This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.
This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

SIMPONI® (golimumab) - Gastroenterology

Updated on 30/01/2019

IMMUNOLOGY
Middle row aphobia under control

*Middlerowaphobia Under Control

*the phobia described above is fictional

SIMPONI – ulcerative colitis indication

SIMPONI (golimumab) is indicated for the treatment of moderately to severely active ulcerative colitis (UC) 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

CONTROL: SIMPONI maintains clinical response in patients with moderate to severe UC2
Adapted from Sandborn WJ et al View Study
QUICK: 51% of patients achieved clinician response at week 63
Adapted from Sandborn WJ et al View Study
CONTINUOUS: In the PURSUIT long-term extension study (LTE) SIMPONI maintained efficacy over 216 weeks5
Adapted from Reinisch W et al View Study
CONVENIENT: SIMPONI’s 4-weekly dosing1 offering convenient dosing for patients View Study

SmartJect® features1

Image showing SmartJect features

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

2. Green safety sleeve – interlock prevents operation until the device is firmly pressed against injection site.

3. Activation button – patients press the raised part of the button to start the injection.

4. Large viewing window – makes it easy to see when the full dose of Simponi has been administered.

5. Expiration date – clearly printed on the side of the autoinjector.

6. Easy-to-grip shape – designed with patients in mind, with an easy-to-grip, oval-shaped body

Dosage and administration

UC: 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.

  Induction Dose Maintenance Dose
Patient <80kgs Week 0
2x (100 mg) injections
Week 2
1x (100mg) injection
Week 6 and every 4 weeks thereafter
Patients with adequate response to induction 1 x (50mg) injection. Patients who have an inadequate response to induction may benefit from continuing with 1 x (100mg) injection
Patient ≥80kgs Week 0
2x (100 mg) injections
Week 2
1x (100 mg) injection
Week 6 and every 4 weeks thereafter
1x (100 mg) injection

Important safety information

SIMPONI patient support materialsFind out more

Related content

 

References

  1. SIMPONI Summary of Product Characteristics.
  2. Sandborn WJ, et al. Gastroenterology 2014;146:96–109.
  3. Sandborn WJ, et al. Gastroenterology 2014;146:85–95.
  4. Probert CSJ, et al. BMJ Open Gastro. 2018;5:e000212. doi:10.1136/bmjgast-2018-000212.
  5. Reinisch W et al. J Crohn's Colitis 2018;12:1053-1066

Supporting documentation

SIMPONI 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Syringe | Patient Information Leaflet for Pre-filled Pen

SIMPONI 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Pen

GB-GOL-00060 | Date of Preparation: January 2019