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Dupixent

Dupixent Dosage/Direction for Use

dupilumab

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
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" under Patient Counselling Information.
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 atopic dermatitis, asthma, prurigo nodularis and CSU patients taking an initial 600 mg dose, administer each of the two DUPIXENT 300 mg injections at different injection sites.
For atopic dermatitis, asthma and CSU 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 under Patient Counselling Information].
Vaccination Prior to Treatment: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT [see Vaccinations under Precautions].
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 23. (See Table 23.)

Click on icon to see table/diagram/image

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 24. (See Table 24.)

Click on icon to see table/diagram/image

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 Adults and Pediatric Patients 12 Years and Older: The recommended dosage of DUPIXENT for adults and pediatric patients (12 years of age and older) is: An initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week.
An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week for patients with oral corticosteroids-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis for which DUPIXENT is indicated.
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 25. (See Table 25.)

Click on icon to see table/diagram/image

For pediatric patients 6-11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, the recommended dosage should be followed in Table 24.
Recommended Dosage for Chronic Rhinosinusitis with Nasal Polyposis: The recommended dosage of DUPIXENT for adult patients is one DUPIXENT 300 mg injection given every other week.
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.
Recommended Dosage for Chronic Obstructive Pulmonary Disease: The recommended dosage of DUPIXENT for adult patients is 300 mg given every other week (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 other week (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 26. (See Table 26.)

Click on icon to see table/diagram/image

Dosage in Missed Doses: 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 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.
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