Patient Medication Information: uses, side effects, how to take - Galafold
What is Galafold used for?
Galafold 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) in an enzyme called alpha-galactosidase A (α-Gal A). Galafold is not to be used in patients with Fabry disease who have other genetic mutations. Your doctor will perform a genetic test to determine if you can take Galafold.
Galafold is NOT for use in children younger than 12 years of age or in adolescents weighing less than 45 kg.
How does Galafold work?
Fabry disease is caused by a defect in the α–Gal A enzyme. This 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.
Galafold works by fixing a defect in the α–Gal A enzyme so that it can work better to reduce the amount of GL-3 that has built up in your cells and tissues. This helps the organs affected by Fabry disease work better.
What are the ingredients in Galafold?
Medicinal ingredients: migalastat hydrochloride
Non-medicinal ingredients: black printing ink, gelatin, indigo carmine (FD&C Blue 2), magnesium stearate, pregelatinized starch (maize), and titanium dioxide.
Galafold comes in the following dosage forms:
Capsule: 123 mg migalastat (as migalastat hydrochloride)
Do not use Galafold if:
- you are allergic to migalastat or any of the other ingredients in Galafold
- you are allergic to any component of the Galafold container
- you are also receiving another medicine used to treat Fabry disease called Enzyme Replacement Therapy (ERT)
- you have severe kidney problems
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Galafold. Talk about any health conditions or problems you may have, including if you:
- have problems with your kidneys
- have problems with your liver
- or your partner are planning a pregnancy
Other warnings you should know about:
Pregnancy: Do not take Galafold if you are pregnant. Galafold may harm an unborn baby. You must tell your healthcare professional if you are or think you may be pregnant before taking Galafold. You must use an effective birth control method while taking Galafold. Talk to your healthcare professional for advice on effective methods of birth control.
- Breast-feeding: You should not breastfeed if you are taking Galafold since it may get into your breast milk and harm your baby. Talk to your healthcare professional if you are planning on breastfeeding in the future.
- Fertility: It is not known if Galafold affects fertility in men and women. Talk to your healthcare professional if you and your partner are planning to have a baby in the future.
- Testing: Before you start taking Galafold your healthcare professional will do tests to check how well your kidneys work. You will also have tests done during your treatment with Galafold to check how Galafold is affecting your blood, kidneys and heart. These tests will be done at least every 6 months, possibly more often.
Driving and using machines: Before doing tasks which require special attention, wait until you know how you respond to Galafold.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Galafold:
- Other medicines used to treat Fabry disease called enzyme replacement therapy (ERT) like agalsidase.
- Caffeine. This includes medicines, supplements or any other products containing caffeine.
How to take Galafold:
- Take one capsule every other day at the same time of the day.
- Do not take Galafold two days in a row.
Take Galafold on an empty stomach. Your body may not absorb the medicine completely if it is taken with food. Do not consume food or caffeine for at least 2 hours before and for 2 hours after you take Galafold. This will give you a period of at least 4 hours of fasting.
- You can drink water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages during this 4-hour fasting period.
- Swallow the capsule whole. Do not cut, crush or chew the capsule.
- Do not stop taking this medicine without talking to your doctor.
- Galafold will be given to you by a healthcare professional who has experience in the diagnosis and treatment of Fabry disease.
- Always take Galafold exactly as your healthcare professional has told you.
- If you are not sure how to take Galafold, talk to your healthcare professional.
How to remove a 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. Using your thumb, press and hold down the purple tab. The tab is at the left side of the carton (See Figure B). 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). |
Your Galafold is packaged in a blister card. Each Galafold blister card has 14 capsules and 14 white cardboard circles. Each blister card is for 28 days. The white cardboard circles are to remind you to take Galafold every other day. Capsules and white cardboard circles for days 1 to 14 of the cycle are on the left side of the blister card. After day 14, follow the arrow to the capsules and cardboard circles for days 15 to 28 of the cycle. These are on the right side of the blister card (See Figure E). Figure E – Front of the blister card  | |
Figure F – Front of the blister card  | Step 5. On your first day of taking Galafold from a new blister card, write the date on the blister card (See Figure F). There is a spot for the date labelled “Starting date:”. |
Figure G – Back of the blister card  | Step 6. Turn the blister card over to show the back side of the card. Find the capsule to remove. Bend the blister card as shown (See Figure G). This will help to raise the oval perforations. |
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. This is ok. |
Figure I – Front of the blister card  | Step 8. Turn the blister card over to show the front side of the blister 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 to remove it (See Figure J). Note: Removing this circle will help you remember which day you do not take Galafold. Take 1 Galafold capsule every other day. Close package and store after each use. |
After Day 2, move to Day 3 and so on through all 28 days on the blister card. Alternate between taking the capsule and pushing out the perforated white cardboard circles for each day of the cycle, up to and including day 28. See Figure K. Figure K – Front of the unfolded blister card. | |
Usual dose:
Adults and adolescents (12 years or older and weigh 45 kg or more):
One 123 mg capsule every other day
Overdose:
If you think you, or a person you are caring for, have taken too much Galafold, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
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Missed Dose:
If you forget to take your capsule, and it is less than 12 hours from when you should have taken it:
- Take the capsule as soon as you remember.
If you forget to take your capsule, and it is more than 12 hours from when you should have taken it:
- Do not take the missed capsule.
- Wait and take a capsule on the day when you would usually take this medicine.
- Never take Galafold two days in a row.
- Never take two capsules to make up for a missed dose.
What are possible side effects from using Galafold?
These are not all the possible side effects you may feel when taking Galafold. If you experience any side effects not listed here, contact your healthcare professional.
- headache, migraine (intense headaches, usually on one side of the head)
- abdominal pain or discomfort, including upper abdominal pain
- back pain
- flank pain (pain in the side)
- joint pain
- muscle pain in the chest
- muscle pain, twitching, spasms or weakness
- painful and twisted neck
- pain in arms or legs
- itching of the eye
- change in vision
- dizziness or a sensation of spinning
- sleep disorder, including somnolence (sleepiness or drowsiness) and insomnia (difficulty falling asleep or staying asleep)
- tremor (unintentional trembling or shaking movements)
- memory problems
- feeling aggressive or impatient
- increased or decreased sense of touch or sensation
- increase or decrease in appetite
- change in typical or normal bowel movements
- constipation
- sudden urge to pass stools or inability to control bowel movements
- indigestion
- nausea and vomiting
- increase or decrease in weight
- dry mouth
- excessive sweating
- night sweats (excessive sweating during the night)
- feeling hot
- feeling tired
- fever
- flu-like feeling (body aches, feeling tired, fever)
- frequent urination
- local swelling
- inflammation (pain, redness and swelling)
- swelling at the front of the neck from an enlarged thyroid gland (goitre)
- dryness in areas that are usually moist such as the mouth, throat or vagina
- itching
- skin rash, redness or changes in the pigmentation of the skin
- hair loss
- nosebleed
- runny nose
- sneezing
- cough
- inflammation of nose and back of the throat (nasopharyngitis)
Galafold may cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Ataxia (lack of muscle coordination): difficulty walking or difficulty with fine motor tasks, lack of coordination | ✓ | ||
| Atrial fibrillation (abnormal heart rhythm which is rapid and irregular): occasional chest pain, heart palpitations, fainting, lightheadedness, rapid heartbeat, shortness of breath | ✓ | ||
| Bile duct stone, biliary dilation (presence of a gallstone in the bile duct, widening of the bile duct): sudden severe pain on the upper right side of the abdomen, fever or chills, jaundice (yellowing of the eyes or skin), dark urine, itching, light-colored stools, nausea and vomiting | ✓ | ||
| Blood in stools | ✓ | ||
| Chest discomfort | ✓ | ||
| Depression | ✓ | ||
| Diarrhea: loose or watery stools | ✓ | ||
| Difficult or labored breathing | ✓ | ||
| Hypertension (high blood pressure): headaches, vision changes, nausea and vomiting | ✓ | ||
| Hypoglycemia (low blood sugar): change in mood or vision, feeling faint or fainting, headache, hunger, rapid heartbeat, shaking, sweating | ✓ | ||
| Irritable bowel syndrome (bouts of pain or cramping of stomach, bloating, diarrhea and/or constipation): swelling, excessive gas | ✓ | ||
| Movement disorders: involuntary muscle movements, lack of coordination, tremor | ✓ | ||
| Myocardial ischemia (lack of blood flow to the heart which can lead to heart attack): sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, sudden heavy sweating | ✓ | ||
| Palpitations: awareness of heartbeat, fluttering of heart, rapid or strong heartbeats | ✓ | ||
| Paresthesia (tingling in extremities): feeling of tingling or pins and needles in hands or feet | ✓ | ||
| Neuralgia (pain that follows the path of the nerve): sudden attacks of severe sharp shooting pain | ✓ | ||
| Peripheral edema (buildup of fluid in the arms / legs which causes the affected tissue to become swollen and stiff, and may cause weight gain) | ✓ | ||
| Proteinuria (protein in the urine): cloudiness of the urine, foaming of the urine, and in severe cases swelling of the feet and legs and weight gain | ✓ | ||
| Psoriasis (chronic skin disease): red, itchy, scaly patches of the skin | ✓ | ||
| Urinary tract infection: difficulty or increased need to urinate, pain or burning sensation when passing urine, pain in the pelvis or mid-back, urine that appears cloudy | ✓ | ||
| UNCOMMON | |||
| Balance problems | ✓ | ||
| Liver injury (damage to the liver): abdominal pain, dark urine, fatigue, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice) | ✓ | ||
| UNKNOWN FREQUENCY | |||
| Angioedema (sudden swelling of skin or mucous membrane [e.g. lip, tongue, eye, etc.]) difficulty breathing; swollen face, hands and feet, genitals, tongue, or throat; swelling of the digestive tract causing diarrhea, nausea or vomiting | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store between 15°C and 30°C in the original package to protect from moisture.
- Keep out of reach and sight 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.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away unused capsules.
If you want more information about Galafold:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website: www.almacgroup.com, or by calling + 44 (0) 28 3833 2200
Amicus Therapeutics Canada Inc.
100 King Street West, Suite 1600
1 First Canadian Place
Toronto ON M5X 1G5
Canada