Dupilumabdosage

DUPIXENT is administered by subcutaneous injection. Atopic Dermatitis Dosage in Adults: Recommended dosage 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: Body Weight Recommended Dosage For pediatric patients 6 months to 5 years of age, no initial loading dose is recommended 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 to 17 Years of Age: Body Weight Initial Loading Dose Subsequent Dosage Q2W – 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 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 AD, CRSwNP, or AFRS For pediatric patients 12 years to 17 years of age (≥60 kg) and adults with AFRS 600 mg (two 300 mg injections) 300 mg every 2 weeks (Q2W) Dosage in Pediatric Patients 6 Years to 11 Years of Age: Body Weight Recommended Dosage For pediatric patients 6 years to 11 years of age, no initial loading dose is recommended 15 to less than 30 kg 300 mg every 4 weeks (Q4W) 30 kg or more 200 mg every 2 weeks (Q2W) For pediatric patients 6 years 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: Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks (Q2W).

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: Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).

Chronic Obstructive Pulmonary Disease: Recommended dosage for adult patients is 300 mg given every 2 weeks (Q2W). Chronic Spontaneous Urticaria Dosage in Adults: Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W). Dosage in Pediatric Patients 2 Years to 5 Years of Age: Body Weight Recommended Dosage For pediatric patients 2 years to 5 years of age with CSU, no initial loading dose is recommended 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 to 17 Years of Age: Body Weight Initial Loading Dose Subsequent Dosage Q2W – 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 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. Allergic Fungal Rhinosinusitis Dosage in Adults: Recommended dosage is 300 mg given every 2 weeks (Q2W). Dosage in Pediatric Patients 6 Years to 17 Years of Age: Body Weight Recommended Dosage Q2W – every 2 weeks; Q4W – every 4 weeks 15 to less than 30 kg 300 mg Q4W 30 to less than 60 kg 200 mg Q2W 60 kg or more 300 mg Q2W

2.1 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.

2.2 Vaccination

Prior to Treatment Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT.

2.3 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.

Table 1: Dosage of DUPIXENT in Pediatric Patients 6 Months to 5 Years of Age with Atopic Dermatitis Body Weight Recommended Dosage For pediatric patients 6 months to 5 years of age with AD, no initial loading dose is recommended. 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 to 17 Years of Age The recommended dosage of DUPIXENT for pediatric patients 6 years to 17 years of age is specified in Table 2.

Table 2: Dosage of DUPIXENT in Pediatric Patients 6 Years to 17 Years of Age with Atopic Dermatitis 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.

2.4 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.

Table 3: Dosage of DUPIXENT in Adult and Pediatric Patients 12 Years and Older with Asthma 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 AD, CRSwNP, or AFRS For pediatric patients 12 years to 17 years of age (≥60 kg) and adults with AFRS 600 mg (two 300 mg injections) 300 mg every 2 weeks (Q2W) Dosage in Pediatric Patients 6 Years to 11 Years of Age The recommended dosage of DUPIXENT for pediatric patients 6 years to 11 years of age is specified in Table 4.

Table 4: Dosage of DUPIXENT in Pediatric Patients 6 Years to 11 Years of Age with Asthma Body Weight Recommended Dosage For pediatric patients 6 years to 11 years of age with asthma, no initial loading dose is recommended. 15 to less than 30 kg 300 mg every 4 weeks (Q4W) 30 kg or more 200 mg every 2 weeks (Q2W) For pediatric patients 6 years 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.

2.5 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).

2.6 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.

Table 5: Dosage of DUPIXENT in Adult and Pediatric Patients 1 Year of Age and Older with Eosinophilic Esophagitis 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)

2.7 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).

2.8 Recommended

Dosage for Chronic Obstructive Pulmonary Disease The recommended dosage of DUPIXENT for adult patients is 300 mg given every 2 weeks (Q2W).

2.9 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 2 Years to 5 Years of Age The recommended dosage of DUPIXENT for pediatric patients 2 years to 5 years of age is specified in Table 6.

Table 6: Dosage of DUPIXENT in Pediatric Patients 2 Years to 5 Years of Age with Chronic Spontaneous Urticaria Body Weight Recommended Dosage For pediatric patients 2 years to 5 years of age with CSU, no initial loading dose is recommended. 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 to 17 Years of Age The recommended dosage of DUPIXENT for pediatric patients 6 years to 17 years of age is specified in Table 7.

Table 7: Dosage of DUPIXENT in Pediatric Patients 6 Years to 17 Years of Age with Chronic Spontaneous Urticaria 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)

2.10 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.

2.11 Recommended

Dosage for Allergic Fungal Rhinosinusitis Dosage in Adults The recommended dosage of DUPIXENT for adult patients is 300 mg given every two weeks (Q2W). Dosage in Pediatric Patients 6 Years to 17 Years of Age The recommended dosage of DUPIXENT for pediatric patients 6 years to 17 years of age is specified in Table 8.

Table 8: Dosage of DUPIXENT in Pediatric Patients 6 Years to 17 Years of Age with Allergic Fungal Rhinosinusitis Body Weight Recommended Dosage 15 to less than 30 kg 300 mg every 4 weeks (Q4W) 30 to less than 60 kg 200 mg every 2 weeks (Q2W) 60 kg or more 300 mg every 2 weeks (Q2W)

2.12 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.

2.13 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.