Drugs & Therapy Perspectives

, Volume 34, Issue 5, pp 197–202 | Cite as

Methotrexate pre-filled autoinjector pen (Nordimet®) for subcutaneous injection: a profile of its use in the EU

  • Kate McKeage
  • Katherine A. Lyseng-Williamson
Adis Drug Q&A


Nordimet® subcutaneous methotrexate pre-filled autoinjector pens are approved for use in adults with rheumatoid arthritis, severe psoriasis, and psoriatic arthritis, as well as in children and adolescents with severe juvenile idiopathic arthritis. Subcutaneous administration of methotrexate may have advantages for some patients in terms of clinical outcomes relative to oral methotrexate because of its higher level of bioavailability, better clinical efficacy and potentially fewer gastrointestinal adverse effects. The Nordimet® pre-filled autoinjector pen was ergonomically designed to enable self-injection, even for those with compromised manual dexterity, and to improve patient comfort, convenience and safety. Self-injection is accomplished in two easy steps and studies indicate that the device is intuitive to use, with a high level of acceptance, usability and satisfaction.



The manuscript was reviewed by: Renske Hebing, Amsterdam Rheumatology and Immunology Center, Reade Rheumatology, Amsterdam, the Netherlands; Anthony Thaniyan, Faculty of Medicine, University of Tabuk, Tabuk, Saudi Arabia. During the peer review process, Nordic Group BV, the marketing-authorization holder of Nordimet®, was offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Compliance with ethical standards


The preparation of this review was not supported by any external funding.

Conflicts of interest

K. McKeage and K.A. Lyseng-Williamson are employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.


  1. 1.
    Bello AE, Perkins EL, Jay R, et al. Recommendations for optimizing methotrexate treatment for patients with rheumatoid arthritis. Open Access Rheumatol. 2017;9:67–79.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Bianchi G, Caporali R, Todoerti M, et al. Methotrexate and rheumatoid arthritis: current evidence regarding subcutaneous versus oral routes of administration. Adv Ther. 2016;33(3):369–78.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Smolen JS, Landewé R, Bijlsma JW, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–77.CrossRefPubMedGoogle Scholar
  4. 4.
    Manalo IF, Gilbert KE, Wu JJ. Subcutaneous methotrexate for symptomatic control of severe recalcitrant psoriasis: safety, efficacy, and patient acceptability. Psoriasis Targ Ther. 2015;5:65–70.Google Scholar
  5. 5.
    Livermore P. Juvenile idiopathic arthritis: updated guide to administering methotrexate. Nurs Child Young People. 2014;26(1):26–9.CrossRefPubMedGoogle Scholar
  6. 6.
    Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75(3):499–510.CrossRefPubMedGoogle Scholar
  7. 7.
    Nordimet solution for injection in pre-filled pen and prefilled syringe: summary of product characteristics. London: European Medicines Agency; 2017.Google Scholar
  8. 8.
    Schiff MH, Sadowski P. Oral to subcutaneous methotrexate dose-conversion strategy in the treatment of rheumatoid arthritis. Rheumatol Int. 2017;37(2):213–8.CrossRefPubMedGoogle Scholar
  9. 9.
    Schiff MH, Jaffe JS, Freundlich B. Head-to-head, randomised, crossover study of oral versus subcutaneous methotrexate in patients with rheumatoid arthritis: drug-exposure limitations of oral methotrexate at doses ≥ 15 mg may be overcome with subcutaneous administration. Ann Rheum Dis. 2014;73(8):1549–51.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Braun J, Kastner P, Flaxenberg P, et al. Comparison of the clinical efficacy and safety of subcutaneous versus oral administration of methotrexate in patients with active rheumatoid arthritis: results of a six-month, multicenter, randomized, double-blind, controlled, phase IV trial. Arthritis Rheum. 2008;58(1):73–81.CrossRefPubMedGoogle Scholar
  11. 11.
    Yadlapati S, Efthimiou P. Inadequate response or intolerability to oral methotrexate: is it optimal to switch to subcutaneous methotrexate prior to considering therapy with biologics? Rheumatol Int. 2016;36(5):627–33.CrossRefPubMedGoogle Scholar
  12. 12.
    Arthur AB, Klinkhoff AV, Teufel A. Safety of self-injection of gold and methotrexate. J Rheumatol. 1999;26(2):302–5.PubMedGoogle Scholar
  13. 13.
    Lee J, Pelkey R, Gubitosa J, et al. Comparing healthcare costs associated with oral and subcutaneous methotrexate or biologic therapy for rheumatoid arthritis in the United States. Am Health Drug Benefits. 2017;10(1):42–9.PubMedPubMedCentralGoogle Scholar
  14. 14.
    Fitzpatrick R, Scott DG, Keary I. Cost-minimisation analysis of subcutaneous methotrexate versus biologic therapy for the treatment of patients with rheumatoid arthritis who have had an insufficient response or intolerance to oral methotrexate. Clin Rheumatol. 2013;32(11):1605–12.CrossRefPubMedGoogle Scholar
  15. 15.
    Pharma Nordic. Normidet® (injectable methotrexate) monograph. Hoofddorp: Nordic Pharma; 2017.Google Scholar
  16. 16.
    Demary W, Schwenke H, Rockwitz K, et al. Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience. Patient Prefer Adherence. 2014;8:1061–71.PubMedPubMedCentralGoogle Scholar
  17. 17.
    Hudry C, Lebrun A, Moura B, et al. Evaluation of usability and acceptance of a new autoinjector intended for methotrexate subcutaneious self-administration in the management of rheumatoid arthritis. Rheumatol Ther. 2017;4(1):183–94.CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Thakur K, Biberger A, Handrich A, et al. Patient perceptions and preferences of two etanercept autoinjectors for rheumatoid arthritis: findings from a patient survey in Europe. Rheumatol Ther. 2016;3(2):245–56.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Andre AD, Brand-Schieber E, Ramirez M, et al. Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs. Patient Prefer Adherence. 2017;11:121–9.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations