Multiple Myeloma

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">CARVYKTI   <span class="Sup">®</span>(ciltacabtagene autoleucel) is a BCMA-directed genetically modified autologous T cell immunotherapy. CARVYKTI is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and genetically modified   <span class="Italics">ex vivo</span>by transduction with a replication-incompetent lentiviral vector to express a CAR comprising an anti-BCMA targeting domain, which consists of two single-domain antibodies linked to a 4-1BB costimulatory domain and a CD3-zeta signaling domain. </p><p>The transduced anti-BCMA CAR T cells are expanded in cell culture, washed, formulated into a suspension and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag. The product is thawed and then infused back into the patient, where the anti-BCMA CAR T cells can recognize and eliminate BCMA-expressing target cells.   <span class="Italics">[see     <a href="#S2.2">Dosage and Administration (2.2)</a>,     <a href="#S16">How Supplied/Storage and Handling (16)</a>].   </span></p><p>In addition to T cells, CARVYKTI may contain Natural Killer (NK) cells. The formulation contains 5% dimethyl sulfoxide (DMSO).</p></section>

CARVYKTI

ciltacabtagene autoleucel

70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection

Carvykti

70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection [Carvykti]

30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection

30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection [Carvykti]

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 - Spanish

Medication Guide 

Submit MSL Request 

Pharmacy List 

Formulary Information

Access & Reimbursement Guide

Prior Authorization Checklist

Coverage Authorization Request 

Coverage Authorization Appeal

Letter of Medical Necessity 

Treatment Center Locator

How To Order Carvykti

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Treatment Process 

Patient Wallet Card 

About Carvykti 

Receiving Carvykti

Patient Stories 

MyCarvykti Patient Support Program 

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Instructions For Use: Multiple Myeloma