DUPIXENT basics
DUPIXENT is the first and only FDA-approved eosinophilic esophagitis (EoE) treatment for adult and pediatric patients aged 12 years and older, weighing at least 40 kg. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two key sources underlying type 2 inflammation in EoE. DUPIXENT is not an immunosuppressant. The mechanism of dupilumab action has not been definitively established.1,2
DUPIXENT has a unique mechanism of action in eosinophilic esophagitis (EoE). It is the first and only dual inhibitor of IL-4 and IL-13 signaling, inhibiting two key sources underlying type 2 inflammation in EoE. The mechanism of dupilumab action has not been definitively established.1,2
DUPIXENT is not a steroid. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two key sources underlying type 2 inflammation in eosinophilic esophagitis. The mechanism of dupilumab action has not been definitively established.1
In addition to eosinophilic esophagitis (EoE), DUPIXENT is also indicated for 4 other disease states: moderate-to-severe atopic dermatitis, moderate-to-severe asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis (PN).1
Using DUPIXENT
There is no requirement for initial lab testing or ongoing lab monitoring with DUPIXENT according to the Prescribing Information.1
DUPIXENT is a medicine that is administered by subcutaneous injection. You may decide whether patients self-administer DUPIXENT at home, or you administer in office.1
Administer the 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. Be sure to rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.1
DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after receiving training in subcutaneous injection technique using the 300 mg pre-filled syringe or 300 mg pre-filled pen. For pediatric patients 12 to 17 years of age, it is recommended that DUPIXENT be administered under the supervision of an adult. There is no loading dose for eosinophilic esophagitis (EoE) patients.1
Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the Instructions for Use.1
The pre-filled syringe and the pre-filled pen each come with their own set of specific instructions and guidelines for administration. After choosing your preferred method of treatment, it is important to provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use to ensure each step is followed correctly. In pediatric patients 12 years of age and older, it is recommended that DUPIXENT be administered under the supervision of an adult.1
Advise patients to follow sharps disposal recommendations after administering DUPIXENT. Patients and/or caregivers should read the appropriate Instructions for Use prior to injecting.1
Download the full Instructions for Use below.
PRE-FILLED SYRINGEINSTRUCTIONS FOR USE – 300 mg
DUPIXENT should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. If necessary, DUPIXENT may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. DUPIXENT should not be stored above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded. Do not expose DUPIXENT to heat or direct sunlight. Do NOT freeze or shake.1
- For the 300 mg/2 mL pre-filled pen or syringe, allow 45 minutes for DUPIXENT to reach room temperature
SEE INFORMATION ON PREPARATION FOR USE, STORAGE, AND HANDLING OF DUPIXENT
If a dose is missed, instruct the patient to administer the dose as soon as possible, and start a new weekly schedule from the date of the last administered dose.1
DUPIXENT safety profile
In the pivotal clinical trial (n=122; pooled safety population), the most common adverse reactions (incidence ≥2% at Week 24) were injection site reactions,a upper respiratory tract infections,b arthralgia, and herpes viral infections.1,c
a Injection site reactions are composed of several terms including, but not limited to, injection site swelling, pain, and bruising.
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infection.
c Herpes viral infections are composed of oral herpes and herpes simplex.
The safety profile of DUPIXENT in 72 pediatric subjects 12 to 17 years of age, weighting at least 40 kg, and adults in Parts A and B was similar.1
Other attributes/
considerations
DUPIXENT is not an immunosuppressant. DUPIXENT is a biologic that inhibits IL-4 and IL-13 signaling, two key sources underlying type 2 inflammation in eosinophilic esophagitis (EoE). The mechanism of dupilumab action has not been definitively established.1,2
DUPIXENT does not have a boxed warning. In the pivotal clinical trial (n=122; pooled safety population), the most common adverse reactions (incidence ≥2% at Week 24) were injection site reactions,a upper respiratory tract infections,b arthralgia, and herpes viral infections.1,c
The safety profile of DUPIXENT in 72 pediatric subjects 12 to 17 years of age, weighing at least 40 kg, and adults in Parts A and B was similar.1
Note: Select Important Safety Information: Warnings and Precautions–Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.1
Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.
a Injection site reactions are composed of several terms including, but not limited to, injection site swelling, pain, and bruising.
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infections.
c Herpes viral infections are composed of oral herpes and herpes simplex.
Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines in patients treated with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines. Limited data are available regarding coadministration of DUPIXENT with non-live vaccines.1
DUPIXENT does NOT have any known drug-to-drug interactions. DUPIXENT is NOT metabolized through the liver or excreted through the kidneys.1
In the pivotal clinical trial (n=122), the most common adverse reactions (incidence ≥2%) in adults and pediatric patients (12+ years of age) were injection site reactions,a upper respiratory tract infections,b arthralgia, and herpes viral infections.1,c
Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.
a Injection site reactions are composed of several terms including, but not limited to, injection site swelling, pain, and bruising.
b Upper respiratory tract infections are composed of several terms including, but not limited to, COVID-19, sinusitis, and upper respiratory tract infections.
c Herpes viral infections are composed of oral herpes and herpes simplex.
No. Tuberculosis testing is not required with DUPIXENT according to the Prescribing Information.1
DUPIXENT Access and Support
DUPIXENT MyWay is a patient support program that provides guidance with the insurance approval process as well as patient-centric education. It also offers financial assistance for eligible patients, one-on-one nursing support, and more.
To contact DUPIXENT MyWay, please call 1-844-DUPIXENT (1-844-387-4936). DUPIXENT MyWay coordinators are available Monday-Friday 8 am to 9 pm ET. On-call nurses are available 24/7 for patient support. The fax number is 1-844-387-9370.
When filling out the DUPIXENT MyWay Enrollment Form, both you and your patient will be required to supply information, such as the patient’s insurance, diagnosis, and prescription. You can email or print the enrollment forms below.
DUPIXENT MyWay
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| FOR GASTROENTEROLOGISTS | |||
| English Enrollment Form | |||
| Spanish Enrollment Form | |||
| FOR ALLERGISTS | |||
| Allergist (EoE) English Enrollment Form | |||
| Allergist (EoE) Spanish Enrollment Form | |||
You can visit DUPIXENT MyWay coverage support and resources webpage to find out about the prior authorization request and appeal process, if necessary.
In addition, CoverMyMeds support is available for DUPIXENT. It provides additional enrollment and prior authorization process-related support for DUPIXENT. Live support is available at 866-452-5017 or covermymeds.com.
If you have a current process for prescribing biologics delivered through a specialty pharmacy, you can utilize that process to get DUPIXENT approved for your patients.
Yes. DUPIXENT MyWay is committed to helping all eligible patients throughout the treatment process. At any time in the process, you or your patient can contact DUPIXENT MyWay for any needed support, such as help covering the cost of DUPIXENT or supplemental injection training. The DUPIXENT MyWay Nurse Educator will communicate directly with your patient and address any questions they may have about DUPIXENT, including the insurance process. While the insurance benefits for DUPIXENT are being confirmed, your patient will receive a Welcome Call from their DUPIXENT MyWay Nurse Educator.
The amount your patients pay for DUPIXENT will largely depend on whether they have insurance, the type of insurance they have, whether their insurance provider considers the medication to be preferred or not preferred, and whether they’ve met their deductible.
EOS/HPF, eosinophils per high-power field.
Get patient access support and information about benefits investigations,
prior authorizations, and medical necessity and appeal letters.