Dupilumab Injection

Unless your doctor tells you otherwise, continue your normal diet.

If you miss dose of dupilumab injection, inject your missed dose as soon as you remember it and resume your original schedule. However, if it is more than 7 days after your missed dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one. Call your doctor if you miss a dose and have questions about what to do.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Dosage Forms And Strengths

DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution available as:

• Injection: 300 mg/2 mL in a single-dose pre-filled syringe with needle shield
• Injection: 300 mg/2 mL in a single-dose pre-filled syringe

DUPIXENT (dupilumab) Injection is a clear to slightly opalescent, colorless to pale yellow solution, supplied in single-dose pre-filled syringes with or without needle shield. Each pre-filled syringe with or without needle shield is designed to deliver 300 mg of DUPIXENT in 2 mL solution.

DUPIXENT is available in cartons containing either 2 pre-filled syringes with needle shield or 2 pre-filled syringes.

Storage And Handling

DUPIXENT is sterile and preservative-free. Discard any unused portion.

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

If necessary, pre-filled syringes may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not store above 77°F (25°C). After removal from the refrigerator, DUPIXENT must be used within 14 days or discarded.

Do not expose the syringe to heat or direct sunlight.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Do NOT freeze. Do NOT expose to heat. Do NOT shake.

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). Revised: Mar 2017

Included as part of the PRECAUTIONS section.

There is no specific treatment for DUPIXENT overdose. In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.