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Dupixent is a brand name for Dupilumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in…
Verbatim from this product's EMA label. Tap a section to expand.
1). Posology Atopic dermatitis Adults The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week administered as subcutaneous injection. Adolescents (12 to 17 years of age) The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 1.
Table 1:
Dose of dupilumab for subcutaneous administration in adolescent patients 12 to 17 years of age with atopic dermatitis 4 Body weight of patient Initial dose Subsequent doses (every other week) less than 60 kg 400 mg (two 200 mg injections) 200 mg 60 kg or more 600 mg (two 300 mg injections) 300 mg Children 6 to 11 years of age The recommended dose of dupilumab for children 6 to 11 years of age is specified in Table 2.
Table 2:
Dose of dupilumab for subcutaneous administration in children 6 to 11 years of age with atopic dermatitis Body weight of patient Initial dose Subsequent doses 15 kg to less than 60 kg 300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 15 300 mg every 4 weeks (Q4W)*, starting 4 weeks after Day 15 dose 60 kg or more 600 mg (two 300 mg injections) 300 mg every other week (Q2W) *the dose may be increased to 200 mg Q2W in patients with body weight of 15 kg to less than 60 kg based on physician’s assessment.
Children 6 months to 5 years of age The recommended dose of dupilumab for children 6 months to 5 years of age is specified in Table 3.
Table 3:
Dose of dupilumab for subcutaneous administration in children 6 months to 5 years of age with atopic dermatitis Body Weight of Patient Initial Dose Subsequent Doses 5 kg to less than 15 kg 200 mg (one 200 mg injection) 200 mg every 4 weeks (Q4W) 15 kg to less than 30 kg 300 mg (one 300 mg injection) 300 mg every 4 weeks (Q4W) Dupilumab can be used with or without topical corticosteroids.
Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas. Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis.
Summary of the safety profile The most common adverse reactions in atopic dermatitis, asthma, and CRSwNP are injection site reactions (includes erythema, oedema, pruritus, pain, and swelling), conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia.
An additional adverse reaction of injection site bruising or haematoma was reported in EoE,COPD and CSU. Additional adverse reactions of injection site induration and injection site dermatitis were reported in COPD and CSU. Additional adverse reactions of injection site rash were reported in COPD.
4). Tabulated list of adverse reactions The dupilumab safety data presented in Table 8 were predominantly derived from 12 randomised, placebo-controlled trials, including atopic dermatitis, asthma, and CRSwNP patients. These studies involved 4,206 patients receiving dupilumab and 2,326 patients receiving placebo during the controlled period are representative of the overall safety profile for dupilumab.
11 Listed in Table 8 are adverse reactions observed in clinical trials and/or postmarketing setting presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 8:
List of adverse reactions MedDRA System Organ Class Frequency Adverse Reaction Infections and infestations Common Conjunctivitis* Oral herpes* Blood and lymphatic system disorders Common Eosinophilia Immune system disorders Uncommon Rare Angioedema# Anaphylactic reaction Serum sickness reaction Serum sickness-like reaction Eye disorders Common Uncommon Rare Conjunctivitis allergic* Keratitis*# Blepharitis*† Eye pruritus*† Dry eye*† Ulcerative keratitis*†# Skin and subcutaneous tissue disorders Uncommon Facial rash# Musculoskeletal and connective tissue disorders Common Arthralgia# General disorders and administration site conditions Common Injection site reactions (includes erythema, oedema, pruritus, pain, swelling, and bruising) *eye disorders and oral herpes occurred predominately in atopic dermatitis studies.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Acute exacerbations of Asthma or COPD Dupilumab must not be used to treat acute symptoms or acute exacerbations of asthma or COPD.
Dupilumab must not be used to treat acute bronchospasm or status asthmaticus. Corticosteroids It is recommended that systemic, topical, or inhaled corticosteroids not be discontinued abruptly upon initiation of therapy with dupilumab.
Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use. 1). Hypersensitivity If a systemic hypersensitivity reaction (immediate or delayed) occurs, discontinue administration of dupilumab immediately and initiate appropriate therapy.
Cases of anaphylactic reaction, angioedema, and serum sickness/serum sickness-like reaction have been reported. 8). Eosinophilic conditions Cases of eosinophilic pneumonia and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (EGPA) have been reported with dupilumab in adult patients who participated in the asthma development program.
Cases of vasculitis consistent with EGPA have been reported with dupilumab and placebo in adult patients with co-morbid asthma in the CRSwNP development program. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia.
Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, 9 conditions which are often treated with systemic corticosteroid therapy.
1.
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Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. If dupilumab treatment interruption becomes necessary, patients can still be successfully re-treated. Asthma Adults and adolescents The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is: • For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.
• For all other patients, an initial dose of 400 mg (two 200 mg injections), followed by 200 mg every other week administered as subcutaneous injection. Children 6 to 11 years of age The recommended dose of dupilumab for paediatric patients 6 to 11 years of age is specified in Table 4.
Table 4:
Dose of dupilumab for subcutaneous administration in children 6 to 11 years of age with asthma 5 Body weight Initial and subsequent doses 15 to less than 30 kg 300 mg every four weeks (Q4W) 30 kg to less than 60 kg 200 mg every other week (Q2W) or 300 mg every four weeks (Q4W) 60 kg or more 200 mg every other week (Q2W) For paediatric patients (6 to 11 years old) with asthma and co-morbid severe atopic dermatitis, as per approved indication, the recommended dose is provided in Table 2.
1). 4). Dupilumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s level of asthma control. Chronic rhinosinusitis with nasal polyposis (CRSwNP) The recommended dose of dupilumab for adult patients is an initial dose of 300 mg followed by 300 mg given every other week.
Dupilumab is intended for long-term treatment. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CRSwNP. Some patients with initial partial response may subsequently improve with continued treatment beyond 24 weeks.
Prurigo Nodularis (PN) The recommended dose of dupilumab for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week. Dupilumab can be used with or without topical corticosteroids.
PN clinical trial data are available for patients treated up to 24 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for PN. Eosinophilic esophagitis (EoE) The recommended dose of dupilumab for adults, adolescents and children 1 year of age and older, weighing at least 15 kg, is specified in Table 5.
Table 5:
Dose of dupilumab for subcutaneous administration in adults, adolescents and children 1 year of age and older with EoE Body Weight Dose 15 to less than 30 kg 200 mg every other week (Q2W) 30 to less than 40 kg 300 mg every other week (Q2W) 40 kg or more 300 mg every week (QW) Dupilumab is intended for long-term treatment.
Chronic obstructive pulmonary disease (COPD) The recommended dose of dupilumab for adult patients is 300 mg given every other week. 6 Dupilumab is intended for long-term treatment. Dosing beyond 52 weeks has not been studied. Consideration should be given to discontinuing treatment in patients who have shown no […]
†the frequencies for eye pruritus, blepharitis, and dry eye were common and ulcerative keratitis was uncommon in atopic dermatitis studies. #from postmarketing reporting. 4). Conjunctivitis and keratitis related events Conjunctivitis and keratitis occurred more frequently in atopic dermatitis patients who received dupilumab compared to placebo in atopic dermatitis studies.
Most patients with conjunctivitis or keratitis recovered or were recovering during the treatment period. In the long-term OLE atopic dermatitis study (AD-1225) at 5 years, the respective rates of conjunctivitis and keratitis remained similar to those in the dupilumab arm in the placebo controlled atopic dermatitis studies.
Among asthma and COPD patients, the frequency of conjunctivitis and keratitis was low and similar between dupilumab and placebo. Among CRSwNP and Prurigo Nodularis (PN) patients the frequency of conjunctivitis was higher in dupilumab than placebo, though lower than that observed in atopic dermatitis patients.
Among patients with EoE and CSU, the frequency of conjunctivitis was low and similar between dupilumab and placebo groups. 4). 12 Eczema herpeticum Eczema herpeticum was reported in < 1% of the dupilumab groups and in < 1 % of the placebo group in the 16-week atopic dermatitis monotherapy adult studies.
9 % of the placebo + TCS group. These rates remained stable at 5 years in the long-term OLE study (AD-1225). Eosinophilia Dupilumab-treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo in the atopic dermatitis, asthma, CRSwNP, COPD and CSU indications.
Eosinophil counts declined to near baseline levels during study treatment and returned to baseline during the asthma open-label extension safety study (TRAVERSE). The mean blood eosinophil levels decreased to below baseline by week 20 and was maintained up to 5 years in the long-term OLE study (AD-1225).
Compared to placebo, no increase in mean blood eosinophil counts was observed in PN (PRIME and PRIME2). Mean and median blood eosinophil counts declined to near baseline or remained below baseline levels in EoE and COPD (BOREAS and NOTUS) during study treatment.
4% of dupilumab-treated patients and 0% in placebo-treated patients in study AD-1539, with median eosinophil counts declining below baseline at end of treatment period. 5 % of patients treated with dupilumab. 2 % […]
These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy. Helminth infection Patients with known helminth infections were excluded from participation in clinical studies. Dupilumab may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signalling.
Patients with pre-existing helminth infections should be treated before initiating dupilumab. If patients become infected while receiving treatment with dupilumab and do not respond to anti- helminth treatment, treatment with dupilumab should be discontinued until infection resolves.
8). Conjunctivitis and keratitis related events Conjunctivitis and keratitis related events have been reported with dupilumab, predominantly in atopic dermatitis patients. g. 8). Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
8). Patients with comorbid asthma Advise patients on dupilumab who also have co-morbid asthma to not adjust or stop their asthma treatments without consultation with their physicians. Monitor patients with comorbid asthma carefully following discontinuation of dupilumab.
Vaccinations Concurrent use of live and live attenuated vaccines with dupilumab should be avoided as clinical safety and efficacy have not been established. It is recommended that patients are brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with dupilumab.
Clinical data are not available to support more specific guidance for live or live attenuated vaccines administration in patients treated with dupilumab. 5). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per 300 mg dose, that is to say essentially ‘sodium-free’.
Polysorbate 80 (E433) This medicine contains 4 mg of polysorbate 80 in each 300 mg dose (2mL). Polysorbates may cause allergic reactions.