Myozyme: 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 MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Alglucosidase α

Indications/Uses

Long-term enzyme replacement therapy in patient w/ Pompe disease (acid α-glucosidase deficiency).

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Dosage/Direction for Use

20 mg/kg by IV infusion once every 2 wk. Infusion rate: Initially 1 mg/kg/hr, may be gradually increased to 2 mg/kg/hr every 30 min until max 7 mg/kg/hr.

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Overdosage

View Myozyme overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity.

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Special Precautions

Infusion associated reactions (IARs). Patient w/ acute illness. Advanced Pompe disease. Monitor patients for signs & symptoms of systemic immune complex-mediated reactions involving skin & other organs during therapy. Perform periodic urinalysis in patients w/ high IgG Ab titres. Discontinue immediately if severe hypersensitivity or anaphylactic reactions occur. Concomitant use w/ immunosuppressive agents. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Decreased O₂ saturation; tachycardia; tachypnoea, cough; vomiting; urticaria, rash; flushing; pyrexia. Increased heart rate, BP & body temp; cyanosis; tremor, dizziness, paraesthesia, headache; throat tightness; retching, nausea, diarrhoea; erythema, maculopapular, flushing; macular & papular rash, pruritus, hyperhidrosis; muscle spasms, muscle twitching, myalgia; HTN, pallor, flushing; irritability, chills, chest discomfort, peripheral oedema, local swelling, fatigue, feeling hot; hypersensitivity; agitation.

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Caution For Usage

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

Storage

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

Description

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

Action

View Myozyme mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB07 - alglucosidase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Thai FDA Category

Presentation/Packing

Form

Myozyme infusion conc 50 mg

Packing/Price

1's

Myozyme

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH