Enoxaparin Sodium, Injection

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KEY POINTS

• This medicine is given by injection to reduce the risk of blood clots in people who are bedridden, have unstable angina or a heart attack, or who are having abdominal, hip, or knee surgery. It is also used to treat blood clots, including DVT and PE. Use it exactly as directed.
• This medicine increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anticoagulant; low molecular weight heparin

Generic and brand names: enoxaparin sodium, injection; Lovenox

What is this medicine used for?

This medicine is given by injection (shot) to treat or prevent deep vein thrombosis (blood clots). It is also used to treat blood clots in the lungs (pulmonary embolisms).

This medicine may be given along with warfarin (Coumadin).

This medicine is used to reduce the risk of blood clots in people who:

• Are having abdominal surgery or knee or hip replacement surgery
• Are bedridden
• Have unstable angina (chest pain), or a heart attack.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to pork products
• A history of bleeding problems or blood disorders
• Eye problems due to diabetes
• Heparin-induced thrombocytopenia (HIT)
• High blood pressure
• Kidney or liver problems
• An artificial heart valve

Tell your provider if you have recently had:

• Surgery for brain, back, or eye problems
• A stroke or transient ischemic attack (TIA), heart infection, or an ulcer

Be sure to tell your provider if you have recently had or are scheduled to have any kind of surgery or procedure on your spine, including a lumbar puncture (spinal tap), or spinal or epidural anesthesia. Also tell your healthcare provider if you are taking any medicine that may increase the risk of bleeding.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

You will be given these shots by your healthcare provider while you are in the hospital. You will be closely watched to be sure that you do not bleed too much or develop any serious side effects.

Sometimes you can give yourself these shots or have someone at home give them to you. Your healthcare provider will teach you how to use this medicine at home. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Do not inject more or less or more often than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nosebleeds, blood in your urine or bowel movements, unusual bruising or bleeding, bleeding that won't stop.

What should I watch out for?

If you have epidural or spinal anesthesia, a spinal tap, or other procedure on your spine while taking this medicine, you may have bleeding or blood clots around the spine that can cause paralysis. Your risk is higher if you:

• You take NSAIDs or other medicines to prevent blood clots.
• You have had problems with your spine, spine surgeries, or spinal or epidural punctures.
• You have a catheter or injection in your back.

Contact your healthcare provider right away if you have back pain, numbness, tingling, weakness or paralysis (especially in your legs and feet), or loss of control over your bladder or bowels.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

You may bruise or bleed more easily while taking this medicine. Also, it may take longer than usual for you to stop bleeding. Be careful to avoid falls or injury while you are taking this medicine. Use a soft brush to brush your teeth. Avoid injury while shaving, cutting fingernails or toenails, or when using sharp objects. To avoid bruising, do not rub the skin where the shot is given.

Do not take aspirin or other products that may increase the risk of bleeding unless your provider tells you to do so. Also, do not drink alcohol unless your healthcare provider approves. Adults over the age of 65 or people who are underweight may be at greater risk for side effects.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Your healthcare provider will watch you closely to make sure the medicine is working and is not causing unwanted side effects. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden confusion or trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Unusual bruising or bleeding (bloody or black tarry bowel movements, bloody urine, nosebleeds, coughing or vomiting blood, unusually heavy menstrual period, injection site bleeding or bruising, dark red spots under your skin); chest pain; irregular heartbeat; trouble breathing; redness, pain, or swelling in lower leg; unexplained fever, chills, or sore throat; lightheadedness or fainting; sudden back pain; unusual tiredness or weakness; bowel or bladder control problems; weakness or paralysis, especially in your legs and feet.

Other: Irritation at injection site, diarrhea, nausea, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Anagrelide (Agrylin)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antidepressants such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), sertraline (Zoloft), and venlafaxine (Effexor)
• Aspirin and other salicylates
• Cancer medicines such as dasatinib (Sprycel), ibritumomab (Zevalin), and omacetaxine (Synribo)
• Diuretics (water pills) such as amiloride, spironolactone (Aldactone), and triamterene (Dyrenium)
• Eplerenone (Inspra)
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), eptifibatide (Integrilin), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), tirofiban (Aggrastat), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as epoprostenol (Flolan, Veletri), iloprost (Ventavis), and treprostinil (Remodulin, Tyvaso)
• Natural remedies such as alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery, chamomile, dong quai, evening primrose, feverfew, fish oil, garlic, ginger, ginkgo, ginseng, green tea, horse chestnut, licorice, red clover, SAMe, turmeric, and white willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentosan (Elmiron)
• Pentoxifylline
• Potassium supplements or salt substitutes that contain potassium
• Tipranavir (Aptivus)
• Vitamin E or multivitamins that contain vitamin E

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

If you have the single-use (prefilled) syringes, discard after use, even if there is medicine left in the syringe.

If you have the multi-use vials, discard any unused medicine 28 days after opening the vial, even if there is medicine left in the vial.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.