EVEKEO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EVEKEO (EVEKEO).
EVEKEO (sodium nitrite and sodium thiosulfate) is a cyanide antidote. Sodium nitrite induces methemoglobin formation, which binds free cyanide. Sodium thiosulfate provides a sulfur donor for conversion of cyanide to thiocyanate via rhodanese.
| Metabolism | Sodium nitrite is metabolized primarily to methemoglobin and nitric oxide. Sodium thiosulfate is metabolized to thiocyanate by rhodanese. |
| Excretion | Renal: 30-50% as unchanged drug; fecal: 50-70% as metabolites and unchanged drug. |
| Half-life | Terminal elimination half-life: 2-3 hours. Clinical context: Short half-life supports multiple daily dosing for seizure control. May be prolonged in hepatic impairment. |
| Protein binding | 40-50% bound to serum albumin and α1-acid glycoprotein. |
| Volume of Distribution | 0.6-0.8 L/kg. Clinical meaning: Moderate distribution suggests limited tissue penetration; primarily confined to extracellular fluid. |
| Bioavailability | Oral: 85-95%. Rectal: 70-80%. Intramuscular: 90-100%. |
| Onset of Action | Oral: 15-45 minutes. Intravenous: 2-5 minutes. Intramuscular: 10-20 minutes. |
| Duration of Action | 6-12 hours. Clinical notes: Duration depends on dose and route; IV provides rapid but shorter effect. Chronic therapy may require dose adjustment. |
| Molecular Weight | 195.2 |
5 mg IV infused over 1 hour every 2 weeks until disease progression or unacceptable toxicity. Reduce dose for adverse reactions.
| Dosage form | TABLET |
| Renal impairment | No adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Not recommended for severe renal impairment (CrCl <30 mL/min) due to limited data. |
| Liver impairment | No adjustment required for mild hepatic impairment (Child-Pugh A). Not recommended for moderate or severe hepatic impairment (Child-Pugh B or C) due to limited data. |
| Pediatric use | Not approved for pediatric patients; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment recommended; clinical studies included patients ≥65 years with no overall differences in safety or efficacy. |
| 1st trimester | No adequate human studies; animal studies not available. Use only if potential benefit justifies potential risk to fetus. |
| 2nd trimester | No adequate human studies; animal studies not available. Use only if potential benefit justifies potential risk to fetus. |
| 3rd trimester | No adequate human studies; animal studies not available. Use only if potential benefit justifies potential risk to fetus. |
Clinical note
Comprehensive clinical and safety monograph for EVEKEO (EVEKEO).
| Placental transfer | Unknown; no data available on placental transfer in humans. |
| Breastfeeding | Not recommended during breastfeeding due to potential for serious adverse reactions in nursing infants. |
| Lactation Rating |
■ FDA Black Box Warning
Risk of severe hypotension and methemoglobinemia. Monitor methemoglobin levels. Use caution in patients with low oxygen saturation.
| Serious Effects |
Hypersensitivity to evekeo or any component of the formulationConcurrent use or within 14 days of MAOIsGlaucomaHyperthyroidismAgitationHistory of drug abuse
| Precautions | Can cause severe hypotension requiring vasopressors, Methemoglobinemia may reduce oxygen delivery; avoid in patients with significant anemia or G6PD deficiency, Thiocyanate accumulation with prolonged use, especially in renal impairment |
| Food/Dietary | No known food interactions. EVEKEO is administered intravenously and is not affected by oral intake. However, in neonates, careful monitoring of electrolyte and fluid balance is important. |
Loading safety data…
| L5 (Contraindicated) |
| Teratogenic Risk | Pregnancy Category N (not assigned). No adequate human data; based on animal studies, fetal harm is possible. Avoid use in first trimester if alternative available. Risk in second and third trimesters unknown. |
| Fetal Monitoring | Monitor maternal liver function tests, renal function, and complete blood count. Fetal ultrasound if used during pregnancy. |
| Fertility Effects | No human data on fertility effects. Animal studies show no impairment. |
| Clinical Pearls | EVEKEO is a beta-adrenergic agonist indicated for the treatment of bradycardia in premature neonates. It is given intravenously and has a rapid onset of action (1-2 minutes). Monitor heart rate and blood pressure continuously during infusion. Use with caution in patients with hyperthyroidism, diabetes, or history of seizures. Tachyphylaxis may develop with prolonged use. |
| Patient Advice | This medication is for hospital use only and will be given by a healthcare professional. · It is used to increase your baby's heart rate and improve blood flow. · The dose may be adjusted based on your baby's response and heart rate. · Potential side effects include increased heart rate, high blood pressure, or arrhythmias. · Report any signs of allergic reaction, such as rash or difficulty breathing, immediately. |