Dupixent Patient Counseling Information

Advise the patient to read the Instructions for Use as follows.
Administration Instructions: Provide proper training to patients and/or caregivers on proper subcutaneous injection technique, including aseptic technique, and the preparation and administration of DUPIXENT prior to use. Advise patients to follow sharps disposal recommendations [see Important Administration Instructions under Dosage & Administration and Instructions for Use as follows].
Hypersensitivity: Advise patients to discontinue DUPIXENT and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions [see Hypersensitivity under Precautions].
Conjunctivitis and Keratitis: Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop [see Conjunctivitis and Keratitis under Precautions].
Eosinophilic Conditions: Advise patients to notify their healthcare provider if they present with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis [see Eosinophilic Conditions under Precautions].
Not for Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Deteriorating Disease: Inform patients that DUPIXENT does not treat acute symptoms or acute exacerbations of asthma or COPD. Inform patients to seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with DUPIXENT [see Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Deteriorating Disease under Precautions].
Reduction in Corticosteroid Dosage: Inform patients to not discontinue systemic or inhaled corticosteroids except under the direct supervision of a healthcare provider. Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy [see Risk Associated with Abrupt Reduction of Corticosteroid Dosage under Precautions].
Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatment without talking to their physicians [see Patients with Co-morbid Asthma under Precautions].
Arthralgia: Advise patients to report new onset or worsening joint symptoms to their healthcare provider [see Arthralgia under Precautions].
Parasitic (Helminth) Infections: Advise patients to notify their healthcare provider if they present with clinical features consistent with helminthic infection [see Parasitic (Helminth) Infections under Precautions].
Vaccinations: Advise patients that vaccination with live vaccines is not recommended immediately prior to and while they are receiving DUPIXENT. Instruct patients to inform their healthcare provider that they are taking DUPIXENT prior to a potential vaccination [see Vaccinations under Precautions].
Instructions for Use: Pre-filled Syringe: Read this Instructions for Use before using the DUPIXENT Pre-filled Syringe. Do not inject yourself or someone else until you have been shown how to inject DUPIXENT. In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver. Your healthcare provider can show you or your caregiver how to prepare and inject a dose of DUPIXENT before you try to do it yourself the first time. Keep these instructions for future use. Call your healthcare provider if you have any questions.
This device is a Single-Dose Pre-filled Syringe (called "DUPIXENT Syringe" in these instructions). It contains 200 mg or 300 mg of DUPIXENT for injection under the skin (subcutaneous injection).
Important Information: Read all of the instructions carefully before using the DUPIXENT Syringe.
Ask your healthcare provider how often you will need to inject the medicine.
Rotate the injection site each time you inject.
Do not use the DUPIXENT Syringe if it has been dropped on a hard surface or damaged.
Do not use the DUPIXENT Syringe if the Needle Cap is missing or not securely attached.
Do not touch the Plunger Rod until you are ready to inject.
Do not inject through clothes.
Do not get rid of any air bubbles in the DUPIXENT Syringe.
To reduce the risk of accidental needle sticks, each pre-filled syringe has a Needle Shield that is automatically activated to cover the needle after you have given your injection.
Do not pull back on the Plunger Rod at any time.
Do not remove the Needle Cap until just before you give the injection.
Throw away (dispose of) the used DUPIXENT Single-Dose Pre-filled Syringe right away after use. See "Step 13: Dispose" as follows.
Do not re-use a DUPIXENT Single-Dose Pre-filled Syringe.
How should I store DUPIXENT: Store DUPIXENT Syringes in the refrigerator between 36°F and 46°F (2°C and 8°C).
Store DUPIXENT Syringes in the original carton to protect them from light.
DUPIXENT Syringes can be stored at room temperature up to 77°F (25°C) up to 14 days. Throw away (dispose of) any DUPIXENT Syringes that have been left at room temperature for longer than 14 days.
Do not shake the DUPIXENT Syringe.
Do not heat the DUPIXENT Syringe.
Do not freeze the DUPIXENT Syringe.
Do not put the DUPIXENT Syringe into direct sunlight.
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 13).
*Items not included in the carton.
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: 200 mg: Wait 30 minutes: Lay the DUPIXENT Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes.
300 mg: 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).
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 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 sharps disposal container, you may use a household container that is: made of a heavy-duty plastic; can be closed with a tightfitting, 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.
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.
Pre-filled Pen: Read the Instructions for Use before using the DUPIXENT Pre-filled Pen. Do not inject yourself or someone else until you have been shown how to inject DUPIXENT. Your healthcare provider can show you or your caregiver how to prepare and inject a dose of DUPIXENT before you try to do it yourself for the first time.
In adolescents 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children less than 12 years of age, DUPIXENT should be given by a caregiver.
This DUPIXENT Pre-filled Pen is only for use in adults and children aged 2 years and older.
Keep this Instructions for Use. Call your healthcare provider if you have any questions.
This DUPIXENT Pre-filled Pen is a single-dose device. It contains 200 mg or 300 mg of DUPIXENT for injection under the skin (subcutaneous injection).
Important Information: Read all of the instructions carefully before using the DUPIXENT Pre-filled Pen.
Ask your healthcare provider how often you will need to inject the medicine.
In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult.
In children 2 years to less than 12 years of age, DUPIXENT should be given by a caregiver.
Choose a different injection site for each injection.
Do not use Dupixent Pre-filled Pen if it has been damaged.
Do not use the Dupixent Pre-filled Pen if the Yellow/Green Cap is missing or not securely attached.
Do not press or touch the Orange/Yellow Needle Cover with your fingers.
Do not inject through clothes.
Do not remove the Yellow/Green Cap until just before you give the injection.
Do not try to put the Yellow/Green Cap back on the DUPIXENT Pre-filled Pen.
Throw away (dispose of) the used DUPIXENT Pre-filled Pen right away after use. See "Step D: Dispose" as follows.
Do not re-use a DUPIXENT Pre-filled Pen.
How should I store DUPIXENT: Store unused DUPIXENT Pre-filled Pens in the refrigerator between 2°C to 8°C.
Store DUPIXENT Pre-filled Pens in the original carton to protect from light.
Do not keep DUPIXENT Pre-filled Pens at room temperature up to 25°C for more than 14 days. Throw away (dispose of) any Dupixent Pre-filled Pens that have been left at room temperature for more than 14 days.
Do not shake the DUPIXENT Pre-filled Pen at any time.
Do not heat the DUPIXENT Pre-filled Pen.
Do not freeze the DUPIXENT Pre-filled Pen.
Do not put the DUPIXENT Pre-filled Pen into direct sunlight.
A. Prepare: A1. Gather supplies: Ensure you have the following: the DUPIXENT Pre-filled Pen, 1 alcohol wipe*, 1 cotton ball or gauze*, a sharps (puncture resistant) disposal container* (see Step D).
*Items not included in the carton.
A2. Look at the Label: Confirm that you have the correct product and dose.
A3. Check Expiration Date: Check the expiration date.
Do not use the DUPIXENT Pre-filled Pen if the expiration date has passed.
A4. Check the Medicine: Look at the medicine through the Window on the Dupixent Pre-filled Pen: Check if the liquid is clear and colourless to pale yellow.
Note: You may see an air bubble, this is normal.
Do not use the DUPIXENT Pre-filled Pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Do not use the DUPIXENT Pre-filled Pen if the window is Yellow.
A5. 200 mg: Wait 30 minutes: Lay the DUPIXENT Pre-filled Pen on a flat surface and let it naturally warm up at room temperature (less than 25°C) for at least 30 minutes.
300 mg: Wait 45 minutes: Lay the DUPIXENT Pre-filled Pen on a flat surface and let it naturally warm up at room temperature (less than 25°C) for at least 45 minutes.
Do not heat the DUPIXENT Pre-filled Pen.
Do not put the DUPIXENT Pre-filled Pen into direct sunlight.
Do not keep DUPIXENT at room temperature for more than 14 days. Dispose of (throw away) any DUPIXENT Pens that have been left at room temperature for longer than 14 days.
B. Choose your injection site: B1. Recommended injection sites are: Thigh.
Stomach except for the 2 inches (5 cm) around your belly button (navel).
Upper Arm: If a caregiver gives your dose, they can also use the outer area of the upper arm.
Choose a different site for each DUPIXENT injection.
Do not inject through clothes.
Do not inject into skin that is tender, damaged, bruised or scarred.
B2. Wash Your Hands.
B3. Prepare the injection site: 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.
C. Give injection: C1. Remove Yellow/Green Cap: Do not twist the Yellow/Green Cap off.
Do not remove the Yellow/Green Cap until you are ready to inject.
Do not press or touch the Orange/Yellow Needle Cover with your fingers. The Needle is inside.
Do not put the Yellow/Green Cap back on the DUPIXENT Pre-filled Pen after you have removed it.
C2. Pinch Skin and Place: Pinch the skin before and during the injection.
Pinching is not needed for adults and children aged 12 years and older.
When placing the Orange/Yellow Needle Cover, hold the DUPIXENT Pre-filled Pen so that you can see the Window.
Place the Orange/Yellow Needle Cover on your skin at approximately a 90-degree angle.
Do not press or touch the Orange/Yellow Needle Cover with your fingers. The Needle is inside.
C3. Press down: Press the DUPIXENT Pre-filled Pen firmly against your skin until you cannot see the Orange/Yellow Needle Cover, and hold.
There will be a "click" when the injection starts.
The Window will start to turn Yellow.
The injection can take up to 15 seconds.
Pinching of skin is not needed for adults and children aged 12 years and older.
C4. Hold firmly: Keep holding the DUPIXENT Pre-filled Pen firmly against your skin.
You may hear a second click.
Check that the entire Window has turned to Yellow.
Then slowly count to 5.
Then lift the pen up off the skin, your injection is complete.
If the Window does not turn completely Yellow, remove the pen and call your healthcare provider.
Do not give yourself a second dose without speaking to your healthcare provider.
Pinching of skin is not needed for adults and children aged 12 years and older.
C5. Remove: After you have completed your injection pull straight up to remove DUPIXENT Pre-filled Pen from the skin.
If you see any blood at the site, lightly dab a cotton ball or gauze pad.
Do not rub your skin after the injection.
D. Dispose: Dispose of DUPIXENT Pre-filled Pens, (Needle inside), and Yellow/Green Caps in a puncture resistant (sharps disposal) container right away after use.
Do not dispose of (throw away) the used DUPIXENT Pre-filled Pens (Needle inside) and Yellow/Green Caps in your household trash.
Do not put the Yellow/Green Cap back on.