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Fabrazyme

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Fabrazyme

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis and Allergic Reactions

Life-threatening anaphylactic and severe allergic reactions have been observed in patients during Fabrazyme (agalsidase beta) infusions. Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion. Interventions have included cardiopulmonary resuscitation, oxygen supplementation, IV fluids, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and IV corticosteroids.

In clinical trials and postmarketing safety experience with Fabrazyme (agalsidase beta) , approximately 1% of patients developed anaphylactic or severe allergic reactions during Fabrazyme (agalsidase beta) infusion.

If anaphylactic or severe allergic reactions occur, immediately discontinue the administration of Fabrazyme (agalsidase beta) and initiate necessary emergency treatment. Because of the potential for severe allergic reactions, appropriate medical support measures should be readily available when Fabrazyme (agalsidase beta) is administered.

The risks and benefits of re-administering Fabrazyme (agalsidase beta) following an anaphylactic or severe allergic reaction should be considered. Extreme care should be exercised, with appropriate medical support measures readily available, if the decision is made to re­administer the product [see WARNINGS AND PRECAUTIONS and Clinical Studies].

Infusion Reactions

In clinical trials with Fabrazyme (agalsidase beta) , approximately 50-55% of patients experienced infusion reactions during Fabrazyme (agalsidase beta) administration, some of which were severe [see WARNINGS AND PRECAUTIONS]. Severe infusion reactions experienced by more than one patient in clinical studies with Fabrazyme (agalsidase beta) included chills, vomiting, hypotension, and paresthesia. Other infusion reactions included pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, urticaria, bradycardia, and somnolence.

Most patients in clinical trials were pretreated with acetaminophen. In patients experiencing infusion reactions, pretreatment with an antipyretic and antihistamine is recommended. Infusion reactions occurred in some patients after receiving pretreatment with antipyretics, antihistamines, and oral steroids. Infusion reactions tended to decline in frequency with continued use of Fabrazyme (agalsidase beta) . However, infusion reactions may still occur despite extended duration of Fabrazyme (agalsidase beta) treatment. If an infusion reaction occurs, decreasing the infusion rate, temporarily stopping the infusion, and/or administrating additional antipyretics, antihistamines, and/or steroids may ameliorate the symptoms. If severe infusion reactions occur, immediate discontinuation of the administration of Fabrazyme (agalsidase beta) should be considered, and appropriate medical treatment should be initiated. Severe reactions are generally managed with administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen, when clinically indicated. Because of the potential for severe infusion reactions, appropriate medical support measures should be readily available when Fabrazyme (agalsidase beta) is administered. Patients who have experienced infusion reactions should be treated with caution when re-administering Fabrazyme (agalsidase beta) .

Compromised Cardiac Function

Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion reactions [see WARNINGS AND PRECAUTIONS]. Patients with compromised cardiac function should be monitored closely if the decision is made to administer Fabrazyme (agalsidase beta) .

Immunogenicity and Re-challenge

In clinical trials with Fabrazyme (agalsidase beta) , a few patients developed IgE antibodies or skin test reactivity specific to Fabrazyme (agalsidase beta) . Two of six patients in the re-challenge study discontinued treatment with Fabrazyme (agalsidase beta) prematurely due to recurrent infusion reactions. Four serious infusion reactions occurred in three patients during Fabrazyme (agalsidase beta) infusions, including bronchospasm, urticaria, hypotension, and development of Fabrazyme (agalsidase beta) -specific antibodies. Other infusion-related reactions occurring in more than one patient during the study included rigors, hypertension, nausea, vomiting, and pruritus. Physicians should consider testing for IgE antibodies in patients who experienced suspected allergic reactions and consider the risks and benefits of continued treatment in patients with anti­Fabrazyme (agalsidase beta) IgE antibodies [see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION].

Patients who have had a positive skin test to Fabrazyme (agalsidase beta) or who have tested positive for Fabrazyme (agalsidase beta) -specific IgE antibody have been re-challenged with Fabrazyme (agalsidase beta) using a re­ challenge protocol [see Clinical Studies ]. Re-challenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available.

Monitoring: Laboratory Tests

There are no marketed tests for antibodies against Fabrazyme (agalsidase beta) . If testing is warranted, contact your local Genzyme representative or Genzyme Corporation at (800) 745-4447.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no animal or human studies to assess the carcinogenic or mutagenic potential of Fabrazyme (agalsidase beta) . There are no studies assessing the potential effect of Fabrazyme (agalsidase beta) on fertility in humans.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of Fabrazyme (agalsidase beta) use in pregnant women. Reproduction studies performed in rats at doses up to 30 times the human dose have revealed no evidence of impaired fertility or negative effects on embryo fetal development due to Fabrazyme (agalsidase beta) . Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Women of childbearing potential should be encouraged to enroll in the Fabry patient registry. The registry will monitor the effect of Fabrazyme (agalsidase beta) on pregnant women and their offspring. For more information, visit www.fabryregistry.com or call (800) 745-4447 [see Patient Counseling Information].

Labor and Delivery

There is no information on the effect of Fabrazyme (agalsidase beta) during labor and delivery. Pregnant females are encouraged to enroll in the Fabry registry [see Patient Counseling Information].

Nursing Mothers

It is not known whether Fabrazyme (agalsidase beta) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fabrazyme (agalsidase beta) is administered to a nursing woman.

Nursing mothers should be encouraged to enroll in the Fabry registry [see Use in Specific Populations and Patient Counseling Information].

Pediatric Use

The safety and efficacy of Fabrazyme (agalsidase beta) were assessed in a multi-national, multi-center, uncontrolled, open-label study in 16 pediatric patients with Fabry disease (14 males, 2 females), ages 8 to 16 years [see Clinical Studies ]. Patients younger than 8 years of age were not included in clinical studies. The safety and efficacy in patients younger than 8 years of age have not been evaluated.

Geriatric Use

Clinical studies of Fabrazyme (agalsidase beta) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Responses in Women

Fabry disease is an X-linked genetic disorder. However, some heterozygous women will develop signs and symptoms of Fabry disease due to the variability of the X-chromosome inactivation within cells.

A total of twelve adult female patients with Fabry disease were enrolled in two separate randomized, double-blind, placebo-controlled clinical studies with Fabrazyme (agalsidase beta) , and two female pediatric patients with Fabry disease, ages 11 years, were evaluated in an open­label, uncontrolled pediatric study [see Use in Specific Populations and Clinical Studies]. Although the safety and efficacy data available in female patients in these clinical studies are limited, there is no indication that female patients respond differently to Fabrazyme (agalsidase beta) compared to males.

Last reviewed on RxList: 2/26/2009
This monograph has been modified to include the generic and brand name in many instances.

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