Brodalumab injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of brodalumab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Moderate to severe plaque psoriasis
Dosage
Adults
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.
Administration
For subcutaneous injection only.
Contraindications
Children under 18 years
Severe infection
Active Crohn's disease
Breastfeeding
Pregnancy
Tuberculosis
Precautions and Warnings
Chronic infection
History of recurrent infection
Suicidal ideation
Depression
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
Pregnancy
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.
Lactation
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.
Side Effects
Anaphylactic reaction
Arthralgia
Bronchitis
Bruising at injection site
Conjunctivitis
Cryptococcosis infection
Diarrhoea
Erythema at injection site
Exacerbation of Crohn's disease
Fatigue
Fungal infection
Haemorrhage (injection site)
Headache
Increased susceptibility to infection
Inflammatory bowel disease
Influenza
Itching (injection site)
Local pain (injection site)
Myalgia
Nasopharyngitis
Nausea
Neutropenia
Oropharyngeal pain
Pharyngitis
Reduced neutrophil count
Respiratory tract infection
Sinusitis
Suicidal tendencies
Tinea infections
Tinea pedis
Ulcerative colitis
Urinary tract infections
Overdosage
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 ).
Further Information
Last Full Review Date: October 2020
Reference Sources
Summary of Product Characteristics: Kyntheum 210mg Solution for Injection. Leo Laboratories Limited. Revised July 2020.
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.