Interferon beta

Multiple Sclerosis

<section class="Section" data-sectioncode="34089-3"><a name="s45"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Peginterferon beta-1a is a covalent conjugate of recombinant interferon beta-1a (approximate molecular weight [MW] 20,000 daltons) with a single, linear methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule (approximate MW 20,000 daltons). Interferon beta-1a is produced as a glycosylated protein using genetically-engineered Chinese hamster ovary cells into which the human interferon beta gene has been introduced.  The amino acid sequence of recombinant interferon beta-1a is identical to that of the human interferon beta counterpart.</p><p>The molecular weight of peginterferon beta-1a is approximately 44,000 daltons, consistent with the mass of the protein, the carbohydrate moieties (approximately 2,500 daltons), and the attached poly(ethylene glycol).</p><p>Peginterferon beta-1a 125 mcg contains 125 mcg of interferon beta-1a plus 125 mcg of poly(ethylene glycol).  Using the World Health Organization International Standard for interferon beta, peginterferon beta-1a has a specific antiviral activity of approximately 100 million International Units (MIU) per mg of protein as determined using an <span class="Italics">in vitro</span> cytopathic effect assay.  Peginterferon beta-1a 125 mcg contains approximately 12 MIU of antiviral activity.</p><div class="Section" data-sectioncode="42229-5"><a name="s46"></a><a name="section-8.1"></a><p></p><p class="First"><span class="Underline">Subcutaneous Administration</span></p><p>PLEGRIDY (peginterferon beta-1a) injection is a sterile, preservative-free solution in a single-dose prefilled pen or single-dose prefilled syringe with a 29-gauge, 0.5-inch needle for subcutaneous use. Each prefilled pen or prefilled syringe delivers 0.5 mL. Each 0.5 mL contains 63 mcg, 94 mcg, or 125 mcg of peginterferon beta-1a, and L-arginine HCl (15.8 mg), glacial acetic acid (0.25 mg), polysorbate 20 (0.025 mg), and sodium acetate trihydrate (0.79 mg) in Water for Injection, USP.  The pH is approximately 4.8.</p></div><div class="Section" data-sectioncode="42229-5"><a name="s47"></a><a name="section-8.2"></a><p></p><p class="First"><span class="Underline">Intramuscular Administration</span></p><p>PLEGRIDY (peginterferon beta-1a) injection is a sterile, preservative-free solution in a single-dose prefilled syringe with a 23-gauge, 1.25-inch needle for intramuscular use. Each prefilled syringe delivers 0.5 mL. Each 0.5 mL contains 125 mcg of peginterferon beta-1a, and L-arginine HCl (15.8 mg), glacial acetic acid (0.25 mg), polysorbate 20 (0.025 mg), and sodium acetate trihydrate (0.79 mg) in Water for Injection, USP. The pH is approximately 4.8.</p></div></section>

Plegridy

peginterferon beta-1a

0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe

0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe [Plegridy]

0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe

0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe [Plegridy]

0.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled Syringe

0.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled Syringe [Plegridy]

0.5 ML peginterferon beta-1a 0.25 MG/ML Auto-Injector

0.5 ML peginterferon beta-1a 0.25 MG/ML Auto-Injector [Plegridy]

0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector

0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector

0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector [Plegridy]

0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector [Plegridy]

Psoriasis (PsO)

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Instructions For Use - Single-Dose Prefilled Pen (SC) Starter Pack: Multiple Sclerosis 

Instructions For Use  - Single-Dose Prefilled Pen (SC) 125 mcg: Multiple Sclerosis 

Instructions For Use - Single-Dose Prefilled Syringe (SC) Starter Pack: Multiple Sclerosis 

Instructions For Use - Single-Dose Prefilled Syringe (SC) 125 mcg: Multiple Sclerosis

Instructions For Use - Single-Dose Prefilled Syringe (IM): Multiple Sclerosis 

Instructions For Use - Titration Kit Single-Dose Prefilled Syringe (IM): Multiple Sclerosis 