Poly(ADP-Ribose) Polymerase Inhibitors

Poly(ADP-Ribose) Polymerase Inhibitor

Fallopian Tube Neoplasms

Ovarian Neoplasms

Peritoneal Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Niraparib is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor.</p><p>The chemical name for niraparib tosylate monohydrate is 2-{4-[(3S)-piperidin-3-yl]phenyl}-<span class="Italics">2H</span>-indazole 7-carboxamide 4-methylbenzenesulfonate hydrate (1:1:1). The molecular formula is C<span class="Sub">26</span>H<span class="Sub">30</span>N<span class="Sub">4</span>O<span class="Sub">5</span>S and it has a molecular weight of 510.61 amu. The molecular structure is shown below:</p><div class="Figure"><a name="id1387"></a><img alt="Chemical Structure" src="zejula-spl-graphic-01.jpg"/></div><p>Niraparib tosylate monohydrate is a white to off-white, non-hygroscopic crystalline solid. Niraparib solubility is pH independent below the pKa of 9.95, with an aqueous free base solubility of 0.7 mg/mL to 1.1 mg/mL across the physiological pH range.</p><p>Each ZEJULA capsule contains 159.4 mg niraparib tosylate monohydrate equivalent to 100 mg niraparib free base as the active ingredient. The inactive ingredients in the <span class="Italics">capsule fill</span> are magnesium stearate and lactose monohydrate. The <span class="Italics">capsule shell</span> consists of titanium dioxide and gelatin in the white capsule body and FD&amp;C Blue No. 1, FD&amp;C Red No. 3, FD&amp;C Yellow No. 5 (tartrazine), and gelatin in the purple capsule cap. The <span class="Italics">black printing ink </span>consists of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and black iron oxide. The <span class="Italics">white printing ink </span>consists of shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, and titanium dioxide.</p></section>

ZEJULA

niraparib

niraparib 100 MG Oral Capsule

Zejula

niraparib 100 MG Oral Capsule [Zejula]

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

Submit MSL Request 

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Zejula Service Request Form 

Enroll in Patient Savings Program 

GSK Patient Assistance Program Eligibiligy & Enrollment 

Quick Start & Bridge Program 

Instructions For Use: 1L Maintenance with Platinum-Reponsive Advanced Ovarian Cancer 