VELMANASE ALFA-TYCV

Other

Brand names: Lamzede

Intravenous

Mechanism of Action

12.1 Mechanism of Action Alpha-mannosidosis is a lysosomal storage disease that results from reduced activity of the enzyme alpha-mannosidase, caused by gene variants in Mannosidase Alpha Class 2B Member 1. Alpha-mannosidase catalyzes the degradation of accumulated mannose-containing oligosaccharides. The deficiency of alpha-mannosidase causes an intra-lysosomal accumulation of mannose-rich oligosaccharides in various tissues. Velmanase alfa-tycv provides an exogenous source of alpha-mannosidase. Velmanase alfa-tycv is internalized via binding to the mannose-6-phosphate receptor on the cell surface and transported into lysosomes where it is thought to exert enzyme activity.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Infusion -Associ ated Reactions (IARs) : If severe IARs occur, discontinue LAMZEDE and initiate appropriate medical treatment
Consider the risks and benefits of re-administering LAMZEDE following severe hypersensitivity reactions (including anaphylaxis)
Prior to LAMZEDE administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids to reduce the risk of infusion-associated reactions (IARs)
Consider the risks and benefits of readministering LAMZEDE following a severe IAR

Known Side Effects

6 documented side effects by frequency

Fever

>10%

Vomiting

1-10%

Abdominal Pain

1-10%

Diarrhea

0.1-1%

Shortness of Breath

0.1-1%

Fatigue

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous