Anaphylaxis and Allergic Reactions

(see BOXED WARNING)

Life-threatening anaphylactic reactions have been observed in some patients during ELAPRASE infusions. Reactions have included respiratory distress, hypoxia, hypotension, seizure, loss of consciousness, urticaria and/or angioedema of the throat or tongue. Biphasic anaphylactic reactions have also been reported to occur after administration of ELAPRASE approximately 24 hours after treatment and recovery from an initial anaphylactic reaction that occurred during ELAPRASE infusion. Interventions for biphasic reactions have included hospitalization, and treatment with epinephrine, inhaled beta-adrenergic agonists, and corticosteroids.

In clinical trials with ELAPRASE, 16/108 patients (15%) experienced infusion reactions during 26 of 8,274 infusions (0.3%) that involved adverse events in at least two of the following three body systems: cutaneous, respiratory, or cardiovascular. Of these 16 patients, 11 experienced significant allergic reactions during 19 of 8,274 infusions (0.2%). One of these episodes occurred in a patient with a tracheostomy and severe airway disease, who received an ELAPRASE infusion while he had a pre-existing febrile illness, and then experienced respiratory distress, hypoxia, cyanosis, and seizure with loss of consciousness.

Because of the potential for severe infusion reactions, appropriate medical support should be readily available when ELAPRASE is administered. Because of the potential for biphasic anaphylactic reactions after ELAPRASE administration, patients who experience initial severe or refractory reactions may require prolonged observation.

When severe infusion reactions occurred during clinical studies, subsequent infusions were managed by use of antihistamines and/or corticosteroids prior to or during infusions, a slower rate of ELAPRASE administration, and/or early discontinuation of the ELAPRASE infusion if serious symptoms developed. With these measures, no patient discontinued treatment permanently due to an allergic reaction.

Patients with compromised respiratory function or acute respiratory disease may be at higher risk of life-threatening complications from infusion reactions. Consider delaying the ELAPRASE infusion in patients with concomitant acute respiratory and/or febrile illness.

If a severe reaction occurs, immediately suspend the infusion of ELAPRASE and initiate appropriate treatment, depending on the severity of the symptoms. Consider resuming the infusion at a slower rate, or, if the reaction is serious enough to warrant it, discontinue the ELAPRASE infusion for that visit.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with ELAPRASE.

ELAPRASE at intravenous doses up to 5 mg/kg, administered twice weekly (about 1.6 times the recommended human weekly dose based on body surface area) had no effect on fertility and reproductive performance in male rats.

Pregnancy: Teratogenic Effects: Category C

Reproduction studies in pregnant female animals have not been conducted with ELAPRASE. It is also not known whether ELAPRASE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ELAPRASE should be given to pregnant women only if clearly needed.

Nursing Mothers

It is not known whether this product is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELAPRASE is administered to a nursing woman.

Pediatric Use

Patients in the clinical studies were age five and older (see CLINICAL STUDIES). Children, adolescents, and adults responded similarly to treatment with ELAPRASE. Safety and efficacy have not been established in pediatric patients less than five years of age.

Geriatric Use

Clinical studies of ELAPRASE did not include patients aged 65 or over. It is not known whether geriatric patients respond differently from younger patients.

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