- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections of brodalumab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Moderate to severe plaque psoriasis
210mg once a week for three weeks. Reduce thereafter to 210mg once every two weeks.
Consider discontinuing treatment if no response after 12 to 16 weeks of treatment. Patients with an initial partial response may improve if treatment is continued beyond 16 weeks.
For subcutaneous injection only.
Children under 18 years
Active Crohn's disease
Precautions and Warnings
History of recurrent infection
History of depression
Inactive Crohn's disease
Inflammatory bowel disease
Latent or healed tuberculosis
Administration of live vaccines is not recommended
Crohn's disease: Monitor patients closely as may cause exacerbation
Discontinue if exacerbation of Crohn's disease
Before starting therapy ensure immunisations are up to date
Consider prophylactic anti-tuberculosis therapy if appropriate
Treatment to be prescribed under the supervision of a specialist
Avoid injection into areas of active skin disease
Record name and batch number of administered product
Warm to room temperature for 30-60 minutes before use
Discontinue if signs and symptoms of inflammatory bowel disease occur
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Advise patient to report any new or worsening depression/suicidal ideation
Advise patient to report symptoms of infection immediately
Consider discontinuing if depression develops
Infants exposed in utero (3rd trimester): Use live vaccines with caution
Consider discontinuing treatment if no response after 12-16 weeks
Discontinue if serious allergic or anaphylactic reaction occurs
Interrupt treatment if severe infection develops
Female: Contraception required during and for 3 months after treatment
Pregnancy and Lactation
Brodalumab is contraindicated during pregnancy.
The manufacturer does not recommend using brodalumab during pregnancy. At the time of writing there is limited published information regarding the use of brodalumab during pregnancy. Potential risks are unknown, however brodalumab is expected to cross the placenta.
Brodalumab is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues brodalumab or discontinues breastfeeding. The presence of brodalumab in human breast milk is unknown but due to its large molecular weight, transfer is not expected. Effects on exposed infants are unknown.
Bruising at injection site
Erythema at injection site
Exacerbation of Crohn's disease
Haemorrhage (injection site)
Increased susceptibility to infection
Inflammatory bowel disease
Itching (injection site)
Local pain (injection site)
Reduced neutrophil count
Respiratory tract infection
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111.
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: October 2020
Summary of Product Characteristics: Kyntheum 210mg Solution for Injection. Leo Laboratories Limited. Revised July 2020.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.