Ixekizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Subcutaneous injection of ixekizumab.
Drugs List
Therapeutic Indications
Uses
Axial spondyloarthritis
Moderate to severe plaque psoriasis
Psoriatic arthritis (unresp to DMARD) monotherapy or combination with MTX
Moderate to severe plaque psoriasis in adults and children who are candidates for systemic therapy.
Active psoriatic arthritis in adult patients who are intolerant or unresponsive to disease-modifying anti-rheumatic therapies in monotherapy or in combination with methotrexate.
Active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Dosage
For psoriatic arthritis with concomitant moderate to severe plaque psoriasis, follow the same dosing schedule as in plaque psoriasis.
Adults
Plaque psoriasis
The recommended dose is 160mg of ixekizumab by subcutaneous injection with initial dosing at Week 0, followed by 80mg at weeks 2, 4, 6, 8, 10, 12, followed by an 80mg maintenance dose every 4 weeks.
Psoriatic arthritis
The recommended dose is 160mg of ixekizumab by subcutaneous injection with initial dosing at Week 0, followed by an 80mg maintenance dose every 4 weeks.
Axial spondyloarthritis (radiographic and non-radiographic)
The recommended dose is 160mg (two 80mg injections) of ixekizumab by subcutaneous injection with initial dosing at Week 0, followed by 80mg maintenance dose every 4 weeks.
Children
Paediatric plaque psoriasis (age 6 years and above)
Body weight greater than 50kg
Recommended starting dose (week 0): 160mg.
Recommended dose every 4 weeks thereafter: 80mg.
Body weight of 25 to 50kg
Recommended starting dose (week 0): 80mg.
Recommended dose every 4 weeks thereafter: 40mg (dose preparation required).
Doses less than 80mg must be prepared by a healthcare professional.
Additional Dosage Information
Consideration should be given to discontinuing treatment in patients who have shown no response up to 16 to 20 weeks of treatment. However some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
After proper training in subcutaneous injection technique, patients may self-inject ixekizumab if a physician determines that this is appropriate. However, the physician should ensure appropriate follow-up of patients.
Injection site may be alternated avoiding areas of skin affected by psoriasis.
Administration
For subcutaneous injection.
Contraindications
Children under 6 years
Children weighing less than 25kg
Severe infection
Breastfeeding
Pregnancy
Tuberculosis
Precautions and Warnings
Children under 18 years
Chronic infection
Females of childbearing potential
History of recurrent infection
Predisposition to infection
Crohn's disease
Hepatic impairment
Inflammatory bowel disease
Latent or healed tuberculosis
Renal impairment
Ulcerative colitis
Administration of live vaccines is not recommended
Crohn's disease: Monitor patients closely as may cause exacerbation
Ulcerative colitis: Monitor patients closely as may cause exacerbation
Consider prophylactic anti-tuberculosis therapy if appropriate
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Do not use if contents have been frozen
Record name and batch number of administered product
Self-admin. - only if adequately trained and have access to expert advice
Use only if the solution is clear
Discontinue if signs and symptoms of inflammatory bowel disease occur
Monitor body weight in children and review dose if necessary
Monitor closely any patient who develops new infection while on treatment
Monitor patient constantly for signs of new infection
Advise patient to report symptoms of infection immediately
Discontinue if allergic reaction occurs
Interrupt treatment if severe infection develops
Not licensed for all indications in all age groups
Female: Contraception required during and for 10 weeks after treatment
Pregnancy and Lactation
Pregnancy
Ixekizumab is contraindicated during pregnancy.
The manufacturer notes that it is preferable to avoid the use of this medication in pregnancy as a precautionary measure.
There is little data from the use of ixekizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Lactation
Ixekizumab is contraindicated during breastfeeding.
The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.
It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys.
Side Effects
Anaphylaxis
Angioedema
Candidiasis (mouth or throat)
Cellulitis
Cellulitis of external ear
Conjunctivitis
Development of neutralising antibodies
Dyspnoea
Eczema
Erysipelas
Exacerbation of Crohn's disease
Herpes simplex
Hypersensitivity reactions
Influenza
Injection site reactions
Nasopharyngitis
Nausea
Neutropenia
Oropharyngeal pain
Rash
Rhinitis
Staphylococcal infection
Thrombocytopenia
Tinea infections
Ulcerative colitis
Upper respiratory tract infection
Urticaria
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: June 2020
Reference Sources
Summary of Product Characteristics: Taltz 80mg solution for injection in pre-filled syringe. Eli Lilly and Company Ltd. Revised June 2020.
Summary of Product Characteristics: Taltz 80mg solution for injection in pre-filled pen. Eli Lilly and Company Ltd. Revised June 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 November 2022
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.