solution , clear , clear
Colorless to slightly yellowClear to slightly opalescent
Generic Name : DUPILUMAB
Route : SUBCUTANEOUS
Dose Form : SYRINGE (ML)
Strength : 300 mg/2 mL
AHFS Therapeutic Classifications
84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
Active Ingredients
CAS
017152 dupilumab 000000000
Inactive Ingredients
CAS
000756 sodium acetate 000127093
002598 sucrose 000057501
DUPIXENT- dupilumab injection, solution
sanofi-aventis U.S. LLC
1 INDICATIONS AND USAGE
DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis 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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
DUPIXENT is administered by subcutaneous injection.
The recommended dose of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.
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.
If a dose is missed, instruct the patient to 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, instruct the patient to wait until the next dose on the original schedule.
2.2 Important Administration Instructions
DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the "Instructions for Use".
For the initial 600 mg dose, administer each of the two DUPIXENT 300 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.
