Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).
STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn’s disease or ulcerative colitis. STELARA concentrate for solution for infusion should only be used for the intravenous induction dose.
STELARA treatment is to be initiated with a single intravenous dose based on body weight. The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation).
Table 1. Initial intravenous dosing of STELARA:
| Body weight of patient at the time of dosing | Recommended dosea | Number of 130 mg STELARA Vials |
|---|---|---|
| ≤55 kg | 260 mg | 2 |
| >55 kg to ≤85 kg | 390 mg | 3 |
| >85 kg | 520 mg | 4 |
a Approximately 6 mg/kg.
The first subcutaneous dose should be given at week 8 following the intravenous dose. For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution for injection (vial) and solution for injection in pre-filled syringe SmPC or pre-filled pen SmPC.
No dose adjustment is needed for elderly patients (see section 4.4).
STELARA has not been studied in these patient populations. No dose recommendations can be made.
The safety and efficacy of STELARA for the treatment of Crohn’s disease or ulcerative colitis in children less than 18 years have not yet been established. No data are available.
STELARA 130 mg is for intravenous use only. It should be administered over at least one hour. For instructions on dilution of the medicinal product before administration, see section 6.6.
Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
3 years.
Do not freeze.
Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of user.
Store in a refrigerator (2°C–8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper. STELARA is available in a 1 vial pack.
The solution in the STELARA vial should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to administration. The solution is clear, colourless to light yellow. The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.
1. Calculate the dose and the number of STELARA vials needed based on patient weight (see section 4.2, Table 1). Each 26 mL vial of STELARA contains 130 mg of ustekinumab. Only use complete vials of STELARA.
2. Withdraw and discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added. (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials-discard 52 mL, for 3 vials- discard 78 mL, for 4 vials- discard 104 mL)
3. Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag. The final volume in the infusion bag should be 250 mL. Gently mix.
4. Visually inspect the diluted solution before administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
5. Administer the diluted solution over a period of at least one hour. Once diluted, the infusion should be completed within eight hours of the dilution in the infusion bag.
6. Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
7. Each vial is for single use only and any unused medicinal product should be disposed of in accordance with local requirements.
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