Guselkumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

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

Generic Medicine Info

Indications and Dosage

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.

Monitoring Parameters

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.

MIMS Class

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 05/09/2019.

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.

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