Ulcerative Colitis (UC) Indication

SIMPONI (golimumab) was developed to fit with patient needs and lifestyle, while continuing to improve functionality and disease outcomes. It is the first and only subcutaneous anti-TNF therapy with convenient monthly dosing following induction doses*. SIMPONI is licensed for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 - mercaptopurine (6 - MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.1

SIMPONI® (golimumab): requires fewer annual injections under the skin than any currently available sub-cutaneous anti-TNF biologic medicine, from day one.1

*Induction doses are administered at week 0 and 2 with maintenance dosing commencing from week 6. Refer to the Summary of Product Characteristics for further details on dosing.1

SmartJect® Features

  1. 1. Hidden needle

Thin needle automatically deploys (first click), then retracts (second click), so your patients never have to see it.

  1. 2. Green safety sleeve

Interlock prevents operation until the device is firmly pressed against injection site.

  1. 3. Activation button

Patients press the raised part of the button to start the injection.

  1. 4. Large viewing window

makes it easy to see when the full dose of SIMPONI has been administered.

  1. 5. Expiration date

clearly printed on the side of the autoinjector.

  1. 6. Easy-to-grip shape

designed with patients in mind, with an easy-to-grip, oval-shaped body.

Dosage and administration

Refer to the Summary of Product Characteristics for further details on indications and dosing.1

SIMPONI should be injected subcutaneously (SC). Treatment should be initiated under the supervision of a physician experienced in the diagnosis and treatment of RA, PsA, AS, nr-Axial SpA or UC. Patients may self-inject, if comfortable doing so after instruction.

Patients weighing <80 kg: initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter. Patients weighing ≥80 kg: initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks. During maintenance treatment, corticosteroids may be tapered, following clinical practice guidelines. Clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). Older people (>65 years): no dose adjustment required. Paediatric patients (<18 years) in indications other than pJIA and patients with renal and hepatic impairment: SIMPONI is not recommended in these populations.

IE-GOL-00056|Date of preparation: November 2020