Abatacept

Refrigerated StorageLactation Safety InformationNew Medicines ·
421412005

Refrigerated Storage

OrenciaBristol-Myers Squibb

Bristol-Myers Squibb
Orencia
Pre-filled syringe and pre-filled pen

Contact Bristol-Myers Squibb in all cases where deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

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

21 May 2019
London MI Service

OrenciaBristol-Myers Squibb

Bristol-Myers Squibb
Orencia
250mg powder for concentrate for solution for infusion

Contact Bristol-Myers Squibb in all cases where deviation from the recommended storage conditions has occurred.Refer to the current BNF for company contact details.

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

21 May 2019
London MI Service

Lactation Safety Information

See summary
Long half-life increases risk of accumulation in breastfed infants
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2020

New Medicines

abatacept biosimilar (M834)Rheumatoid arthritis (RA) - combined with methotrexate but can be used alone

Information

abatacept biosimilar (M834)
Biosimilar
Momenta & Mylan
Momenta & Mylan

Development and Regulatory status

Phase I Clinical Trials
Phase I Clinical Trials
Phase I Clinical Trials

Category

Biosimilar of abatacept, a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
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) - combined with methotrexate but can be used alone
Parenteral

OrenciaIdiopathic inflammatory myopathies (IIM) in adults

Information

Orencia
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

T cell co-stimulation blocker
IIM are a heterogeneous group of diseases that are characterised by inflammation of muscle tissue (myositis) which can lead to profound weakness, fatigue and disability. A base case study in Sweden indicated that the estimated incidence of IIM between 2007 and 2011 was 11 (13 for women and 9.7 for men) per 1,000,000 person years [1].
Idiopathic inflammatory myopathies (IIM) in adults
Subcutaneous injection

OrenciaLupus nephritis IV formulation

Information

Orencia
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Dec 19No longer in company pipeline [7].

Category

T cell co-stimulation blocker
In 2001, prevalence of lupus nephritis was estmiated at 4.4 per 100,000 UK population [2].
Lupus nephritis IV formulation
Intravenous

Trial or other data

Jun 18Data presented at EULAR 2018 from NCT01714817, which completed in May 2018, showed that the trial did not meet its primary endpoint at one year [5].