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Dupixent, 150 mg/ml 2 ml syringes 2 pcs

Name: Dupixent, 150 mg/ml 2 ml syringes 2 pcs
SKU: 492795
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EAN: 3664798014600 SKU: 492795 Categories: Bronchial asthma, Corticosteroid hormones, Medicine, Pain and fever

Description

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

Dupilumab

Composition

Active ingredients:

Dupilumab – 150 mg,

Excipients: L-histidine and L-histidine hydrochloride monohydrate – 3.1 mg, L-arginine hydrochloride – 10.51 mg, sodium acetate trihydrate and glacial acetic acid – 0.75 mg, sucrose – 49.88 mg, polysorbate 80 – 2 mg, water d/I – up to 1 ml.

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

Live vaccines

The use of Dupixent® with live vaccines has not been studied.

Live vaccines should not be given during treatment with Dupixent®.

Non-living (inactivated) vaccines

Immune responses to vaccination were studied in a study in which patients with atopic dermatitis received Dupixent® weekly at a dose of 300 mg for 16 weeks. After 12 weeks of therapy with dupilumab, patients were vaccinated with Tdap (T-cell-dependent, Adacel®) and meningococcal polysaccharide vaccine (T-cell-independent, Menomune®) and immune responses were evaluated after 4 weeks. In patients who received both dupilumab and placebo, responses with antibody formation to tetanus and meningococcal polysaccharide vaccines were similar. In this study, no adverse interactions were found between any of these non-vaccines and dupilumab.

Interactions with CYP450 isoenzyme substrates

In a clinical study conducted in patients with atopic dermatitis, the effects of dupilumab on the pharmacokinetics of CYP isoenzyme substrates were evaluated. Data from this study did not indicate clinically significant effects of dupilumab on the activity of the CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9 isoenzymes.

Interaction with other medicinal products for the treatment of bronchial asthma

The effect of dupilumab on the pharmacokinetics of concomitantly administered drugs is not expected. Data obtained on the basis of population analysis does not indicate the effect of concomitantly administered drugs on pharmacokinetics of dupilumab in patients with moderate or severe bronchial asthma.

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.

Influence on ability to drive vehicles and operate machinery

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

Contraindications

Hypersensitivity to dupilumab or any of the excipients of the drug (see
Children under 18 years of age in patients with moderate to severe atopic dermatitis due to unspecified efficacy and safety.
Children under 12 years of age in patients with moderate to severe bronchial asthma due to unspecified efficacy and safety.

With caution.

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

Bacterial conjunctivitis (1.9%) General disorders and disorders at the site of administration

System-organ class	Frequency	Unintended reactions
Infectious and parasitic diseases	Often		Conjunctivitis (4.0%)
		Oral herpes (3.8%)

		Herpes simplex (Herpes simplex)b (1.7%) <
Blood and lymphatic system disorders	Often	Eosinophilia (1.7%)
Visual disturbances	Often		Allergic conjunctivitis (7.0%)
		Itchy eyes (2.9%)
			Blepharitis (4.5%)
		Dry eye syndrome (1.8%)
	Very common		Injection site reactions (15.9%)

a Combined data from placebo-controlled clinical trials with monotherapy (SOLO 1, SOLO 2, and a phase 2 dose-finding study) and the placebo-controlled CHRONOS trial with concomitant use of topical GCS for the treatment of atopic dermatitis: patients received the drug at a dose of 300 mg once every 2 weeks and 300 mg once a week with or without topical GCS for 16 weeks.
b In clinical trials, cases with herpetic infections (Herpes simplex) manifested skin and mucosal lesions were usually of mild to moderate severity and did not include herpetic eczema. Cases of herpetic eczema have been reported separately, and the incidence was lower in patients treated with Dupixent® compared to the placebo group.

The safety profile of the combination treatment with Dupixent® + topical GCS for 52 weeks was consistent with its safety profile observed by week 16.

Bronchial asthma

Table 2. Adverse reactions observed in clinical trials in patients with bronchial asthma

System-organ class	Frequency	Unwanted reactions
General and injection site disorders	Very common	Erythema at the injection site (14.6%)
	Often	Edema at the injection site (4.8%)
		Often	Itching at the injection site (4.7%)
	Very rare	Anaphylaxis (0.04%)

Conjunctivitis

During the 52-week treatment period in the clinical trial with concomitant use of topical GCS (CHRONOS) conjunctivitis was reported in 16% of cases in the group of patients receiving Dupixent® in a dose of 300 mg once every 2 weeks + topical GCS (20 per 100 patient-years) and in 9% of cases in the placebo group + topical GCS (10 per 100 patient-years). In clinical trials in patients with bronchial asthma the incidence of conjunctivitis was similar in the groups receiving Dupixent® or placebo.

Herpetic eczema and Herpes zoster

In clinical studies in patients with atopic dermatitis the incidence of herpetic eczema was similar in the groups receiving Dupixent® and in the placebo group. In a 16-week monotherapy study, Herpes zoster was reported in < 0.1% of cases in the group receiving Dupixent® (< 1 per 100 patient-years) and < 1% in the placebo group (1 per 100 patient-years). In a 52-week clinical study with concomitant use of topical GCS (CHRONOS) Herpes zoster was reported in 1% of cases in the group receiving Dupixent® + topical GCS (1 per 100 patient-years) and in 2% in the placebo group (2 per 100 patient-years). In clinical trials in patients with bronchial asthma the incidence of Herpes zoster was similar in the groups receiving Dupixent® or placebo.

Hypersensitivity

In clinical trials in atopic dermatitis, one case of serum disease and one case of serum disease-like reaction were reported after administration of Dupixent® (both adverse events were rated as serious). One serious case of anaphylaxis after Dupixent® administration was reported in the study of bronchial asthma (see section “Special Precautions”).

Eosinophils

Patients who received Dupixent® had a higher mean initial increase from baseline in eosinophils compared to patients who received placebo. Eosinophil counts decreased to near baseline levels during the study.

The incidence of treatment-induced eosinophilia (≥500 cells/μL) was similar in the patient groups receiving Dupixent® and placebo.
Treatment-induced eosinophilia (≥5000 cells/μL) was reported in less than 2% of patients receiving Dupixent® and less than 0.5% of patients receiving placebo.

Infections

No increase in the overall incidence of infections or serious infections during treatment with Dupixent® was observed in clinical studies compared to placebo. In 16-week clinical trials in which Dupixent® monotherapy was used, serious infections were reported in 1.0% of patients treated with placebo and 0.5% of patients treated with dupilumab. In the 52-week CHRONOS trial, serious infections were reported in 0.6% of patients receiving placebo and 0.2% of patients receiving Dupixent®.

In clinical trials in patients with bronchial asthma, there was no increase in the overall incidence of infections or serious infections during treatment with Dupixent® compared to placebo. In a 24-week clinical trial, serious infections were reported in 1.0% of patients receiving dupilumab and 1.1% of patients receiving placebo. In the 52-week QUEST study, serious infections were reported in 1.3% of patients receiving dupilumab and 1.4% of patients receiving placebo.

Cardiovascular events

. In a 1-year placebo-controlled study in patients with bronchial asthma (QUEST), cardiovascular thromboembolic events (cardiovascular deaths, nonfatal myocardial infarctions, and nonfatal strokes) were reported in 1 case (0.2%) in the group of patients receiving Dupixent® 200 mg once every 2 weeks; 4 cases (0.6%) in the group of patients receiving Dupixent® 300 mg once every 2 weeks and 2 cases (0.3%) in the placebo group. In a 1-year placebo-controlled study in patients with atopic dermatitis (CHRONOS), cardiovascular thromboembolic events (cardiovascular deaths, nonfatal myocardial infarctions and nonfatal strokes) were reported in 1 case (0.9%) in the group of patients receiving Dupixent® 300 mg once every 2 weeks + topical GCS; 0 cases (0.0%) in the group of patients receiving Dupixent® 300 mg once a week + topical GCS and 1 case (0.3%) in the placebo + topical GCS group.

Immunogenicity

Like all protein drugs, Dupixent® may cause allergic reactions.

Approximately 6% of patients with atopic dermatitis or bronchial asthma who received Dupixent® at a dose of 300 mg once every 2 weeks for 52 weeks developed antibodies against dupilumab (AT); approximately 2% of patients had persistent AT and approximately 2% had neutralizing antibodies.

Approximately 9% of patients with bronchial asthma who received Dupixent® at a dose of 200 mg once every 2 weeks for 52 weeks had antibody formation against dupilumab; approximately 4% had persistent antibodies and approximately 4% had neutralizing antibodies.

Approximately 5% of patients in the placebo groups in the 52-week trials had positive antibodies to Dupicent®; approximately 2% had persistent AT and approximately 1% had neutralizing antibodies.

The antibody formation reaction generally did not affect systemic exposure to dupilumab or the safety or efficacy of the drug. Fewer than 0.4% of patients had high antibody titers to dupilumab associated with decreased systemic exposure and efficacy. In addition, one patient was found to have serum disease and another patient had a serum disease-like reaction (< 0.1%) associated with high antibody titers (see Special Instructions).

The observed frequency of persistent AT and neutralizing activity is highly dependent on the sensitivity and specificity of the analytical method used. In addition, the observed frequency of AT-positive status in the assay may depend on several factors, including the assay technique, method of sample processing, time of sample collection, concomitant medications, and the underlying disease status in each individual case. For these reasons, comparing the frequency of antibody production to dupilumab with the frequency of antibody production to other drugs can be misleading.

Overdose

No safety problems have been found in clinical studies with single intravenous doses up to 12 mg/kg.

There is no specific antidote in case of overdose with Dupixent®. In case of overdose it is necessary to monitor patient’s condition for timely detection of signs and symptoms of adverse events and immediately prescribe an appropriate symptomatic treatment.

Pregnancy use

Pregnancy

There are only limited data on the use of dupilumab in pregnant women. No direct or indirect adverse effects with respect to reproductive toxicity have been observed in animal studies. Dupixent® may be used during pregnancy only if the expected benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding

It is unknown whether dupilumab is excreted into human breast milk. Given the benefit of breastfeeding to the infant and the continued benefit to the mother, a decision should be made to discontinue breastfeeding or to withdraw Dupixent® during the breastfeeding period.

Additional information

Weight	0.102 kg
Conditions of storage	Store at 2 to 8 ° C in the original package to protect it from light. Do not freeze. Keep out of the reach of children.
Manufacturer	Sanofi Winthrop Industry, France
Medication form	solution
Brand	Sanofi Winthrop Industry