Nexviazyme 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

Avalglucosidase α

Indications/Uses

Long-term enzyme replacement therapy of Pompe disease (acid α-glucosidase deficiency).

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Dosage/Direction for Use

IV 20 mg/kg once every 2 wk. Infantile-onset Pompe disease (IOPD) May be increased to 40 mg/kg every other wk or decreased to 20 mg/kg every other wk. Patient 1.25-5 kg Max infusion rate: 9.6 mg/kg/hr. Late-onset Pompe disease Patient 1.25-5 kg Max infusion rate: 4.8 mg/kg/hr.

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Overdosage

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

Contraindications

Life-threatening hypersensitivity.

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Special Precautions

Discontinue use if severe hypersensitivity, anaphylaxis or infusion-associated reactions occur. Advanced Pompe disease; patients susceptible to fluid vol overload or w/ acute underlying resp illness or compromised cardiac &/or resp function. Immunogenicity. Concomitant use of general anaesth for central venous catheter or other surgical procedures in IOPD patients w/ cardiac hypertrophy. May affect ability to drive & use machines. Hepatic & moderate or severe renal impairment. Pregnancy & lactation. Infants <6 mth.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity; headache; nausea; pruritus, rash. Anaphylaxis; dizziness, tremor, somnolence, burning sensation; ocular & conjunctival hyperaemia, eye pruritus, eyelid oedema; tachycardia; HTN, flushing, hypotension, cyanosis, hot flush, pallor; cough, dyspnoea; resp distress, throat irritation, oropharyngeal pain; diarrhoea, vomiting, lip swelling, swollen tongue, abdominal & upper abdominal pain, dyspepsia; urticaria, erythema, palmar erythema, hyperhidrosis, erythematous & pruritic rash, skin plaque; muscle spasms, myalgia, pain in extremity, flank pain; fatigue, chills, chest discomfort, pain, flu-like illness, infusion site pain, pyrexia, asthenia, face oedema, feeling cold & hot, sluggishness; increased BP & body temp, decreased O₂ saturation.

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Caution For Usage

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

Storage

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

Description

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

Action

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MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB22 - avalglucosidase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Regulatory Classification

Presentation/Packing

Form

Nexviazyme powd for infusion 100 mg

Packing/Price

1's

Nexviazyme

avalglucosidase alfa

Manufacturer:

Sanofi

Distributor:

DKSH