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Fabagal®Injection

Agalsidase beta for Injection

Classification
Prescription medicine > Orphan drug
Therapeutic Area
Fabry Disease
Active Substance
Agalsidase beta
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Product Appearance
White to off-white lyophilized cake or powder in colorless and transparent vial; after reconstitution, each vial will yield a clear and colorless solution
Quantitative Composition
(per 1 vial)
Purpose Ingredient Quantity
Active ingredient Agalsidase beta (In house) 37 mg
Stabilizer D-Mannitol (USP) 222 mg
Buffer Sodium phosphate Monobasic dihydrate (USP) 23.09 mg
Sodium phosphate Dibasic dihydrate (USP) 39.52 mg
Indications and Usage
Fabagal (agalsidase beta) is indicated for long-term enzyme replacement therapy in patients with a confimed diagnosis of Fabry disease (a-galactosidase A deficiency).
Dosage and Administration
The recommended dosage of Fabagal (agalsidase beta) is 1 mg/kg body weight infused every two weeks as an intravenous (IV) infusion. Patients should receive antipyretics prior to infusion.
The initial IV infusion rate is no more than 0.25 mg/min (15 mg/hr). The infusion rate may be slowed in the event of infusion reactions. After patient tolerance to the infusion is well established, the infusion rate may be increased in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hr) with each subsequent infusion. For patients weighing < 30 kg, the maximum infusion rate should remain at 0.25 mg/min (15 mg/hr). For patients weighing > 30 kg, the administration duration should not be less than 1.5 hours (based on individual patient tolerability).
Patients who have had a positive skin test to agalsidase beta or who have tested positive for anti-agalsidase beta IgE may be successfully rechallenged with Fabagal. The initial rechallenge administration should be a low dose at a lower infusion rate, (e.g., 1/2 of the therapeutic dose (0.5 mg/kg) at 1/25 of the initial standard recommended rate (0.01 mg/min). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/min), as tolerated.
Storage Condition
Sealed container, refrigeration (2~8°C)
Package Unit
1 vial (35mg)/box
Reporting Adverse Events
If you have experienced an adverse event or adverse drug reaction from Fabagal®, please call at 82-31-696-4631(Korea only) or send an email to safety.isuabxis@isu.co.kr.

*The information provided in this product page of ISU ABXIS’s corporate website is for general information purposes only and does not constitute product advertising or medical advice. The material contained herein is not intended to be a source of prevention, diagnosis, and treatment without consulting healthcare professionals. Please discuss it with your doctor for any medical advice and medication guide for the product.