Plegridy Prefilled Syringe Starter Kit
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Uses
PLEGRIDY (peginterferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
History
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Other Information
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 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.
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.
Sources
Plegridy Prefilled Syringe Starter Kit Manufacturers
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Biogen Idec Inc.
![Plegridy Prefilled Syringe Starter Kit (Peginterferon Beta-1a) Kit Plegridy Pen Starter Kit (Peginterferon Beta-1a) Kit Plegridy Prefilled Syringe (Peginterferon Beta-1a) Injection, Solution Plegridy Pen (Peginterferon Beta-1a) Injection, Solution [Biogen Idec Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Plegridy Prefilled Syringe Starter Kit | Biogen Idec Inc.
2.1 Dosing InformationPLEGRIDY is administered subcutaneously.
The recommended dosage of PLEGRIDY is 125 micrograms injected subcutaneously every 14 days.
Treatment initiation
Patients should start treatment with 63 micrograms on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 1). A PLEGRIDY Starter Pack is available containing two prefilled pens or syringes: 63 micrograms (dose 1) and 94 micrograms (dose 2).
Table 1: Schedule for Dose Titration Dose Time* Amount (micrograms) Color of Pen or
Syringe Label*Dosed every 14 days
Dose 1 On day 1 63 Orange Dose 2 On day 15 94 Blue Dose 3 On day 29 and every 14 days thereafter 125 (full dose) Grey 2.2 Important Administration Instructions (All Dosage Forms)Healthcare professionals should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe. Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections are abdomen, back of the upper arm, and thigh.
Each PLEGRIDY pen and syringe is provided with the needle pre-attached. Prefilled pens and syringes are for a single dose only and should be discarded after use.
2.3 Premedication for Flu-like SymptomsProphylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.
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