Recombinant Human Growth Hormone

Septo-Optic Dysplasia

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-11"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Lonapegsomatropin-tcgd is a long-acting prodrug of a human growth hormone (somatropin) produced by recombinant DNA technology using <span class="Italics">E. coli</span>. Lonapegsomatropin-tcgd consists of a parent drug, somatropin, that is conjugated to a methoxypolyethylene glycol carrier (4 × 10 kDa mPEG) via a proprietary TransCon Linker and has a molecular weight of 63 kDa (released somatropin is 22 kDa). <span class="Italics">In vitro</span> assay confirms the minimum potency of released somatropin is NLT 2.5 IU/mg.</p><p>SKYTROFA (lonapegsomatropin-tcgd) for injection is a sterile, preservative-free, white to off-white lyophilized powder available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and the diluent, Water for Injection, in the other chamber. SKYTROFA prefilled cartridge must be used with SKYTROFA Auto-Injector to provide an automatic mixing step for reconstitution prior to subcutaneous use.</p><p>After reconstitution, each prefilled cartridge delivers:</p><ul class="Disc"><li>0.273 mL containing 3 mg lonapegsomatropin-tcgd, succinic acid (0.32 mg), trehalose dihydrate (22.7 mg), and tromethamine for pH adjustment to 5.</li><li>0.327 mL containing 3.6 mg lonapegsomatropin-tcgd, succinic acid (0.39 mg), trehalose dihydrate (27.1 mg), and tromethamine for pH adjustment to 5.</li><li>0.391 mL containing 4.3 mg lonapegsomatropin-tcgd, succinic acid (0.46 mg) and trehalose dihydrate (32.5 mg) and tromethamine for pH adjustment to 5.</li><li>0.473 mL containing 5.2 mg lonapegsomatropin-tcgd, succinic acid (0.56 mg) and trehalose dihydrate (39.3 mg) and tromethamine for pH adjustment to 5.</li><li>0.286 mL containing 6.3 mg lonapegsomatropin-tcgd, succinic acid (0.34 mg) and trehalose dihydrate (21.2 mg) and tromethamine for pH adjustment to 5.</li><li>0.345 mL containing 7.6 mg lonapegsomatropin-tcgd, succinic acid (0.41 mg) and trehalose dihydrate (25.5 mg) and tromethamine for pH adjustment to 5.</li><li>0.414 mL containing 9.1 mg lonapegsomatropin-tcgd, succinic acid (0.49 mg) and trehalose dihydrate (30.6 mg) and tromethamine for pH adjustment to 5.</li><li>0.5 mL containing 11 mg lonapegsomatropin-tcgd, succinic acid (0.59 mg) and trehalose dihydrate (37 mg) and tromethamine for pH adjustment to 5.</li><li>0.605 mL containing 13.3 mg lonapegsomatropin-tcgd, succinic acid (0.71 mg) and trehalose dihydrate (44.8 mg) and tromethamine for pH adjustment to 5.</li></ul></section>

Skytrofa

lonapegsomatropin

lonapegsomatropin-tcgd

lonapegsomatropin-tcgd 11 MG Cartridge

lonapegsomatropin-tcgd 11 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 13.3 MG Cartridge

lonapegsomatropin-tcgd 13.3 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 3 MG Cartridge

lonapegsomatropin-tcgd 3 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 3.6 MG Cartridge

lonapegsomatropin-tcgd 3.6 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 4.3 MG Cartridge

lonapegsomatropin-tcgd 4.3 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 5.2 MG Cartridge

lonapegsomatropin-tcgd 5.2 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 6.3 MG Cartridge

lonapegsomatropin-tcgd 6.3 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 7.6 MG Cartridge

lonapegsomatropin-tcgd 7.6 MG Cartridge [Skytrofa]

lonapegsomatropin-tcgd 9.1 MG Cartridge

lonapegsomatropin-tcgd 9.1 MG Cartridge [Skytrofa]

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

Instructions For Use: Growth Hormone Deficiency

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeals 

Patient Consent Form 

Ascendis Signature Access Program & Prescription Form 

Enroll in Patient Savings Program 

Other HCP Resources 

Patient Brochure 

Skytrofa Patient Support Program Brochure 

About Skytrofa 

FAQs: Growth Hormone Deficiency

Ascendis Signature Access Program (A·S·A·P) Patient Support Program 

Patient Resources 

Doctor Discussion Guide 

Patient Resources - Spanish 

Instructions For Use: Growth Hormone Defiency 