Migalastat oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of migalastat.
Drugs List
Therapeutic Indications
Uses
Fabry disease with amenable mutations
Dosage
Adults
123mg on alternate days to be taken at the same time of the day.
Children
Aged 16 years and older
123mg on alternate days to be taken at the same time of the day.
Under 16 years
Contraindicated.
Additional Dosage Information
Missed dose
A missed dose should only be taken if it is within 12 hours of the normal time that the dose is taken. If more than 12 hours have passed the next dose should be taken on the normal day at the normal time according to the every other day dosing schedule i.e. it should not be taken on 2 consecutive days.
Contraindications
Children under 16 years
Breastfeeding
Pregnancy
Renal impairment - eGFR below 30ml/minute/1.73m sq
Precautions and Warnings
Treatment to be initiated and supervised by a specialist
Advise patient to have no food for 2 hours before or after dose
Monitor renal function before and at 6 monthly intervals during treatment
Perform echocardiography at 6 monthly intervals during treatment
Discontinue if any deterioration in cardiac status occurs
Discontinue if renal function deteriorates
Female: Ensure adequate contraception during treatment
Migalastat is not for use with enzyme replacement therapy or for patients with non-amenable mutations.
Pregnancy and Lactation
Pregnancy
Migalastat is contraindicated during pregnancy.
The manufacturer advises that migalastat is not recommended in pregnant women or in women of childbearing potential not using any contraception.
At the time of writing there is limited data from the use of migalastat in pregnant women. Studies in animals have shown reproductive toxicity although this was at a dose much higher than the dose used in humans.
Lactation
Migalastat is contraindicated during breastfeeding.
The manufacturer advises that a decision should be made whether to discontinue breastfeeding or to discontinue migalastat taking into account the risks and benefits to the nursing infant and mother.
Animal studies indicate that migalastat is excreted into breast milk, however presence in human breast milk is unknown.
Side Effects
Abdominal pain
Constipation
Creatine phosphokinase increased
Depression
Diarrhoea
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Epistaxis
Extremity pain
Faecal urgency
Fatigue
Headache
Hypoaesthesia
Muscle spasm
Myalgia
Nausea
Pain
Palpitations
Paraesthesia
Proteinuria
Pruritus
Rash
Torticollis
Vertigo
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Summary of Product Characteristics: Galafold 123mg hard capsules. Amicus Therapeutics UK Ltd. Revised May 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 29 March 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.