Guselkumab


Concise Prescribing Info
Indications/Uses
Plaque psoriasis.
Dosage/Direction for Use
Adult : SC Initial: 100 mg at weeks 0 and 4, then every 8 weeks thereafter. Discontinue treatment if no response after 16 weeks.
Dosage Details
Subcutaneous
Plaque psoriasis
Adult: In patients with moderate to severe cases who are candidates for systemic therapy or phototherapy: Initially, 100 mg at weeks 0 and 4, then every 8 weeks thereafter. Discontinue therapy if no response after 16 weeks.
Contraindications
Hypersensitivity. Clinically important active infections (e.g. TB, sepsis, hepatitis B). Concomitant use with live vaccines.
Special Precautions
Patient with history of chronic or recurrent infections, latent TB with unconfirmed adequate course of TB treatment. Pregnancy and lactation.
Adverse Reactions
Significant: Infections (e.g. upper respiratory tract infections, gastroenteritis, tinea infections, herpes simplex infections), hypersensitivity reactions (e.g. urticaria, dyspnoea).
Gastrointestinal disorders: Diarrhoea.
General disorders and admin site conditions: Inj site reactions (e.g. erythema, pain).
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash.
MonitoringParameters
Conduct TB screening prior to initiation and periodically during treatment. Monitor for signs and symptoms of infection and active TB during and after treatment.
Drug Interactions
Enhanced immunosuppressive effects with belimumab, infliximab.
Potentially Fatal: May enhance adverse/toxic effects of live vaccines.
Action
Description: Guselkumab is a recombinant human immunoglobulin G1 (IgG1 lambda) monoclonal antibody that 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: Approx 5.5 days.
Distribution: Crosses placenta. Volume of distribution: Approx 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.
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 05/09/2019.

Anon. Guselkumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/09/2019.

Buckingham R (ed). Guselkumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/09/2019.

Tremfya Injection (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/09/2019.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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