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Safety in Lactation: Systemic preparations for eczema and psoriasis

7 January 2019Drugs used orally or parenterally for severe eczema and psoriasis have a varied pharmacology, mainly either modifying the immune response to the disease or modifying…
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Refrigerated Storage

EnbrelPfizer limited

Pfizer limited
Enbrel
Powder and solvent for solution for injection

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

Enbrel may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks of removal from refrigeration.

Contact Pfizer in all cases where a deviation from the recommended storage conditions has occurred. See current BNF for contact details.

Yes - 4 weeks from date of excursion
No
27 July 2020
London MI Service

BenepaliBiogen

Biogen
Benepali
25 mg & 50mg solution for injection in pre-filled syringe; 50 mg solution for injection in pre-filled pen.

In the event of an inadvertent temperature excursion the following data may be used:
Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Benepali should be discarded if not used within four weeks of removal from refrigeration.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

4 weeks
No
19 March 2021
London MI service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
See summary
Limited published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2019

For psoriasis

For psoriasis
Topical psoriasis preparation / corticosteroid if appropriate
Limited published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2019

New Medicines

NepextoRheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and spondylarthritis

Information

Nepexto
Biosimilar
Mylan UK
Lupin

Development and Regulatory status

Licensed but not launched
Launched
Unknown
Feb 21Viatris do not currently plan to launch Nepexto in the UK [8].
Nov 20Upjohn merges with Mylan to form Viatris [7].
Sep 20Nepexto is not a Mylan UK product. Lupin is the originator, and under the terms of the agreement made in Jun 18, Mylan will commercialise Nepexto in Europe (presumably not UK), Australia, New Zealand, Latin America, Africa and most markets throughout Asia. It is not known at present if there are plans to market Nepexto in the UK, and which company will do so [5,6].
Aug 20Launched in Germany by Mylan [5].
Jun 20The EC has granted marketing authorization for Nepexto®, a biosimilar etanercept, for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis [4].
Mar 20Recommended for EU approval by CHMP; the recommended indications are as for the originator product - treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis [3].
Jun 18Lupin entered an agreement with Mylan to commercialise YLB113 [1].
May 18Lupin´s etanercept biosimilar was accepted for review by the EMA [1].

Category

TNF inhibitor
The incidence of rheumatoid arthritis is around 1.5 men and 3.6 women developing RA per 10,000 people per year, more women than men [2].
Rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and spondylarthritis
Subcutaneous

etanercept biosimilar (CHS-0214)Rheumatoid arthritis (RA)

Information

etanercept biosimilar (CHS-0214)
Biosimilar
Coherus Biosciences
Coherus Biosciences

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fusion peptide consisting of two molecules of the p75 tumour necrosis factor (TNF)-α receptor linked to the Fc portion of immunoglobulin.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year.
Rheumatoid arthritis (RA)
Subcutaneous injection

etanercept biosimilar (CHS-0214)Psoriasis

Information

etanercept biosimilar (CHS-0214)
Biosimilar
Coherus Biosciences
Coherus Biosciences

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Tumour necrosis factor inhibitor
Prevalence is thought to vary among ethnic groups, with a higher prevalence among Scandinavian populations. Approximately 2% of Europeans have psoriasis: plaque psoriasis is the most common type, representing 90% of cases.
Psoriasis
Subcutaneous injection