Indications &
Usage
Usage
What age is Dupixent indicated for in Atopic Dermatitis and Asthma?
6 years and older
In Demographics & Baseline Characteristics of CRSwNP Trials, what was the Mean age (years) for SINUS-24 study?
50
14.3 Chronic Rhinosinusitis with Nasal Polyposis (Table 16)
What % of subjects receiving Dupixent in SINUS-24 & SINUS-52 experienced arthralgia?
3%
6.1 Clinical Trials Experience - CRSwNP - Table 6
How many syringes/pens come in 1 pack of Dupixent?
2
(16 HOW SUPPLIED/STORAGE AND HANDLING)
What's the mechanism of action for Dupixent?
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes.
Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.
12.1 Mechanism of Action
Topical Corticosteroids
How many combined patients were studied in SINUS-24 & SINUS-52?
724 adult patients
(14.3 Chronic Rhinosinusitis with Nasal Polyposis)
What % of patients receiving Dupixent in SINUS-24 & SINUS-52 experienced Eosinophilia as an adverse reaction?
1%
6.1 Clinical Trials Experience - CRSwNP - Table 6
What ages is the pre-filled pen indicated for?
The DUPIXENT pre-filled pen is for use in adult and pediatric patients aged 12 years and older
2.1 Important Administration Instructions
What is the dose linearity for Dupixent?
Dupilumab exhibited nonlinear target-mediated pharmacokinetics with exposures increasing in a greater than dose-proportional manner. The systemic exposure increased by 30-fold when the dose increased 8-fold following a single dose of dupilumab from 75 mg to 600 mg (i.e., 0.25-times to 2-times the recommended dose).
12.3 Pharmacokinetics - Dose Linearity
What age is Dupixent indicated for in CRSwNP?
Adult patients (18 years and older)
What percentage of patients reported previous sinus surgery and what percentage of patients reported prior systemic corticosteroid use in the previous 2 years?
63% surgery; 74% steroid use
(14.3 Chronic Rhinosinusitis with Nasal Polyposis)
Which immune system adverse reaction has been identified during post-approval use of Dupixent?
Angioedema
6.3 Postmarketing Experience
What are the 3 strengths of Dupixent available in the pre-filled Syringe?
300 mg of DUPIXENT in 2 mL solution
200 mg of DUPIXENT in 1.14 mL solution
100 mg of DUPIXENT in 0.67 mL solution
(16 HOW SUPPLIED/STORAGE AND HANDLING)
How is Dupixent supplied?
DUPIXENT (dupilumab) Injection is supplied as a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution for subcutaneous injection. DUPIXENT is provided as either a single-dose pre-filled syringe with needle shield or a single-dose pre-filled pen in a siliconized Type-1 clear glass syringe. The needle cap is not made with natural rubber latex.
11 - Description
What is the limitation of use for Dupixent with the Asthma indication?
DUPIXENT is not indicated for the relief of acute bronchospasm or status asthmaticus
What is proper Patient Counseling for someone who experiences Arthralgia?
Advise patients to report new onset or worsening joint symptoms to their healthcare provider
(5.7 Warnings and Precautions)
(17 Patient Counseling Information)
What strengths of Dupixent are available in the pre-filled pen?
300 mg of DUPIXENT in 2 mL solution
200 mg of DUPIXENT in 1.14 mL solution
(16 HOW SUPPLIED/STORAGE AND HANDLING)
What's the bioavailability of dupilumab following a SC dose?
similar between AD, asthma, & CRSwNP subjects, ranging between 61% and 64%.
12.3 Pharmacokinetics - Absorption
Approximately what percentage of patients receiving Dupixent 300mg Q2W for 52 weeks developed antibodies?
5%
6.2 - Immunogenicity
If an Atopic Dermatitis patient weighs 45kg, what is the recommended dosage?
Loading dose = 400mg (two 200mg injections)
Maintenance dose = 200mg every 2 weeks
2.3 Recommended Dosage for Atopic Dermatitis
With Cytochrome P450 Substrates, where was the largest effect observed?
The largest effect was observed for metoprolol (CYP2D6) with an increase in AUC of 29%.
12.3 Pharmacokinetics - Drug Interaction Studies - Cytochrome P450 Studies