Dupilumab pre-filled device
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of dupilumab.
Drugs List
Therapeutic Indications
Uses
Chronic rhinosinusitis with nasal polyposis
Moderate/severe atopic dermatitis when other therapy unsuitable/ineffective
Severe atopic dermatitis in children when other therapy is unsuitable
Severe eosinophilic asthma with atopic eczema or adjunct to oral steroids
Severe eosinophilic asthma: Add-on maintenance treatment
Dosage
Treatment should be initiated by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis, severe eosinophilic asthma or chronic rhinosinusitis with nasal polyposis.
Patients receiving concomitant oral corticosteroids who show a clinical improvement with dupilumab, may reduce their steroid dose. This reduction should be gradual.
Patients may self administer following appropriate training.
In asthma patients, the need for continued therapy should be considered at least on an annual basis, determined by the patient's level of asthma control.
Not all available strengths are licensed for all indications.
Adults
Atopic Dermatitis
Initial dose of 600mg, given as two subcutaneous injections of 300mg into different injection sites.
Maintenance dose of 300mg every other week.
Severe Asthma (patients on oral corticosteroids) or Severe Asthma and co-morbid Atopic Dermatitis
Initial dose of 600mg, given as two subcutaneous injections of 300mg into different injection sites.
Maintenance dose of 300mg every other week.
Severe Asthma
Initial dose of 400mg, given as two subcutaneous injections of 200mg into different injection sites.
Maintenance dose of 200mg every other week.
Chronic rhinosinusitis with nasal polyposis
Initial dose of 300mg.
Maintenance dose of 300mg every other week.
Children
Children over 12 years
Atopic Dermatitis
60kg and over:
Initial dose of 600mg, given as two subcutaneous injections of 300mg into different injection sites.
Maintenance dose of 300mg every other week.
Less than 60kg:
Initial dose of 400mg, given as two subcutaneous injections of 200mg into different injection sites.
Maintenance dose of 200mg every other week.
Severe Asthma (patients on oral corticosteroids) or Severe Asthma and Co-Morbid Moderate-To-Severe Atopic Dermatitis
Initial dose of 600mg, given as two subcutaneous injections of 300mg into different injection sites.
Maintenance dose of 300mg every other week.
Severe Asthma
Initial dose of 400mg, given as two subcutaneous injections of 200mg into different injection sites.
Maintenance dose of 200mg every other week.
Children 6 to 11 years
Severe Atopic Dermatitis
60kg and over:
Initial dose of 600mg, given as two subcutaneous injections of 300mg into different injection sites.
Maintenance dose of 300mg every other week.
15 to 60kg:
Initial dose of 300mg, given as one subcutaneous injections of 300mg into different injection sites on day 1, followed by 300mg on day 15.
Maintenance dose of 300mg every four weeks. Dose may be increased to 200mg every other week based on clinical judgement.
Additional Dosage Information
Missed dose
If dose is missed administer dose as soon as possible. Then resume dosing at regular scheduled time.
Atopic dermatitis
Consider discontinuation of treatment in patients that show no response after 16 weeks of treatment. Initial partial response that is improved beyond 16 weeks may be seen in some patients.
Chronic rhinosinusitis with nasal polyposis
Consider discontinuation of treatment in patients that show no response after 24 weeks of treatment. Initial partial response that is improved beyond 24 weeks may be seen in some patients.
Administration
To be administered as a subcutaneous injection into the thigh or abdomen, except for 5cm around the navel.
The upper arm may be used if the patient does not self administer.
Contraindications
Children under 6 years
Children weighing less than 15kg
Breastfeeding
Precautions and Warnings
Children under 12 years
Susceptibility to helminth infections
Pregnancy
Administration of live vaccines is not recommended
Not suitable for acute treatment of asthma
Avoid abrupt withdrawal of concurrent corticosteroids
Not all available products are licensed for all age groups
Not all available strengths are licensed for all indications
Not all presentations are licensed for all indications
Treat helminth infection before initiation of therapy
Treatment to be prescribed under the supervision of a 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
Dermatitis: monitor asthma patients on discontinuation
Monitor retreated patients for symptoms of delayed hypersensitivity
Perform ophthalmological examination if signs and symptoms of keratitis
Perform ophthalmological examination in cases of unresolved conjunctivitis
Advise patient to report any blurred vision or any other eye symptoms
Withdraw treatment gradually under supervision of a specialist
Consider temporary discontinuation if helminth infection occurs
Discontinue if hypersensitivity reactions occur
Advise patient to consult physician if condition worsens / does not improve
Pregnancy and Lactation
Pregnancy
Use dupilumab with caution during pregnancy.
The manufacturer recommends dupilumab is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies do not indicate harmful effects with respect to reproductive toxicity. At the time of writing there is limited human data available. Risks are unknown.
Lactation
Dupilumab is contraindicated during breastfeeding.
The manufacturer advises discontinuing breastfeeding or discontinuing dupilumab. It is unknown if dupilumab is excreted in breast milk or absorbed systemically after ingestion. Effects on exposed infants are unknown.
Side Effects
Allergic conjunctivitis
Anaphylactic reaction
Angioedema
Arthralgia
Blepharitis
Conjunctivitis
Eczema herpeticum
Eosinophilia
Eosinophilic pneumonia
Erythema at injection site
Eye pruritus
Headache
Itching (injection site)
Keratitis
Local pain (injection site)
Oedema (injection site)
Oral herpes
Serum sickness
Serum sickness-like reactions
Ulcerative keratitis
Vasculitis
Visual disturbances
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: March 2021
Reference Sources
Summary of Product Characteristics: Dupixent 200mg solution for injection. Sanofi-Aventis Groupe. Revised November 2020.
Summary of Product Characteristics: Dupixent 300mg solution for injection. Sanofi-Aventis Groupe. Revised November 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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