Brand Name
Dupixent
Generic Name
Dupilumab
View Brand Information FDA approval date: March 28, 2017
Classification: Interleukin-4 Receptor alpha Antagonist
Form: Injection
What is Dupixent (Dupilumab)?
DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.
Approved To Treat
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Brand Information
Dupixent (Dupilumab)
1DOSAGE FORMS AND STRENGTHS
DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution in a:
Single-dose pre-filled syringe with needle shield as:
- Injection: 300 mg/2 mL (150 mg/mL)
- Injection: 200 mg/1.14 mL (175 mg/mL)
Single-dose pre-filled pen as:
- Injection: 300 mg/2 mL (150 mg/mL)
- Injection: 200 mg/1.14 mL (175 mg/mL)
2CONTRAINDICATIONS
DUPIXENT is contraindicated in patients who have known hypersensitivity to dupilumab or any excipients of DUPIXENT
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
- Conjunctivitis and Keratitis
- Psoriasis
- Arthralgia and Psoriatic Arthritis
- Parasitic (Helminth) Infections
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of DUPIXENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Immune system disorders: angioedema
- Musculoskeletal system disorders: psoriatic arthritis
- Skin and subcutaneous tissue disorders: Facial skin reactions, including erythema, rash, scaling, edema, papules, pruritus, burning, and pain; new-onset psoriasis, vasculitis
4OVERDOSAGE
There is no specific treatment for DUPIXENT overdose. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
5DESCRIPTION
Dupilumab, an interleukin-4 receptor alpha antagonist, is a human monoclonal antibody of the IgG4 subclass that binds to the IL-4Rα subunit and inhibits IL-4 and IL-13 signaling. Dupilumab has an approximate molecular weight of 147 kDa.
Dupilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture.
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.
Each 300 mg pre-filled syringe or pre-filled pen delivers 300 mg dupilumab in 2 mL which also contains L-arginine hydrochloride (10.5 mg), L-histidine (6.2 mg), polysorbate 80 (4 mg), sodium acetate (2 mg), sucrose (100 mg), and water for injection, pH 5.9.
Each 200 mg pre-filled syringe or pre-filled pen delivers 200 mg dupilumab in 1.14 mL which also contains L-arginine hydrochloride (12 mg), L-histidine (3.5 mg), polysorbate 80 (2.3 mg), sodium acetate (1.2 mg), sucrose (57 mg), and water for injection, pH 5.9.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
7INSTRUCTIONS FOR USE DUPIXENT®(DU-pix-ent) (dupilumab) injection, for subcutaneous use Single-Dose Pre-filled Syringe with Needle Shield
Read this Instructions for Use before using the DUPIXENT Pre-filled Syringe.
This device is a
The parts of the DUPIXENT Syringe are shown below:
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
Do not pull off the Needle Cap until you are ready to inject.Do not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Step 2: Prepare
Ensure you have the following:
- the DUPIXENT Pre-filled Syringe
- 1 alcohol wipe*
- 1 cotton ball or gauze*
- a sharps disposal container* (See
*
Step 3: Check
When you receive your DUPIXENT Syringes, always check to see that:
- you have the correct medicine and dose.
- the expiration date on the Single-Dose Pre-filled Syringe has not passed.
Do not use the DUPIXENT Syringe if the expiration date has passed.
Step 4: Inspect
Look at the medicine through the Viewing Window on the DUPIXENT Syringe:
Check to see if the liquid is clear and colorless to pale yellow.
Note: You may see an air bubble, this is normal.
Do not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Step 5: Wait 45 minutes
Lay the DUPIXENT Syringe on a flat surface and let it naturally warm to room temperature for at least 45 minutes.
Do not heat the DUPIXENT Syringe.Do not put the DUPIXENT Syringe into direct sunlight.Do not keep DUPIXENT Syringes at room temperature for more than 14 days. Throw away (dispose of) any DUPIXENT Syringes that have been left at room temperature for longer than 14 days.
Step 6: Choose your injection site
- You can inject into your thigh or stomach, except for the 2 inches (5 cm) around your belly button (navel).
- If a caregiver injects your dose, they can also use the outer area of the upper arm.
- Choose a different site each time you inject DUPIXENT.
Do not inject into skin that is tender, damaged, bruised or scarred. 
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let your skin dry before injecting.
Do not touch the injection site again or blow on it before the injection.
Step 8: Remove Needle Cap
Hold the DUPIXENT Syringe in the middle of the Syringe Body with the Needle pointing away from you and pull off the Needle Cap.
Do not put the Needle Cap back on.Do not touch the Needle.Inject your medicine right away after removing the Needle Cap.
Step 9: Pinch
Pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around your belly button, or outer area of the upper arm if injected by your caregiver). The figure below shows an example of pinching a fold of skin on your stomach.
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Step 11: Push
Relax the pinch.
Push the Plunger Rod down slowly and steadily as far as it will go until the DUPIXENT Syringe is empty.
Note: You will feel some resistance. This is normal.
Step 12: Release and Remove
Lift your thumb to release the Plunger Rod until the Needle is covered by the Needle Shield and then remove the Syringe from the injection site.
Lightly press a cotton ball or gauze on the injection site if you see any blood.
Do not put the Needle Cap back on.Do not rub your skin after the injection.
Step 13: Dispose
Put your used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
Do not dispose of (throw away) Needles, DUPIXENT Syringes, and Needle Caps in your household trash.If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used Needles and Syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Do not put the Needle Cap back on.
Manufactured by: Regeneron Pharmaceuticals, Inc. Tarrytown, NY 10591
Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)
© 2023 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July 2023
8INSTRUCTIONS FOR USE DUPIXENT®(DU-pix-ent) (dupilumab) injection, for subcutaneous use Single-Dose Pre-filled Syringe with Needle Shield
Read this Instructions for Use before using the DUPIXENT Pre-filled Syringe.
This device is a
The parts of the DUPIXENT Syringe are shown below:
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
Do not pull off the Needle Cap until you are ready to inject.Do not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Step 2: Prepare
Ensure you have the following:
- the DUPIXENT Pre-filled Syringe
- 1 alcohol wipe*
- 1 cotton ball or gauze*
- a sharps disposal container* (See
*
Step 3: Check
When you receive your DUPIXENT Syringes, always check to see that:
- you have the correct medicine and dose.
- the expiration date on the Single-Dose Pre-filled Syringe has not passed.
Do not use the DUPIXENT Syringe if the expiration date has passed.
Step 4: Inspect
Look at the medicine through the Viewing Window on the DUPIXENT Syringe:
Check to see if the liquid is clear and colorless to pale yellow.
Note: You may see an air bubble, this is normal.
Do not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Step 5: Wait 30 minutes
Lay the DUPIXENT Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes.
Do not heat the DUPIXENT Syringe.Do not put the DUPIXENT Syringe into direct sunlight.Do not keep DUPIXENT Syringes at room temperature for more than 14 days. Throw away (dispose of) any DUPIXENT Syringes that have been left at room temperature for longer than 14 days.
Step 6: Choose your injection site
- You can inject into your thigh or stomach, except for the 2 inches (5 cm) around your belly button (navel).
- If a caregiver injects your dose, they can also use the outer area of the upper arm.
- Choose a different site each time you inject DUPIXENT.
Do not inject into skin that is tender, damaged, bruised or scarred. 
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let your skin dry before injecting.
Do not touch the injection site again or blow on it before the injection.
Step 8: Remove Needle Cap
Hold the DUPIXENT Syringe in the middle of the Syringe Body with the Needle pointing away from you and pull off the Needle Cap.
Do not put the Needle Cap back on.Do not touch the Needle.Inject your medicine right away after removing the Needle Cap.
Step 9: Pinch
Pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around your belly button, or outer area of the upper arm if injected by your caregiver). The figure below shows an example of pinching a fold of skin on your stomach.
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Step 11: Push
Relax the pinch.
Push the Plunger Rod down slowly and steadily as far as it will go until the DUPIXENT Syringe is empty.
Note: You will feel some resistance. This is normal.
Step 12: Release and Remove
Lift your thumb to release the Plunger Rod until the Needle is covered by the Needle Shield and then remove the Syringe from the injection site.
Lightly press a cotton ball or gauze on the injection site if you see any blood.
Do not put the Needle Cap back on.Do not rub your skin after the injection.
Step 13: Dispose
Put your used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
Do not dispose of (throw away) Needles, DUPIXENT Syringes, and Needle Caps in your household trash.If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used Needles and Syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Do not put the Needle Cap back on.
Manufactured by: Regeneron Pharmaceuticals, Inc. Tarrytown, NY 10591
Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)
© 2023 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July 2023
9Instructions for Use
DUPIXENT
This Instructions for Use contains information on how to inject DUPIXENT.
Read this Instructions for Use before using the DUPIXENT Pre-filled Pen.
This DUPIXENT Pre-filled Pen is only for use in adults and children aged 2 years and older.
This DUPIXENT Pre-filled Pen is a single-dose device. It contains 200 mg of DUPIXENT for injection under the skin (subcutaneous injection).
The parts of the DUPIXENT Pre-filled Pen are shown below:
10INSTRUCTIONS FOR USE DUPIXENT®(DU-pix-ent) (dupilumab) injection, for subcutaneous use Single-Dose Pre-filled Syringe with Needle Shield
Read this Instructions for Use before using the DUPIXENT Pre-filled Syringe.
This device is a
The parts of the DUPIXENT Syringe are shown below:
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
Do not pull off the Needle Cap until you are ready to inject.
Do not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Step 2: Prepare
Ensure you have the following:
- the DUPIXENT Pre-filled Syringe
- 1 alcohol wipe*
- 1 cotton ball or gauze*
- a sharps disposal container* (See
*Items not included in the carton
Step 3: Check
When you receive the DUPIXENT Syringes, always check to see that:
- you have the correct medicine and dose.
- the expiration date on the Single-Dose Pre-filled Syringe has not passed.
Do not use the DUPIXENT Syringe if the expiration date has passed.
Step 4: Inspect
Look at the medicine through the Viewing Window on the DUPIXENT Syringe:
Check to see if the liquid is clear and colorless to pale yellow.
Note: You may see an air bubble, this is normal.
Do not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Step 5: Wait 30 minutes
Lay the DUPIXENT Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes.
Do not heat the DUPIXENT Syringe.
Do not put the DUPIXENT Syringe into direct sunlight.
Do not keep DUPIXENT Syringes at room temperature for more than 14 days. Throw away (dispose of) any DUPIXENT Syringes that have been left at room temperature for longer than 14 days.
Step 6: Choose the injection site
- You can inject into the thigh, outer area of the upper arm or stomach, except for the 2 inches (5 cm) around the belly button (navel).
- Choose a different site each time you inject DUPIXENT.
Do not inject into skin that is tender, damaged, bruised or scarred. 
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let the skin dry before injecting.
Do not touch the injection site again or blow on it before the injection.
Step 8: Remove Needle Cap
Hold the DUPIXENT Syringe in the middle of the Syringe Body with the Needle pointing away from you and pull off the Needle Cap.
Do not put the Needle Cap back on.
Do not touch the Needle.Inject the medicine right away after removing the Needle Cap.
Step 9: Pinch
Pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around the belly button, or outer area of the upper arm). The figure below shows an example of pinching a fold of skin on the stomach.
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Step 11: Push
Relax the pinch.
Push the Plunger Rod down slowly and steadily as far as it will go until the DUPIXENT Syringe is empty.
Note: You will feel some resistance. This is normal.
Step 12: Release and Remove
Lift your thumb to release the Plunger Rod until the Needle is covered by the Needle Shield and then remove the Syringe from the injection site.
Lightly press a cotton ball or gauze on the injection site if you see any blood.
Do not put the Needle Cap back on.
Do not rub the skin after the injection.
Step 13: Dispose
Put used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
Do not dispose of (throw away) Needles, DUPIXENT Syringes, and Needle Caps in your household trash.If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used Needles and Syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Do not put the Needle Cap back on.
Manufactured by: Regeneron Pharmaceuticals, Inc. Tarrytown, NY 10591
Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals,
© 2023 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: July 2023
11PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton
NDC 0024-5914-01
Rx Only
DUPIXENT
300 mg/2 mL (150 mg/mL)
For Subcutaneous Use Only.
300 mg/2 mL
2
Keep out of reach of children. Do not use after
Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
sanofi | REGENERON
12PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Syringe Carton
NDC 0024-5918-01
Rx Only
DUPIXENT
200 mg/1.14 mL (175 mg/mL)
For Subcutaneous Use Only.
200 mg/1.14 mL
2
Keep out of reach of children. Do not use after
Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
sanofi | REGENERON
13PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Pen Carton
NDC 0024-5915-02
DUPIXENT
300 mg/2 mL (150 mg/mL)
For Subcutaneous Use Only.
2
Keep out of reach of children. Do not use
Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
300 mg/2 mL
sanofi | REGENERON
14PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Pen Carton
NDC 0024-5919-02
DUPIXENT
200 mg/1.14 mL (175 mg/mL)
For Subcutaneous Use Only.
2
Keep out of reach of children. Do not use after
Store refrigerated at 36° to 46°F (2° to 8°C) in
200 mg/1.14 mL
sanofi | REGENERON
15PRINCIPAL DISPLAY PANEL - 100 mg/0.67 mL Syringe Carton
NDC 0024-5911-02
Rx Only
DUPIXENT
100 mg/0.67 mL (150 mg/mL)
For Subcutaneous Use Only.
2
Keep out of reach of children. Do not use after
Store refrigerated at 36° to 46°F (2° to 8°C) in the original carton.
100 mg/0.67 mL
sanofi | REGENERON
