FABRAZYME Agalsidase Beta 35mg Injection

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DESCRIPTION

Fabrazyme (Agalsidase beta) 35mg  is the first specific  drug used to treat  Fabry disease, an inherited and often life-threatening disorder characterized by the progressive build-up of a substance known as GL-3 within the cells. Fabrazyme works as an enzyme replacement therapy (ERT),which replaces the enzyme responsible for lowering GL-3 that is missing or deficient in people with Fabry disease.

Manufacturer :  Sanofi Genzyme

ADDITIONAL INFORMATION

Strengths available :  35mg

Form :  Injection

Storage :  Store at temperature between 2°C – 8°C

FDA Approval : US FDA Approved

Date of Approval : April 24, 2003

Dosage :

The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous (IV) infusion.

The initial IV infusion rate should be 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 Fabrazyme or who have tested positive for anti-Fabrazyme IgE may besuccessfully re-challenged with Fabrazyme. The initial re-challenge administration should be a low dose at a lower infusion rate, e.g., 1/2 the therapeutic dose (0.5 mg/kg) at 1/25 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 of0.25 mg/min), as tolerated

SIDE EFFECTS

More common side effects are Blurred vision, chest pain or discomfort, confusion, cough, producing mucus, difficulty breathing, difficulty in moving, dizziness, fatigue, faintness or lightheadedness when getting up from a lying or sitting position suddenly, feeling unusually cold shivering, headache, hives or welts, irregular heartbeat, itching, joint pain, muscle aching or cramping, muscle pains or stiffness, nervousness, pain, pounding in the ears, redness of skin, shortness of breath, skin rash, stomach pain, sweating , swelling of ankles, feet, and lower legs, swollen joints, tightness in chest, unusual tiredness or weakness, wheezing.

PACK SIZE

Pack of 1 Vial

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