Fabrazyme (Agalsidase Beta-Rch)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
agalsidase beta-rch
Drug Class
enzyme replacement therapy
Used For
treatment of Fabry Disease
How Taken
intravenous infusion every two weeks

What Is Fabrazyme Used For?

Fabrazyme is a specialized medication designed to treat a rare genetic condition called Fabry Disease.

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.

Good to know: Fabrazyme is administered by trained healthcare professionals in a controlled medical setting to ensure safety and proper monitoring.

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How to Take Fabrazyme

Fabrazyme is given as an intravenous infusion by trained healthcare professionals in a hospital or clinic setting.

Dosage Instructions

The recommended dosage 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 duration that's right for you.

Home Treatment Option

Your doctor may advise that you can receive treatment at home if you meet certain criteria. A Home Infusion Guide for Patients/Carers is available with detailed information about home infusion.

Important: Keep all appointments with your treating doctor or clinic to ensure you receive infusions at the appropriate times for best treatment results.

Available Tablet Strengths

5mg
5mg Tablet White to off-white powder, Vial • 5 mL glass vial
35mg
35mg Tablet White to off-white powder, Vial • 20 mL glass vial

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 important to discuss your medical history and current medications with your doctor.

Who Should Not Take Fabrazyme

You should not receive Fabrazyme if you have ever had an allergic reaction to agalsidase beta or any of the ingredients in the medication.

Medical Conditions to Discuss

Tell your doctor about any other medical conditions you have and all medicines you are taking, including vitamins and supplements bought without a prescription.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your doctor. Fabrazyme should only be used during pregnancy if clearly needed. Caution should be exercised when using Fabrazyme while breastfeeding as many drugs pass into breast milk.

Children Under 8 Years: Safety in children below the age of 8 years 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.

Important: You may need different amounts of your other medicines or different medicines may need to be taken when using Fabrazyme.

  • Tell your doctor about all medicines you are taking
  • Include prescription medications
  • Over-the-counter medicines
  • Vitamins and supplements
  • Herbal products

Alcohol & Driving

Fabrazyme may affect your ability to drive or operate machinery safely.

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 when doing activities requiring attention such as riding bicycles or climbing.

Storage

Fabrazyme will be stored in the hospital or clinic pharmacy and will be used immediately after it has been prepared for infusion. You do not need to worry about storing this medication at home.

Overdose Information

Your treating doctor is trained to calculate the correct dose. 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 if you meet certain criteria. A Home Infusion Guide for Patients/Carers is available with detailed information about home infusion.

The recommended schedule is once every two weeks. It's important to keep all appointments to ensure you receive infusions at the appropriate times for best treatment results.

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 the age of 8 years 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.

Yes, remind any doctor, dentist or pharmacist you visit that you are being treated with Fabrazyme, as this information is important for your overall care.

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.

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