Fabrazyme: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Agalsidase-β

Indications/Uses

Fabry disease.

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Dosage/Direction for Use

IV infusion 1 mg/kg every 2 wk. Patients should receive antipyretics prior to infusion. Initial infusion rate: Max: 0.25 mg/min (15 mg/hr). May be increased in increments of 0.05-0.08 mg/min (3-5 mg/hr) w/ each subsequent infusion. Patients weighing ≥30 kg Max infusion rate: Not <1.5 hr, <30 kg Max infusion rate: 0.25 mg/min (15 mg/hr). Patients tested for anti-Fabrazyme IgE Initial rechallenge Should be low dose at a lower infusion. If tolerated, may be increased to 1 mg/kg & increase by slowly titrating upwards (doubled every 30 min up to a max rate of 0.25 mg/min).

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Overdosage

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Special Precautions

Immediately discontinue if anaphylactic or severe allergic reactions occur. Pretreatment w/ an antipyretic & antihistamine is recommended in patients experiencing infusion reactions. Monitor patients w/ compromised cardiac function. Consider testing for IgE Abs in patients experienced suspected allergic reactions. Pregnancy & lactation. Childn <8 yr. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Chills, pyrexia, feeling hot or cold, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, HTN, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, peripheral edema, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face edema, rash, & somnolence.

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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

View Fabrazyme storage conditions for details to ensure optimal shelf-life.

Description

View Fabrazyme description for details of the chemical structure and excipients (inactive components).

Action

View Fabrazyme mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Thai FDA Category

Patient Counseling Information

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Presentation/Packing

Form

Fabrazyme powd for inj 35 mg

Packing/Price

20 mL x 1's

Form

Fabrazyme powd for inj 5 mg

Packing/Price

5 mL x 1's

Fabrazyme

agalsidase beta

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH