Enoxaparin Sodium (enoxaparin sodium)

Dosages for enoxaparin sodium or other low molecular weight heparins (LMWHs) or unfractionated heparin sodium cannot be used interchangeably on a unit-for-unit (or mg-for-mg) basis. Enoxaparin sodium has an approximate anti-factor Xa activity of 100 units/mg according to the World Health Organization (WHO) First International Low Molecular Weight Heparin Reference Standard.

If an LMWH is used for anticoagulation in children, ACCP suggests that dosage of the drug be adjusted to a target anti-factor Xa level of 0.5-1 units/mL based on a sample taken 4-6 hours, or 0.5-0.8 units/mL based on a sample taken 2-6 hours, following subcutaneous administration.

Enoxaparin sodium is administered by deep subcutaneous injection; it must not be given IM. The drug also is administered IV (as a direct IV injection) in certain situations. (See ST-Segment-Elevation Myocardial Infarction and also see Non-ST-Segment-Elevation Acute Coronary Syndrome under Dosage and Administration.)

Patients should be supine during administration of the drug.

To avoid loss of drug when using the prefilled syringes, the manufacturer states that air should not be expelled from the syringe prior to injection. If the prescribed dose is less than the full syringe volume, the excess syringe volume should be ejected until only the prescribed dose remains in the syringe.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Active major bleeding.

*Immune-mediated heparin-induced thrombocytopenia within the prior 100 days or associated with circulating antiplatelet antibodies.

*Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions), heparin, pork products, benzyl alcohol, or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse effects of enoxaparin (i.e., occurring in at least 1% of patients receiving the drug in clinical studies) include bleeding, anemia, ecchymosis, thrombocytopenia, elevation of serum aminotransferase concentrations, fever, nausea, diarrhea, peripheral edema, dyspnea, injection site pain, and confusion.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of enoxaparin have not been established in children younger than 18 years of age.

Each mL of enoxaparin sodium injection in multiple-dose vials contains 15 mg of benzyl alcohol as a preservative. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates, including fatal reactions and the ''gasping syndrome''. Toxicity appears to have resulted from administration of large amounts (i.e., about 100-400 mg/kg daily) of benzyl alcohol in these neonates. Because benzyl alcohol may cross the placenta, the manufacturer states that the preservative-free formulations of enoxaparin should be used in pregnant women whenever possible.

There are no adequate and well-controlled studies of enoxaparin in pregnant women. Animal studies indicate that enoxaparin crosses the placenta; however, available data in humans indicate that low molecular weight heparins (LMWHs) do not cross the placenta. Available human data also have not shown evidence of teratogenicity or fetotoxicity. In a review of approximately 600 retrospectively followed pregnancies in women exposed to enoxaparin, the incidences of congenital anomalies did not exceed what would be expected in the general population. Maternal and neonatal hemorrhage did occur in some of the followed pregnancies. The American College of Obstetricians and Gynecologists (ACOG) considers LMWHs to be generally safe in pregnancy.

Pregnancy alone is associated with an increased risk of thromboembolism, which is even higher in women with a history of thromboembolism and certain high-risk pregnancy conditions, including hereditary or acquired thrombophilias and the presence of a mechanical prosthetic heart valve. The pharmacokinetics of LMWHs differ in pregnant versus nonpregnant women because of changes in volume of distribution resulting in increased plasma volume, decreased half-life, and changes in renal clearance. Some clinicians recommend frequent monitoring of anti-factor Xa concentrations and adjustment of enoxaparin sodium dosage in pregnant women with mechanical prosthetic heart valves to ensure a consistent anticoagulant effect.

All patients receiving anticoagulants such as enoxaparin, including pregnant women, are at risk for bleeding. Hemorrhage can occur at any site and may lead to death of mother and/or fetus. Pregnant women receiving enoxaparin should be apprised of the potential hazards to the mother and fetus associated with enoxaparin use during pregnancy, and such women should be carefully monitored for evidence of bleeding or excessive anticoagulation. Use of enoxaparin may result in epidural or spinal hematomas in women receiving neuraxial anesthesia during labor and delivery. Pregnant women receiving enoxaparin should be monitored for bleeding and for any unexpected changes in coagulation parameters. As delivery approaches, use of a shorter-acting anticoagulant should be considered.

Use of enoxaparin in pregnant women with mechanical prosthetic heart valves may result in valve thrombosis. (See Patients with Mechanical Prosthetic Heart Valves under Cautions.)

It is not known whether enoxaparin is distributed into milk; studies in lactating rats demonstrated very limited distribution of enoxaparin into milk. It is not known whether enoxaparin affects the breast-fed child or affects milk production. The benefits of breast-feeding should be considered along with the importance of the drug to the woman and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition.

The American College of Obstetricians and Gynecologists (ACOG) considers low molecular weight heparins (LMWHs) to be compatible with lactation. The American College of Chest Physicians (ACCP) recommends that LMWHs be continued in nursing women who are already receiving such therapy; the small amounts of drug detected in the milk of nursing women are not likely to be clinically important.

No substantial differences in efficacy have been observed in geriatric patients relative to younger adults. In geriatric patients, a higher incidence of bleeding complications has been observed following administration of enoxaparin sodium at a dosage of 1.5 mg/kg once daily or 1 mg/kg every 12 hours, and the risk of bleeding complications increases with age. Enoxaparin should be used with care in geriatric patients, and careful attention to dosing intervals and concomitant medications (particularly antiplatelet drugs) is advised. Monitoring (e.g., using anti-factor Xa assay) of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered.