Alternate Name(s):
SIMPONI
Classification:
Human monoclonal antibody, Tumour Necrosis Factor Alpha Inhibitor
Original Date:
August 2012
Revised Date:
December 2019
Indications:
- Treatment of pediatric patients between 2 to 18 years who have moderate to severe active Ulcerative Colitis who had an inadequate response to, or are unable to tolerate conventional therapies, or who require continuous corticosteroid therapy for:
- inducing and maintaining clinical response
- improving endoscopic appearance of the mucosa during induction
- inducing clinical remission
- achieve and sustain clinical remission in induction responders
Reconstitution and Stability:
- Available as single-use preservative-free pre-filled syringes and Smartject auto injectors: 50 mg/0.5 mL and 100 mg/1 mL. Clear colourless to light yellow solution.
- Store syringes in original packaging refrigerated (2-8 C) DO NOT FREEZE. DO NOT SHAKE.
- Protect from light.
- May be stored at room temperature (up to 25 C) for a maximum single period of 30 days in the original packaging protected from light. Once stored at room temperature, do NOT return product to refrigerator. Discard after 30 days.
- Remove syringe from fridge and allow to come to room temperature for 30 min before administration.
Compatibility:
- N/A
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | YES |
| IM | NO |
| IV Push | NO |
| IV Intermittent Infusion | NO |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Pediatric:
Induction dose
- 200 mg subcutaneously at week 0
- 100 mg subcutaneously 2 weeks after first treatment (Week 2)
Maintenance dose
- 100 mg subcutaneously every 4 weeks
Potential hazards of parenteral administration:
- Stopper contains a dry natural rubber, so there is potential for an allergic reaction for patients with latex allergy.
- Injection site reactions, headache, upper respiratory tract infections, sinusitis, nasopharyngitis, rash, constipation, fatigue, fever.
- Increased susceptibility for the development of opportunistic bacterial, viral and fungal infections including tuberculosis (TB) and hepatitis B (reactivation). TB screening and hepatitis B infection screening should be done prior to therapy initiation.
- Prior to therapy initiation, ensure patient has all immunizations up to date according to the public immunization guideline of their respective province or residency. Do not administer live vaccines concurrently with golimumab.
- Administration in conjunction with other TNF Alpha blockers and Anakinra is not recommended secondary to increased risk for serious infections without proven therapeutic benefit.
References:
Simponi Product Information, Janssen Biotech, Inc 2018