Recommended Topic Related To:

Plegridy

"Introduction to drugs for the treatment of multiple sclerosis

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (brain) that leads to degeneration of nerves in the brain. There is no cure for multiple s"...

Plegridy

PLEGRIDY
(peginterferon beta-1a) Autoinjector for Subcutaneous Injection

DRUG DESCRIPTION

PLEGRIDY (peginterferon beta-1a) is an interferon beta-1a to which a single, linear 20,000 dalton (Da) methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde molecule is covalently attached to the alpha amino group of the N-terminal amino acid residue.

The interferon beta-1a portion of PLEGRIDY 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 the recombinant interferon beta-1a is identical to that of the human interferon beta counterpart. The molecular mass of PLEGRIDY is approximately 44,000 Da, consistent with the mass of the protein (approximately 20,000 Da), the carbohydrate moieties (approximately 2,500 Da), and the attached poly(ethylene glycol). However, because of the extended and flexible nature of the attached poly(ethylene glycol) chain, the apparent mass of PLEGRIDY in solution is greater than 300,000 Da. The more than 10-fold increase in apparent mass of PLEGRIDY compared to interferon beta-1a has been shown to contribute to the reduced clearance in vivo.

PLEGRIDY 125 micrograms contains 125 micrograms of interferon beta-1a plus 125 micrograms of poly(ethylene glycol). Using the World Health Organization International Standard for interferon beta, PLEGRIDY has a specific antiviral activity of approximately 100 million International Units (MIU) per mg of protein as determined using an in vitro cytopathic effect assay. PLEGRIDY 125 micrograms contains approximately 12 MIU of antiviral activity. PLEGRIDY contains no preservative.

PLEGRIDY PEN Single-Dose Prefilled Pen

PLEGRIDY PEN is composed of an autoinjector that surrounds a prefilled glass syringe containing 0.5 mL of a sterile solution in water for injection of 63, 94, or 125 micrograms of peginterferon beta-1a, 15.8 mg of L-arginine HCl, 0.79 mg of sodium acetate trihydrate, 0.25 mg of glacial acetic acid, and 0.025 mg of polysorbate 20. The pH is approximately 4.8.

PLEGRIDY Single-Dose Prefilled Syringe

A prefilled syringe of PLEGRIDY for subcutaneous injection contains 0.5 mL of a sterile solution in water for injection of 63, 94, or 125 micrograms of peginterferon beta-1a, 15.8 mg of L-arginine HCl, 0.79 mg of sodium acetate trihydrate, 0.25 mg of glacial acetic acid, and 0.025 mg of polysorbate 20. The pH is approximately 4.8.

Last reviewed on RxList: 8/27/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Multiple Sclerosis

Get the latest treatment options.