Guselkumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

Subcutaneous
Plaque psoriasis

Adult: Moderate to severe cases in patients who are candidates for systemic therapy or phototherapy: Initially, 100 mg at weeks 0 and 4, followed by a maintenance dose of 100 mg every 8 weeks. Consider treatment discontinuation if there is no response after 16 weeks.

Subcutaneous
Psoriatic arthritis

Adult: As monotherapy or in combination with methotrexate in patients who had an inadequate response or are intolerant to a previous disease-modifying antirheumatic drugs (DMARDs) therapy: Initially, 100 mg at weeks 0 and 4, followed by a maintenance dose of 100 mg every 8 weeks. In patients who are at high risk for joint damage: 100 mg every 4 weeks may be considered. Consider treatment discontinuation if there is no response after 24 weeks.

Contraindications

Hypersensitivity. Clinically important active infections (e.g. active TB). Concurrent administration of live vaccines.

Special Precautions

Patient with history of chronic or recurrent infections; history of latent or active TB with unconfirmed adequate course of TB treatment. Pregnancy and lactation.

Adverse Reactions

Significant: Serious hypersensitivity reactions, including anaphylaxis, dyspnoea and urticaria; increased risk of infections (e.g. upper respiratory tract infections, gastroenteritis, tinea infections, herpes simplex infections), antibody formation; elevated hepatic transaminase (in patients receiving every 4 weeks doses for psoriatic arthritis).
Gastrointestinal disorders: Diarrhoea.
General disorders and administration site conditions: Inj site reactions (e.g. erythema, pain, swelling, pruritus, bruising).
Investigations: Decreased neutrophil count.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Bronchitis.
Skin and subcutaneous tissue disorders: Rash.

Monitoring Parameters

Evaluate for TB infection prior to initiation and periodically during treatment. Perform hepatitis B virus (HBV) or hepatitis C virus screening before starting therapy in all patients, and for HBV carriers during and several months after treatment; HIV screening in high-risk patients prior to therapy initiation. Obtain CBC with differential and complete metabolic panel at baseline; liver enzymes at baseline and regularly thereafter (in patients receiving every 4 weeks doses for psoriatic arthritis). Closely monitor for signs and symptoms of infection and active TB during and after treatment.

Drug Interactions

Potentially Fatal: May enhance adverse or toxic effects of live vaccines.

Action

Description:
Mechanism of Action: Guselkumab is a recombinant human immunoglobulin G₁ lambda (IgG₁ lambda) monoclonal antibody. It selectively binds to the p19 subunit of interleukin-23 (IL-23), a cytokine involved in the normal inflammatory and immune responses, thereby inhibiting the release of proinflammatory cytokines and chemokines.
Pharmacokinetics:
Absorption: Bioavailability: Approx 49%. Time to peak plasma concentration: 5.5 days.
Distribution: Volume of distribution: 13.5 L.
Metabolism: Degraded via catabolic pathways into small peptides and amino acids.
Excretion: Elimination half-life: Approx 15-18 days.

Storage

Store between 2-8°C. Do not freeze. Protect from light. Do not shake.

MIMS Class

Immunosuppressants / Psoriasis, Seborrhea & Ichthyosis Preparations

ATC Classification

L04AC16 - guselkumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

References

Anon. Guselkumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/05/2022.

Anon. Guselkumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/05/2022.

Buckingham R (ed). Guselkumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/05/2022.

Joint Formulary Committee. Guselkumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/05/2022.

Tremfya (Johnson & Johnson Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/05/2022.

Tremfya 100 mg Solution for Injection in Pre-filled Pen (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk.

Tremfya Injection (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/05/2022.

Disclaimer: This information is independently developed by MIMS based on Guselkumab 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 © 2024 MIMS. All rights reserved. Powered by MIMS.com