lisdexamfetamine VYVANSE
Class: StimulantFDA Indications: ADHD, Binge Eating Disorder
Off-Label Use:
Prescribing
FDA Schedule IIForms: 10, 20, 30, 40, 50, 60, 70mg capsule; 10, 20, 30, 40, 50, 60mg Tablet Chewable
Dose Range: 10-70 mg/day
Starting: 30 mg once daily in the morning; may increase in increments of 10 mg or 20 mg at weekly intervals until optimal response is obtained; maximum: 70 mg/day
Stopping: Taper to avoid withdrawal
Monitoring: Perform a targeted cardiac history, and cardiac exam before initiation. Monitor baseline blood pressure, heart rate, and ECG.
Precautions
Contraindications: Advanced atherosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, agitated state, hx of drug abuse, use with (or within 14 days of) an MAO inhibitorSerious Side Effects: Serious cardiovascular events. Sudden cardiac death, stroke, and MI. Can exacerbate pre-existing bipolar or psychotic disorder. May lower seizure threshold.
Drugs to Avoid in Congenital Long QT
Side Effects: decreased appetite, weight loss, nausea, peripheral vasculopathy
Pharmacodynamics
1° MOA: Promotes presynaptic DA & NE releaseTarget: VMAT2 (inhibitor), NET & DAT (competitive inhibitor & pseudosubstrate), MAO (inhibitor, weak)
Pharmacokinetics
t½: 1° TMAX: 3.8°Substrate of: Via hydrolytic activity of RBCs to dextroamphetamine and l-lysine
Inhibits: ∅ ; Induces: ∅
Active Metabolites: Dextroamphetamine
DDIs
- - avoid with MAO inhibitors
- - may ↑ levels and effects of opioids and sympathomimetics
Misc
- - pharmacologically inactive prodrug consisting of d-AMP covalently bound to L-lysine; this bond is subsequently hydrolyzed in vivo releasing the active d-AMP molecule
- - this conversion occurs primarily in blood due to hydrolytic activity occurring within RBCs by an as yet unidentified hydrolase
- - the resulting release profile supports once-daily administration without the necessity to employ sustained-release dosage technologies
- - considered a "slow-dose" stimulant
- - t½ of parent inactive prodrug is <1°; t½ of resultant d-AMP is 9-11°
- - administration with food is observed to prolong the TMAX by ~1° (from 3.8° at fasted state to 4.7° after a high-fat meal)
Special Populations
Category Undefined.—Majority of data based on illicit amphetamine and methamphetamine use. May increase risk for premature birth and low birth weight. Newborns may experience withdrawal. Children may experience behavioral problems.
Majority of data based on illicit amphetamine and methamphetamine use. Amphetamine are excreted into breast milk in higher concentrations than present in mothers serum. May decrease milk production. Can cause irritability, agitation, and crying in nursing infants.
In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy
GFR ≥30 mL/minute/1.73 mm2: No dosage adjustments required
GFR 15 to <30 mL/minute/1.73 m2: Max dose: 50 mg/day
GFR <15 mL/minute/1.73 mm2: Max dose: 30 mg/day
ESRD requiring hemodialysis: Max=m dose: 30 mg/day; lisdexamfetamine and dextroamphetamine are not dialyzable
Use caution in this age group due to CNS stimulant adverse effects