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Brand Name :
Vyalev
Synonyms :
foscarbidopa/foslevodopa
Class :
Decarboxylase Inhibitors, Antiparkinson Agents, Dopamine Precursors
Brand Name :
Vyalev
Synonyms :
foscarbidopa/foslevodopa
Class :
Decarboxylase Inhibitors, Antiparkinson Agents, Dopamine Precursors
Adult
Solution for SC injection
(120mg/2400mg)/10ml single-dose vial
(foscarbidopa/foslevodopa)
Pending FDA approval
Safety and efficacy are not established.
Foscarbidopa/foslevodopa are mostly soluble prodrugs of carbidopa and levodopa which allows concentrated SC infusion for sustained therapeutic levels.
Foscarbidopa converted to carbidopa inhibits dopa decarboxylase.
Frequency defined:
>10%
Infusion/catheter site reactions
Hallucinations
Dyskinesia
1-10%
Constipation
Peripheral swelling
Agitation
Balance disorder
Insomnia
Psychotic disorder
None
Coadministration with a nonselective MAO inhibitor
Cautions:
Falling asleep
Hallucinations/psychosis
Impulse control
Dyskinesia
Cardiovascular ischemic event
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion of the drug into the human breast milk is unknown
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
Aromatic amino acid decarboxylase inhibitor reduces breakdown of levodopa in peripheral tissues to increase levodopa in the brain. Levodopa converts to dopamine in the brain due to dopamine depletion.
Pharmacodynamics:
Levodopa crosses the blood-brain barrier when it is taken with dopaminergic neurons. Foscarbidopa converted into carbidopa inhibits aromatic L-amino acid decarboxylase in periphery.
Pharmacokinetic:
Distribution:
Protein binding as follows:
Levodopa: <10%
Carbidopa: ~36%
Metabolism:
It is converted with alkaline phosphatases into carbidopa and levodopa.
Excretion and elimination:
Half-life as follows:
Levodopa: ~1.5 hrs
Carbidopa: ~2 hrs
It is administered though subcutaneous route.
Generic Name: foscarbidopa/foslevodopa
Why do we use foscarbidopa/foslevodopa?
Foscarbidopa/foslevodopa is latest FDA approved drug indicated in treatment of Parkinson’s disease.
It is also used in management of motor symptoms including tremor, bradykinesia, and postural instability.
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