Stelara Vial 45 mg

/ Janssen

Plaque psoriasis
The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, followed by a 45mg dose 4 weeks later, and then every 12 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Patients with body weight > 100 kg: For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90mg dose 4 weeks later, and then every 12 weeks thereafter. In these patients, 45 mg was also shown to be efficacious. However, 90 mg resulted in greater efficacy.
Psoriatic arthritis (PsA)
The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, followed by a 45mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Elderly (≥ 65 years): No dose adjustment is needed for elderly patients.
Renal and hepatic impairment: STELARA has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of STELARA in children with psoriasis less than 12 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Paediatric plaque psoriasis (12 years and older)
The recommended dose of STELARA based on body weight is shown in tables 1 and 2 on SmPC.
STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Crohn’s Disease
In the treatment regimen, the first dose of STELARA is administered intravenously. For the posology of the intravenous dosing regimen, see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC.
The first subcutaneous administration of 90 mg STELARA should take place at week 8 after the intravenous dose. After this, dosing every 12 weeks is recommended.
Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time.
Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks.
Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment.
Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit by week 16 or 16 weeks after switching to the 8-weekly dose.
Immunomodulators and/or corticosteroids may be continued during treatment with STELARA. In patients who have responded to treatment with STELARA, corticosteroids may be reduced or discontinued in accordance with standard of care.
If therapy is interrupted, resumption of treatment with subcutaneous dosing every 8 weeks is safe and effective.
Elderly (≥ 65 years): No dose adjustment is needed for elderly patients.
Renal and hepatic impairment: STELARA has not been studied in these patient populations. No dose recommendations can be made.
Paediatric population: The safety and efficacy of STELARA in treatment of Crohn’s disease in children less than 18 years have not yet been established. No data are available.
Method of administration: STELARA 45mg vials or pre-filled syringes are for subcutaneous injection only. If possible, areas of the skin that show psoriasis should be avoided as injection sites.
After proper training in subcutaneous injection technique, patients or their caregivers may inject STELARA if a physician determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Patients or their caregivers should be instructed to inject the prescribed amount of STELARA according to the directions provided in the package leaflet.
Comprehensive instructions for administration are given in the package leaflet.

Plaque psoriasis: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to, have a contraindication to, or who are intolerant to other systemic therapies including ciclosporin, methotrexate or Psoralen plus U.V (PUVA).
Paediatric plaque psoriasis: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other
systemic therapies or phototherapies.
Psoriatic arthritis (PsA): STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Crohn’s Disease: 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.

Hypersensitivity to the active substance or to any of the excipients. Clinically important, active infection.

Infections: Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections. In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA.
Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection.
Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection.
STELARA must not be given to patients with active tuberculosis. Treatment of latent tuberculosis infection should be initiated prior to administering STELARA. Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and STELARA should not be administered until the infection resolves.
Malignancies: Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy. Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies.
All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer.
Systemic and respiratory hypersensitivity reactions:
Systemic: Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment. Anaphylaxis and angioedema have occurred. If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of STELARA should be discontinued.
Respiratory: Cases of allergic alveolitis and eosinophilic pneumonia have been reported during post-approval use of ustekinumab. Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalisation. Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids. If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment.
Vaccinations: It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.. Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines.No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA. Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
See prescribing information for full details.

The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis psoriatic arthritis and Crohn’s disease clinical studies with ustekinumab were nasopharyngitis, and headache.
Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis. The overall safety profile was similar for patients with psoriasis, psoriatic arthritis and Crohn’s disease. No new safety concerns were identified with up to 2 years of treatment in patients with Crohn’s Disease.
See prescribing information for full details.

Live vaccines should not be given concurrently with STELARA.
No interaction studies have been performed in humans. In the population pharmacokinetic analysis of the phase III studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin,
levothyroxine) on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products. The basis for this analysis was that at least 100 patients (>5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn’s disease.
The results of an in vitro study do not suggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates.
In psoriasis studies, the safety and efficacy of STELARA in combination with
immunosuppressants, including biologics, or phototherapy have not been evaluated. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA. In Crohn’s disease studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA.

Pregnancy: There are no adequate data from the use of ustekinumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Breastfeeding: It is unknown whether ustekinumab is excreted in human breast milk. Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breastfeeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breastfeeding to the child and the benefit of STELARA therapy to the woman.
See prescribing information for full details.

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without doselimiting 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.

Storage: Store in a refrigerator (2ºC – 8ºC). Do not freeze.