LOVENOX (enoxaparin sodium)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Cerebral amyloid angiopathy
Hemorrhage
Intracranial bleeding

There are 21 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bacterial endocarditis
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Deep peripheral nerve block
Deep plexus block
Diabetic retinopathy
Gastrointestinal hemorrhage
Gastrointestinal ulcer
Hemorrhagic stroke
Heparin-induced thrombocytopenia
Increased risk of bleeding
Increased risk of bleeding due to coagulation disorder
Invasive procedure on brain
Invasive procedure on spine
Mechanical prosthetic heart valve present
Neuraxial anesthesia
Placement of indwelling epidural catheter
Platelet aggregation inhibition
Severe uncontrolled hypertension
Surgical procedure on eye proper
Thrombocytopenic disorder

There are 0 moderate contraindications.

There are 30 severe adverse reactions.

More Frequent	Less Frequent
None.	Acute cognitive impairment Anemia Ecchymosis Fever Hematuria Peripheral edema Thrombocytopenic disorder

Rare/Very Rare

Acute generalized exanthematous pustulosis Allergic dermatitis Anaphylaxis Angioedema Cholestatic hepatitis Cutaneous vasculitis Dermal necrosis Dyspnea Eosinophilia Hematoma Hemorrhage Heparin-induced thrombocytopenia Hepatocellular damage Hyperkalemia Hyperlipidemia Hypersensitivity drug reaction Osteoporosis Purpura Skin rash Spinal epidural hematoma Thrombocytosis Thrombosis in heparin-induced thrombocytopenia Urticaria

There are 7 less severe adverse reactions.

More Frequent	Less Frequent
None.	Diarrhea Nausea Pruritus of skin

Rare/Very Rare
Abnormal hepatic function tests Alopecia Headache disorder Injection site sequelae

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.