Aldurazyme: Side Effects & Dosing

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 Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Laronidase

Indications/Uses

Hurler & Hurler-Scheie forms of mucopolysaccharidosis I & Scheie form w/ moderate to severe symptoms.

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Dosage/Direction for Use

Recommended dose: 0.58 mg/kg IV infusion once wkly over approx 3-4 hr. Infusion rate: Initially 10 mcg/kg/hr, may be incrementally increased every 15 min during the 1st hr until max of 200 mcg/kg/hr maintained for 2-3 hr. Pre-treatment is recommended 60 min prior to start of the infusion & may include antihistamines, antipyretics or both. Patient >20 kg Total vol: 250 mL, ≤20 kg Total vol: 100 mL.

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Overdosage

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Warnings

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Special Precautions

Discontinue if anaphylaxis or other severe allergic reactions occur. Acute febrile or resp illness. Patients susceptible to fluid overload, w/ acute underlying resp illness or compromised cardiac &/or resp function. Patients should receive antipyretics &/or antihistamines 60 min prior to infusion. Pregnancy & lactation. Childn. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Flushing, pyrexia, headache, rash, abdominal pain or discomfort & inj site reaction; otitis media, chills, increased BP, decreased O₂ saturation. Angioedema, hypotension, paresthesia, feeling hot, hyperhidrosis, tachycardia, vomiting, back pain, & cough.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Aldurazyme detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB05 - laronidase ; 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

Aldurazyme infusion 2.9 mg/5 mL

Packing/Price

1's

Aldurazyme

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH