Patient leaflet - Galafold 123 mg hard capsules
1. What Galafold is and what it is
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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 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.
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;
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Driving and using machines
It is unlikely that this medicine will affect your ability to drive and use machines.
3. How to take 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.
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.
Step 1: Remove the adhesive seal holding the cover.
Lift the cover of your Galafold carton (see Figure A).
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.
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 A
Figure C
Figure B - Opened carton
Step 4: Unfold the blister card
(see Figure D).
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
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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).
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.
Step 7: REMOVE the oval perforated cardboard (see Figure H).
Note: After removing the cardboard, the white backing of the foil
Figure D - Front of the blister card
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Day
Figure F - Front of the blister card y 8 Day 10
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Figure H - Back of the blister card
Figure G - Back of the 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 your doctor. 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 if it 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
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
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.
- 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 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. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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 (6.4x18.0 mm) containing white to pale brown powder. Galafold is available in a blister pack containing 14 capsules.
PX3971
271-01