Patient Medication Information: uses, side effects, how to take - Replagal
What is REPLAGAL used for?
REPLAGAL is used to treat patients with a confirmed diagnosis of Fabry Disease.
For the following indication REPLAGAL has been approved with conditions (NOC/c). This means it has passed Health Canada’s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional. REPLAGAL (agalsidase alfa) is indicated for:
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What is a Notice of Compliance with Conditions (NOC/c)?
A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada.
Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments.
Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug’s performance after it has been sold, and to report their findings to Health Canada.
How does REPLAGAL work?
REPLAGAL is a long-term enzyme replacement therapy when the level of enzyme in the body is absent or lower than normal as in Fabry Disease.
What are the ingredients in REPLAGAL?
Medicinal ingredients: agalsidase alfa
Non-medicinal ingredients: polysorbate 20, sodium chloride, sodium hydroxide, sodium phosphate monobasic monohydrate, and water for injection.
REPLAGAL comes in the following dosage forms:
1 mg/mL concentrate for solution for injection.
Do not use REPLAGAL if:
- you are allergic (hypersensitive) to agalsidase alfa, the medicinal ingredient, or to any of the other ingredients in REPLAGAL or its container
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take REPLAGAL. Talk about any health conditions or problems you may have, including if:
you experience any of the following during infusion with REPLAGAL:
- High fever, chills, sweating, fast heart rate
- Nausea or are vomiting
- Headaches, feel light-headedness or fatigue
- Hives
Swelling in your hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing
Your doctor/nurse may stop the infusion temporarily (5 – 10 minutes) until the symptoms go away and then begin the infusion again.
Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time you can still be given REPLAGAL even if these symptoms occur.
- you experience a severe allergic (anaphylactic-type) reaction. The administration of REPLAGAL will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor.
- treatment with REPLAGAL makes your body produce antibodies.
- you have advanced renal disease.
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 REPLAGAL:
- Chloroquine
- Amiodarone
- Benoquin
- Gentamicin
How to take REPLAGAL:
REPLAGAL treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic disease. Infusion of REPLAGAL at home may be considered for patients who are tolerating their infusions well.
REPLAGAL has to be diluted in 9 mg/mL (0.9%) sodium chloride solution before use. After dilution, REPLAGAL is given in a vein. This will usually be in your arm. The infusion will be given every 2 weeks. Each time you are treated, it will take 40 minutes for REPLAGAL to be given to you in a vein. Do not use REPLAGAL if you notice that there is discoloration or other foreign particles present.
Usual dose:
Adults: The dose is an intravenous infusion (in a vein) of 0.2 mg for every kg you weigh over 40 minutes. This would be about 14 mg or four 5 mL vials (glass bottles) of REPLAGAL for an average size (70 kg) individual. The intravenous infusion will be given every 2 weeks.
Children and adolescents: For children and adolescents 7-18 years old, a dose of 0.2 mg/kg every 2 weeks may be used.
Overdose:
There is no experience of overdose with REPLAGAL.
| If you think you, or a person you are caring for, have taken too much REPLAGAL, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using REPLAGAL?
These are not all the possible side effects you may have when taking REPLAGAL. If you experience any side effects not listed here, tell your healthcare professional.
Most common side effects with REPLAGAL include headache, pain in limb, dizziness, back pain, fatigue, tingling, sore throat, chills, pain, swelling of the hands or feet, muscle pain, worsened fatigue, rash, ringing in ears, flushing, and worsened ringing in the ears.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop running infusion and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Abdominal pain | √ | ||
| Arthralgia: joint pain | √ | ||
| Asthenia: weakness | √ | ||
| Chest pain | √ | √ | |
| Cough | √ | ||
| Diarrhea | √ | ||
| Dyspnea: trouble breathing | √ | √ | |
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop running infusion and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Hypoesthesia: loss of sensation | √ | ||
| Nasopharyngitis: sore nose or throat | √ | ||
| Nausea | √ | ||
| Neuropathic pain: burning or shooting pain | √ | ||
| Palpitations: pounding or irregular heartbeat | √ | √ | |
| Pyrexia: fever | √ | ||
| Tremor | √ | ||
| Vomiting | √ | ||
| COMMON | |||
| Abdominal discomfort | √ | ||
| Atrial fibrillation: fast and irregular heartbeats | √ | √ | |
| Chest or throat tightness | √ | √ | |
| Erythema: reddening of the skin | √ | ||
| Hypersensitivity | √ | ||
| Hypertension | √ | ||
| Malaise: uneasiness | √ | ||
| Tachycardia: abnormally fast heart rate | √ | √ | |
| UNCOMMON | |||
| Anaphylactic reaction: severe allergic reaction | √ | √ | |
| Tachyarrhythmia: fast heartbeats | √ | √ | |
| NOT KNOWN | |||
| Heart failure (shortness of breath, swelling) | √ | ||
| Myocardial ischemia: heart attack (chest pain, shortness of breath, pain in arm, neck, or jaw) | √ | √ | |
| Ventricular extrasystoles: irregular extra heartbeats | √ | √ | |
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:
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 REPLAGAL in a refrigerator at 2 to 8°C.
Keep out of reach and sight of children.
If you want more information about REPLAGAL:
- 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.takeda.com/en-ca), or by calling 1-800-268-2772.
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Last Revised SEP 28, 2021
REPLAGAL® and the REPLAGAL Logo® are registered trademarks of Shire Human Genetic Therapies, Inc.
TAKEDA™ and the TAKEDA Logo® are trademarks of Takeda Pharmaceutical Company Limited, used under license.