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Dupixent

Dupixent Patient Counseling Information

dupilumab

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Patient Counseling Information
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 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 Reduction of Corticosteroid Dosage under Precautions].
Reduction in Corticosteroid Dosage: Inform patients to not discontinue systemic corticosteroids except under the direct supervision of a physician. 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 Parasitic (Helminth) Infections under Actions].
Atopic Dermatitis Patients with Comorbid Asthma: Advise atopic dermatitis patients with comorbid asthma not to adjust or stop their asthma treatment without talking to their physicians [see Atopic Dermatitis Patients with Comorbid Asthma under Precautions].
Instructions for Use: 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. 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 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 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 2°C and 8°C.
Store DUPIXENT Syringes in the original carton to protect it from light.
DUPIXENT Syringes can be stored at room temperature up to 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: 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).
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 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.
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