Medicinal Products

ELAPRASE 2 mg / ml concentrate for solution for infusion Box of 1 vial of 3 ml

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Idursulfase
laboratory: Shire HG Therapies Ltd

Solution for solution for IV infusion
All forms

Indication

Elaprase is indicated for the long-term treatment of male patients over 5 years of age with Hunter's syndrome (Mucopolysaccharidosis Type II, MSP II) and for whom delay in treatment would be detrimental, ie ie patients with cardiac lesions (valvulopathy, cardiomyopathy, PAH) or respiratory disease (obstructive respiratory syndrome, mixed respiratory insufficiency, recurrent pseudo-asthma attacks) or breakage of stature growth in prepubertal children.

Dosage ELAPRASE 2 mg / ml concentrate for solution for infusion Box of 1 vial of 3 ml

- The dosage is the same for adults and children over 5 years of age and is 0.5 mg / kg body weight per week.
Administration is by intravenous infusion.
The duration of the infusion is initially 3 hours (see section pharmacodynamic properties) and can be gradually reduced to 1 hour in the absence of reactions related to the infusion (see section warnings and precautions for use).
- See instructions for use, handling and disposal instructions for preparation and administration.
- There are no efficacy and safety data in subjects with renal or hepatic impairment.

Against indications

- Hypersensitivity to the active substance or to any of the excipients.
- Pregnancy and breast-feeding: Elaprase is not indicated for women. As a result, no reproductive studies have been conducted in female animals and no data on the passage of idursulfase in breast milk.

Elaprase side effects

- Most adverse reactions reported for the 64 patients who received Elaprase at 0.5 mg / kg per week or 0.5 mg / kg every other week during the controlled phase II / III study placebo over 52 weeks were of mild to moderate severity.
- The most commonly observed adverse reactions were infusion-related reactions . In the weekly infusion therapy group, 202 infusion-related reactions were reported in 22 of the 32 patients. In the treatment group receiving infusion every other week, 145 infusion-related reactions were reported in 22 of the 32 patients. In the placebo group, 128 infusion-related reactions were reported in 21 of the 32 patients. The nature and severity of these reactions were comparable to those observed in the Elaprase groups. Among these infusion-related reactions, the most common were skin reactions (rash, pruritus, urticaria), fever, headache, hypertension, and hot flashes. The frequency of infusion-related reactions has decreased over time if Elaprase treatment has been continued.
- The list of side effects with Elaprase is given in the table below. The information is presented by organ system classes and frequency (very frequent (> 1/10) or frequent (> 1/100, <1/10)]. The occurrence of an event in a patient is defined as frequent given the small number of patients treated. Within each frequency category, adverse effects are presented in descending order of severity.
ADVERSE EFFECTS OBSERVED IN CLINICAL TRIALS IN 64 PATIENTS:
Classes of organ systems: Undesirable effects (Common terms).
- disorders of the nervous system:
. Very common : Headache.
. Frequent : Dizziness, tremors, anxiety.
- Eye disorders:
Common : Increased chest pain
- Cardiac disorders:
Common : Arrhythmia *, cyanosis, tachycardia.
- Vascular disorders:
. Very common : Hypertension, hot flashes.
. Frequency : Hypotension.
- Respiratory, thoracic and mediastinal disorders:
Common : Bronchospasm, pulmonary embolism *, coughing, wheezing, tachypnea, dyspnea.
- Gastrointestinal disorders:
. Very common : Dyspepsia.
. Common : Abdominal pain, nausea, diarrhea, vomiting, swelling of the tongue.
- Skin and subcutaneous tissue disorders:
. Very common : Urticaria, rash, pruritus.
. Common : Edema of the face, erythema, eczema.
- Musculoskeletal and systemic disorders:
Common : Arthralgia, myalgia, neck pain, chest pain.
- General disorders and anomalies at the site of administration:
. Very common : Fever, edema at the infusion site.
. Frequent : stiffness, malaise, fatigue, peripheral edema.
- Investigations:
Frequency : Elevation of blood alkaline phosphatase, elevation of blood lactate dehydrogenase.
* see the serious side effects below.
- Adverse events have been defined as events occurring during treatment whose causality is suspected. The definition excluded non-serious events reported once in a single patient. Events occurring during treatment that were at least 9% higher than placebo were also considered adverse events.
- In all clinical studies, serious adverse events have been reported in 5 patients receiving 0.5 mg / kg of Elaprase weekly or every other week. Four patients experienced a hypoxic episode during one or more infusions. These episodes required oxygen therapy in three patients with underlying obstructive airway disease (including two tracheotomized patients). The most serious episode, which was associated with a brief seizure, occurred in a patient who received an infusion during a respiratory attack with fever. In the last patient, whose underlying pathology was less severe, spontaneous resolution occurred shortly after interruption of the infusion. These events did not reappear during subsequent infusions, which were performed at a lower rate and after administration of treatment, usually low dose steroids, antihistamine, and beta-agonist nebulization. In the fifth patient with pre-existing cardiopathy, premature ventricular complexes and pulmonary embolism were diagnosed in the study.
IMMUNOGENICITY:
In the 52-week, placebo-controlled phase II / III study, IgG antibodies to idursulfase were detected at any point in the study in 30 of 64 patients receiving idursulfase (47%). %). In four of these patients, it was observed in vitro that the anti-idursulfase antibodies had neutralizing effects on the activity of idursulfase. Anti-idursulfase IgM antibodies were also detected in 2 of these 30 patients, but no patient developed IgA or IgE antibodies. In the idursulfase group each week, the rate of infusion-related reactions was higher among patients with IgG antibodies than among non-carriers. However, this phenomenon was not observed in patients receiving idursulfase every other week. In the latter, the overall rate of infusion-related reactions was almost identical among patients with IgG antibodies and among non-carriers. Overall rates of infusion-related reactions have decreased over time, regardless of whether patients have antibodies.

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