Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Galafold 123 mg hard capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Migalastat hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Galafold contains the active substance migalastat. This medicine is used for the long-term treatment of Fabry disease in adults and adolescents aged 12 years and older who have certain genetic mutations (changes). Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A). Depending upon the kind of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent. This enzyme defect leads to abnormal deposits of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease. This medicine works by stabilising the enzyme that your body produces naturally, so that it can work better to reduce the amount of GL-3 that has accumulated in your cells and tissues.
2.
What you need to know before you take it
e Galafold
Do not take Galafold if you:
- are allergic to migalastat or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions 123 mg migalastat capsules are not for children (≥12 years) weighing less than 45 kg. Talk to your doctor before taking Galafold if you are currently taking enzyme replacement therapy. You should not take Galafold if you are also receiving enzyme replacement therapy. Your doctor will monitor your condition and whether your medicine is working every 6 months while you are taking Galafold. If your condition worsens, your doctor may evaluate you further or may discontinue your treatment with Galafold.
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Talk to your doctor before taking Galafold if you have severely reduced kidney function as Galafold is not recommended for use in patients with severe renal insufficiency (GFR less than 30 mL/min/1.73m2). Children Children <12 years This medicine has not been studied in children under the age of 12 years; therefore,the safety and efficacy in this age group has not been established. Other medicines and Galafold Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including supplements and herbal medicines. Especially tell your doctor if you take caffeine containing medicines or supplements as these medicines may affect how Galafold works if taken during fasting period. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Pregnancy, breast-feeding, and fertility Pregnancy There is very limited experience with the use of this medicine in pregnant women. Galafold is not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Women who could become pregnant should use effective birth control while taking Galafold. Breast-feeding Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse. It is not yet known whether this medicine passes into breast milk. Your doctor will decide whether you need to stop breast-feeding or temporarily stop your medicine, considering the benefit of breast-feeding to the baby and the benefit of Galafold to the mother. Fertility in men It is not yet known if this medicine affects fertility in men. The effects of Galafold on fertility in humans have not been studied. Fertility in women It is not yet known if this medicine affects fertility in women. If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice. Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.
3.
How to take it
Galafold
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure. Take one capsule every other day at the same time of the day. Do not take Galafold on two consecutive days. 2
Do not consume food or caffeine at least 2 hours before and 2 hours after taking your medicine. This minimum 4 hours fast around taking your medicine is needed to allow your medicine to be fully absorbed. Water (plain, flavored, sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the 4-hour fasting period. Swallow the capsule whole. Do not cut, crush, or chew the capsule. Figure A
Step 1: Remove the adhesive seal holding the cover. Lift the cover of your Galafold carton (see Figure A).
Figure B – Opened carton
Step 2: Press and continue holding down the purple tab with your thumb at the left side of the carton (see Figure B), and continue to Step 3.
Figure C
Step 3: Now GRASP the tab on the right side where it says "PULL OUT HERE" and pull out the folded blister card (see Figure C).
Figure D – Front of the blister card
Step 4: Unfold the blister card (see Figure D).
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Taking Galafold Capsule: One Galafold blister card = 14 hard capsules = 28 days of treatment with Galafold, and 14 white cardboard circles. The white cardboard circles are to remind you to take Galafold every other day. The arrow directs the patient to begin the next 2 weeks of treatment. Figure E – Front of the blister card
Figure F – Front of the blister card
Step 5: On your first day of taking this medicine from a new blister card, record the date on the blister card (see Figure F).
Figure G – Back of the blister card
Step 6: TURN the card OVER showing the back of the card. LOCATE capsule to remove. BEND the card as shown (see Figure G). Note: Bending the card helps raise the oval perforated cardboard.
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Figure H – Back of the blister card
Step 7: REMOVE the oval perforated cardboard (see Figure H). Note: After removing the cardboard, the white backing of the foil may be present, which is ok.
Figure I – Front of the blister card
Step 8: TURN the card OVER showing the front of the card. PUSH the capsule out (see Figure I).
Figure J – Front of the blister card Step 9: On the next day, move to the perforated white cardboard circle on the top row labelled Day 2. Press down on the white cardboard circle removing it (see Figure J). Note: Removing this white circle will help you remember which day you do not take the medicine. Take 1 Galafold capsule every other day. Close package and store after each use.
After Day 2, move to Day 3 on the blister card. Alternate daily between taking the capsule and pushing out the perforated white cardboard circles, up to and including day 28. Figure K – Front of the unfolded blister card
If you take more Galafold than you should If you take more capsules than you should, then you should stop taking the medicine and contact yourdoctor. You may get a headache and feel dizzy. If you forget to take Galafold If you forget to take your capsule at the usual time but remember later, you can take the capsule only ifit is within 12 hours of your normal dosing time. If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule. Do not take two capsules to make up for your missed dose. If you stop taking Galafold Do not stop taking this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common: may affect more than 1 in 10 people •
Headache
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Common: may affect up to 1 in 10 people • • • • • • • • • • •
Palpitations (the feeling of a pounding heart) Sensation of spinning (vertigo) Diarrhoea Feeling sick (nausea) Stomachache Constipation Dry mouth Sudden need to defecate Indigestion (dyspepsia) Tiredness Raised levels of creatine phosphokinase in blood tests
• • • • • • • • •
Weight gain Muscle spasms Muscle pain (myalgia) Painful stiff neck (torticollis) Tingling in extremities (paraesthesia) Dizziness Reduced sense of touch or sensation (hypoaesthesia) Depression Protein in the urine (proteinuria)
• • • • •
Shortness of breath (dyspnoea) Nose bleed (epistaxis) Rash Persistent itch (pruritus) Pain
Uncommon: may affect up to 1 in 100 people •
Sudden swelling of skin or mucous membrane (e.g. lip, tongue, eye, etc) or both (angioedema)
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
Galafold
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. Theexpiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in theoriginal package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how tothrow away medicines you no longer use. These measures will help protect the environment.
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6.
Contents of the pack and other information
What Galafold contains The active substance is migalastat. Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat The other ingredients are: Capsule contents: Pregelatinised starch (maize)and magnesium stearate Capsule shell: Gelatin, titanium dioxide (E171), and indigo carmine (E132) Printing ink: Shellac, black iron oxide, and potassium hydroxide What Galafold looks like and contents of the pack Opaque, blue, and white hard capsules, marked with "A1001" in black ink, size 2 hard capsule (6.4×18.0 mm) containing white to pale brown powder. Galafold is available in a blister pack containing 14 capsules. Marketing Authorisation Holder Amicus Therapeutics UK Limited One Globeside Fieldhouse Lane Marlow Buckinghamshire SL7 1HZ Manufacturer Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth A91 P9KD Ireland This leaflet was last revised in 12/2024.
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Frequently asked questions about Galafold 123 mg hard capsules
How do I take Galafold 123 mg hard capsules?
Galafold 123 mg hard capsules comes as capsule containing 123mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Galafold 123 mg hard capsules?
The active substance in Galafold 123 mg hard capsules is migalastat hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Galafold 123 mg hard capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Galafold 123 mg hard capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: migalastat hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Galafold is indicated for long-term treatment of adults and adolescents aged 12 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).
4.2. Posology and method of administration
Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4).
Posology
The recommended dosage regimen is 123 mg migalastat (1 capsule) once every other day at the same time of day.
Missed dose
Galafold should not be taken on 2 consecutive days. If a dose is missed entirely for the day, the patient should take the missed dose of Galafold only if it is within 12 hours of the normal time the dose is taken. If more than 12 hours has passed the patient should resume taking Galafold at the next planned dosing day and time according to the every other day dosing schedule.
Special populations
Elderly population
No dosage adjustment is required based on age (see section 5.2).
Renal impairment
Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m2 (see section 5.2).
Hepatic impairment
No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Paediatric population
Adolescents aged 12 to <18 years and weighing ≥45 kg
123 mg migalastat (1 capsule) taken once every other day at the same time of the day (see section 5.2).
Children <12 years
The safety and efficacy of Galafold in children aged less than 12 years have not yet been established. No data are available.
Method of administration
For oral use.
Galafold exposure is decreased by approximately 40% when taken with food and 60% when taken with coffee (see sections 4.5 and 5.2). Food and caffeine should not be consumed at least 2 hours before and 2 hours after taking Galafold to give a minimum 4 hours fast (see section 4.5).
Water (plain, flavored, sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the 4-hour fasting period.
Galafold should be taken every other day at the same time of day to ensure optimal benefits to the patient.
Capsules must be swallowed whole. The capsules must not be cut, crushed, or chewed.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to migalastat. In case of meaningful clinical deterioration, further clinical evaluation or discontinuation of treatment with Galafold should be considered.
Galafold is not indicated for use in patients with non-amenable mutations (see section 5.1).
No reduction in proteinuria was observed in patients treated with Galafold.
Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m2 (see section 5.2).
Limited data suggest that co-administration of a single dose of migalastat and a standard enzyme replacement therapy infusion results in an increased exposure to agalsidase of up to 5-fold. This study also indicated that agalsidase has no effect on the pharmacokinetics of migalastat. Galafold is not intended for concomitant use with enzyme replacement therapy.
Paediatric population
123 mg migalastat capsules are not for children (≥12 years) weighing less than 45 kg, (see section 5.2).
4.5. Interaction with other medicinal products and other forms of interaction
Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4. Furthermore, migalastat is not an inhibitor or a substrate of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5. Migalastat is not a substrate for MDR1 or BCRP, nor is it an inhibitor of BCRP, MDR1, or BSEP human efflux transporters. In addition, migalastat is not a substrate for MATE1, MATE2-K, OAT1, OAT3, or OCT2, nor is it an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2-K human uptake transporters.
Effect of other drugs on migalastat
Co-administration of migalastat with caffeine decreases migalastat systemic exposure (AUC and Cmax) which may reduce Galafold efficacy (see section 5.2). Avoid co‑administration of Galafold with caffeine at least 2 hours before and 2 hours after taking Galafold (see section 4.2).
4.6. Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
Galafold is not recommended in women of childbearing potential not using contraception.
Pregnancy
There are limited data from the use of Galafold in pregnant women. In rabbits, developmental toxicity was observed only at maternally toxic doses (see section 5.3). Galafold is not recommended during pregnancy.
Breast-feeding
It is not known whether Galafold 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 Galafold, taking into account the benefit of breast-feeding for the child relative to the benefit of therapy for the mother.
Fertility
The effects of Galafold 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 (see section 5.3). Migalastat did not affect fertility in female rats.
4.7. Effects on ability to drive and use machines
Galafold has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold.
Tabulated list of adverse reactions
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.
Table 1: Adverse reactions with Galafold
System organ class
Frequency
Adverse reaction (preferred term)
Psychiatric disorders
Common
Depression
Nervous system disorders
Very common
Headache
Common
Paraesthesia, dizziness, hypoaesthesia
Ear and labyrinth disorders
Common
Vertigo
Cardiac disorders
Common
Palpitations
Respiratory, thoracic, and mediastinal disorders
Common
Dyspnoea, epistaxis
Gastrointestinal disorders
Common
Diarrhoea, nausea, abdominal pain, constipation, dry mouth, defaecation urgency, dyspepsia
Skin and subcutaneous tissue disorders
Common
Rash, pruritus
Uncommon
Angioedema*
Musculoskeletal and connective tissue disorders
Common
Muscle spasms, myalgia, torticollis, pain in extremity
Renal and urinary disorders
Common
Proteinuria
General disorders and administration site conditions
Common
Fatigue, pain
Investigations
Common
Blood creatine phosphokinase increased, weight increased
* Reported from post-marketing data
Adolescent population
The safety assessment in 21 adolescents (12 to <18 years of age and weighing ≥45 kg) is based on 1-year safety data from the open label AT1001-020 study in which subjects received the same dosage regimen as adults (see section 5.2). No age‑specific differences in adverse reactions were observed between adolescent and adult subjects. The frequency, type and severity of adverse reactions in adolescents are expected to be the same as in adults based on these data.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In case of overdose, general medical care is recommended. Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- GALAFOLD 123 mg prescriptionMIGALASTATUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- GalafoldMigalastatum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Galafold 123 mg hard capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.