Formulary
Guselkumab: Indications, Dosing, Side Effects and Interactions
Guselkumab is a recombinant human monoclonal antibody that binds selectively to interleukin-23 and blocks the activity of pro-inflammatory cytokines.
MedNext Academy | 3 min read
Guselkumab: Indications, Dosing, Side Effects and Interactions
Guselkumab is a recombinant human monoclonal antibody that binds selectively to interleukin-23 and blocks the activity of pro-inflammatory cytokines.
Drug action
Guselkumab is a recombinant human monoclonal antibody that binds selectively to interleukin-23 and blocks the activity of pro-inflammatory cytokines.
Indications and dose
**Moderate-to-severe plaque psoriasis (under expert supervision)**
- **Adult** (By Subcutaneous Injection): Initially 100 mg, then 100 mg after 4 weeks, then maintenance 100 mg every 8 weeks, consider discontinuation of treatment if no response after 16 weeks.
**Psoriatic arthritis (under expert supervision)**
- **Adult** (By Subcutaneous Injection): Initially 100 mg, then 100 mg after 4 weeks, then maintenance 100 mg every 8 weeks, a maintenance dose of 100 mg every 4 weeks may be considered in patients at high risk for joint damage, consider discontinuation of treatment if no response after 24 weeks.
Cautions
Risk of infection Cautions, further information Risk of infection Manufacturer advises consider anti-tuberculosis therapy before initiation of guselkumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Manufacturer advises consider completion of appropriate immunisations according to current guidelines before initiating treatment (consult product literature for appropriate interval between vaccination and administration of guselkumab).
Contraindications
Clinically significant active infection
Side effects
Common or very common With parenteral use Arthralgia; diarrhoea; headache; increased risk of infection; skin reactions Rare or very rare With parenteral use Hypersensitivity Frequency not known With parenteral use Hepatic function abnormal; hypertransaminasaemia
Interactions
**Severe interactions:**
- Interactions with CYP450 substrates In a Phase I study in patients with moderate to severe plaque psoriasis, changes in systemic exposures (C max and AUC inf ) of midazolam, Swarfarin, omeprazole,...
**Other interactions (4):**
- There is no need for dose adjustment when coadministering guselkumab and CYP450 substrates.
- Concomitant immunosuppressive therapy or phototherapy In psoriasis studies, the safety and efficacy of guselkumab in combination with immunosuppressants, including biologics, or phototherapy have...
- In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of guselkumab.
- In Crohn's disease and ulcerative colitis studies, concomitant use of immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP]) or corticosteroids did not appear to influence the safety or...
Pregnancy
Avoid (limited information available). M
Breast feeding
Specialist sources indicate use with caution (no information available). Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract; waiting for at least 2 weeks postpartum to resume treatment may minimise transfer to infant.
Medicinal forms
Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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