Fabrazyme (Agalsidase Beta-Rch)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Fabrazyme Used For?
Fabrazyme is a specialized medication designed to treat Fabry Disease, a rare genetic condition where the body doesn’t produce enough of a specific enzyme.
Primary Uses
Fabrazyme is used as enzyme replacement therapy specifically for patients with Fabry Disease who do not produce enough of their own α-galactosidase enzyme.
How It Works
Fabrazyme is a recombinant human α-galactosidase enzyme. It works by restoring enzyme activity levels sufficient to remove accumulated substances called glycosphingolipids from cells and tissues, and prevents further accumulation of these substances.
How to Take Fabrazyme
Fabrazyme is given as an intravenous infusion by trained healthcare professionals in a hospital or clinic setting. Your doctor may also approve home treatment if you meet certain criteria.
Dosage Instructions
The recommended dose is 1 mg/kg of body weight given once every two weeks. The infusion is given directly into a vein and may take several hours to complete. Your doctor will determine the exact dose and infusion time that’s right for you.
What If You Miss a Dose?
It’s important to keep all appointments with your treating doctor or clinic to receive Fabrazyme infusions at the appropriate times. This ensures the medicine has the best chance of providing effective treatment for your condition.
Important: Fabrazyme is only used under the supervision of a doctor who is knowledgeable in treating Fabry disease.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Headaches
- Dizziness and lightheadedness
- Sleepiness
- Local reactions at injection site (redness, itchiness, tenderness, pain, warmth, burning, stinging, swelling, hard lumps or scars)
- Runny nose
- Flushing or redness of skin
- Pale skin
- Muscle soreness, aching, tenderness, weakness
- Shaking or pins and needles
- Nausea and vomiting
- Stomach ache
Seek immediate medical attention if you experience:
- Signs of allergic reaction (shortness of breath, wheezing, difficulty breathing)
- Swelling of face, lips, tongue or other body parts
- Skin rash, itching or hives
- Difficulty swallowing
- Changes in heartbeat (increase or decrease)
- Chest pain
Important Warnings
Before starting Fabrazyme treatment, it’s essential to discuss your medical history and any allergies with your healthcare provider.
Who Should Not Take Fabrazyme
You should not receive Fabrazyme if you are allergic to agalsidase-beta, agalsidase, or any of the other ingredients in the medication. Always check the ingredients list to ensure you can safely use this medicine.
Medical Conditions to Discuss
Tell your doctor about any other medical conditions you have and all medicines you are currently taking. Your doctor needs this information to ensure Fabrazyme is safe and appropriate for you.
Pregnancy and Breastfeeding
If you are pregnant or planning to become pregnant, discuss this with your doctor. Fabrazyme should only be used during pregnancy if clearly needed. If you are breastfeeding or plan to breastfeed, talk to your doctor as caution should be exercised since many drugs pass into breast milk.
Children Under 8 Years: Safety in children below 8 years of age has not been studied. If your child has been prescribed Fabrazyme, discuss this with your child’s treating doctor.
Drug Interactions
While no specific studies have been conducted between Fabrazyme and other medicines, some medications may interfere with how Fabrazyme works.
- Tell your doctor about all medicines, vitamins, and supplements you are taking
- Some medicines may affect how well Fabrazyme works
- You may need different amounts of your other medicines
- Your doctor will decide whether adjustments are needed
Alcohol & Driving
Fabrazyme may affect your ability to drive or operate machinery safely due to potential side effects.
Alcohol
No specific alcohol interactions are mentioned in the prescribing information. However, discuss alcohol consumption with your doctor.
Driving and Operating Machinery
Be careful before driving or using machines until you know how Fabrazyme affects you. The medication may cause dizziness, lightheadedness, tiredness, and sleepiness. Children should be careful with activities requiring attention such as riding bicycles or climbing.
Storage
Fabrazyme will be stored in the hospital or clinic pharmacy by healthcare professionals. The medication is used immediately after it has been prepared for infusion, so you don’t need to worry about storing it at home.
Overdose Information
Your treating doctor is trained to calculate the correct dose for you. There have been no reported overdoses of Fabrazyme. If you think you or your child have been given too much Fabrazyme, seek urgent medical attention. In case of emergency, contact the Poisons Information Centre by calling 13 11 26.
Frequently Asked Questions
Fabrazyme is intended to restore enzyme activity levels sufficient to remove accumulated substances and prevent further accumulation. Your doctor will monitor your response to treatment through regular tests.
Yes, your doctor may advise that you can be treated at home provided you meet certain criteria. A Home Infusion Guide for Patients/Carers is available. Please contact your doctor if you would like to be treated at home.
The recommended schedule is once every two weeks. It’s important to keep all appointments to ensure the medicine has the best chance of providing effective treatment.
For less serious side effects like headaches or injection site reactions, speak to your doctor or nurse if they worry you. For serious side effects like allergic reactions, difficulty breathing, or chest pain, tell your doctor or nurse straight away.
Fabrazyme can be used in children, but safety in children below 8 years of age has not been studied. If your child has been prescribed Fabrazyme, discuss this with your child’s treating doctor.
Fabrazyme is given directly into a vein by a trained healthcare professional in a hospital or clinic. The infusion may take several hours to complete, and your doctor will determine the exact time needed.
Yes, your treating doctor may wish to test your body’s response to Fabrazyme to make sure it is working effectively. Have any tests when your treating doctor recommends them.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.