Drug reference

Galsulfase

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1149

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Drug Action

Galsulfase is a recombinant form of human N-acetylgalactosamine-4-sulfatase.

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Indications And Dose

Mucopolysaccharidosis VI (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 1 mg/kg once weekly

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Cautions

Acute febrile illness (consider delaying treatment). acute respiratory illness (consider delaying treatment). infusion-related reactions can occur. respiratory disease

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Safety

Side Effects

▶Common or very common Abdominal pain. angioedema. apnoea. arthralgia. asthma. chest pain. chills. conjunctivitis. corneal opacity. cough. dyspnoea. ear pain. fever. headache. hearing impairment. hypertension . hypotension. increased risk of infection. malaise. nasal congestion. nausea. pain. reﬂexes absent. respiratory disorders. skin reactions. tremor. umbilical hernia. vomiting ▶Frequency not known Arrhythmias. cyanosis. hypoxia. infusion related reaction. nerve disorders. pallor. paraesthesia. shock SIDE-EFFECTS, FURTHER INFORMATION Infusion-related reactions often occur, they can be managed by slowing the infusion rate or interrupting the infusion, and can be minimised by pre-treatment with an antihistamine and an antipyretic. Recurrent infusion-related reactions may require pre-treatment with a corticosteroid — consult product literature for details.

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Pregnancy

Manufacturer advises avoid unless essential.

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Breast Feeding

Manufacturer advises avoid—no information available.

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Dose and formulations

Directions For Administration

For intravenous infusion (Naglazyme ®), give intermittently in Sodium chloride 0.9%; dilute requisite dose with infusion ﬂuid to ﬁnal volume of 250 mL and mix gently; infuse through a 0.2 micron in-line ﬁlter; give approx. 2.5% of the total volume over 1 hour, then infuse remaining volume over next 3 hours; if body-weight under 20 kg and at risk of ﬂuid overload, dilute requisite dose in 100 mL infusion ﬂuid and give over at least 4 hours.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Naglazyme (BioMarin Europe Ltd) A Galsulfase 1 mg per 1 ml Naglazyme 5mg/5ml solution for infusion vials | 1 vial P £982.00

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Dose text by age group

Adult

1 mg/kg once weekly

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1149

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Galsulfase

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1149

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Drug Action

Galsulfase is a recombinant form of human N-acetylgalactosamine-4-sulfatase.

PDF page 1149

Indications And Dose

Mucopolysaccharidosis VI (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 1 mg/kg once weekly

PDF page 1149

Cautions

Acute febrile illness (consider delaying treatment). acute respiratory illness (consider delaying treatment). infusion-related reactions can occur. respiratory disease

PDF page 1149

Safety

Side Effects

PDF page 1149

Pregnancy

Manufacturer advises avoid unless essential.

PDF page 1149

Breast Feeding

Manufacturer advises avoid—no information available.

PDF page 1149

Dose and formulations

Directions For Administration

PDF page 1149

Medicinal Forms

PDF page 1149

Dose text by age group

Adult

1 mg/kg once weekly

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1149

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.