EVEKEO ODT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EVEKEO ODT (EVEKEO ODT).
EVEKEO ODT (amphetamine) is a CNS stimulant that increases extracellular levels of dopamine and norepinephrine by blocking their reuptake into presynaptic neurons and inhibiting monoamine oxidase, leading to enhanced neurotransmission.
| Metabolism | Hepatic via CYP2D6 to active metabolites (e.g., 4-hydroxyamphetamine, norephedrine) and inactive metabolites. |
| Excretion | Renal: approximately 50% as unchanged drug and metabolites; fecal: minimal (<10%) |
| Half-life | 3-5 hours in healthy adults; prolonged in renal impairment (up to 20 hours in ESRD) |
| Protein binding | 70-80% bound to albumin |
| Volume of Distribution | 2.6 L/kg |
| Bioavailability | Oral (ODT): 75-85% |
| Onset of Action | Oral (ODT): within 1-1.5 hours |
| Duration of Action | 6-8 hours; may be longer in hepatic impairment |
0.25 mg orally as a single dose; may repeat once after 30 minutes if required.
| Dosage form | TABLET, ORALLY DISINTEGRATING |
| Renal impairment | No dose adjustment necessary for renal impairment; not studied in dialysis. |
| Liver impairment | Contraindicated in Child-Pugh Class C; use with caution in Class A/B with reduced dose. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dose adjustment; use with caution due to increased sensitivity to adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EVEKEO ODT (EVEKEO ODT).
| Breastfeeding | No human data; excreted in rat milk. M/P ratio unknown. Not recommended during breastfeeding due to potential for infant CNS effects. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in pregnancy; causes fetal harm. First trimester: high risk of major malformations including craniofacial defects, cardiovascular abnormalities. Second/third trimesters: fetal growth restriction, oligohydramnios, neonatal renal impairment. |
| Fetal Monitoring |
■ FDA Black Box Warning
Amphetamines have a high potential for abuse. Administration for prolonged periods may lead to drug dependence. Misuse may cause sudden death or serious cardiovascular adverse events.
| Serious Effects |
["Known hypersensitivity to amphetamine products or other components of EVEKEO ODT.","Concurrent use or within 14 days of monoamine oxidase inhibitors (MAOIs) due to hypertensive crisis risk.","Glaucoma","Hyperthyroidism","Agitated states","History of drug abuse","Symptomatic cardiovascular disease including structural cardiac abnormalities, coronary artery disease, and cardiomyopathy","Moderate to severe hypertension"]
| Precautions | ["Serious cardiovascular events including sudden death in patients with pre-existing structural cardiac abnormalities or other serious heart problems.","Blood pressure and heart rate increase; monitor.","Psychiatric adverse events including exacerbation of pre-existing psychosis, mania, and aggressive behavior.","Long-term suppression of growth; monitor weight and height in pediatric patients.","Seizures; use with caution in patients with seizure disorders.","Peripheral vasculopathy including Raynaud's phenomenon.","Serotonin syndrome risk when used with other serotonergic drugs."] |
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| Avoid in pregnancy; if exposed, monitor fetal anatomy ultrasound, fetal growth, and amniotic fluid index. Maternal renal function and blood pressure monitoring. |
| Fertility Effects | May impair fertility in females; case reports of menstrual irregularities and anovulation. Reversible upon discontinuation. Males: not studied. |