Tralokinumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of tralokinumab.
Drugs List
Therapeutic Indications
Uses
Moderate/severe atopic dermatitis
For the treatment of moderate to severe atopic dermatitis in adults and adolescent patients 12 years and older who are candidates for systemic therapy.
Dosage
Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of atopic dermatitis.
Tralokinuamb can be used with or without topical corticosteroids.
Injection sites should be rotated with each dose and should avoid skin that is tender, damaged or has bruises or scars.
Adults
Initial dose: 600mg (four 150mg injections).
Maintenance: 300mg (two 150mg injections) administered every other week.
Every fourth week dosing can be considered for patients that achieve clear or almost clear skin after 16 weeks of treatment, although this may not be suitable for patients weighing over 100kg.
Consider discontinuation of treatment in patients who show no response after 16 weeks of treatment.
Children
Children aged 12 years and older
Initial dose: 600mg (four 150mg injections).
Maintenance: 300mg (two 150mg injections) administered every other week.
Every fourth week dosing can be considered for patients that achieve clear or almost clear skin after 16 weeks of treatment, although this may not be suitable for patients weighing over 100kg.
Consider discontinuation of treatment in patients who show no response after 16 weeks of treatment.
Additional Dosage Information
Missed dose
If a dose is missed, the dose should be administered as soon as possible. Regular scheduled dosing can then be resumed.
Administration
For subcutaneous injection only.
Tralokinumab is administered by subcutaneous injection into the thigh or abdomen, except 5cm around the navel. If someone else administers, the upper arm can be used.
After removing the pre-filled syringes from the refrigerator, they should be allowed to reach room temperature by waiting for 30 minutes before injecting.
Contraindications
Children under 12 years
Breastfeeding
Pregnancy
Precautions and Warnings
Patients over 75 years
Susceptibility to helminth infections
Moderate hepatic impairment
Severe renal impairment
Administration of live vaccines is not recommended
Treat helminth infection before initiation of therapy
Treatment to be initiated by specialist
Contains polysorbate
Avoid injection into broken or bruised skin
For subcutaneous use only
Record name and batch number of administered product
Self-admin. - only if adequately trained and have access to expert advice
Vary injection site during prolonged therapy
Perform ophthalmological examination in cases of unresolved conjunctivitis
Consider temporary discontinuation if helminth infection occurs
Discontinue if hypersensitivity reactions occur
Discontinue if no response to treatment after 16 weeks
Patients with helminth infections were excluded from clinical studies. It is not known whether tralokinumab will influence the immune response against helminth infections by inhibiting IL-13 signalling.
Pregnancy and Lactation
Pregnancy
Tralokinumab is contraindicated during pregnancy.
The manufacturer recommends that it is preferable to avoid the use of tralokinumab during pregnancy. At the time of writing there is limited amount of data from the use of tralokinumab during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Lactation
Tralokinumab is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues breastfeeding or discontinues tralokinumab. It is unknown whether tralokinumab is excreted in human milk or absorbed after ingestion.
Side Effects
Allergic conjunctivitis
Conjunctivitis
Eczema herpeticum
Eosinophilia
Injection site reactions
Keratitis
Upper respiratory tract infection
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 2021
Reference Sources
Summary of Product Characteristics: Adtralza 150mg solution for injection in pre-filled syringe. LEO Laboratories Limited. Revised December 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 October 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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