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REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Replagal 1 mg/ml concentrate for solution for infusion

Agalsidase alfa

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

  1. What is Replagal and what is it used for
  2. What you need to know before you are given Replagal
  3. How Replagal is given
  4. Possible side effects
  5. Storage of Replagal
  6. Contents of the pack and further information

1. What is Replagal and what is it used for

The active substance of Replagal is agalsidase alfa (1 mg/ml). Agalsidase alfa is a form of the human enzyme α-galactosidase. It is produced by activating the α-galactosidase A gene in cells. The enzyme is then removed from the cells and converted into a sterile concentrate for solution for infusion.

Replagal is used to treat adult patients, as well as adolescents and children from 7 years of age, with a confirmed diagnosis of Fabry disease. It is used as long-term enzyme replacement therapy when the level of enzymes in the body is absent or lower than normal, as occurs in Fabry disease.

After 6 months of treatment, Replagal significantly reduced pain in patients compared to patients treated with placebo (inactive medicine). Replagal reduced left ventricular mass in treated patients compared to patients treated with placebo. These results suggest that the symptoms of the disease are improving or that the disease is stabilizing.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Replagal

You should not be given Replagal

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

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Replagal.

If you notice any of these effects during or after an infusion, you should tell your doctor immediately:

  • high fever, chills, sweating, rapid heartbeat
  • vomiting
  • dizziness
  • hives (urticaria)
  • swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing.

Your doctor may temporarily stop the infusion (5-10 minutes) until the symptoms disappear and then restart the infusion. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time, you can still receive Replagal even if these symptoms occur.

If you have a severe allergic reaction (anaphylactic type), the administration of Replagal will be stopped immediately and your doctor will have to start appropriate treatment.

If your body produces antibodies due to treatment with Replagal, this will not make Replagal less effective and the antibodies may disappear over time.

If you have advanced kidney disease, you may find that your treatment with Replagal has a limited effect on your kidneys. Talk to your doctor or pharmacist before you start taking Replagal.

Children

Experience in children from 0 to 6 years is limited, and therefore, no dose can be recommended for this age group.

Using Replagal with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are using any medicine that contains chloroquine, amiodarone, benoquin, or gentamicin. There is a theoretical risk of decreased agalsidase alfa activity.

Pregnancy and breastfeeding

The limited clinical data available on exposure to Replagal during pregnancy do not indicate any adverse effects on the mother or the newborn.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines while you are receiving Replagal.

3. How Replagal is given

This medicine should be administered and supervised by trained personnel who will also calculate the dose to be administered to you.

The recommended dose is an infusion of 0.2 mg per kilogram of body weight. This corresponds to approximately 14 mg or 4 vials (glass bottles) of Replagal for a person weighing about 70 kg.

Use in children and adolescents

For children and adolescents from 7 to 18 years of age, a dose of 0.2 mg/kg every two weeks can be used.

Children and adolescents may be more likely than adults to experience an infusion-related reaction. Talk to your doctor if you experience any side effects during the infusion.

Method of administration

Replagal must be diluted in a 9 mg/ml sodium chloride solution (0.9%) before administration.

After dilution, Replagal is administered through a vein, usually in the arm.

The infusion will be given every two weeks.

Each time you receive treatment, it will take 40 minutes to administer Replagal through the vein. The treatment will be supervised by a doctor specializing in the treatment of Fabry disease.

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

Medicine questions

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience a severe allergic reaction (anaphylactic type), the administration of Replagal will be stopped immediately and your doctor will have to start appropriate treatment.

Most of them are mild or moderate. Approximately 1 in 7 patients (very common reaction) may have a reaction during or after the infusion of Replagal (infusion-related reaction). These reactions include chills, headache, nausea, fever, flushing, fatigue, low blood pressure, instability, sweating, difficulty breathing, itching, tremors, cough, and vomiting. However, some side effects can be serious and may require treatment. Infusion-related reactions affecting the heart, including heart rhythm problems, myocardial ischemia, and heart failure, may occur in patients with Fabry disease affecting the heart (frequency not known). Your doctor may temporarily stop the infusion (5-10 minutes) until the symptoms disappear and then restart the infusion. Your doctor may also treat the symptoms with other medicines (antihistamines or corticosteroids). Most of the time, you can still receive Replagal even if these symptoms occur.

List of other side effects:

Very common: may affect more than 1 in 10 people

  • general pain or discomfort

Common: may affect up to 1 in 10 people

  • tingling, numbness, or pain in fingers or toes, changes in taste, eye watering, abnormal eyelid reflex, ringing in the ears, muscle twitching, prolonged sleep
  • palpitations, increased heart rate, increased blood pressure
  • cough, chest pain or tightness, hoarseness, throat pain or tightness, sticky secretions in the throat, nasal secretions, cold symptoms
  • vomiting, abdominal pain or discomfort, diarrhea
  • acne, redness, itching, or rash on the skin, rash at the infusion site
  • back pain or discomfort, muscle pain, joint pain, bone and muscle discomfort, swelling of the limbs or joints
  • feeling of cold or heat, flu-like symptoms, nausea, feeling of lack of energy

Uncommon: may affect up to 1 in 100 people

  • severe allergic reaction (anaphylactic type)

Children and adolescents

The side effects reported in children were, in general, similar to those reported in adults. However, infusion-related reactions (fever, difficulty breathing, chest pain) and worsening of pain occurred more frequently.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Replagal

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 label and carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Do not use Replagal if you notice changes in color or presence of foreign particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Replagal

  • The active substance is agalsidase alfa. Each ml of Replagal contains 1 mg of agalsidase alfa.
  • The other ingredients are: Sodium phosphate monobasic monohydrate

Polysorbate 20

Sodium chloride

Sodium hydroxide

Water for injections

Appearance and pack size of the product

Replagal is a concentrate for solution for infusion. Your medicine is available in vials containing 3.5 mg/3.5 ml of agalsidase alfa. Packs of 1, 4, or 10 vials are available. Not all pack sizes may be marketed.

Marketing authorisation holder

Shire Human Genetic Therapies AB

Vasagatan 7

111 20 Stockholm

Sweden

Tel: +44(0)1256 894 959

E-mail: [email protected]

Manufacturer

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza

50 – 58 Baggot Street Lower

Dublin 2

Ireland

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. It also provides links to other web sites on rare diseases and orphan medicines.

This information is intended only for healthcare professionals:

Instructions for use, handling, and disposal

Treatment with Replagal should be supervised by a doctor experienced in the care of patients with Fabry disease or other inherited metabolic disorders.

Replagal is administered at a dose of 0.2 mg/kg body weight every two weeks, by intravenous infusion over 40 minutes.

  1. Calculate the dose and number of Replagal vials needed.
  2. Dilute the total volume of Replagal concentrate needed in 100 ml of a 9 mg/ml sodium chloride solution for infusion (0.9% w/v). Take precautions to ensure the sterility of the prepared solutions, as Replagal does not contain any preservative or bacteriostatic agent; an aseptic technique should be used. Once diluted, the solution should be gently mixed, without shaking.
  3. The solution should be visually inspected for particulate matter and color changes before administration.
  4. The infusion solution will be administered over 40 minutes, using an intravenous line with an in-line filter. Since there are no preservatives, it is recommended to start administration as soon as possible. However, the chemical and physical stability of the diluted solution has been demonstrated for 24 hours at 25 °C.
  5. Do not use the same intravenous line for the infusion of Replagal and the concomitant infusion of other agents.
  6. For single use. Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

Online doctors for REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Discuss questions about REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Daniel Cichi

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Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Dr. Rita Isabel Calero Garcia is a physician with extensive experience in emergency medical care, general medicine, and healthcare assistance in various clinical and out-of-hospital settings.

She currently works as a physician at the Canary Islands Emergency Service (Servicio de Urgencias Canario – SUC), where she is responsible for the assessment and care of patients in medical emergency situations, performing the initial diagnosis, patient stabilization, and coordination with hospital services when necessary.

She has also developed her professional activity within the Primary Care Management Service, providing consultations in general medicine. In this setting she is responsible for patient follow-up, management of acute and chronic conditions, as well as health promotion and disease prevention.

She has also worked as a physician in a mobile ICU unit, providing medical assistance in out-of-hospital emergencies, treating critical patients and participating in medicalized patient transport.

In addition, she has collaborated with the Red Cross, participating in healthcare support units, providing medical assistance at events and supporting emergency interventions.

Furthermore, she has provided medical services in the private sector with Salvaser, conducting clinical assessments of patients and providing healthcare services within private medical services.

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Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

Throughout his career, he has participated in various medical and academic projects, including a research fellowship in Spain, where he contributed to evidence-based studies in the field of family medicine. This experience allowed him to broaden his global perspective on healthcare and comprehensive patient care.

Dr. Correa Bellido has worked with several healthcare providers in Spain, focusing particularly on patient-centered care and public health initiatives aimed at communities with limited access to healthcare services.

In addition, he actively participates in international medical conferences and workshops, which allows him to stay up to date with the latest medical advances and collaborate with healthcare professionals from different countries.

Dr. Correa Bellido provides comprehensive care for a wide variety of medical conditions, including:

  • respiratory infections
  • gastrointestinal disorders
  • cardiovascular problems
  • endocrine and metabolic diseases
  • musculoskeletal and dermatological conditions
  • as well as mental health conditions such as anxiety and depression.

He also treats infectious and allergic diseases, general health concerns, and provides guidance on prevention and healthy lifestyle habits.

His services include virtual consultations, diagnosis and management of acute and chronic diseases, prescription renewals, and personalized medical advice.

With a patient-centered approach and a strong commitment to continuous learning, Dr. Correa Bellido provides accessible and high-quality healthcare to patients both in Spain and around the world.

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Antonio Cayatte

General medicine 44 years exp.

Dr Antonio Cayatte is a physician in General and Acute Medicine with over 30 years of experience across clinical care, medical research, and education. He offers online consultations for adults with a wide range of symptoms, both acute and chronic. His clinical background includes: 

  • assessment of sudden or unclear symptoms
  • ongoing care for chronic conditions
  • follow-up after hospital discharge
  • interpretation of test results
  • medical support while abroad

Dr Cayatte earned his degree from the University of Lisbon and taught internal medicine at Boston University School of Medicine. He holds active medical registrations in both Portugal and the UK and is a Fellow of the American Heart Association. Consultations are available in English and Portuguese. Patients value his clarity, professionalism, and balanced approach to evidence-based care.

Dr. Antonio Cayatte provides comprehensive care for a broad spectrum of common health concerns, including:

  • Respiratory & ENT: acute bronchitis, concerns related to pneumonia, sinusitis, tonsillitis, ear infections, sore throat conditions, and allergic rhinitis
  • Eye Health: allergic and infectious conjunctivitis, as well as red or irritated eyes
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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Sviatoslav Chekhun

Oncology 13 years exp.

Dr. Sviatoslav Chekhun is a medical oncologist with international clinical and research experience, specializing in modern medical oncology and a personalized approach to cancer treatment.

Currently (since 2025), he works as a Medical Oncologist at Institut Català d’Oncologia (Girona, Spain). Previously, he completed his residency in Medical Oncology and was involved in clinical research at Hospital Universitari Germans Trias i Pujol.

Dr. Chekhun has a strong academic and scientific background. He served as a lecturer in Internal Medicine at O.O. Bohomolets National Medical University and conducted research in experimental oncology at the R.E. Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology.

Earlier in his career, he worked as a medical oncologist at the Kyiv City Clinical Oncological Center and contributed to regulatory evaluation of medicinal products at the State Expert Center of the Ministry of Health of Ukraine.

When to consult Dr. Chekhun:

  •  for diagnosis or clarification of a cancer diagnosis
  •  to obtain a second opinion on an existing treatment plan 
  •  when you need a personalized treatment strategy 
  •  for interpretation of test results, CT, MRI, PET-CT, and biopsies 
  •  when choosing between treatment options (chemotherapy, targeted therapy, immunotherapy) 
  •  in case of doubts about treatment strategy or disease progression 

Consultation format

Dr. Chekhun provides online consultations, where you can receive:

  •  expert second opinion 
  •  detailed case review 
  •  recommendations based on current international treatment guidelines 
  •  personalized treatment and follow-up plan 

Important:
Prescription and monitoring of medications must be carried out by your treating physician in an in-person (offline) setting. An online consultation does not replace a face-to-face visit but helps you make more informed decisions about your treatment.

Dr. Sviatoslav Chekhun combines clinical practice, research, and international experience, enabling him to provide patients with modern, evidence-based approaches in oncology.

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Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Frequently Asked Questions

Is a prescription required for REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION?

REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

What is the active substance in REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION?

The active ingredient in REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION is agalsidase alfa. This information helps identify medicines with the same composition but different brand names.

Who manufactures REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION?

REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION is manufactured by Shire Human Genetic Therapies Ab. Pharmacy brands and packaging may differ depending on the distributor.

Which doctors can assess the use of REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION online?

Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

How to buy REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION in Spain?

Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.

You can buy REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.

To obtain a prescription, you can use Oladoctor:

What are the alternatives to REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION?

Other medicines with the same active substance (agalsidase alfa) include REPLAGAL 1 mg/ml CONCENTRATE FOR INFUSION SOLUTION, ALDURAZYME, 100 U/mL Concentrate for Infusion Solution, BRINEURA 150 MG SOLUTION FOR INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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