Agalsidase beta

Generic name: Agalsidase Beta
Brand names: Fabrazyme
Dosage form: intravenous powder for injection (35 mg; 5 mg)
Drug class: Lysosomal enzymes

Usage of Agalsidase beta

Agalsidase beta is used in the treatment of Fabry disease (a deficiency of alpha-galactosidase A enzyme) in adults and children at least 2 years old.

Agalsidase beta may also be used for purposes other than those listed here.

Agalsidase beta side effects

Get emergency medical help if you have signs of an allergic reaction:

wheezing, chest tightness, trouble breathing, feeling light-headed;

skin rash, hives, flushing (warmth, redness, or tingly feeling);

trouble swallowing; or

swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you have any of these signs of an infusion reaction:

chest pain, tightness in your throat, fast or slow heartbeats, pounding in your neck or ears;

shortness of breath, stuffy nose, feeling hot or cold;

tiredness, drowsiness, dizziness, feeling like you might pass out;

rash, itching, numbness or tingling;

nausea, vomiting, stomach pain, diarrhea; or

headache, muscle pain, swelling in your hands or feet.

Common side effects of agalsidase beta may include:

fever, chills, cough;

dizziness;

swelling in your hands or feet;

numbness or tingling;

feeling tired;

rash; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Agalsidase beta

Tell your doctor if you have ever had:

heart problems; or

an allergic reaction to agalsidase beta or have antibodies to the medication.

Tell your doctor if you are pregnant or breastfeeding.

Your name may be listed on a Fabry disease patient registry. This is to track the progress of your disease and to evaluate the treatment effects of agalsidase beta. Taking part in this registry is especially important if you are pregnant or breast-feeding.

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How to use Agalsidase beta

Usual Adult Dose for Fabry Disease:

1 mg/kg via IV infusion every 2 weeksINFUSION RATE: Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr); once tolerance to the infusion is well established, may increase infusion rate in increments of 0.05 to 0.08 mg/min with each subsequent infusionMaximum infusion rate (weight less than 30 kg): 0.25 mg/minuteMinimum infusion duration (weight 30 kg or greater): 1.5 hours (based on individual patient tolerability) Comments:-Antipyretics are recommended prior to infusions; anti-histamines should also be given in patients who have had an infusion-associated reaction.-For patients who have had a positive skin test, see dose adjustment section for rechallenge administration. Use: For treatment of patients with confirmed Fabry disease.

Usual Pediatric Dose for Fabry Disease:

2 years or older: 1 mg/kg via IV infusion every 2 weeksINFUSION RATE: Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr); once tolerance to the infusion is well established, may increase infusion rate in increments of 0.05 to 0.08 mg/min with each subsequent infusionMaximum infusion rate (weight less than 30 kg): 0.25 mg/minuteMinimum infusion duration (weight 30 kg or greater): 1.5 hours (based on individual patient tolerability) Comments:-Antipyretics are recommended prior to infusions; anti-histamines should also be given in patients who have had an infusion-associated reaction. -For patients who have had a positive skin test, see dose adjustment section for rechallenge administration. Use: For treatment of patients 2 years or older with confirmed Fabry disease.

Warnings

Many people have a severe reaction to agalsidase beta. Tell your caregiver if you have a skin rash or hives, fever, chills, headache, muscle pain, dizziness, numbness, swelling, vomiting, diarrhea, chest pain, trouble swallowing or breathing, fast or slow heart rate, or severe dizziness.

What other drugs will affect Agalsidase beta

Other drugs may affect agalsidase beta, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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