Enoxaparin

What is Enoxaparin?

• Enoxaparin sodium (Lovenox) injection is a low molecular weight heparin (LMWH) is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.

Enoxaparin

EnoxaparinSodium

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Enoxaparin sodium ball-and-stick

What are the uses of this medicine?

Enoxaparin sodium (Lovenox) is used for:

• the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE).
• the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium
• the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium
• the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
• Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI).

How does this medicine work?

• The sodium salt of enoxaparin, a low molecular weight, synthetic heparin.
• As an anticoagulant/antithrombotic agent, enoxaprin's mechanism of action is similar to that of heparin, although it exhibits a higher ratio of anti-Factor Xa to anti-Factor IIa activity.
• This agent also has anti-inflammatory properties, inhibiting monocyte adhesion to tumor necrosis factor alpha- or lipopolysaccharide-activated endothelial cells.
• Compared to unfractionated heparins, the use of enoxaparin is associated with lower incidences of osteoporosis and heparin-induced thrombocytopenia.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Active major bleeding.
• History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies.
• Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions).
• Known hypersensitivity to heparin or pork products.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin), anagrelide (Agrylin), aspirin or nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), prasugrel (Effient), sulfinpyrazone (Anturane), ticlopidine (Ticlid), and tirofiban (Aggrastat).

Is this medicine FDA approved?

• Enoxaparin (ee nox' a par' in) was the first small molecular weight heparin (average 4,500 daltons) to be approved for use in the United States (1993) and is available in liquid solution in several forms (ampoules, syringes) generically and under the brand name Lovenox.

How should this medicine be used?

Recommended dosage: Abdominal Surgery:

• The recommended dose of enoxaparin sodium injection is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
• The usual duration of administration is 7 to 10 days.

Hip or Knee Replacement Surgery:

• The recommended dose of enoxaparin sodium injection is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery.
• Administer the initial dose 12 to 24 hours after surgery, provided that hemostasis has been established.
• The usual duration of administration is 7 to 10 days.
• A dose of enoxaparin sodium injection of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks.

Medical Patients During Acute Illness:

• The recommended dose of enoxaparin sodium injection is 40 mg once a day administered by subcutaneous injection for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness.
• The usual duration of administration is 6 to 11 days.

Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism:

• The recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered subcutaneously in patients with acute deep vein thrombosis without pulmonary embolism, who can be treated at home in an outpatient setting.
• The recommended dose of enoxaparin sodium injection is 1 mg/kg every 12 hours administered subcutaneously or 1.5 mg/kg once a day administered subcutaneously at the same time every day for inpatient (hospital) treatment of patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment).

Unstable Angina and Non-Q-Wave Myocardial Infarction:

• The recommended dose of enoxaparin sodium injection is 1 mg/kg administered subcutaneously every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily) in patients with unstable angina or non-Q-wave myocardial infarction.

Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin:

• 1 mg/kg administered subcutaneously once daily.

Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin:

• 30 mg single intravenous bolus plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously once daily.

Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin:

• 1 mg/kg administered subcutaneously once daily (no initial bolus).

Administration:

• Enoxaparin comes as an injection in a syringe.
• Do not administer enoxaparin sodium by intramuscular injection.
• Administer enoxaparin sodium injection by intravenous or subcutaneous injection only.
• It is usually given twice a day.
• You will probably begin using the drug while you are in the hospital and then use it for a total of 10 to 14 days.
• Continue to use enoxaparin even if you feel well. Do not stop taking enoxaparin without talking to your doctor.
• Enoxaparin is usually injected in the stomach area.
• You must use a different area of the stomach each time you give the shot.
• If you have questions about where to give the shot, ask your healthcare provider.
• Each syringe has enough drug in it for one shot.
• Do not use the syringe and needle more than one time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Enoxaparin Sodium Injection

This medicine is available in fallowing brand namesː

• Lovenox

What side effects can this medication cause?

The most common side effects of this medicine may include:

• bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain.

Less common, but serious side effects may include:

• Spinal/epidural hematomas
• Increased Risk of Hemorrhage
• Thrombocytopenia

What special precautions should I follow?

• Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
• Use enoxaparin sodium injection with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors.
• Enoxaparin sodium injection should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage.
• Enoxaparin sodium injection may cause Heparin-Induced Thrombocytopenia (HIT) or Heparin-Induced Thrombocytopenia with Thrombosis (HITTS). Only use enoxaparin sodium injection in patients with a history of HIT if more than 100 days have elapsed since the prior HIT episode and no circulating antibodies are present.
• Thrombocytopenia can occur with the administration of enoxaparin sodium injection. Monitor platelet count closely.
• Enoxaparin sodium injection cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins.
• Use of enoxaparin sodium injection for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves may result in valve thrombosis. Women and their fetuses may be at increased risk. Monitor more frequently and adjust dosage as needed.
• It is unknown whether enoxaparin sodium injection is excreted in human milk. There is no information available on the effect of enoxaparin or its metabolites on the breastfed child, or on the milk production.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hemorrhagic complications

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Injected enoxaparin sodium injection may be largely neutralized by the slow intravenous injection of protamine sulfate (1% solution).
• The dose of protamine sulfate should be equal to the dose of enoxaparin sodium injected: 1 mg protamine sulfate should be administered to neutralize 1 mg enoxaparin sodium injection, if enoxaparin sodium injection was administered in the previous 8 hours.
• An infusion of 0.5 mg protamine per 1 mg of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration.
• Particular care should be taken to avoid overdosage with protamine sulfate.
• Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.
• Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available.

Can this medicine be used in pregnancy?

• Placental transfer of enoxaparin was observed in the animal studies.
• Hemorrhage can occur at any site and may lead to death of mother and/or fetus.
• Pregnant women should be apprised of the potential hazard to the fetus and the mother if enoxaparin sodium injection is administered during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness of enoxaparin sodium injection in pediatric patients have not been established.
• Enoxaparin sodium injection is not approved for use in neonates or infants.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Enoxaparin sodium

Inactive ingredients:

• Water

Who manufactures and distributes this medicine?

Manufactured In Italy By:

• Italfarmaco S.p.A.
• Milano, Italy

Manufactured For:

• Teva Pharmaceuticals USA, Inc.
• North Wales, PA

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• KEEP OUT OF THE REACH OF CHILDREN.

• Dailymed label info on Enoxaparin
• FDA Enoxaparin

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