Eosinophilic Esophagitis Treatments

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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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Related Clinical Trials

A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
Enrollment Status: Recruiting
Publish Date: June 18, 2026
Intervention Type: Drug
Study Phase: Phase 3

Summary: This study is researching an experimental drug called dupilumab (called study drug). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment. The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE. The study is looking ...

A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
A U.S. Registry of Eosinophilic Esophagitis Patients Treated With DUPIXENT® As Standard of Care
Enrollment Status: Recruiting
Publish Date: June 18, 2026
Intervention Type: Drug

Summary: This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE. Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to...

Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE
Enrollment Status: Recruiting
Publish Date: June 17, 2026
Intervention Type: Drug
Study Phase: Phase 2

Summary: This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last...

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Therapeutic outcomes of biologic switching in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis.
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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
  • Ocular disorders: Ectropion, cicatricial disease/cicatricial ectropion, punctal stenosis/canalicular obstruction, symblepharon, and temporary or ongoing vision loss, including visual impairment and blindness associated with conjunctivitis, keratitis, or blepharitis [see
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:
Image
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
ImageDo not pull off the Needle Cap until you are ready to inject.
ImageDo not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Image
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
*
Image
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.
ImageDo not use the DUPIXENT Syringe if the expiration date has passed.
Image
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.
ImageDo not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Image
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.
ImageDo not heat the DUPIXENT Syringe.
ImageDo not put the DUPIXENT Syringe into direct sunlight.
ImageDo 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.
Image
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.
ImageDo not inject into skin that is tender, damaged, bruised or scarred.
Image
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let your skin dry before injecting.
ImageDo not touch the injection site again or blow on it before the injection.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not touch the Needle.
Inject your medicine right away after removing the Needle Cap.
Image
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.
Image
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Image
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.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not rub your skin after the injection.
Image
Step 13: Dispose
Put your used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
ImageDo 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.
ImageDo not put the Needle Cap back on.
Image
Logo
Manufactured by: Regeneron Pharmaceuticals, Inc. Tarrytown, NY 10591
Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)
© 2025 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: May 2025
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:
Image
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
ImageDo not pull off the Needle Cap until you are ready to inject.
ImageDo not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Image
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
*
Image
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.
ImageDo not use the DUPIXENT Syringe if the expiration date has passed.
Image
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.
ImageDo not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Image
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.
ImageDo not heat the DUPIXENT Syringe.
ImageDo not put the DUPIXENT Syringe into direct sunlight.
ImageDo 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.
Image
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.
ImageDo not inject into skin that is tender, damaged, bruised or scarred.
Image
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let your skin dry before injecting.
ImageDo not touch the injection site again or blow on it before the injection.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not touch the Needle.
Inject your medicine right away after removing the Needle Cap.
Image
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.
Image
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Image
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.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not rub your skin after the injection.
Image
Step 13: Dispose
Put your used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
ImageDo 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.
ImageDo not put the Needle Cap back on.
Image
Logo
Manufactured by: Regeneron Pharmaceuticals, Inc. Tarrytown, NY 10591
Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)
© 2025 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: May 2025
9INSTRUCTIONS FOR USE
DUPIXENT
This Instructions for Use contains information on how to inject DUPIXENT Pre-filled Pen.
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:
Image
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:
Image
Step 1: Remove
Remove the DUPIXENT Syringe from the carton by holding the middle of the Syringe Body.
ImageDo not pull off the Needle Cap until you are ready to inject.
ImageDo not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Image
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
Image
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.
ImageDo not use the DUPIXENT Syringe if the expiration date has passed.
Image
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.
ImageDo not use the DUPIXENT Syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Image
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.
ImageDo not heat the DUPIXENT Syringe.
ImageDo not put the DUPIXENT Syringe into direct sunlight.
ImageDo 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.
Image
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.
ImageDo not inject into skin that is tender, damaged, bruised or scarred.
Image
Step 7: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Let the skin dry before injecting.
ImageDo not touch the injection site again or blow on it before the injection.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not touch the Needle.
Inject the medicine right away after removing the Needle Cap.
Image
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.
Image
Step 10: Insert
Insert the Needle completely into the fold of the skin at about a 45° angle.
Image
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.
Image
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.
ImageDo not put the Needle Cap back on.
ImageDo not rub the skin after the injection.
Image
Step 13: Dispose
Put used Needles, DUPIXENT Syringes, and Needle Caps in a FDA-cleared sharps disposal container right away after use.
ImageDo 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.
ImageDo not put the Needle Cap back on.
Image
Logo
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
PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Syringe Carton
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
PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Syringe Carton
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°F to 46°F (2°C to 8°C) in the original carton.
300 mg/2 mL
New
sanofi | REGENERON
PRINCIPAL DISPLAY PANEL - 300 mg/2 mL Pen Carton
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
Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original
200 mg/1.14 mL
New
sanofi | REGENERON
PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Pen Carton
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
PRINCIPAL DISPLAY PANEL - 100 mg/0.67 mL Syringe Carton