pamoate, PLGA microspheres powder, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg to be reconstituted with the provided 2 mL sterile diluent.</p><p>Each vial contains:</p><table><col width="325"/><col width="200"/><col width="200"/><col width="200"/><col width="200"/><col width="200"/><tfoot><tr class="First Last"><td colspan="4">*corresponds to 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg of pasireotide base, respectively.</td></tr></tfoot><tbody class="Headless"><tr class="First"><td class="Toprule"></td><td class="Toprule"><span class="Bold">10 mg</span></td><td class="Toprule"><span class="Bold">20 mg</span></td><td class="Toprule"><span class="Bold">30 mg</span></td><td class="Toprule"><span class="Bold">40 mg</span></td><td class="Toprule"><span class="Bold">60 mg</span></td></tr><tr><td class="Toprule">Pasireotide pamoate</td><td class="Toprule">13.71 mg*          </td><td class="Toprule">27.42 mg*          </td><td class="Toprule">41.13 mg*          </td><td class="Toprule">54.84 mg*          </td><td class="Toprule">82.26 mg*          </td></tr><tr><td>Poly(D,L-lactide-co-glycolide) [50-60:40-50] </td><td>13.15 mg</td><td>26.29 mg</td><td>39.44 mg</td><td>52.58 mg</td><td>78.87 mg</td></tr><tr class="Last"><td>Poly(D,L-lactide-co-glycolide) [50:50]</td><td>13.15 mg</td><td>26.29 mg</td><td>39.44 mg</td><td>52.58 mg</td><td>78.87 mg</td></tr></tbody></table><p>Each diluent prefilled syringe contains:       </p><table><col width="275"/><col width="200"/><tbody class="Headless"><tr class="First"><td>Mannitol</td><td>90 mg</td></tr><tr><td>Carboxymethylcellulose sodium</td><td>14 mg</td></tr><tr><td>Poloxamer 188</td><td>4 mg</td></tr><tr class="Last"><td>Water for injections</td><td>add to 2 mL</td></tr></tbody></table></section>

Signifor LAR

pasireotide

Signifor

pasireotide 20 MG Injection

pasireotide 20 MG Injection [Signifor]

pasireotide 40 MG Injection

pasireotide 40 MG Injection [Signifor]

pasireotide 60 MG Injection

pasireotide 60 MG Injection [Signifor]

pasireotide 30 MG Injection

pasireotide 30 MG Injection [Signifor]

pasireotide 10 MG Injection

pasireotide 10 MG Injection [Signifor]

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

Medication Guide 

Submit MSL Request 

Pharmacy List

Reimbursement Information

Coverage Authorization Request 

Coverage Authorization Appeals 

R.A.R.E. Patient Support Start Form 

Enroll in Patient Savings Program

Patient Assistance Program 

Other HCP Resources: Cushing's Disease 

Other HCP Resources: Acromegaly 

About Signifor LAR: Cushing's Disease 

FAQs: Cushing's Disease 

Patient Resources: Cushing's Disease 

R.A.R.E. Support Program

FAQs: Acromegaly 

About Signifor LAR: Acromegaly 

Patient Resources: Acromegaly 

Instructions For Use: Acromegaly

Instructions For Use: Cushing's Disease

Patient Brochure: Cushing's Disease

Symptom Diary: Cushing's Disease

Disease Overview Brochure: Cushing's Disease

Disease Overview Brochure: Acromegaly

Symptom Diary: Acromegaly