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Fabrazyme

Fabrazyme

agalsidase beta

Manufacturer:

Sanofi

Distributor:

DKSH
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Agalsidase β
Indications/Uses
Fabry disease. Reduction of globotriaosylceramide (GL-3) deposition in capillary endothelium of kidney & certain other cell types.
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Dosage/Direction for Use
1 mg/kg IV infusion every 2 wk. Infusion rate: Initially ≤0.25 mg/min (15 mg/hr), may be increased in 0.05-0.08 mg/min (3-5 mg/hr) increments based on tolerance.
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Overdosage
View Fabrazyme overdosage for action to be taken in the event of an overdose.
Warnings
For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Fabrazyme detailed prescribing information
Special Precautions
Discontinue use if severe hypersensitivity, anaphylaxis or infusion-associated reactions occur. Pretreatment w/ antihistamine, antipyretics &/or corticosteroids prior to initiation. Closely monitor patients w/ compromised cardiac function. Immunogenicity. Pregnancy & lactation. Ped <8 yr. Elderly ≥65 yr.
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Adverse Reactions
URTI, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, rash, pain in extremity, myalgia, lower resp tract infection, pain, back pain, HTN, pruritus, tachycardia, excoriation, increased blood creatinine, tinnitus, dyspnea, fall, burning sensation, anxiety, depression, wheezing, hypoacusis, chest discomfort, fungal & viral infection, hot flush. Immunogenicity. Ped: Abdominal pain, pharyngitis, fever, nausea, vomiting, rhinitis, diarrhea, arthralgia.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Fabrazyme detailed prescribing information
Storage
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Description
View Fabrazyme description for details of the chemical structure and excipients (inactive components).
Action
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MIMS Class
Other Agents Affecting Metabolism
ATC Classification
A16AB04 - agalsidase beta ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.
Patient Counseling Information
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Presentation/Packing
Form
Fabrazyme powd for infusion 35 mg
Packing/Price
(single-use) 1's
Form
Fabrazyme powd for infusion 5 mg
Packing/Price
(single-use) 1's
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