Replagal Dosage & Drug Information

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 Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Agalsidase α

Indications/Uses

Long-term enzyme replacement therapy in patients w/ confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).

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Dosage/Direction for Use

0.2 mg/kg every other wk by IV infusion over 40 min.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Risk of idiosyncratic infusion-related reactions. Immediately discontinue administration if severe hypersensitivity or anaphylactic reactions occur. IgG Abs may develop. Contains 14.2 mg Na per vial, equiv to 0.7% of WHO-recommended max daily intake of 2 g Na for an adult. Presence of extensive renal damage (eGFR <60 mL/min) may limit renal response to enzyme replacement therapy. Limited data available in patients on dialysis or post-kidney transplantation. No studies have been performed in patients w/ hepatic impairment. Caution when prescribing to pregnant or breast-feeding women. Safety & efficacy have not yet been established in childn <6 yr & elderly >65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Peripheral oedema; headache, dizziness, neuropathic pain, tremor, hypoesthesia, paraesthesia; tinnitus; palpitations; dyspnoea, cough, nasopharyngitis, pharyngitis; vomiting, nausea, abdominal pain, diarrhoea; rash; arthralgia, limb pain, myalgia, back pain; chest pain, rigors, pyrexia, pain, asthenia, fatigue. Dysgeusia, hypersomnia; increased lacrimation; aggravated tinnitus; tachycardia, atrial fibrillation; HTN, hypotension, flushing; hoarseness, throat tightness, rhinorrhoea; abdominal discomfort; urticaria, erythema, pruritus, acne, hyperhidrosis; musculoskeletal discomfort, peripheral swelling, joint swelling; hypersensitivity; chest tightness, aggravated fatigue, feeling hot, feeling cold, flu-like illness, discomfort, malaise.

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Drug Interactions

Potential inhibition of intracellular α-galactosidase activity w/ chloroquine, amiodarone, benoquin or gentamicin.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Replagal 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

A16AB03 - agalsidase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Replagal conc for soln for infusion (vial) 3.5 mg/3.5 mL

Packing/Price

1's

Replagal

agalsidase alfa

Manufacturer:

Takeda

Distributor:

Zuellig