Amgevita (adalimumab) Formulation | Amgen

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AMGEVITA® IS CITRATE-FREE1

Citrate-free formulations may be associated with reduced injection site pain when compared with citrate-containing formulations1–3

Reduced injection site pain may improve compliance to treatment.4
Injection site pain perception from bioequivalence clinical trials: Results of an exploratory analysis3,4*
CI = Confidence interval
*The study reports results of patient perception of injection site pain and injection site reactions from two bioequivalence trials with AMGEVITA® compared with citrate-containing adalimumab in rheumatoid arthritis and plaque psoriasis. In both trials, injection site pain was an exploratory objective. Subject perception of injection site pain assessed after injection on a 100 mm horizontal visual analogue scale, with the left-hand extreme described as ‘No pain at all’ and right-hand extreme as ‘A lot of pain’. Measurements taken within 5 minutes of injection in the safety analysis set.
The citrate-containing adalimumab formulation studied above is no longer available in the majority of European markets.
  1. AMGEVITA® (adalimumab) Summary of Product Characteristics. Available at: www.ema.europa.eu. Last revised March 2020.
  2. Nash P, et al. Rheumatol Ther. 2016;3:257–70.
  3. Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98:212–21.
  4. Krishnan E, et al. EULAR Amsterdam, Netherlands, 2018; PosterFRI0115.
  5. Krishnan E, et al. ECCO Vienna, Austria, 2018; Poster P497.

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AMGEVITA® is authorised for the following indications by the European Commission:
AMGEVITA® is an adalimumab biosimilar indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis and paediatric uveitis.
> See full indication
AMGEVITA® (adalimumab) Summary of Product Characteristics. Available at: www.ema.europa.eu. Last revised March 2020.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.