Etanercept

Articles · Refrigerated Storage · Lactation Safety Information · New Medicines ·

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Articles

Safety in Lactation: Drugs which suppress the rheumatic disease process

Disease-modifying anti-rheumatic drugs (DMARDs) have a varied pharmacology, mainly either modifying the immune response to the disease or modifying the disease process. The choice of… Abatacept Adalimumab Anakinra Azathioprine Belimumab Certolizumab pegol Chloroquine Ciclosporin Etanercept Golimumab Hydroxychloroquine Infliximab Leflunomide Methotrexate Penicillamine Rituximab Sodium aurothiomalate Sulfasalazine Tocilizumab Ustekinumab

Refrigerated Storage

Enbrel · Pfizer 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.

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

4 weeks
No
14th May 2018
London MI Service

Benepali · Biogen

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
17th April 2019
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
16th 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
16th September 2019

New Medicines

Nepexto · Rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and spondylarthritis

Information

Nepexto
Biosimilar
Mylan
Mylan

Development and Regulatory status

Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
Unknown
Mar 20 · Recommended 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 18 · Lupin entered an agreement with Mylan to commercialise YLB113 [1].
May 18 · Lupin´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