Dupixent (Dupilumab)
Dosage & administration
DUPIXENT is administered by subcutaneous injection. (
DUPIXENT is administered by subcutaneous injection.
DUPIXENT is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the "Instructions for Use".
The DUPIXENT pre-filled pen is for use in adult and pediatric patients aged 2 years and older.
The DUPIXENT pre-filled syringe is for use in adult and pediatric patients aged 6 months and older.
A caregiver or patient 12 years of age and older may inject DUPIXENT using the pre-filled syringe or pre-filled pen. In pediatric patients 12 years of age and older, administer DUPIXENT under the supervision of an adult. In pediatric patients 6 months to less than 12 years of age, administer DUPIXENT by a caregiver.
For patients with AD, asthma, PN, CSU, and BP taking an initial 600 mg dose, administer each of the two DUPIXENT 300 mg injections at different injection sites.
For patients with AD, asthma, and CSU taking an initial 400 mg dose, administer each of the two DUPIXENT 200 mg injections at different injection sites.
Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.
Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.
The DUPIXENT "Instructions for Use" contains more detailed instructions on the preparation and administration of DUPIXENT
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
| Body Weight | Initial and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
| Body Weight | Initial Loading Dose | Subsequent DosageQ2W – every 2 weeks; Q4W – every 4 weeks |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg Q4W |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg Q2W |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg Q2W |
The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older is specified in Table 3.
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for pediatric patients 6 to 11 years of age is specified in Table 4.
| Body Weight | InitialFor pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years of age with asthma and co-morbid moderate-to-severe AD, follow the recommended dosage as per Table 2 which includes an initial loading dose
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older is specified in Table 3.
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for pediatric patients 6 to 11 years of age is specified in Table 4.
| Body Weight | InitialFor pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years of age with asthma and co-morbid moderate-to-severe AD, follow the recommended dosage as per Table 2 which includes an initial loading dose
| Body Weight | Initial Dose and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per Table 2 which includes an initial loading dose. (
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
The recommended dosage of DUPIXENT for adult and pediatric patients 1 year of age and older, weighing at least 15 kg, is specified in Table 5.
| Body Weight | Recommended Dosage |
|---|---|
| 15 to less than 30 kg | 200 mg every 2 weeks (Q2W) |
| 30 to less than 40 kg | 300 mg every 2 weeks (Q2W) |
| 40 kg or more | 300 mg every week (QW) |
| Body Weight | Recommended Dosage in Adult and Pediatric Patients 1 Year and Older, Weighing At Least 15 kg |
|---|---|
| 15 to less than 30 kg | 200 mg every 2 weeks (Q2W) |
| 30 to less than 40 kg | 300 mg every 2 weeks (Q2W) |
| 40 kg or more | 300 mg every week (QW) |
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every 2 weeks (Q2W).
Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg Q2W |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg Q2W |
Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W). Use DUPIXENT in combination with a tapering course of oral corticosteroids.
By using PrescriberAI, you agree to the AI Terms of Use.
Dupixent prescribing information
Indications and Usage, Chronic Rhinosinusitis with Nasal Polyps (DUPIXENT is indicated as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). | 09/2024 | |||||||||
Indications and Usage, Chronic Obstructive Pulmonary Disease (DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Limitations of Use DUPIXENT is not indicated for the relief of acute bronchospasm. | 09/2024 | |||||||||
Indications and Usage, Chronic Spontaneous Urticaria (DUPIXENT is indicated for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: DUPIXENT is not indicated for treatment of other forms of urticaria. | 04/2025 | |||||||||
Indications and Usage, Bullous Pemphigoid (DUPIXENT is indicated for the treatment of adult patients with bullous pemphigoid (BP). | 06/2025 | |||||||||
Dosage and Administration, Chronic Rhinosinusitis with Nasal Polyps (The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks (Q2W). | 09/2024 | |||||||||
Dosage and Administration, Chronic Obstructive Pulmonary Disease (The recommended dosage of DUPIXENT for adult patients is 300 mg given every 2 weeks (Q2W). | 09/2024 | |||||||||
Dosage and Administration, Chronic Spontaneous Urticaria (Dosage in Adults The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W). Dosage in Pediatric Patients 12 to 17 Years of Age The recommended dosage of DUPIXENT for pediatric patients 12 to 17 years of age is specified in Table 6.
| 04/2025 | |||||||||
Dosage and Administration, Bullous Pemphigoid (The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W). Concomitant Oral Corticosteroids: Use DUPIXENT in combination with a tapering course of oral corticosteroids. Once disease control has occurred, gradually taper corticosteroids after which continue DUPIXENT as monotherapy. In case of relapse, corticosteroids may be added if medically advisable. | 06/2025 | |||||||||
Dosage and Administration, Missed Doses (If a weekly dose is missed, administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose. If an every 2 week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, administer the dose, starting a new schedule based on this date. If an every 4 week dose is missed, administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, administer the dose, starting a new schedule based on this date. | 06/2025 | |||||||||
Warnings and Precautions, Hypersensitivity (Hypersensitivity reactions, including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum and erythema multiforme have been reported. A case of AGEP was reported in an adult subject who participated in the bullous pemphigoid development program. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT [see Adverse Reactions (6.1, 6.2)and Clinical Pharmacology (12.6)] . | 06/2025 | |||||||||
Warnings and Precautions, Conjunctivitis and Keratitis (Conjunctivitis and keratitis adverse reactions have been reported in clinical trials [see Adverse Reactions (6.1)] .Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Among subjects with asthma, the frequencies of conjunctivitis and keratitis were similar between DUPIXENT and placebo. In adult subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared to 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program. Among subjects with EoE, there were no reports of conjunctivitis and keratitis in the DUPIXENT group in placebo-controlled trials. In subjects with PN, the frequency of conjunctivitis was 4% in the DUPIXENT group compared to 1% in the placebo group; these subjects recovered or were recovering during the treatment period. There were no cases of keratitis reported in the PN development program. Among subjects with COPD, the frequency of conjunctivitis and keratitis was 1.4% and 0.1% in the DUPIXENT group and 1% and 0% in the placebo group, respectively. In subjects with CSU, the frequency of conjunctivitis was similar between DUPIXENT and placebo. There were no cases of keratitis reported in the CSU development program. Among subjects with BP, the frequency of conjunctivitis and keratitis was 7.5% and 3.8% in the DUPIXENT group and 0% and 0% in the placebo group, respectively. Conjunctivitis and keratitis adverse events have also been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate. | 06/2025 | |||||||||
Warnings and Precautions (Conjunctivitis and keratitis adverse reactions have been reported in clinical trials [see Adverse Reactions (6.1)] .Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Among subjects with asthma, the frequencies of conjunctivitis and keratitis were similar between DUPIXENT and placebo. In adult subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared to 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program. Among subjects with EoE, there were no reports of conjunctivitis and keratitis in the DUPIXENT group in placebo-controlled trials. In subjects with PN, the frequency of conjunctivitis was 4% in the DUPIXENT group compared to 1% in the placebo group; these subjects recovered or were recovering during the treatment period. There were no cases of keratitis reported in the PN development program. Among subjects with COPD, the frequency of conjunctivitis and keratitis was 1.4% and 0.1% in the DUPIXENT group and 1% and 0% in the placebo group, respectively. In subjects with CSU, the frequency of conjunctivitis was similar between DUPIXENT and placebo. There were no cases of keratitis reported in the CSU development program. Among subjects with BP, the frequency of conjunctivitis and keratitis was 7.5% and 3.8% in the DUPIXENT group and 0% and 0% in the placebo group, respectively. Conjunctivitis and keratitis adverse events have also been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate. Patients being treated for asthma may present with clinical features of eosinophilic pneumonia or eosinophilic granulomatosis with polyangiitis (EGPA). These events may be associated with the reduction of oral corticosteroid therapy. Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adults who participated in the asthma development program. Cases of EGPA have been reported with DUPIXENT in adults who participated in the asthma development program as well as in adults with co-morbid asthma in the CRSwNP development program. Advise patients to report signs of eosinophilic pneumonia and EGPA to their healthcare provider. Consider withholding DUPIXENT if eosinophilic pneumonia or EGPA are suspected. Cases of new-onset psoriasis have been reported with the use of DUPIXENT for the treatment of atopic dermatitis and asthma, including in patients without a family history of psoriasis. In postmarketing reports, onset of psoriasis varied from weeks to months after the first dose of DUPIXENT and resulted in partial or complete resolution of psoriasis with discontinuation of dupilumab, with or without use of supplemental treatment for psoriasis (topical or systemic). Those who continued on dupilumab received supplemental treatment for psoriasis to improve associated symptoms. Advise patients to report new-onset psoriasis symptoms to their healthcare provider. If symptoms persist or worsen, consider dermatologic evaluation and/or discontinuation of DUPIXENT. Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization [see Adverse Reactions (6.1)] . In postmarketing reports, onset of arthralgia was variable, ranging from days to months after the first dose of DUPIXENT.Cases of new-onset psoriatic arthritis requiring systemic treatment have been reported with the use of DUPIXENT. Some patients' symptoms resolved while continuing treatment with DUPIXENT, and other patients recovered or were recovering following discontinuation of DUPIXENT. Advise patients to report new onset or worsening joint symptoms to their healthcare provider. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT. | 04/2025 | |||||||||
Warnings and Precautions (Conjunctivitis and keratitis adverse reactions have been reported in clinical trials [see Adverse Reactions (6.1)] .Conjunctivitis and keratitis occurred more frequently in AD subjects who received DUPIXENT compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period. Among subjects with asthma, the frequencies of conjunctivitis and keratitis were similar between DUPIXENT and placebo. In adult subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared to 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program. Among subjects with EoE, there were no reports of conjunctivitis and keratitis in the DUPIXENT group in placebo-controlled trials. In subjects with PN, the frequency of conjunctivitis was 4% in the DUPIXENT group compared to 1% in the placebo group; these subjects recovered or were recovering during the treatment period. There were no cases of keratitis reported in the PN development program. Among subjects with COPD, the frequency of conjunctivitis and keratitis was 1.4% and 0.1% in the DUPIXENT group and 1% and 0% in the placebo group, respectively. In subjects with CSU, the frequency of conjunctivitis was similar between DUPIXENT and placebo. There were no cases of keratitis reported in the CSU development program. Among subjects with BP, the frequency of conjunctivitis and keratitis was 7.5% and 3.8% in the DUPIXENT group and 0% and 0% in the placebo group, respectively. Conjunctivitis and keratitis adverse events have also been reported with DUPIXENT in postmarketing settings, predominantly in AD patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Advise patients or their caregivers to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate. DUPIXENT should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. Do not use DUPIXENT to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with DUPIXENT. | 09/2024 |
DUPIXENT is an interleukin-4 receptor alpha antagonist indicated:
for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (
for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (
DUPIXENT is indicated for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
for the treatment of adult patients with prurigo nodularis (PN). (
DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).
as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. (
for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. (
for the treatment of adult patients with bullous pemphigoid (BP). (
DUPIXENT is administered by subcutaneous injection. (
DUPIXENT is administered by subcutaneous injection.
DUPIXENT is intended for use under the guidance of a healthcare provider. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the "Instructions for Use".
The DUPIXENT pre-filled pen is for use in adult and pediatric patients aged 2 years and older.
The DUPIXENT pre-filled syringe is for use in adult and pediatric patients aged 6 months and older.
A caregiver or patient 12 years of age and older may inject DUPIXENT using the pre-filled syringe or pre-filled pen. In pediatric patients 12 years of age and older, administer DUPIXENT under the supervision of an adult. In pediatric patients 6 months to less than 12 years of age, administer DUPIXENT by a caregiver.
For patients with AD, asthma, PN, CSU, and BP taking an initial 600 mg dose, administer each of the two DUPIXENT 300 mg injections at different injection sites.
For patients with AD, asthma, and CSU taking an initial 400 mg dose, administer each of the two DUPIXENT 200 mg injections at different injection sites.
Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.
Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.
The DUPIXENT "Instructions for Use" contains more detailed instructions on the preparation and administration of DUPIXENT
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
| Body Weight | Initial and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
| Body Weight | Initial Loading Dose | Subsequent DosageQ2W – every 2 weeks; Q4W – every 4 weeks |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg Q4W |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg Q2W |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg Q2W |
The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older is specified in Table 3.
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for pediatric patients 6 to 11 years of age is specified in Table 4.
| Body Weight | InitialFor pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years of age with asthma and co-morbid moderate-to-severe AD, follow the recommended dosage as per Table 2 which includes an initial loading dose
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older is specified in Table 3.
| Initial Loading Dose | Subsequent Dosage |
|---|---|
| 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| Or | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps | |
| 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
The recommended dosage of DUPIXENT for pediatric patients 6 to 11 years of age is specified in Table 4.
| Body Weight | InitialFor pediatric patients 6 to 11 years of age with asthma, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years of age with asthma and co-morbid moderate-to-severe AD, follow the recommended dosage as per Table 2 which includes an initial loading dose
| Body Weight | Initial Dose and Subsequent Dosage |
|---|---|
| 15 to less than 30 kg | 300 mg every 4 weeks (Q4W) |
| ≥30 kg | 200 mg every 2 weeks (Q2W) |
For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per Table 2 which includes an initial loading dose. (
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| Body Weight | InitialFor pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended.and Subsequent Dosage |
|---|---|
| 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
The recommended dosage of DUPIXENT for pediatric patients 6 years of age and older is specified in Table 2.
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
DUPIXENT 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.
The recommended dosage of DUPIXENT for adult and pediatric patients 1 year of age and older, weighing at least 15 kg, is specified in Table 5.
| Body Weight | Recommended Dosage |
|---|---|
| 15 to less than 30 kg | 200 mg every 2 weeks (Q2W) |
| 30 to less than 40 kg | 300 mg every 2 weeks (Q2W) |
| 40 kg or more | 300 mg every week (QW) |
| Body Weight | Recommended Dosage in Adult and Pediatric Patients 1 Year and Older, Weighing At Least 15 kg |
|---|---|
| 15 to less than 30 kg | 200 mg every 2 weeks (Q2W) |
| 30 to less than 40 kg | 300 mg every 2 weeks (Q2W) |
| 40 kg or more | 300 mg every week (QW) |
The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every 2 weeks (Q2W).
Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
| Body Weight | Initial Loading Dose | Subsequent Dosage |
|---|---|---|
| 30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg Q2W |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg Q2W |
Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W). Use DUPIXENT in combination with a tapering course of oral corticosteroids.
DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution in a:
Single-dose pre-filled syringe with needle shield as:
- Injection: 300 mg/2 mL (150 mg/mL)
- Injection: 200 mg/1.14 mL (175 mg/mL)
Single-dose pre-filled pen as:
- Injection: 300 mg/2 mL (150 mg/mL)
- Injection: 200 mg/1.14 mL (175 mg/mL)
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DUPIXENT during pregnancy.
Healthcare providers and patients may call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/ to enroll in or to obtain information about the registry.
DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT