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Elelyso

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Elelyso

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis

As with any intravenous protein product, severe allergic reactions are possible. Anaphylaxis has been reported in patients treated with ELELYSO [see ADVERSE REACTIONS]. If anaphylaxis occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated.

In patients who have experienced anaphylaxis during infusion with ELELYSO, caution should be exercised upon rechallenge; appropriate medical support should be readily available [see ADVERSE REACTIONS].

Allergic And Infusion Reactions

Infusion reactions (including allergic reactions), defined as a reaction occurring within 24 hours of the infusion, were the most commonly observed reactions in patients (44%-46%) treated with ELELYSO in clinical studies [see ADVERSE REACTIONS]. The most commonly observed symptoms of infusion reactions were headache (16%), chest pain or discomfort (6%), asthenia (7%), fatigue (5%), urticaria (7%), erythema (5%), increased blood pressure (5%), back pain and arthralgia (7%), and flushing (6%). Other infusion or allergic reactions reactions included, angioedema, wheezing, dyspnea, coughing, cyanosis, and hypotension. Most of these reactions were mild and did not require treatment intervention.

Base the management of infusion reactions on the type and severity of the reaction, e.g., slowing the infusion rate or treatment with medications such as antihistamines and antipyretics.

Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required. Patients were not routinely pre-medicated prior to infusion of ELELYSO during clinical studies.

Nonclinical Toxicology

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 taliglucerase alfa. In a male and female fertility study in rats, taliglucerase alfa did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 55 mg/kg/day (about 5 times the recommended human dose of 60 Units/kg based on the body surface area).

Use In Specific Populations

Pregnancy

Category B

Reproduction studies with taliglucerase alfa have been performed in pregnant rats at intravenous doses up to 55 mg/kg/day (about 5 times the recommended human dose of 60 Units/kg based on the body surface area) and in pregnant rabbits at intravenous doses up to 27.8 mg/kg/day (about 5 times the recommended human dose of 60 Units/kg based on the body surface area). These studies did not reveal any evidence of impaired fertility or harm to the fetus due to taliglucerase alfa. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ELELYSO should be used during pregnancy only if clearly needed. .

Nursing Mothers

There are no data from studies in lactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELELYSO is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of ELELYSO in pediatric patients have not been established. One 8 year-old pediatric patient experienced a serious adverse reaction (gastroenteritis).

Geriatric Use

During clinical studies 8 patients aged 65 or older were treated with ELELYSO. Clinical studies of ELELYSO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 5/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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