Dupixent

Question 1

Are there any data available on the use of DUPIXENT during pregnancy?

Accepted Answer

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.

Question 2

What is the estimated background risk of major birth defects and miscarriage for the indicated population?

Accepted Answer

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Question 3

Is DUPIXENT safe to use while breastfeeding?

Accepted Answer

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.

Question 4

Can DUPIXENT be used in pediatric patients?

Accepted Answer

Safety and efficacy in pediatric patients under 18 years of age have not been established.

Question 5

Is there any information on the use of DUPIXENT in geriatric patients?

Accepted Answer

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.

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)

Body Weight	Initial Loading Dose	Subsequent Dosage *
* Q2W – every other week; 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

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)

Body Weight	Initial Dose 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)

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