Dupixent, 150 mg/ml 2 ml syringes 2 pcs

• Atopic dermatitis of moderate to severe course in adult patients with insufficient response to therapy with topical drugs or when such drugs are not recommended for use.
  The drug Dupixent® can be used in monotherapy or simultaneously with topical drugs.
• Additional maintenance therapy for moderate to severe bronchial asthma in patients aged 12 years and older with an eosinophilic phenotype or in patients with hormone-dependent bronchial asthma receiving oral glucocorticosteroids.
  

Active ingredient

Composition

How to take, the dosage

General Guidelines

Dupixent® is given subcutaneously.

Atopic dermatitis

The recommended dose of Dupixent® in adult patients is 600 mg (2 injections of 300 mg) initially, then 300 mg every 2 weeks. Depending on individual therapeutic response, the dose may be increased to 300 mg weekly.

Bronchial asthma

The recommended dose of Dupixent® in adult patients and children (12 years and older):

The initial dose is 400 mg (2 injections of 200 mg), followed by 200 mg every 2 weeks. Depending on individual therapeutic response the dose may be increased up to 300 mg every 2 weeks.
– initial dose – 600 mg (2 injections of 300 mg), further – 300 mg every 2 weeks for patients with glucocorticosteroid-dependent bronchial asthma or with concomitant moderate or severe atopic dermatitis in which Dupixent® is indicated.

If a dose is missed, the patient should receive the injection as soon as possible and then continue treatment according to the prescribed dosing regimen.

Particular patient groups

– Children

The safety and effectiveness of Dupixent® in children and adolescents under 18 years of age with atopic dermatitis has not been established.

The safety and effectiveness of Dupixent® in children under 12 years of age with bronchial asthma has not been established.

– Elderly patients

Dose adjustment is not required in elderly patients.

– Hepatic impairment

There are no data on the use of the drug in patients with hepatic impairment.

– Renal failure

Dose adjustment is not required in patients with mild to moderate renal failure. There are no data on the use of the drug in patients with severe renal impairment.

– Body weight

There is no need to adjust the dosing regimen depending on the patient’s body weight.

How to administer

Pharmaceuticals should be inspected before administration to see if the solution contains solid particles or if the solution shows an abnormal coloration. If the product contains solids or if the solution becomes abnormally colored, the product should not be injected.

The solution in the pre-filled safety syringe or pre-filled syringe must be warmed to room temperature before injection with Dupixent®. For this purpose it is recommended to allow it to stand at room temperature for 45 minutes (for 300 mg dosage) or 30 minutes (for 200 mg dosage).

If necessary, the pre-filled syringe can be stored at room temperature (up to 25°C) for a maximum of 14 days. The product should not be stored at temperatures above 25°C. After removal from the refrigerator, Dupixent® must be used within 14 days or disposed of.

The syringes should be protected from heat and direct sunlight.

If the starting dose is 600 mg, two injections of 300 mg each should be given at different injection sites.

If the starting dose is 400 mg, two 200 mg injections should be given at different injection sites.

The treatment with Dupixent® should be given under medical supervision. Either the patient or a caregiver can inject the drug.

Patients and/or caregivers must be trained to prepare and administer an injection of Dupixent® prior to administration of Dupixent® as described in the “Instructions for Preparing and Administering an Injection of Dupixent®, 300 mg in a Prefilled Single-Spray Syringe with a Safety System, “Instructions for Preparing and Administering an Injection of Dupixent®, 300 mg in a Prefilled Disposable Syringe” and “Instructions for Preparing and Administering an Injection of Dupixent®, 200 mg in a Prefilled Disposable Syringe with a Protection System.”

Dupixent® can be injected subcutaneously by the patient using a pre-filled disposable syringe into the thigh or abdomen, except for the 5 cm diameter area immediately around the navel. If another person is administering the injection, the drug can also be injected into the upper arm.

It is recommended that the injection site be changed each time the product is injected.

The injection of Dupixent® should not be performed in areas of painful or damaged skin, bruising or scarring.
All unused product residues and consumables must be disposed of in accordance with local law requirements.

Interaction

Special Instructions

Hypersensitivity

In the event of a systemic hypersensitivity reaction, treatment with Dupixent® should be stopped immediately and appropriate therapy initiated. In clinical studies in the use of Dupixent® in atopic dermatitis, one case of a serum-like reaction and one case of serum disease after drug administration have been reported (both adverse reactions were considered serious). In a study of bronchial asthma, one case of anaphylaxis after Dupixent® administration was reported.

Conjunctivitis

Conjunctivitis was more common in patients with atopic dermatitis who received Dupixent®. Most patients with conjunctivitis recovered or recovered during the treatment period. Among patients with bronchial asthma, the incidence of conjunctivitis was low and similar in the groups treated with Dupixent® and placebo. Patients should report the first occurrence or worsening of eye symptoms to their physician.

Eosinophilic conditions

Patients with bronchial asthma may develop severe systemic eosinophilia, sometimes as clinical signs of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, which are often treated with systemic corticosteroids. These events can usually, but not always, be associated with a reduction in oral corticosteroids. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy occurring in their patients with eosinophilia. Cases of eosinophilic pneumonia and vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported with Dupixent® in adult patients who participated in a clinical trial of the drug for bronchial asthma. An association between the use of Dupixent® and these conditions has not been established.

Bronchial asthma exacerbation symptoms or worsening conditions

Dupixent® should not be prescribed to treat symptoms of acute asthma worsening or exacerbations. Dupixent® is not used to treat acute bronchospasm or asthmatic status.

Dose reduction of glucocorticosteroids

The use of systemic, topical or inhaled glucocorticosteroids should not be abruptly interrupted after starting therapy with Dupixent®. Dose reduction of glucocorticosteroids, if necessary, should be gradual and should be performed under the direct supervision of a physician. Dose reduction of glucocorticosteroids may be accompanied by systemic withdrawal symptoms and/or manifestation of conditions not previously seen due to systemic glucocorticosteroid therapy.

Helminthiasis (worm infestations)

Patients with detected helminthiasis have not been included in clinical trials. It is unknown whether Dupixent® may affect the immune response in helminth infestations. Patients with existing helminth infections should be treated before starting treatment with Dupixent®. If during treatment with Dupixent® the patient becomes infected with helminthiasis and antihelminthic drugs are ineffective, treatment with Dupixent® should be stopped until the parasitic disease is cured.

Patients with atopic dermatitis and concomitant bronchial asthma should be advised not to change their treatment without consulting their physician. When discontinuing treatment with Dupixent® possible effects on other atopic diseases should be taken into consideration.

The drug Dupixent® has no or negligible effect on the ability to drive vehicles and operate other mechanisms.

Contraindications

Side effects

Atopic dermatitis
The following classification is used to describe the incidence of adverse reactions: Very common ≥10%; common ≥1% and < 10%; infrequent ≥0.1% and < 1%; rare ≥0.01% and < 0.1%; very rare < 0.01%; frequency unknown (the incidence of the adverse reaction cannot be determined from available data).

Table 1. Adverse reactions observed in clinical trials in patients with atopic dermatitis

Overdose

Pregnancy use