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Lamzede Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vials—1, 5, 10
Manufacturer
Generic Availability
NO
Mechanism of Action
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.
Lamzede Indications
Indications
Non-central nervous system manifestations of alpha-mannosidosis.
Lamzede Dosage and Administration
Adults and Children
Consider pretreatment with antihistamines, antipyretics, and/or corticosteroids. ≤49kg: Give as IV infusion over ≥60mins. ≥50kg: max infusion rate of 25mL/hr. 1mg/kg once weekly; flush line with NaCl 0.9% inj. Dosage modifications due to hypersensitivity and/or infusion-related reactions: see full labeling.
Lamzede Contraindications
Not Applicable
Lamzede Boxed Warnings
Boxed Warning
Severe hypersensitivity reactions.
Lamzede Warnings/Precautions
Warnings/Precautions
Have cardiopulmonary resuscitation equipment readily available. Discontinue immediately and treat if severe hypersensitivity or infusion-associated reaction (eg, anaphylaxis) occurs; consider withholding dose for 15–30mins or slowing rate (25–50%) if mild to moderate reaction occurs. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 14 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Lamzede Pharmacokinetics
Elimination
Half-life: 33.6 hours (in those with alpha-mannosidosis).
Lamzede Interactions
Not Applicable
Lamzede Adverse Reactions
Adverse Reactions
Hypersensitivity reactions, anaphylaxis, infusion-associated reactions, nasopharyngitis, pyrexia, headache, arthralgia.
Lamzede Clinical Trials
See Literature
Lamzede Note
Not Applicable
Lamzede Patient Counseling
See Literature
