Brodalumab


Concise Prescribing Info
Indications/Uses
Moderate to severe plaque psoriasis.
Dosage/Direction for Use
Adult : SC 210 mg once weekly for 3 doses (week 0, 1, and 2), then every 2 weeks thereafter. Discontinue therapy if no response after 16 weeks.
Dosage Details
Subcutaneous
Plaque psoriasis
Adult: Moderate to severe cases in patients requiring systemic therapy or phototherapy and have failed to response, or have lost response to other systemic therapies: 210 mg once weekly for 3 doses (week 0, 1, and 2), then every 2 weeks thereafter. Discontinue therapy if no response after 16 weeks.
Contraindications
Active Crohn’s disease, clinically important active infections (e.g. active tuberculosis). Concomitant use with live vaccines.
Special Precautions
Patient with history of Crohn’s disease, depression or suicidality, chronic or recurrent infection. Pregnancy and lactation.
Adverse Reactions
Significant: Suicidal ideation and behaviour, serious infections and fungal infection, cryptococcal meningitis, exacerbation of Crohn’s disease.
Blood and lymphatic system disorders: Neutropenia.
Gastrointestinal disorders: Diarrhoea, nausea, oropharyngeal pain.
General disorders and admin site conditions: Fatigue.
Infections and infestations: Influenza, fungal infections including tinea infections (e.g. tinea pedis, tinea versicolor, tinea cruris), skin and mucosal candidiasis.
Injury, poisoning and procedural complications: Injection site reactions (e.g. erythema, pain, pruritus, bruising, haemorrhage).
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache.
MonitoringParameters
Monitor for signs and symptoms of infections and signs of suicidal ideation or behaviour. Perform TB evaluation prior to initiation of therapy.
Drug Interactions
May increase serum concentration of midazolam.
Potentially Fatal: May diminish therapeutic and enhance adverse/toxic effects of live vaccines.
Action
Description: Brodalumab is a recombinant human monoclonal (IgG2) antibody which selectively binds to with high affinity and antagonises the interleukin-17 receptor A (IL-17RA). It blocks the activity with cytokine IL-17RA IL-17A, IL-17F, IL-17A/F heterodimer and IL-25, leading to inhibition of cytokine-induced responses, including release of inflammatory cytokines and chemokines.
Pharmacokinetics:
Absorption: Bioavailability: Approx 55% (SC). Time to peak plasma concentration: Approx 3 days.
Distribution: Crosses placenta, enters breastmilk (small amounts). Volume of distribution: 8.9 ± 9.4 L.
Metabolism: Undergoes degradation via catabolic pathways into small peptides and amino acids.
Storage
Store between 2-8°C. Do not freeze. Protect from light. Stable for 14 days at room temperature (≤25°C).
MIMS Class
ATC Classification
L04AC12 - brodalumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Disclaimer: This information is independently developed by MIMS based on Brodalumab 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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