LOVENOX (PRESERVATIVE FREE)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LOVENOX (PRESERVATIVE FREE) (LOVENOX (PRESERVATIVE FREE)).
Low molecular weight heparin (LMWH) that potentiates antithrombin III, accelerating inactivation of factor Xa and thrombin.
| Metabolism | Metabolized primarily by desulfation and depolymerization in the liver via heparinases; renally eliminated as unchanged drug and metabolites. |
| Excretion | Renal: 40-60% as unchanged drug and low molecular weight fragments via glomerular filtration; biliary/fecal: negligible. |
| Half-life | Terminal half-life: 3-5 hours after subcutaneous injection; prolonged in renal impairment (up to 8-10 hours with CrCl <30 mL/min). |
| Protein binding | Approximately 90% bound to antithrombin III (minor binding to other plasma proteins). |
| Volume of Distribution | 4-7 L (0.06-0.1 L/kg) – predominantly confined to intravascular space. |
| Bioavailability | Subcutaneous: ~90-100% (almost complete absorption). |
| Onset of Action | Subcutaneous: 30-60 minutes (anti-Factor Xa activity detectable within 30 min). |
| Duration of Action | Subcutaneous: Anti-Factor Xa activity persists for approximately 12 hours; clinical anticoagulation effect lasts 12-24 hours. |
1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg subcutaneously once daily.
| Dosage form | INJECTABLE |
| Renal impairment | For CrCl <30 mL/min: reduce dose to 1 mg/kg subcutaneously once daily. For CrCl 30-50 mL/min: no dose adjustment required, but monitor carefully. |
| Liver impairment | No specific dose adjustment recommended for hepatic impairment; caution in severe hepatic impairment due to increased bleeding risk. |
| Pediatric use | Neonates: 1.5 mg/kg subcutaneously every 12 hours. Infants and children: 1 mg/kg subcutaneously every 12 hours. |
| Geriatric use | No specific dose adjustment, but increased risk of bleeding; monitor renal function and adjust dose if CrCl <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LOVENOX (PRESERVATIVE FREE) (LOVENOX (PRESERVATIVE FREE)).
| Breastfeeding | Excreted into breast milk in negligible amounts; M/P ratio not clinically significant; compatible with breastfeeding; no adverse effects in nursing infants reported. |
| Teratogenic Risk | Low risk of teratogenicity; enoxaparin does not cross the placenta and is not associated with fetal malformations. In the first trimester, risk of teratogenicity is minimal but consider anticoagulation alternatives if VTE prophylaxis needed; second and third trimesters: no known teratogenic risk, but increased risk of maternal bleeding and placental abruption; perinatal: risk of neonatal bleeding if administered near delivery. |
■ FDA Black Box Warning
Spinal/epidural hematomas, including subsequent paralysis, may occur in patients anticoagulated with LMWH or heparinoids who receive neuraxial anesthesia or undergo spinal puncture. Risk increased by use of indwelling epidural catheters, concomitant use of drugs affecting hemostasis, history of traumatic or repeated epidural/spinal punctures, or history of spinal deformity or surgery.
| Serious Effects |
Active major bleeding; history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITT); hypersensitivity to heparin or pork products; not recommended for use in patients with prosthetic heart valves, especially pregnant women (risk of valve thrombosis).
| Precautions | Risk of bleeding; thrombocytopenia, including heparin-induced thrombocytopenia (HIT); use in renal impairment (reduce dose if CrCl <30 mL/min); elderly patients (increased bleeding risk); pregnancy (category B); use with caution in patients with history of heparin-induced thrombocytopenia; monitor for signs of bleeding. |
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| Fetal Monitoring | Monitor maternal anti-Xa levels (peak 3-4 hours post-dose) if dose adjustment needed; assess platelet count every 2-3 days for heparin-induced thrombocytopenia; monitor for signs of bleeding, placental abruption, and fetal distress via nonstress test or biophysical profile in high-risk pregnancies. |
| Fertility Effects | No known adverse effects on fertility; may be used in assisted reproductive technology for thrombophilia without impairing implantation or ovarian function. |