Xenpozyme 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

Olipudase α

Indications/Uses

Enzyme replacement therapy non-CNS manifestations of acid sphingomyelinase deficiency (ASMD) in paed & adult patients w/ type A/B or B.

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Dosage/Direction for Use

IV Dose escalation: Adult ≥18 yr Initially 0.1 mg/kg, followed by 0.3 mg/kg on wk 2 & 4 then 0.6 mg/kg on wk 6 & 8, followed by 1 mg/kg on wk 10 then 2 mg/kg on wk 12, followed by 3 mg/kg on wk 14. Maintenance: 3 mg/kg every 2 wk. Paed 0 to <18 yr Initially 0.03 mg/kg, followed by 0.1 mg/kg on wk 2 then 0.3 mg/kg on wk 4 & 6, followed by 0.6 mg/kg on wk 8 & 10 then 1 mg/kg on wk 12, followed by 2 mg/kg on wk 14 then 3 mg/kg on wk 16. Maintenance: 3 mg/kg every 2 wk.

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Overdosage

View Xenpozyme 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 or anaphylaxis occur. Infusion-associated reactions. Immunogenicity. Monitor ALT or AST levels prior to & during therapy. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & for 14 days after last dose. Not recommended during pregnancy. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; nausea, abdominal pain, vomiting; urticaria, pruritus; myalgia; pyrexia; increased C-reactive protein. Anaphylaxis & hypersensitivity; ocular hyperaemia & discomfort, eye pruritus; palpitations, tachycardia; hypotension, hot flush, flushing; pharyngeal oedema & swelling, throat tightness & irritation, wheezing, larynx irritation, dyspnoea; diarrhoea, upper abdominal & GI pain, abdominal discomfort; hepatic pain; angioedema, fixed eruption, rash, papular, macular, maculopapular, erythematous, pruritic & morbilliform rash, papule, macule, erythema; bone & back pain, arthralgia; pain, chills, catheter site pain, related reaction, pruritus & swelling, fatigue, asthenia; increased ALT, AST, serum ferritin & body temp, abnormal C-reactive protein.

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Caution For Usage

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

Storage

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

Description

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

Action

View Xenpozyme mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Other Agents Affecting Metabolism

ATC Classification

A16AB25 - olipudase alfa ; Belongs to the class of enzymes. Used in the treatment of alimentary tract and metabolism problems.

Regulatory Classification

Presentation/Packing

Form

Xenpozyme powd for infusion 20 mg

Packing/Price

1's

Xenpozyme

Manufacturer:

Genzyme

Distributor:

DKSH