Dupixent®(Dupilumab) | ®() |
|---|---|
Prescription Only | Prescription Only |
| Dosage & Administration | Dosage & Administration comparison data |
Administration | |
Subcutaneous Injection. Learn more. | |
Dosing | |
Dosage in Adults : Initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week Pediatric Dosing by weight. . Learn more. | |
Latin Shorthand | |
Adults: 600 mg (2 x 300mg) then 300 mg q2w. Learn more. | |
| Financial Assistance | Financial Assistance comparison data |
Out-Of-Pocket Costs With Copay Card | |
$0. Learn more. | |
Annual Cap | |
$13,000. Learn more. | |
Assistance Expiration | |
Each calendar year. Learn more. | |
Generics | |
No lower-cost generic available | No lower-cost generic available |
| Physician Advisory | Physician Advisory comparison data |
Adverse Reactions | |
Most common adverse reactions are:
Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and eosinophilia.
Chronic Rhinosinusitis with Nasal Polyposis (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea. . Learn more. | |
Mechanism of Actions (MoA) | |
Interleukin 4 Receptor Alpha Antagonist. Learn more. | |
Special Populations | |
Are there any data available on the use of DUPIXENT during pregnancy? There are no available data on DUPIXENT use in pregnant women to inform any drug-associated risk. Human IgG antibodies are known to cross the placental barrier, so DUPIXENT may be transmitted from the mother to the developing fetus. However, in an enhanced pre- and post-natal developmental study in pregnant monkeys, no adverse developmental effects were observed in offspring born 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. What is the estimated background risk of major birth defects and miscarriage for the indicated populations? The estimated background risks 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. The background risks in the U.S. general population of major birth defects and miscarriages are 2 to 4% and 15 to 20% of clinically recognized pregnancies, respectively. Is DUPIXENT safe to use while breastfeeding? There are no data on the presence of dupilumab (the active ingredient in DUPIXENT) in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. The effects of local gastrointestinal 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. Can DUPIXENT be used in pediatric patients? Safety and efficacy in pediatric patients under 18 years of age have not been established. Is there any information on the use of DUPIXENT in geriatric patients? Of the 1472 subjects with atopic dermatitis exposed to DUPIXENT in a dose-ranging study and placebo-controlled trials, 67 subjects were 65 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects. | |