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Ustekinumab

Generic Medicine Info
Indications and Dosage
Intravenous, Subcutaneous
Crohn's disease
Adult: For moderate to severe cases in patients who have had inadequate response with, lost response to, or were intolerant of conventional therapy or tumour necrosis factor-α (TNF-α) antagonist or have contraindications to such therapies: Induction of remission: Patients weighing ≤55 kg: 260 mg as a single dose; >55-≤85 kg: 390 mg as a single dose; >85 kg: 520 mg as a single dose. Doses are given via IV infusion over at least 1 hour. Maintenance of remission: 90 mg via SC inj, initiated 8 weeks after the IV dose, then repeated every 8 or 12 weeks thereafter according to response. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Intravenous, Subcutaneous
Ulcerative colitis
Adult: For moderate to severe cases in patients who have had inadequate response with, lost response to, or were intolerant of conventional therapy or biologic agent or have contraindications to such therapies: Induction of remission: Patients weighing ≤55 kg: 260 mg as a single dose; >55-≤85 kg: 390 mg as a single dose; >85 kg: 520 mg as a single dose. Doses are given via IV infusion over at least 1 hour. Maintenance of remission: 90 mg via SC inj, initiated 8 weeks after the IV dose, then repeated every 8 or 12 weeks thereafter according to response. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Subcutaneous
Plaque psoriasis
Adult: For moderate to severe cases in patients who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies (e.g. methotrexate, ciclosporin, psoralen and ultraviolet A [PUVA]): Patients weighing ≤100 kg: 45 mg at weeks 0 and 4, then every 12 weeks thereafter; >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Child: For moderate to severe cases in patients who are inadequately controlled by or are intolerant of other systemic therapies or phototherapeis: ≥6 years Patients weighing <60 kg: 0.75 mg/kg at weeks 0 and 4, then every 12 weeks thereafter; ≥60-≤100 kg: 45 mg at weeks 0 and 4, then every 12 weeks thereafter; >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).

Subcutaneous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate in patients with inadequate response to previous non-biological DMARD therapy: 45 mg at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, in patients weighing >100 kg: 90 mg at weeks 0 and 4, then every 12 weeks thereafter. Discontinue therapy if there is no response after 28 weeks. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
What are the brands available for Ustekinumab in Malaysia?
Reconstitution
Solution for IV infusion (130 mg/26 mL vial): Withdraw and discard a volume from a 250 mL infusion bag of NaCl 0.9% or NaCl 0.45% solution equal to the volume of ustekinumab to be added. Add ustekinumab to the infusion bag to make a final total volume of 250 mL. Gently mix the solution.
Contraindications
Hypersensitivity. Active infection (e.g. active tuberculosis).
Special Precautions
Patient with chronic infection or history of recurrent infection; history of prolonged immunosuppressant therapy, history of PUVA treatment; predisposition to infections (e.g. diabetes, residence or travel from areas of endemic mycoses); genetically deficient in interleukin (IL)-12 or IL-23; history of malignancy or who developed malignancy during ustekinumab treatment. Patient receiving or who has undergone allergy immunotherapy. Some available products are approved as biosimilars to the reference biological ustekinumab (Stelara®). Interchangeability and product availability may vary between countries; refer to local or product-specific guidelines. Avoid vaccinations with live viral or live bacterial vaccines (e.g. BCG vaccine). Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Increased risk of infections, including reactivation of latent infections, serious bacterial, mycobacterial, fungal, and viral infections; increased risk of malignancy (e.g. multiple cutaneous squamous cell carcinomas); serious hypersensitivity reactions (e.g. anaphylaxis, angioedema, bullous pemphigoid); interstitial pneumonia, eosinophilic pneumonia, cryptogenic organising pneumonia; posterior reversible encephalopathy syndrome (PRES); exfoliative dermatitis (particularly in patients with psoriasis); CV events (e.g. MI); lupus-related conditions (e.g. cutaneous lupus erythematosus, lupus-like syndrome).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Fatigue, inj site reactions (e.g. pain, erythema).
Immune system disorders: Antibody development.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, myalgia.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: URTI, oropharyngeal pain, nasopharyngitis, sinusitis.
Skin and subcutaneous tissue disorders: Pruritus.
Monitoring Parameters
Evaluate for the presence of tuberculosis infection before treatment initiation. Monitor CBC with differential and LFTs. Assess for signs and symptoms of active tuberculosis or infection, non-melanoma skin cancer, and PRES.
Drug Interactions
Concomitant use with live viral or live bacterial vaccines may enhance the adverse effects and decrease the therapeutic effect of the vaccines.
Action
Description:
Mechanism of Action: Ustekinumab, an immunosuppressive agent, is a recombinant human monoclonal antibody. It binds to and interferes with interleukin (IL)-12 and IL-23 cytokines, which are involved in inflammatory and immune responses such as activation of natural killer (NK) cell, activation and differentiation of CD4+ T-cell. It also inhibits 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% (SC). Time to peak plasma concentration: Approx 8.5 days (SC).
Distribution: Crosses the placenta; enters breast milk (very small amounts). Volume of distribution: 57-83 mL/kg (IV).
Excretion: Elimination half-life: Approx 3 weeks (range: 15-45 days).
Storage
Subcutaneous:
Vial: Store between 2-8°C. Do not freeze or shake. Protect from light. Pre-filled syringe or pen: Store between 2-8°C. Do not freeze or shake. Protect from light. If necessary, may be stored at up to 30°C.

Intravenous:
Vial: Store between 2-8°C. Do not freeze or shake. Protect from light.

Storage recommendations may vary between individual products. Refer to specific product guidelines.
MIMS Class
Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
L04AC05 - ustekinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
References
Brayfield A, Cadart C (eds). Ustekinumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.

Janssen-Cilag (New Zealand) Ltd. Stelara Solution for Injection in Vial or Injection in Pre-filled Syringe; Stelara Concentrate for Solution for Infusion; Stelara Solution for Injection in Pre-filled Pen data sheet 14 November 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 06/08/2025.

Joint Formulary Committee. Ustekinumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.

Otulfi 45 mg Solution for Injection in Pre-filled Syringe (Fresenius Kabi Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.

Pzychiva 130 mg Concentrate for Solution for Infusion (Samsung Bioepis UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.

Stelara 90 mg Solution for Injection in Pre-filled Syringe (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.

Stelara Injection, Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.

Stelara Solution for Injection in Pre-filled Syringe; Stelara 130 mg/26 mL Concentrate for Solution for Infusion; Stelara Solution for Injection in Single-use Vial (Johnson & Johnson Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/08/2025.

Steqeyma Injection, Solution (Celltrion USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.

Ustekinumab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/08/2025.

Ustekinumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/08/2025.

Wezlana Injection, Solution (Optum Health Solutions [Ireland] Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.

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 © 2025 MIMS. All rights reserved. Powered by MIMS.com
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