Drug Detail:Dupixent pre-filled pen (Dupilumab [ doo-pil-ue-mab ])
Generic Name: Dupilumab 300mg in 2mL
Dosage Form: injection, solution
Drug Class: Interleukin inhibitors
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 to 17 years of age, 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 AD, asthma, and PN patients taking an initial 600 mg dose, administer each of the two DUPIXENT 300 mg injections at different injection sites.
For AD and asthma patients 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 (5.9)].
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 other week (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 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.
| 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 other week (Q2W) |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every other week (Q2W) |
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 polyposis | |
| 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 | 100 mg every other week (Q2W) or 300 mg every four weeks (Q4W) |
| ≥30 kg | 200 mg every other week (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 Polyposis
The recommended dosage of DUPIXENT for adult patients is 300 mg given every other week.
Recommended Dosage for Eosinophilic Esophagitis
The recommended dosage of DUPIXENT for adult and pediatric patients 12 years of age and older, weighing at least 40 kg, is 300 mg given 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 other week (Q2W).
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 other 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, wait until the next dose on the original schedule.
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, 30 minutes for the 200 mg/1.14 mL pre-filled syringe or pre-filled pen, and 100 mg/0.67 mL pre-filled syringe) 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.
