What is the difference between Lumizyme and Myozyme?

What is the difference between Lumizyme and Myozyme?

Myozyme is indicated for infantile-onset Pompe disease; Lumizyme is indicated for patients aged ≥8 years. Although both drugs have been shown to improve patient survival rates, they both also have a boxed warning, because of the possibility of life-threatening allergic reactions.

Where is Lumizyme manufactured?

–(BUSINESS WIRE)–Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA has granted U.S. marketing approval for LumizymeTM (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium.

How do you dilute Lumizyme?

1. Prepare the infusion bag with 0.9% Sodium Chloride for Injection, USP, to be used for diluting the reconstituted Lumizyme solution.
2. Slowly withdraw the reconstituted solution from each vial, taking care to avoid foaming in the syringe.

Is lumizyme a biologic?

Genzyme will launch the same biologic under two different names in the US after the FDA decided the drug produced at 2000L was considerably different to the 160L version.

When was lumizyme approved by the FDA?

Lumizyme, a lysosomal glycogen-specific enzyme, was approved by the FDA in 2010 with a REMS to restrict its use to treatment of patients with late (non-infantile) onset Pompe disease who are eight years of age and older.

How much does enzyme replacement therapy cost?

Paying for Enzyme Replacement Therapy ERT can be very expensive, totaling up to $200,000 or more each year. Insurance may cover most of this cost, and resources are available if you need help paying for ERT treatments.

How is lumizyme produced?

Lumizyme is produced using recombinant DNA technology, a process that allows scientists to alter the genetic make-up of an organism in order to produce human proteins such as enzymes. This highly complex biomanufacturing process was developed after many years of research and testing.

How long is a lumizyme infusion?

The total volume of infusion is determined by the patient’s body weight and should be administered over approximately 4 hours. If severe infusion or allergic reactions occur, immediate discontinuation of the administration of Lumizyme should be considered, and appropriate medical treatment should be initiated.

How is vpriv made?

VPRIV is made in a human cell line using Shire’s gene activation technology. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme. VPRIV is used for the long-term treatment of patients with type 1 Gaucher disease.

How is the dose of Lumizyme calculated for a patient?

A patient’s dose and the vials required for that dose can be calculated with the following formulas: Lumizyme dose in mg = Patient weight in kg X 20 mg/kg Actual body weight was used as the basis for dosing in Lumizyme clinical trials.

What kind of powder is used for Lumizyme?

Lumizyme is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder that must first be reconstituted before administration. For more details on Lumizyme reconstitution and dilution, see the Handling & Preparation page.

When to discontinue the administration of Lumizyme?

If severe infusion or allergic reactions occur, immediate discontinuation of the administration of Lumizyme should be considered, and appropriate medical treatment should be initiated. Appropriate medical support should be readily available when Lumizyme is administered.

What kind of filter is needed for Lumizyme?

Once prepared, the diluted Lumizyme solution should be filtered through a 0.2 μm, low protein-binding, in-line filter during administration to remove any visible particles. These filters are NOT provided in the product package.