SIMPONI® (golimumab (rmc)) is a once-monthly self-injectable biologic treatment for adults with1:

  •        moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate
  •        active psoriatic arthritis, alone or with the medicine methotrexate
  •        active ankylosing spondylitis
  •        moderate to severe ulcerative colitis
  •        Non-radiographic axial spondyloarthritis (nr-Axial SpA)

1.  SIMPONI Product Information

Indications

Ulcerative colitis (UC)

SIMPONI is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy.

Rheumatoid arthritis (RA)

SIMPONI®, in combination with methotrexate, is indicated for the treatment of moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate. SIMPONI® has also been shown to inhibit the progression of joint damage as measured by X-ray.

Psoriatic arthritis (PsA)

 SIMPONI®, alone or in combination with methotrexate, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. SIMPONI® has also been shown to inhibit the progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function.

Ankylosing spondylitis (AS)

SIMPONI® is indicated for the treatment of active ankylosing spondylitis in adult patients.

(see CLINICAL TRIALS in Product Information)

Non-radiographic axial spondyloarthritis (nr-Axial SpA)

SIMPONI is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).

PBS Information

Authority Required. Please consult the PBS schedule for full information, available at www.pbs.gov.au.

For further information on how to access the online PBS Health Professional Online Services (HPOS) portal, please refer here

PDF icon Access Authority for biologic prescriptions online.pdf

Dosage and Administration

SIMPONI® treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or ulcerative colitis. After proper training in SC injection technique, patients may self-inject with SIMPONI® if their physician determines that this is appropriate, with medical follow-up as necessary.

Ulcerative colitis

SIMPONI 200 mg given as a subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks, thereafter. During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Rheumatoid arthritis

SIMPONI® 50 mg given as a subcutaneous injection once a month, on the same date each month.

Psoriatic arthritis

SIMPONI® 50 mg given as a subcutaneous injection once a month, on the same date each month.

Ankylosing spondylitis

SIMPONI 50 mg given as a subcutaneous injection once a month, on the same date each month.

Non-radiographic axial spondyloarthritis

SIMPONI 50 mg given as a subcutaneous injection once a month, on the same date each month. Available data in non-radiographic axial spondyloarthiritis suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.

For further information please consult Dosage and Administration in ​Product Information.

Did you know SIMPONI can be PBS reimbursed every 4 weeks for RA, AS and PsA?*
*Refer to the PBS Schedule for full authority information.

Safety Information

Please review ​Product Information before prescribing

SIMPONI Patient Support Program

The SIMPONI patient support program is a dedicated program exclusively for patients who have been prescribed SIMPONI®. If offers personalised, practical advice and information about SIMPONI® and Arthritis. Additional free services, which members can choose to receive include:

  • Comprehensive patient starter kit, including a cooler bag, travel pack, patient information booklet and injection guide, sharps container and alcohol swabs
  • Individualised one-to-one nurse support
  • Personalized injection reminder service
  • Pathology collection service in the home
  • Patient wellbeing support kit (smoking cessation, sun protection, skin care and oral care)
  • Access to patient educational resources

Download the patient support program enrolment form here or refer your patients to the patient enrolment portal.

EMPOWERED Website

The EMPOWERED website is an innovative online resource developed for and by patients and healthcare professionals managing rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. This educational initiative was developed by Arthritis Australia, and proudly supported by Janssen Cilag.

PDF icon Janssen_Commitment_to_Rheumatology_LB.pdf

PDF icon Empowered Leaflet.pdf