Chemical formula: C₆H₁₃NO₄ Molecular mass: 163.172 g/mol PubChem compound: 176077
Migalastat interacts in the following cases:
The effects of migalastat on fertility in humans have not been studied. Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed. Complete reversibility was seen after 4 weeks off-dose. Similar findings have been noted pre-clinically following treatment with other iminosugars. Migalastat did not affect fertility in female rats.
There are limited data from the use of migalastat in pregnant women. In rabbits, developmental toxicity was observed only at maternally toxic doses. Migalastat is not recommended during pregnancy.
It is not known whether migalastat is secreted in human milk. However, migalastat has been shown to be expressed in the milk of lactating rats. Accordingly, a risk of migalastat exposure to the breast-feeding infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue migalastat, taking into account the benefit of breast-feeding for the child relative to the benefit of therapy for the mother.
Migalastat is not recommended in women of childbearing potential not using contraception.
The effects of migalastat on fertility in humans have not been studied. Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed. Complete reversibility was seen after 4 weeks off-dose. Similar findings have been noted pre-clinically following treatment with other iminosugars. Migalastat did not affect fertility in female rats.
Migalastat has no or negligible influence on the ability to drive and use machines.
The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received migalastat.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class.
Adverse reactions with migalastat in clinical trials:
Common: Depression
Very common: Headache
Common: Paraesthesia, Dizziness, Hypoaesthesia
Common: Vertigo
Common: Palpitations
Common: Dyspnoea, Epistaxis
Common: Diarrhoea, Nausea, Abdominal pain, Constipation, Dry mouth, Defaecation urgency, Dyspepsia
Common: Rash, Pruritus
Common: Muscle spasms, Myalgia, Torticollis, Pain in extremity
Common: Proteinuria
Common: Fatigue, Pain
Common: Blood Creatine Phosphokinase increased, Weight increased
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