Ustekinumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Plaque psoriasis ≤100 kg: 45 mg; >100 kg: 90 mg. Repeat same dose after 4 weeks then every 12 weeks thereafter. Psoriatic arthritis Monotherapy or combined with methotrexate: ≤100 kg: 45 mg; >100 kg: 90 mg. Repeat same dose after 4 weeks then every 12 weeks thereafter. IV/SC Crohn’s disease; Ulcerative colitis ≤55 kg: 260 mg; >55-≤85 kg: 390 mg; >85 kg; 520 mg. Dose is given as a single dose via IV infusion over 60 minutes. Maintenance: 90 mg via SC inj starting 8 weeks after IV induction dose, and then every 8 or 12 weeks thereafter depending on response.
Dosage Details
Parenteral
Crohn's disease, Ulcerative colitis
Adult: In patients with moderate to severe cases: Recommended dose: ≤55 kg: 260 mg; >55-≤85 kg: 390 mg; >85 kg: 520 mg. Dose is given as a single dose via IV infusion over 60 minutes. Maintenance: 90 mg via SC inj starting 8 weeks after IV induction dose, then every 8 or 12 weeks thereafter depending on response.

Subcutaneous
Plaque psoriasis
Adult: In patients with moderate to severe cases: ≤100 kg: 45 mg; >100 kg: 90 mg. Repeat dose after 4 weeks then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks.
Child: ≥12 years <60 kg: 0.75 mg/kg; ≥60-≤100 kg: 45 mg; >100 kg: 90 mg. Repeat dose after 4 weeks then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks.

Subcutaneous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate: ≤100 kg: 45 mg; >100 kg: 90 mg. Repeat dose after 4 weeks then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks.
Reconstitution
IV: Withdraw and discard a volume of 0.9% or 0.45% NaCl from a 250 mL infusion bag equal to the volume of ustekinumab (vial labelled as 130 mg) to be added. Add the required dosage and volume of ustekinumab to the infusion bag to a final volume of 250 mL.
Contraindications
Severe or active infections (e.g. active tuberculosis). Administration of live viral or live bacterial vaccines.
Special Precautions
Patient with history of new/recurrent infections; chronic, latent or localised infection, underlying conditions that may predispose to infection (e.g. diabetes mellitus), IL-12 or -23 genetic deficiency; history of malignancy, prolonged immunosuppression, PUVA treatment; undergoing allergen immunotherapy, or phototherapy. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Antibody formation, hypersensitivity reactions (e.g. anaphylaxis, angioedema), malignancy (e.g. multiple cutaneous squamous cell carcinoma), noninfectious pneumonia (e.g. interstitial pneumonia, eosinophilic pneumonia, cryptogenic organising pneumonia). Rarely, exfoliative dermatitis (in patients with psoriasis).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain.
General disorders and administration site conditions: Fever, injection site reactions (erythema, pain), fatigue.
Infections and infestations: Influenza.
Musculoskeletal and connective tissue disorders: Back pain, arthralgia, myalgia.
Nervous system disorders: Headache, dizziness.
Reproductive system and breast disorders: Vaginal mycosis, vulvovaginal candidiasis.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, bronchitis, upper respiratory tract infection, sinusitis, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Pruritus.
Potentially Fatal: Serious infections (e.g. bacterial, mycobacterial, fungal, viral). Rarely, reversible posterior leucoencephalopathy syndrome.
MonitoringParameters
Perform TB screening prior to initiation and periodically thereafter. Monitor CBC and ustekinumab-antibody formation. Monitor for signs and symptoms of infection, reversible posterior leucoencephalopathy syndrome, and malignancies.
Drug Interactions
May decrease the protective effect of allergen immunotherapy (i.e. decreased tolerance), increasing the risk of an allergic reaction.
Potentially Fatal: May enhance the adverse effects and diminish the therapeutic effects of live vaccines.
Action
Description: Ustekinumab is a recombinant human monoclonal antibody. It binds to and inhibits interleukins (IL)-12 and IL-23 cytokines which are involved in inflammatory and immune responses such as natural killer (NK) cell activation and CD4+ T-cell activation and differentiation. It also interferes with the expression of tumour necrosis factor-α (TNF-α), monocyte chemotactic protein-1 (MCP-1), IL-8, and interferon-inducible protein-10 (IP-10).
Pharmacokinetics:
Absorption: Bioavailability: Approx 57%. Time to peak plasma concentration: Approx 8.5 days (SC).
Distribution: Crosses the placenta and enters breast milk. Volume of distribution: 57-83 mL/kg (IV).
Excretion: Elimination half-life: 15-45 days.
Storage
Store between 2-8°C. Protect from light. Do not shake or freeze.
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
References
Anon. Ustekinumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/06/2020.

Buckingham R (ed). Ustekinumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2020.

Joint Formulary Committee. Ustekinumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2020.

Stelara 130 mg Concentrate for Solution for Infusion (Janssen Biologics B.V.). European Medicines Agency [online]. Accessed 20/07/2020.

Stelara Injection, Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/06/2020.

Stelara Solution for Injection in Pre-Filled Syringe; 130 mg/26 mL Concentrate for Solution for Infusion (Johnson & Johnson Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 03/06/2020.

Disclaimer: This information is independently developed by MIMS based on Ustekinumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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