Dupixent
(dupilumab)Dosage & Administration
DUPIXENT is administered by subcutaneous injection.
Atopic Dermatitis
Dosage in Adults :
Dosage in Pediatric Patients 6 Months to 5 Years of Age :
| 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) |
Dosage in Pediatric Patients 6 Years of Age and Older :
| Body Weight | Initial Loading Dose | Subsequent Dosage * |
|---|---|---|
| 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 |
Asthma
Dosage in Adult and Pediatric Patients 12 Years and Older :
| 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) |
Dosage in Pediatric Patients 6 to 11 Years of Age :
| 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.
Chronic Rhinosinusitis with Nasal Polyps :
Eosinophilic Esophagitis :
| 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) |
Prurigo Nodularis :
Chronic Obstructive Pulmonary Disease :
Chronic Spontaneous Urticaria
Dosage in Adults :
Dosage in Pediatric Patients 12 to 17 Years of Age :
| 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 |
Bullous Pemphigoid :
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.
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Dupixent Prescribing Information
Atopic Dermatitis
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.
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.
Limitations of Use
DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus.
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).
Eosinophilic Esophagitis
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).
Prurigo Nodularis
DUPIXENT is indicated for the treatment of adult patients with prurigo nodularis (PN).
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.
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.
Bullous Pemphigoid
DUPIXENT is indicated for the treatment of adult patients with bullous pemphigoid (BP).
Important Administration Instructions
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".
Use of Pre-filled Pen or Pre-filled Syringe
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.
Administration Instructions
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 [see Instructions for Use].
Vaccination Prior to Treatment
Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT [see Warnings and Precautions (5.10)].
Recommended Dosage for Atopic Dermatitis
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 6 Months to 5 Years of Age
The recommended dosage of DUPIXENT for pediatric patients 6 months to 5 years of age is specified in Table 1.
| 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) |
Dosage in Pediatric Patients 6 Years of Age and Older
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) |
Concomitant Topical Therapies
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 for Asthma
Dosage in Adult and Pediatric Patients 12 Years and Older
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) |
Dosage in Pediatric Patients 6 to 11 Years of Age
The recommended dosage of DUPIXENT for pediatric patients 6 to 11 years of age is specified in Table 4.
| Body Weight | Initial * 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 [see Dosage and Administration (2.3)].
Recommended Dosage for 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).
Recommended Dosage for Eosinophilic Esophagitis
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) |
Recommended Dosage for Prurigo Nodularis
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).
Recommended Dosage for Chronic Obstructive Pulmonary Disease
The recommended dosage of DUPIXENT for adult patients is 300 mg given every 2 weeks (Q2W).
Recommended Dosage for 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.
| 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) |
Recommended Dosage for 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.
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.
Preparation for Use
Before injection, remove DUPIXENT from the refrigerator and allow DUPIXENT to reach room temperature (45 minutes for the 300 mg/2 mL pre-filled syringe or pre-filled pen, and 30 minutes for the 200 mg/1.14 mL pre-filled syringe or pre-filled pen) without removing the needle cap. After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.
Inspect DUPIXENT visually for particulate matter and discoloration prior to administration. DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible particulate matter, is discolored or cloudy (other than clear to slightly opalescent, colorless to pale yellow). DUPIXENT does not contain preservatives; therefore, discard any unused product remaining in the pre-filled syringe or pre-filled pen.
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)
Pregnancy
Pregnancy Exposure Registry
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.
Risk Summary
Available data from case reports and case series with DUPIXENT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Human IgG antibodies are known to cross the placental barrier; therefore, DUPIXENT may be transmitted from the mother to the developing fetus. There are adverse effects on maternal and fetal outcomes associated with asthma in pregnancy (see Clinical Considerations). In an enhanced pre- and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after subcutaneous administration of a homologous antibody against interleukin-4-receptor alpha (IL-4Rα) during organogenesis through parturition at doses up to 10-times the maximum recommended human dose (MRHD) (see Data).
The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-Associated Maternal and/or Embryo-fetal Risk
In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
Fetal/Neonatal Adverse Reactions
Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, DUPIXENT may be present in infants exposed in utero. The potential clinical impact of dupilumab exposure in infants exposed in utero should be considered.
Data
Animal Data
In an enhanced pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of homologous antibody against IL-4Rα up to 10 times the MRHD (on a mg/kg basis of 100 mg/kg/week) from the beginning of organogenesis to parturition. No treatment-related adverse effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.
Lactation
Risk Summary
There are no data on the presence of dupilumab in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure to dupilumab on the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DUPIXENT and any potential adverse effects on the breastfed child from DUPIXENT or from the underlying maternal condition.
Pediatric Use
Atopic Dermatitis
The safety and effectiveness of DUPIXENT have been established in pediatric patients 6 months of age and older with moderate-to-severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Use of DUPIXENT in this age group is supported by data from the following clinical trials:
- AD-1526 which included 251 pediatric subjects 12 years of age and older with moderate-to-severe AD. Of the 251 subjects, 82 were treated with DUPIXENT 200 mg Q2W (<60 kg) or 300 mg Q2W (≥60 kg) and 85 were treated with matching placebo
- AD-1652 which included 367 pediatric subjects 6 to 11 years of age with severe AD. Of the 367 subjects, 120 were treated with DUPIXENT 300 mg Q4W + TCS (15 to <30 kg) or 200 mg Q2W + TCS (≥30 kg) and 123 were treated with matching placebo + TCS
- AD-1539 which included 162 pediatric subjects 6 months to 5 years of age with moderate-to-severe AD. Of the 162 subjects, 83 were treated with DUPIXENT 200 mg Q4W + TCS (5 to <15 kg) or 300 mg Q4W + TCS (15 to <30 kg) and 79 subjects were assigned to be treated with matching placebo + TCS
- AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 years of age and older treated with DUPIXENT ± TCS, 368 pediatric subjects 6 to 11 years of age treated with DUPIXENT ± TCS, and 180 pediatric subjects 6 months to 5 years of age treated with DUPIXENT ± TCS
- Liberty-AD-HAFT which included 27 pediatric subjects 12 years of age and older with atopic dermatitis with moderate-to-severe hand and/or foot involvement treated with DUPIXENT (N=14) or matching placebo (N=13)
The safety and effectiveness were generally consistent between pediatric and adult patients. In addition, hand-foot-and-mouth disease was reported in 9 (5%) pediatric subjects and skin papilloma was reported in 4 (2%) pediatric subjects 6 months to 5 years of age treated with DUPIXENT ± TCS in AD-1434. These cases did not lead to study drug discontinuation [see Adverse Reactions (6.1) and Clinical Studies (14.1)].
Safety and effectiveness of DUPIXENT have not been established in pediatric patients younger than 6 months of age with AD.
Asthma
The safety and effectiveness of DUPIXENT for an add-on maintenance treatment in patients with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma have been established in pediatric patients 6 years of age and older. Use of DUPIXENT for this indication is supported by evidence from adequate and well-controlled studies in adult and pediatric patients 6 years and older [see Clinical Studies (14.2)].
Pediatric Subjects 12 to 17 Years of Age:
A total of 107 pediatric subjects 12 to 17 years of age with moderate-to-severe asthma were enrolled in QUEST and received either 200 mg (N=21) or 300 mg (N=18) DUPIXENT (or matching placebo either 200 mg [N=34] or 300 mg [N=34]) Q2W. Asthma exacerbations and lung function were assessed in both pediatric subjects 12 to 17 years of age and adults. For both the 200 mg and 300 mg Q2W doses, improvements in FEV1 (LS mean change from baseline at Week 12) were observed (0.36 L and 0.27 L, respectively). For the 200 mg Q2W dose, subjects had a reduction in the rate of severe exacerbations that was consistent with adults. Dupilumab exposure was higher in pediatric subjects 12 to 17 years of age than that in adults at the respective dose level which was mainly accounted for by difference in body weight [see Clinical Pharmacology (12.3)].
The adverse event profile in pediatric subjects 12 to 17 years of age was generally similar to the adults [see Adverse Reactions (6.1)].
Pediatric Subjects 6 to 11 Years of Age:
A total of 408 pediatric subjects 6 to 11 years of age with moderate-to-severe asthma were enrolled in VOYAGE, which evaluated doses of 100 mg Q2W or 200 mg Q2W. Improvement in asthma exacerbations and lung function were demonstrated [see Clinical Studies (14.2)]. The effectiveness of DUPIXENT 300 mg Q4W in subjects 6 to 11 years of age with body weight 15 to <30 kg was extrapolated from efficacy of 100 mg Q2W in VOYAGE with support from population pharmacokinetic analyses showing higher drug exposure levels with 300 mg Q4W [see Clinical Pharmacology (12.3)]. Subjects who completed the treatment period of the VOYAGE study could participate in the open-label extension study (LTS14424). Eighteen subjects (≥15 to <30 kg) out of 365 subjects were exposed to 300 mg Q4W in this study, and the safety profile in these eighteen subjects was consistent with that seen in VOYAGE. Additional safety for DUPIXENT 300 mg Q4W is based upon available safety information from the pediatric AD indication [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)].
Safety and effectiveness of DUPIXENT have not been established in pediatric patients younger than 6 years of age with asthma.
CRSwNP
The safety and effectiveness of DUPIXENT for add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) have been established in pediatric patients aged 12 years and older. Use of DUPIXENT for this indication is supported by evidence from adequate and well-controlled studies of DUPIXENT as add-on maintenance treatment in adults with inadequately controlled CRSwNP (SINUS-24 and SINUS-52) with the following additional data:
- Pharmacokinetic (PK) data from adult and pediatric patients aged 12 years and older with moderate-to-severe asthma and adult patients with inadequately controlled CRSwNP
- Safety data in pediatric patients aged 12 years and older with moderate-to-severe asthma [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.3)]
Safety and effectiveness of DUPIXENT have not been established in pediatric patients younger than 12 years of age with CRSwNP.
EoE
The safety and effectiveness of DUPIXENT for the treatment of EoE have been established in pediatric subjects 1 year of age and older, weighing at least 15 kg. Use of DUPIXENT in this population is supported by an adequate well-controlled study in adults and 72 pediatric subjects 12 to 17 years of age (Study EoE-1), a clinical study in 61 pediatric subjects 1 to 11 years of age (Study EoE-2), and pharmacokinetic data in adult and pediatric subjects 1 to 17 years of age. The safety of DUPIXENT in pediatric subjects 1 to 17 years of age was similar to adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.4)].
Safety and effectiveness of DUPIXENT have not been established in pediatric patients younger than 1 year of age, or weighing less than 15 kg, with EoE.
Prurigo Nodularis
Safety and effectiveness of DUPIXENT have not been established in pediatric patients with PN.
Chronic Obstructive Pulmonary Disease
The safety and effectiveness of DUPIXENT have not been established in pediatric patients with COPD. COPD is largely a disease of adult patients.
Chronic Spontaneous Urticaria
The safety and effectiveness of DUPIXENT for the treatment of CSU in patients who remain symptomatic despite H1 antihistamine treatment have been established in pediatric patients 12 years of age and older. The use of DUPIXENT in this indication is supported by evidence from two adequate and well-controlled studies in adults with additional pharmacokinetic data in 6 pediatric patients 12 years of age and older, and safety data in pediatric patients in other indications [see Dosage and Administration (2.9), Clinical Pharmacology (12.3), and Clinical Studies (14.7)].
Safety and effectiveness of DUPIXENT have not been established in pediatric patients younger than 12 years of age, and/or weighing less than 30 kg, with CSU.
Bullous Pemphigoid
The safety and effectiveness of DUPIXENT have not been established in pediatric patients with BP. BP is largely a disease of adult patients.
Geriatric Use
Of the 1539 subjects with AD exposed to DUPIXENT in a dose-ranging study and placebo-controlled trials, 70 subjects were 65 years or older. Clinical trials of DUPIXENT in AD did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.
Of the 1977 subjects with asthma exposed to DUPIXENT, a total of 240 subjects were 65 years or older. Efficacy and safety in this age group was similar to the overall study population.
Of the 440 subjects with CRSwNP exposed to DUPIXENT, a total of 79 subjects were 65 years or older. Efficacy and safety in this age group were similar to the overall study population.
Clinical studies of DUPIXENT in EoE did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger adult subjects.
Of the 152 subjects with PN exposed to DUPIXENT, a total of 37 were 65 years or older including 8 subjects 75 years or older. Clinical trials did not include a sufficient number of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
Of the 1874 subjects with COPD randomized in clinical trials of DUPIXENT, a total of 1072 were 65 years or older, while 244 subjects were 75 years or older. No overall differences in safety or effectiveness of DUPIXENT have been observed between subjects 65 years of age and older and younger adult subjects.
Of the 198 subjects with CSU exposed to DUPIXENT, a total of 30 subjects were 65 years or older, including 7 subjects 75 years or older. Efficacy and safety in subjects 65 years or older were similar to the overall study population.
Of the 53 subjects with BP exposed to DUPIXENT, a total of 40 were 65 years or older, including 22 subjects 75 years or older. Ten percent of subjects aged 65 years and older treated with DUPIXENT had an adverse reaction of vision blurred compared to zero in younger adult subjects.
DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT [see Warnings and Precautions (5.1)].
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)].
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.
Eosinophilic Conditions
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.
Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Acute Deteriorating Disease
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.
Risk Associated with Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of therapy with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-morbid Asthma
Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Psoriasis
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 and Psoriatic Arthritis
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.
Parasitic (Helminth) Infections
Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if DUPIXENT will influence the immune response against helminth infections.
Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Adverse reactions of helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric subjects 6 to 11 years old who participated in the pediatric asthma development program [see Adverse Reactions (6.1)].
Vaccinations
Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines. Limited data are available regarding coadministration of DUPIXENT with non-live vaccines [see Clinical Pharmacology (12.2)].