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For Healthcare Professionals Only

STELARA® 45 mg and 90 mg solution for injection and 130 mg concentrate for solution for infusion PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S):

Ustekinumab

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S):

Plaque psoriasis adults: Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA.
Plaque psoriasis paediatrics: Moderate to severe plaque psoriasis in adolescent patients from 12 years of age, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic arthritis: Alone or in combination with methotrexate for treatment of active psoriatic arthritis in adult patients when response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Crohn's Disease: Treatment of adult patients with moderately to severely active Crohn's disease who had inadequate response with/lost response to/were intolerant to either conventional therapy or TNFα antagonist or have contraindications to such therapies.

DOSAGE & ADMINISTRATION:

Adults: Under guidance and supervision of a physician experienced in diagnosis and treatment of psoriasis/psoriatic arthritis/Crohn's disease. Psoriasis or psoriatic arthritis. Subcutaneous (s.c.) injection. Avoid areas with psoriasis. Self-injecting patients or caregivers ensure appropriate training. Physicians are required to follow-up and monitor patients.
Plaque psoriasis, adults & elderly:
Patients ≤100kg, 45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks.
Patients >100 kg, 90 mg at week 0 followed by a 90 mg dose at week 4, then every 12 weeks (45 mg was less effective in these patients).
Plaque psoriasis paediatrics (12 years and older):
Patients <60 kg, 0.75 mg/kg at week 0, followed by 0.75 mg/kg at week 4 then every 12 weeks thereafter.
Patients ≥60 - ≤100kg, 45 mg at week 0 followed by 45 mg at week 4, then every 12 weeks.
Patients >100 kg, 90mg at week 0, followed by 90mg at week 4, then every 12 weeks.
Psoriatic arthritis, adults & elderly:
45 mg at week 0 followed by a 45 mg dose at week 4, then every 12 weeks. Alternatively, 90 mg may be used in patients with a body weight >100 kg.
Consider discontinuation if no response after 28 weeks.
Crohn's Disease:
Initial single intravenous infusion dose based on body weight (260 mg or 390 mg or 520 mg) diluted in sodium chloride solution and given over at least one hour. At week 8 after intravenous dose, 90 mg s.c. dose is given; followed by every 12 weeks (or 8 weeks based on clinical judgement). Consider discontinuation if no response at 16 weeks. Immunomodulators and/or corticosteroids may be continued but consider reducing/discontinuing corticosteroids if responding to Stelara. If therapy interrupted, resume s.c. every 8 weeks if safe/effective
Children: <12 years Not recommended for psoriasis. <18 years - Not recommended for psoriatic arthritis and Crohn's disease.
Renal & Hepatic impairment: Not studied.

CONTRAINDICATIONS:

Hypersensitivity to product; clinically important, active infection.

SPECIAL WARNINGS & PRECAUTIONS:

Infections: Potential to increase risk of infections and reactivate latent infections. Caution in patients with a chronic infection or history of recurrent infection, particularly TB. Patients should be evaluated for tuberculosis prior to initiation of STELARA. Consider anti-tuberculosis therapy prior to initiation of STELARA in patients with past history of latent or active tuberculosis. Patients should seek medical advice if signs or symptoms suggestive of an infection occur. If a serious infection develops, closely monitor and STELARA should not be administered until infection resolves.
Malignancies: Potential to increase risk of malignancy. No studies in patients with history of malignancy or in patients who develop malignancy while receiving STELARA. Monitor all patients, in particular those older than 60, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment for non-melanoma skin cancer.
Concomitant immunosuppressive therapy: Caution, including when changing immunosuppressive biologic agents.
Hypersensitivity reactions: Serious hypersensitivity reactions (anaphylaxis and angioedema) reported, in some cases several days after treatment. If these occur appropriate therapy should be instituted and STELARA discontinued.
Latex sensitivity: Needle cover contains natural rubber (latex), may cause allergic reactions.
Immunotherapy: Not known whether STELARA affects allergy immunotherapy.
Serious skin conditions: Exfoliative dermatitis reported following treatment.
Discontinue STELARA if drug reaction is suspected.

SIDE EFFECTS:

Common: upper respiratory tract infection, nasopharyngitis, dizziness, headache, oropharyngeal pain, diarrhoea, nausea, vomiting, pruritus, back pain, myalgia, arthralgia, fatigue, injection site erythema, injection site pain.
Other side effects: cellulitis, serious hypersensitivity reactions (including anaphylaxis, angioedema), skin exfoliation, exfoliative dermatitis, lower respiratory tract infection.
Studies show adverse events reported in ≥12 year olds with plaque psoriasis were similar to those seen in previous studies in adults with plaque psoriasis.
Refer to SmPC for other side effects.

FERTILITY:

The effect of ustekinumab has not been evaluated.

PREGNANCY:

Should be avoided. Women of childbearing potential: Use effective contraception during treatment and for at least 15 weeks post-treatment.

LACTATION:

Limited data in humans.

INTERACTIONS:

In vitro, STELARA had no effect on CYP450 activities.
Vaccinations: Live vaccines should not be given concurrently with STELARA, and should be withheld for at least 15 weeks after last dose of STELARA. STELARA can resume at least 2 weeks after such vaccinations. No data on secondary transmission of infection by live vaccines in patients receiving STELARA.
Concomitant immunosuppressive therapy: Psoriasis: Safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated.
Psoriatic arthritis: concomitant MTX did not appear to affect STELARA. Crohn's disease: concomitant immunosupressive or corticosteroid therapy did not appear to affect STELARA.

Refer to SmPC for full details of interactions.

LEGAL CATEGORY: POM

PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBERS & BASIC NHS COSTS:

PRESENTATIONS PACK SIZES MARKETING AUTHORISATION NUMBER(S) BASIC NHS COSTS
45 mg vial 1 vial EU/1/08/494/001 £2147
45 mg pre-filled syringe 1 syringe EU/1/08/494/003 £2147
90 mg pre-filled syringe 1 syringe EU/1/08/494/004 £2147
130 mg vial 1 vial EU/1/08/494/005 £2147

MARKETING AUTHORISATION HOLDER: JANSSEN-CILAG INTERNATIONAL NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG UK.

Prescribing information last revised: 09/2017

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.