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Fabrazyme

Last reviewed on RxList: 12/6/2019
Fabrazyme Side Effects Center

Last reviewed on RxList 12/6/2019

What Is Fabrazyme?

Fabrazyme (agalsidase beta) for intravenous infusion is a man-made form of the naturally-occurring enzyme a-galactosidase A that is used in the treatment of Fabry disease.

What Are Side Effects of Fabrazyme?

Common side effects of Fabrazyme include signs of allergic reaction such as:

  • difficulty breathing
  • closing of the throat
  • hives
  • rash
  • itching
  • fever
  • shaking
  • chest tightness
  • high or low blood pressure
  • fast heartbeats
  • muscle pain
  • stomach pain
  • nausea or vomiting
  • dizziness
  • numbness or tingling, and
  • headache

Dosage for Fabrazyme

The recommended dosage of Fabrazyme is 1.0 mg/kg body weight administered every 2 weeks as an IV infusion.

What Drugs, Substances, or Supplements Interact with Fabrazyme?

Fabrazyme may interact with other drugs. Tell your doctor all medications and supplements you use.

Fabrazyme During Pregnancy and Breastfeeding

Fabrazyme is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or could become pregnant during treatment. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Fabrazyme (agalsidase beta) for intravenous infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Fabrazyme Consumer Information

Get emergency medical help if you have signs of an allergic reaction:

  • skin rash, hives, flushing (warmth, redness, or tingly feeling);
  • trouble swallowing, chest discomfort, difficult breathing, feeling light-headed; or
  • swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you have any of these signs of an infusion reaction:

  • fever, headache, chills, stuffy nose, muscle pain, back pain, dizziness, drowsiness, tired feeling;
  • pale skin, feeling hot or cold, itching, numbness or tingly feeling, swelling in your hands or feet;
  • nausea, vomiting, tight feeling in your throat, stomach pain, diarrhea;
  • chest pain, fast or slow heart rate, feeling short of breath; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • fever, chills, cough;
  • dizziness;
  • swelling in your hands or feet;
  • numbness or tingling;
  • feeling tired;
  • rash; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Fabrazyme (Agalsidase Beta)

Fabrazyme Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Anaphylaxis and Allergic Reactions [see WARNINGS AND PRECAUTIONS]
  • Infusion-associated Reactions [see WARNINGS AND PRECAUTIONS]
  • Compromised Cardiac Function [see WARNINGS AND PRECAUTIONS]
  • Immunogenicity and Rechallenge [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in patients in clinical practice.

The data described below reflect exposure of 80 patients, ages 16 to 61 years, to 1 mg/kg Fabrazyme every two weeks in two separate double-blind, placebo-controlled clinical trials, for periods ranging from 1 to 35 months (mean 15.5 months). All 58 patients enrolled in one of the two studies continued into an open-label extension study of Fabrazyme treatment for up to 54 additional months. Patients were treated with antipyretics and antihistamines prior to the infusions.

Most Common Adverse Reactions

Table 2 enumerates adverse reactions that occurred during the double-blind treatment periods of the two placebo-controlled trials (Study 1 and Study 2) [see Clinical Studies]. The most common adverse reactions reported with Fabrazyme were infusion-associated reactions, (Fabrazyme 59% vs placebo 27%) some of which were severe.

Common adverse reactions which occurred in ≥ 20% of patients treated with Fabrazyme and > 2.5% compared to placebo are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness and rash.

Table 2: Summary of Common Adverse Reactions* in Clinical Trials of Patients with Fabry Disease

Adverse Reaction Fabrazyme
(n=80 )
%
Placebo
(n=60)
%
  Upper respiratory tract infection 44 30
  Chills 43 12
  Pyrexia 39 22
  Headache 39 28
  Cough 33 25
  Paresthesia 31 18
  Fatigue 24 17
  Peripheral edema 21 7
  Dizziness 21 8
  Rash 20 10
  Pain in extremity 19 8
  Nasal congestion 19 15
  Lower respiratory tract infection 18 7
  Pain 16 13
  Back pain 16 10
  Myalgia 14 5
  Hypertension 14 5
  Feeling cold 11 2
  Pruritus 10 3
  Tachycardia 9 3
  Sinusitis 9 3
  Excoriation 9 2
  Increased blood creatinine 9 5
  Tinnitus 8 3
  Dyspnea 8 2
  Respiratory tract congestion 8 2
  Toothache 6 3
  Pharyngitis 6 2
  Fall 6 3
  Burning sensation 6 0
  Anxiety 6 3
  Depression 6 2
  Wheezing 6 0
  Hypoacusis 5 0
  Chest discomfort 5 2
  Fungal infection 5 0
  Viral infection 5 0
  Muscle spasms 5 2
  Hot flush 5 0
* Reported at rate of at least 5% in Fabrazyme-treated patients and greater than 2.5% compared to placebo-treated patients.

Serious and/or frequently occurring (≥ 5% incidence) related adverse reactions based on a pooled analysis of 150 patients treated with Fabrazyme consisted of one or more of the following: chills, pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, hypertension, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, edema peripheral, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face edema, rash, and somnolence. The occurrence of somnolence can be attributed to clinical trial specified pretreatment with antihistamines. Most infusion-related reactions requiring intervention were ameliorated with slowing of the infusion rate, temporarily stopping the infusion, and/or administration of antipyretics, antihistamines, or steroids.

Other reported serious adverse events included stroke, pain, ataxia, bradycardia, cardiac arrhythmia, cardiac arrest, decreased cardiac output, vertigo, and nephrotic syndrome. These adverse events also occur as manifestations of Fabry disease; an alteration in frequency or severity cannot be determined from the small numbers of patients studied.

Adverse Reactions In Pediatric Patients

The safety profile of Fabrazyme in pediatric Fabry disease patients, ages 8 to 16 years, was found to be consistent with that seen in adults [see Use In Specific Populations and Clinical Studies]. The safety of Fabrazyme in patients younger than 8 years of age has not been evaluated.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other agalsidase products may be misleading.

The following data reflect the percentage of patients whose test results were considered positive for antibodies to Fabrazyme using an ELISA and radioimmunoprecipitation (RIP) assay for antibodies.

Ninety-five of 121 (79%) adult patients and 11 of 16 (69%) pediatric patients (106 of 137, 74% of all patients) treated with Fabrazyme in clinical studies have developed IgG antibodies to Fabrazyme. Most patients who develop IgG antibodies do so within the first three months of exposure. IgG seroconversion in pediatric patients was associated with prolonged half-life of Fabrazyme, a phenomenon rarely observed in adult patients [see CLINICAL PHARMACOLOGY and Use In Specific Populations]. A possible cause for this prolongation likely pertains to the ability of antibodies to act as “carriers” for their antigens. Among the 14 female patients exposed to Fabrazyme in clinical studies, six (adult patients) developed IgG antibodies to Fabrazyme.

IgG antibodies to Fabrazyme were purified from 15 patients with high antibody titers (≥12,800) and studied for inhibition of in vitro enzyme activity. Under the conditions of this assay, most of these 15 patients had inhibition of in vitro enzyme activity ranging between 21%-74% at one or more time points during the study. Assessment of inhibition of enzyme uptake in cells has not been performed. No general pattern was seen in individual patient reactivity over time. The clinical significance of binding and/or inhibitory antibodies to Fabrazyme is not known. In patients followed in the open-label extension study, reduction of GL-3 in plasma and GL-3 inclusions in superficial skin capillaries was maintained after antibody formation.

Testing for IgE antibodies was performed in approximately 60 patients in clinical trials who experienced moderate to severe infusion-associated reactions or in whom mast cell activation was suspected. Seven of these patients tested positive for Fabrazyme-specific IgE antibodies or had a positive skin test to Fabrazyme. Patients who have had a positive skin test to Fabrazyme, or who have tested positive for Fabrazyme-specific IgE antibodies in clinical trials with Fabrazyme have been rechallenged [see Clinical Studies, WARNINGS AND PRECAUTIONS, and DOSAGE AND ADMINISTRATION].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Fabrazyme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Cardiovascular: cardiorespiratory arrest, cardiac failure, myocardial infarction, palpitations,
  • Infections: sepsis and pneumonia
  • Infusion-associated reactions: anaphylaxis [see WARNINGS AND PRECAUTIONS], localized angioedema (including auricular swelling, eye swelling, dysphagia, lip swelling, edema, pharyngeal edema, face swelling, and swollen tongue), and bronchospasm.
  • General: hyperhidrosis, asthenia, infusion site reaction
  • Lymphatic: lymphadenopathy
  • Musculoskeletal: arthralgia
  • Nasopharyngeal: rhinorrhea
  • Neurologic: cerebrovascular accident, hypoesthesia, oral hypoesthesia
  • Ophthalmologic: increased lacrimation
  • Pulmonary: respiratory failure, hypoxia
  • Renal: renal failure
  • Dermatologic: erythema
  • Vascular: leukocytoclastic vasculitis

Read the entire FDA prescribing information for Fabrazyme (Agalsidase Beta)

Related Resources for Fabrazyme

Related Drugs

© Fabrazyme Patient Information is supplied by Cerner Multum, Inc. and Fabrazyme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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