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In the U.S.—

Lovenox

In Canada—

Lovenox

• Antithrombotic

Enoxaparin ( e-nox-a-PA-rin) is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. This medicine is used for several days after hip or knee replacement surgery, and in some cases following abdominal surgery, while you are unable to walk. It is during this time that blood clots are most likely to form. Enoxaparin is also used if you are unable to get out of bed because of a serious illness. In addition, enoxaparin is used to prevent blood clots from forming in the arteries of the heart during certain types of chest pain and heart attacks. Enoxaparin also may be used for other conditions as determined by your doctor.

Enoxaparin is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For enoxaparin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to enoxaparin or to heparin. Also tell your health care professional if you are allergic to any other substances, such as foods, especially pork or pork products, preservatives, or dyes.

Pregnancy—Enoxaparin has not had adequate studies performed in pregnant women. However, if you are pregnant your doctor will need to closely monitor you because of an increased risk of bleeding. In pregnant women who have an artificial heart valve, enoxaparin is not recommended.

Breast-feeding—It is not known whether this medicine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of enoxaparin in children with use in other age groups.

Older adults—This medicine has been tested and has been shown to cause an increased risk of side effects or problems in older people than it does in younger adults. You doctor may adjust your dose, especially if you are less than 45 kg (99 lbs.) of body weight or in elderly patients with decreased kidney function.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using enoxaparin, it is especially important that your health care professional know if you are taking any of the following:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) including:
• Ketorolac tromethamine (e.g., Toradol)—use of this drug when receiving spinal or epidural anesthesia can lead to long term neurological problems

• Drugs affecting platelet aggregation or affect blood clotting ability such as:
• Aspirin or
• Dipyridamole (e.g., SK-Dipyridamole) or
• Divalproex (e.g., Depakote) or
• Inflammation or pain medicine, except narcotics, or
• Plicamycin (e.g., Mithracin) or
• Salicylates (e.g., choline salicylate (Arthropan), magnesium salicylate (Doan's), salsalate (Disalcid), or
• Sulfinpyrazone (e.g., Anturane) or
• Thrombolytic agents (e.g. alteplase (Activase), anistreplase (Eminase), streptokinase (Streptase), urokinase (Abbokinase) or
• Ticlopidine (e.g., Ticlid)
• Valproic acid (e.g., Depakene)—Using any of these medicines together with enoxaparin may increase the risk of bleeding

Other medical problems—The presence of other medical problems may affect the use of enoxaparin. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease or bleeding problems or
• Blood vessel problems or
• Heart infection or
• Heart valves, prosthetic or
• High blood pressure (hypertension) or
• Kidney disease or
• Liver disease or
• Septic shock or
• Stomach ulcer (active) or
• Threatened miscarriage—The risk of bleeding may be increased

Also, tell your doctor if you have received enoxaparin or heparin before and had a reaction to either of them called thrombocytopenia, or if new blood clots formed while you were receiving the medicine.

In addition, tell your doctor if you have recently given birth, fallen or suffered a blow to the body or head, or had medical or dental surgery. These events may increase the risk of serious bleeding when you are taking enoxaparin.

If you are using enoxaparin at home, your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional if you have any problems using the medicine.

Put used syringes in a puncture-resistant, disposable container, or dispose of them as directed by your health care professional.

Dosing—

The dose of enoxaparin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of enoxaparin. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For prevention of deep venous thrombosis (hip or knee replacement surgery):
    • Adults—30 milligrams (mg) injected under the skin every twelve hours for seven to ten days. Alternatively, for hip replacement surgery, the dose may be 40 mg injected under the skin once a day for three weeks.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis (abdominal surgery):
    • Adults—40 mg injected under the skin once a day for seven to ten days.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of coronary arterial thrombosis:
    • Adults—1 mg per kilogram (kg) (0.45 mg per pound) of body weight injected under the skin every twelve hours for two to eight days.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of deep venous thrombosis (in patients with a serious illness who cannot get out of bed):
    • Adults—40 mg injected under the skin once a day for six to eleven days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of certain types of chest pain and heart attack
    • Adults—1 mg per kg (2.2 lbs) of body weight every 12 hours injected under the skin for two to eight days. Aspirin 100 to 325 mg orally once a day may also be given.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Tell all your medical doctors and dentists that you are using this medicine.

Check with your doctor immediately if you notice any of the following side effects:

• Bruising or bleeding, especially bleeding that is hard to stop. Bleeding inside the body sometimes appears as bloody or black, tarry stools, or faintness.
• Back pain; burning, pricking, tickling, or tingling sensation; leg weakness; numbness; paralysis; or problems with bowel or bladder function.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop using this medicine and check with your doctor immediately if any of the following side effects occur:

• More common
  • Black, tarry stools;  bleeding gums;  blood in urine or stools;  coughing up blood;  difficulty in breathing or swallowing;  dizziness;  headache;  increased menstrual flow or vaginal bleeding;  moderate to severe pain or numbness in the arms, legs, hands, feet;  nosebleeds;  pale skin;  paralysis;  pinpoint red spots on skin;  prolonged bleeding from cuts;  red or black, tarry stools;  red or dark brown urine;  shortness of breath;  swelling of ankles, feet, fingers;  troubled breathing with exertion;  unusual bleeding or bruising;  unusual tiredness or weakness 
  
  

• Less common
  • Bruising;  chest discomfort;  collection of blood under the skin;  confusion;  continuing bleeding or oozing from the nose and/or mouth, or surgical wound;  convulsions ;  difficult or labored breathing;  fever;  irritability;  lightheadedness ;  lower back pain;  pain or burning while urinating;  swelling of hands and/or feet;  tightness in chest;  uncontrolled bleeding at site of injection;  wheezing ;  vomiting of blood or material that looks like coffee grounds 
  
  

• Rare
  • Back pain;  burning, pricking, tickling, or tingling sensation;  chest pain;  chills;  cough;  dizziness or lightheadedness when getting up from a lying or sitting position;  fainting;  fast or irregular heartbeat ;  fever;  general feeling of discomfort or illness;  leg weakness;  paralysis;  problems with bowel or bladder function;  shortness of breath;  skin rash or hives;  sneezing;  sore throat;  sudden fainting;  swelling of the face, genitals, mouth, or tongue;  thickening of bronchial secretions;  troubled breathing;  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • Diarrhea;  irritation, pain, or redness at place of injection;  nausea;  vomiting 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 07/28/1998

Revised: 11/20/2002