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Peginterferon beta-1a

Published
Topics: Allergy and immunologyInfection and infectious diseasesNew Medicines · NHS England commissioned new medicinesPatent expiriesPeginterferon beta-1aStability outside the fridge ·
Contents
  1. dm+d
  2. Refrigerated Storage
    1. Plegridy · Biogen
  3. New Medicines
    1. Plegridy · Relapsing remitting multiple sclerosis (MS) in adults - intramuscular route of administration

dm+d

27983711000001101

Refrigerated Storage

PlegridyBiogen

Biogen
Plegridy
Solution for injection in a pre-filled pen; 63 and 94 micrograms (initiation pack); and 125 micrograms

In the event of an inadvertent temperature excursion the following data may be used:

Plegridy can be stored at room temperature (up to 25°C) for up to 30 days as long as it is stored away from light.

If Plegridy is at room temperature for a total of 30 days, it should be used or discarded.

If it is not clear if Plegridy has been stored at room temperature 30 days or more, it should be discarded.

Contact Biogen for additional information in cases where a deviation from the recommended storage conditions has occurred. Please refer to the BNF for contact details.

19 March 2021
London MI Service

New Medicines

Plegridy Relapsing remitting multiple sclerosis (MS) in adults - intramuscular route of administration

Information

Plegridy
New route of administration
Biogen
Biogen

Development and Regulatory status

Launched
Launched
None
December 2020
Dec 20Approved in EU [3].
Oct 20EU CHMP recommends addition of a new route of administration (intramuscular use) for an existing formulation (125 micrograms in 0.5 ml) already authorised for subcutaneous use. The recommended indication for intramuscular use is the same as the currently authorised indication for Plegridy and is use in adult patients for the treatment of relapsing remitting multiple sclerosis [1].

Category

An interferon beta-1a conjugated with a single, linear molecule of 20,000 Da methoxy poly(ethyleneglycol)-O-2-methylpropionaldehyde (20 kDa mPEG-O-2-methylpropionaldehyde) at a degree of substitution of 1 mole of polymer/mole of protein.
MS estimated prevalence is 190 cases per 100,000 population. MS is more than twice as common in females than males. The highest prevalence for MS occurs in the 60 to 69 years age group for both sexes. The MS estimated incidence in England is between 8 and 11 new cases per 100,000 population [2].
Relapsing remitting multiple sclerosis (MS) in adults - intramuscular route of administration
Intramuscular