Dupilumab

What is Dupilumab?

• Dupilumab (Dupixent) is an interleukin-4 receptor alpha antagonist used for allergic diseases such as eczema (atopic dermatitis), asthma and nasal polyps which result in chronic sinusitis.

What are the uses of this medicine?

This medicine used:

• to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. Dupixent can be used with or without topical corticosteroids.
• with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Dupixent may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing.
• with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.

How does this medicine work?

Dupilumab (doo pil' ue mab) is a recombinant human IgG4 monoclonal antibody to the IL-4 receptor subunit alpha which blocks the activation of the IL-4 signaling pathway. IL-4 plays a critical role in Th-2 inflammatory reactions, important in mediation of allergic and atopic conditions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have known hypersensitivity to dupilumab or any of its excipients.

What drug interactions can this medicine cause?

• Avoid use of live vaccines in patients treated with Dupixent.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

• Dupixent is administered by subcutaneous injection, either by pre-filled syringe or pre-filled pen. The Dupixent pre-filled pen is only for use in adults and adolescents aged 12 years and older.

Recommended Dosageː

Atopic Dermatitis

• Dosing in Adults

The recommended dose of Dupixent for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).

• Dosing in Pediatric Patients (6 to 17 Years of Age)

The recommended dose of Dupixent for patients 6 to 17 years of age as shown below:

Body Weight	Initial Dose	Subsequent Doses
15 to less than 30 kg	600 mg (two 300 mg injections)	300 mg every 4 weeks (Q4W)
30 to less than 60 kg	400 mg (two 200 mg injections)	200 mg every other week (Q2W)
60 kg or more	600 mg (two 300 mg injections)	300 mg every other week (Q2W)

• Concomitant Topical Therapies

Dupixent can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

• Asthma

The recommended dose of Dupixent for adults and adolescents (12 years of age and older) is:

• an initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week or
• an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week
• for patients with oral corticosteroids-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis for which Dupixent is indicated, start with an initial dose of 600 mg followed by 300 mg given every other week

• Chronic Rhinosinusitis with Nasal Polyposis

The recommended dose of Dupixent for adult patients is 300 mg given every other week.

Administration

• Use Dupixent exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much Dupixent to inject and how often to inject it.
• Dupixent comes as a single-dose pre-filled syringe with needle shield or as a pre-filled pen.
• Dupixent is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections of Dupixent, you or your caregiver should receive training on the right way to prepare and inject Dupixent. Do not try to inject Dupixent until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that Dupixent be given by or under the supervision of an adult. In children younger than 12 years of age, Dupixent should be given by a caregiver.
• If your dose schedule is every other week and you miss a dose of Dupixent: Give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your Dupixent injection.
• If your dose schedule is every 4 weeks and you miss a dose of Dupixent: Give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your Dupixent injection.
• If you inject more Dupixent than prescribed, call your healthcare provider right away.
• Your healthcare provider may prescribe other medicines to use with Dupixent. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe with needle shield.
• Injection: 200 mg/1.14 mL solution in a single-dose pre-filled syringe with needle shield.
• Injection: 300 mg/2 mL solution in a single-dose pre-filled pen.
• Injection: 200 mg/1.14 mL solution in a single-dose pre-filled pen.

This medicine is available in fallowing brand namesː

• Dupixent

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reactions
• eye and eyelid inflammation, including redness, swelling, and itching
• pain in the throat (oropharyngeal pain)
• cold sores in your mouth or on your lips
• high count of a certain white blood cell (eosinophilia)
• trouble sleeping (insomnia)
• toothache
• gastritis
• joint pain (arthralgia)

The following additional side effects have been reported with Dupixent:

• facial rash or redness

Dupixent can cause serious side effects, including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis
• Eye problems
• Inflammation of your blood vessels

What special precautions should I follow?

• Hypersensitivity reactions (urticaria, rash, erythema nodosum, anaphylaxis, and serum sickness) have occurred after administration of Dupixent. Discontinue Dupixent in the event of a hypersensitivity reaction.
• Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received Dupixent. Patients should report new onset or worsening eye symptoms to their healthcare provider.
• Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy. Be alert to vasculitic rash, worsening pulmonary symptoms, and/or neuropathy, especially upon reduction of oral corticosteroids.
• Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of therapy with Dupixent. Decrease steroids gradually, if appropriate.
• Treat patients with pre-existing helminth infections before initiating therapy with Dupixent. If patients become infected while receiving treatment with Dupixent and do not respond to anti-helminth treatment, discontinue treatment with Dupixent until the infection resolves.

What to do in case of emergency/overdose?

Management for overdosage:

• 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.

Can this medicine be used in pregnancy?

• Available data from case reports and case series with Dupixent use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Dupixent during pregnancy.
• Healthcare providers and patients may call 1-877-311-8972.

Can this medicine be used in children?

• Atopic Dermatitisː

The safety and efficacy of Dupixent have been established in pediatric patients 6 years of age and older with moderate-to-severe atopic dermatitis. Safety and efficacy in pediatric patients <6 years of age with atopic dermatitis have not been established.

• Asthmaː

Safety and efficacy in pediatric patients (<12 years of age) with asthma have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dupilumab
• Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.

Who manufactures and distributes this medicine?

• Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 U.S. License No. 1760
• Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

What should I know about storage and disposal of this medication?

• 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, Dupixent 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 Dupixent to heat or direct sunlight.
• Do NOT freeze.
• Do NOT shake.

• Dailymed label info on Dupilumab
• FDA Dupilumab

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