Abatacept
Refrigerated StorageLactation Safety InformationNew Medicines · Published , updated
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].