Dupilumab Subcutaneous

Dupilumab injection is used alone or in combination with other medicines (eg, topical corticosteroids) to treat moderate to severe atopic dermatitis.

dupilumab is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For dupilumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to dupilumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dupilumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dupilumab injection in the elderly. Safety and efficacy have not been established.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking dupilumab, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using dupilumab with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dupilumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, history of or
• Parasitic infection—Use with caution. It is not known if dupilumab may affect patients with these conditions.

• Conjunctivitis (pink eye) or
• Keratitis (inflammation of the cornea of the eye)—Use with caution. May make these conditions worse.

A nurse or other trained health professional will give you dupilumab. dupilumab is given as a shot under your skin, usually in the thigh or abdomen (stomach) area.

dupilumab should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dupixent® may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using dupilumab at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

If you use Dupixent® at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are tender, damaged, bruised, or scarred.

If the medicine in the prefilled syringe has changed color, or if you see particles in it, do not use it.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Dosing

The dose of dupilumab will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dupilumab. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled syringe):
  • For moderate to severe atopic dermatitis:
    • Adults—At first, 600 milligrams (mg) (two 300 mg injections) injected under the skin at different injection sites. Then, your dose will be reduced to 300 mg every 2 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dupilumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Blistering or crusting of the skin
• itchiness, redness of the eyes
• excessive tearing
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• reddening of the skin
• scaly patches on the skin
• sores or white patches on the lips, mouth, or throat

• Burning or dry eyes
• fever
• pain, swelling of the eye or eyelid

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.