Galafold 123 mg hard capsules: detailed information

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Galafold 123 mg hard capsules

Migalastat

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

What Galafold is and what it is used for
What you need to know before taking Galafold
How to take Galafold
Possible side effects
How to store Galafold
Contents of the pack and other information

1. What Galafold is and what it is used 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 specific genetic mutations (changes in genetic material).

Fabry disease is caused by a deficiency of an enzyme called alpha-galactosidase A (α-Gal A). Depending on the type of mutation (change in genetic material) in the gene that produces α-Gal A, the enzyme may not function properly or may be completely absent. This enzyme deficiency leads to abnormal accumulations of a fatty substance known as globotriaosylceramide (GL-3) in the kidneys, heart, and other organs, causing the symptoms of Fabry disease.

This medicine works by stabilizing the enzyme that the body naturally produces, so that it can function more effectively in reducing the amount of accumulated GL-3 in cells and tissues.

2. What you need to know before taking Galafold

Do not take Galafold:

if you are allergic to migalastat or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The 123 mg capsules of migalastat are not indicated for children (≥12 years) weighing less than
45 kg body weight.

Inform your doctor before taking Galafold if you are receiving enzyme replacement therapy.

You must not take Galafold if you are also receiving enzyme replacement therapy.

While you are taking Galafold, your doctor should assess your condition and whether your medication is working every 6 months. If your condition worsens, your doctor should perform additional tests or discontinue treatment with Galafold.

Consult your doctor before taking Galafold if you have severely reduced kidney function, as Galafold is not recommended in patients with severe renal impairment (with an eGFR below 30 ml/min/1.73 m²).

Children

Children <12 years

This medicine has not been studied in children under 12 years of age. Therefore, safety and efficacy have not been established in this age group.

Other medicines and Galafold

Inform 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, such as supplements or herbal medicines.

Especially inform your doctor if you are taking medicines or supplements containing caffeine, as these may affect the activity of Galafold if taken during the fasting period.

Be aware of the medicines you are taking. Keep a list and show it to your doctor and pharmacist each time you receive a new medicine.

Pregnancy, breastfeeding, and fertility

Pregnancy

There are very limited data regarding the use of this medicine in pregnant women. The use of Galafold during pregnancy is not recommended. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Women who could become pregnant should use an effective method of contraception while taking Galafold.

Breastfeeding

Do not take this medicine if you are breastfeeding until you have consulted your doctor, pharmacist, or nurse. It is not known whether this medicine is excreted in breast milk. Your doctor will decide whether you should discontinue breastfeeding or temporarily stop treatment, taking into account the benefits of breastfeeding for the infant and the benefits of Galafold for the mother.

Fertility in males

It is not known whether this medicine affects male fertility. The effects of Galafold on fertility have not been studied in humans.

Fertility in females

It is not known whether this medicine affects female fertility.

If you are planning to become pregnant, consult your doctor, pharmacist, or nurse.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

3. How to take Galafold

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse.

The recommended dose is one capsule every other day, taken at the same time of day. Do not take Galafold on two consecutive days.

Do not consume any food or caffeine at least 2 hours before and 2 hours after taking the medicine. This minimum 4-hour fasting period around the time of dosing is necessary to ensure complete absorption of the medicine.

During the 4-hour fasting period, you may drink water (plain, flavored, sweetened), pulp-free fruit juices, and non-caffeinated carbonated beverages.

Swallow the capsules whole. Do not split, crush, or chew the capsules.

Figure A

Two hands opening a rectangular drug package showing illustrated instructions and informative text inside

Step 1: Remove the adhesive seal that

keeps the flap closed.

Lift the flap to open the Galafold carton

(see Figure A).

Figure B: Opened carton

Technical drawing showing two hands unfolding a folded leaflet with instructions and small circular schematic diagrams

Step 2: Press the purple tab with your

thumb on the left side of the carton

without releasing it (see Figure B) and proceed to step 3.

Figure C

Technical drawing of two hands holding and opening a rectangular medication package with text and circular informational icons

Step 3: Now GRASP the tab on the right

side, where it says “PULL FROM HERE”, and remove the folded blister

(see Figure C).

Figure D: Front side of the blister

Diagram of a package insert with two rows of small black and white numbered containers and an arrow indicating direction of use

Step 4: Unfold the blister

(see Figure D).

How to take Galafold capsules:

One Galafold blister = 14 hard capsules = 28 days of Galafold treatment and 14 white circles.

The white circles are to remind you to take Galafold every other day.

The arrow indicates to the patient when to start the next two weeks of treatment.

Figure E: Front side of the blister

Therapy calendar diagram with two rows of capsules numbered from day 1 to 28 and circles to mark completed days, with an arrow between day 14 and 15

Figure F: Front side of the blister

Black and white drawing of a hand using a pencil to mark the start date on a medical calendar with days numbered from 1 to 8

Step 5: On the first day you start taking this

medication, mark the date on the new blister

(see Figure F).

Figure G: Back side of the blister

Two hands holding and separating a medication blister pack with rows of circular and oval dotted compartments for pills

Step 6: TURN THE BLISTER OVER to view the

back side.

LOCATE the capsule you wish to remove.

FOLD the blister as shown here (see Figure G).

Note: When folding the blister, the perforated oval will protrude.

A hand gently lifting the edge of an oval-shaped grey tablet or coating against a white background Figure H: Back side of the blister

Step 7: REMOVE the perforated oval A vertical circle formed by a black dashed line on a white background (see

Figure H).

Note: After removing the oval, the white backing layer may still remain. This is correct.

Figure I: Front side of the blister

Illustration of a hand holding a blister pack with capsules arranged by days, labeled in Spanish with days 2, 3, 4, 5, 6, and 7

Step 8: TURN THE BLISTER OVER to view the

front side.

PUSH the capsule out

(see Figure I).

Figure J: Front side of the blister

Technical drawing of a blister pack with white and two-colored pills arranged by days 1 to 6, with fingers indicating the start date

Step 9: The following day, move to the white circle

in the top row marked as

Day 2.

Press the white circle to

perforate it (see Figure J).

Note: Perforating this white circle will help you remember the days on which you should not take the medication.

Take 1 Galafold capsule once every other day.

Close and store the carton after each use.

After Day 2, proceed to Day 3 on the blister.

Alternate the days on which you take the capsule and perforate the white circles, continuing through Day 28, inclusive.

Figure K: Unfolded front side of the blister

Diagram of a medical calendar with grey and white circles above numbered oval cells indicating days 1 to 28

If you take more Galafold than you should

If you take more capsules than you should, stop taking the medicine and consult your doctor. You may experience headache and dizziness.

If you forget to take Galafold

If you forget to take the capsule at the usual time and remember later, you may take the capsule only if it is within 12 hours of the usual time you take your dose. If more than 12 hours have passed, you should resume taking Galafold on the next scheduled day at the usual time, according to the every-other-day dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Galafold

Do not stop treatment without first talking to your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

Headache

Common: may affect up to 1 in 10 people

Palpitations (sensation of strong heartbeat)
Abnormal sensation of movement (vertigo)
Diarrhea
Nausea
Stomach pain
Constipation
Dry mouth
Sudden need to defecate (to go to the bathroom)
Indigestion (dyspepsia)

Feeling tired
High levels of creatine phosphokinase in the blood
Weight gain
Muscle spasms
Muscle pain (myalgia)
Painful neck stiffness (torticollis)
Tingling in the limbs (paresthesia)

Dizziness
Reduced sense of touch (hypoesthesia)
Depression
Protein in the urine (proteinuria)
Shortness of breath (dyspnea)
Nosebleed (epistaxis)
Rash
Persistent itching (pruritus)
Pain

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galafold

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Galafold

The active substance is migalastat. Each capsule contains migalastat hydrochloride equivalent to 123 mg of migalastat.
The other components are:

Capsule contents: pregelatinized starch (corn) and magnesium stearate

Capsule shell: gelatin, titanium dioxide (E171) and indigo carmine (E132)

Printing ink: shellac, black iron oxide and potassium hydroxide

Appearance of Galafold and contents of the pack

Blue and white opaque hard capsules marked with «A1001» in black ink, hard capsule size 2 (6.4 x 18.0 mm) containing a white to light brown powder.

Galafold is available in a 14-capsule blister pack.

Marketing Authorization Holder

Amicus Therapeutics Europe Limited

Block 1, Blanchardstown Corporate Park

Ballycoolin Road

Blanchardstown, Dublin

D15 AKK1

Ireland

Tel: +353 (0) 1 588 0836

Fax: +353 (0) 1 588 6851