Dupixent

DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis 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.

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

Dupilumab reduces the effects of substances in the body that can cause inflammation.

Dupilumab is used to treat moderate-to-severe eczema in adults.

Dupilumab is usually given after topical medicines (for use on the skin) have been tried without successful treatment of symptoms.

Dupilumab may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use dupilumab if you are allergic to it.

To make sure dupilumab is safe for you, tell your doctor if you have:

• asthma;

• eye problems; or

• a parasite infection (such as roundworms or tapeworms).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dupilumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Dupilumab is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember, or within 7 days after it was scheduled. If you are more than 7 days late, skip the missed dose. Do not use extra medicine to make up the missed dose.

General

Dupilumab is available in the following dosage form(s) and strength(s):

• Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe with needle shield.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• Administer by subcutaneous injection.1

• The recommended dose is an initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week.1

In the U.S.

• Dupixent

Available Dosage Forms:

• Solution

Therapeutic Class: Dermatological Agent

Pharmacologic Class: Monoclonal Antibody

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

This medicine is available only with your doctor's prescription.

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

This medicine 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 this medicine 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 this medicine 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 this medicine. 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 this medicine, 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.

• If you have an allergy to Dupixent (dupilumab) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Dupixent with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Live Vaccines

Avoid use of live vaccines in patients treated with Dupixent.

Non-Live Vaccines

Immune responses to vaccination were assessed in a study in which subjects with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab (twice the recommended dosing frequency). After 12 weeks of Dupixent administration, subjects were vaccinated with a Tdap vaccine (Adacel®) and a meningococcal polysaccharide vaccine (Menomune®). Antibody responses to tetanus toxoid and serogroup C meningococcal polysaccharide were assessed 4 weeks later. Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated subjects. Immune responses to the other active components of the Adacel and Menomune vaccines were not assessed.

Interactions with CYP450 Substrates

The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-4, IL-6, IL-10, IL-13, TNFα, and IFN) during chronic inflammation. Thus, Dupixent, an antagonist of IL-4 receptor alpha, could modulate the formation of CYP450 enzymes.

Therefore, upon initiation or discontinuation of Dupixent in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.