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 population?

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.

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.

Dupixent Prescribing & Dosing Schedule

Last Update: Oct, 09 2024

Dupixent(dupilumab)

DUPIXENT 100 MG in 0.67 ML Prefilled Syringe

NO BOXED WARNING

Dosage & Administration

Atopic Dermatitis
Dosage in Adults :

* Recommended dosage 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 :

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 :

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

Asthma
Dosage in Adult and Pediatric Patients 12 Years and Older :

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 polyps
600 mg (two 300 mg injections)	300 mg every 2 weeks (Q2W)

Dosage in Pediatric Patients 6 to 11 Years of Age :

Body Weight	Initial Dose and Subsequent Dosage
15 to less than 30 kg	300 mg every four weeks (Q4W)
≥30 kg	200 mg every other week (Q2W)

For pediatric patients 6 to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per Table 2 which includes an initial loading dose.

Chronic Rhinosinusitis with Nasal Polyps :

* Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every other week (Q2W).

Eosinophilic Esophagitis :

Body Weight	Recommended Dosage in Adult and Pediatric Patients 1 Year and Older, Weighing At Least 15 kg
15 to less than 30 kg	200 mg every other week (Q2W)
30 to less than 40 kg	300 mg every other week (Q2W)
40 kg or more	300 mg every week (QW)

Prurigo Nodularis :

* Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).

Chronic Obstructive Pulmonary Disease :

* Recommended dosage for adult patients is 300 mg given every other week (Q2W).

Get Your Patient on Dupixent

See your patient's specific prior authorization requirements including coverage restrictions and step therapies

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Dupixent Prescribing Information

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Dupixent Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form

Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form

Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form

Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form

Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form

Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form

Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form

Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form

Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form

Coverage Authorization Appeal

Coverage Authorization Request

Dupixent MyWay Enrollment Forms - All Indications

Medical Exception Letter

PA Checklist: Asthma

PA Checklist: Atopic Dermatitis

PA Checklist: Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)

PA Checklist: Eosinophilic Esophagitis

PA Checklist: Prurigo Nodularis

Benefits investigation

Dupixent MyWay Enrollment Forms - All Indications

Dupixent Financial Assistance Options

Copay savings program

Dupixent MyWay Enrollment Forms - All Indications

Enroll in Patient Savings Program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

Dupixent MyWay Enrollment Forms - All Indications

Bridge Program

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

Dupixent MyWay Enrollment Forms - All Indications

Dupixent Patient Assitance Program Eligibility (Through Dupixent MyWay Program )

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.