Generic Name
Enoxaparin
Brand Names
Lovenox, Enoxiluv
FDA approval date: March 29, 1993
Classification: Low Molecular Weight Heparin
Form: Injection, Kit
What is Lovenox (Enoxaparin)?
Enoxaparin sodium injection, USP is a low molecular weight heparin indicated for: Prophylaxis of deep vein thrombosis in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness. For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injection.
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Brand Information
Lovenox (enoxaparin sodium)
WARNING: SPINAL/EPIDURAL HEMATOMAS
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. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, and other anticoagulants
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
- Optimal timing between the administration of Lovenox and neuraxial procedures is not known
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis
1DOSAGE FORMS AND STRENGTHS
Lovenox is a clear, colorless to pale-yellow solution available in two concentrations.
2CONTRAINDICATIONS
Lovenox is contraindicated 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
- Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of Lovenox)
3ADVERSE REACTIONS
The following serious adverse reactions are also discussed in other sections of the labeling:
- Spinal/epidural hematomas
- Increased Risk of Hemorrhage
- Thrombocytopenia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During clinical development for the approved indications, 15,918 patients were exposed to Lovenox. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1,578 for prophylaxis of ischemic complications in unstable angina and non–Q-wave myocardial infarction, 10,176 for treatment of acute ST-elevation myocardial infarction, and 857 for treatment of deep vein thrombosis with or without pulmonary embolism. Lovenox doses in the clinical trials for prophylaxis of deep vein thrombosis following abdominal or hip or knee replacement surgery or in medical patients with severely restricted mobility during acute illness ranged from 40 mg subcutaneously once daily to 30 mg subcutaneously twice daily. In the clinical studies for prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction doses were 1 mg/kg every 12 hours and in the clinical studies for treatment of acute ST-segment elevation myocardial infarction Lovenox doses were a 30 mg intravenous bolus followed by 1 mg/kg every 12 hours subcutaneously.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of epidural or spinal hematoma formation with concurrent use of Lovenox and spinal/epidural anesthesia or spinal puncture. The majority of patients had a postoperative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis.
Local reactions at the injection site (e.g. nodules, inflammation, oozing), systemic allergic reactions (e.g. pruritus, urticaria
Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, hematoma in body tissues). Very rare cases of hyperlipidemia have also been reported, with one case of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined.
Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported.
Osteoporosis has also been reported following long-term therapy.
4DRUG INTERACTIONS
Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If coadministration is essential, conduct close clinical and laboratory monitoring
5OVERDOSAGE
Accidental overdosage following administration of Lovenox may lead to hemorrhagic complications. Injected Lovenox 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 Lovenox injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Lovenox, if Lovenox was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of Lovenox may be administered if Lovenox was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of Lovenox may be administered if the aPTT measured 2 to 4 hours after the first infusion remains prolonged.
If at least 12 hours have elapsed since the last Lovenox injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%). 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. For additional information consult the labeling of protamine sulfate injection products.
6DESCRIPTION
Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.
Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is:
STRUCTURAL FORMULA
Lovenox 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
Lovenox 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative
7HOW SUPPLIED/STORAGE AND HANDLING
Lovenox is available in two concentrations (see
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. Instruct the patient to seek immediate medical attention if any of these symptoms occur.
Inform patients:
- of the instructions for injecting Lovenox if they continue Lovenox therapy after discharge from the hospital.
- that it may take them longer than usual to stop bleeding.
- that they may bruise and/or bleed more easily when they use Lovenox.
- that they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician
- that risks are associated with the use of benzyl alcohol, a preservative in Lovenox multiple-dose vials, in neonates, infants, and pregnant women.
- to tell their physicians and dentists they are taking Lovenox and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken
- to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs
9INSTRUCTIONS FOR USE
LOVENOX
(enoxaparin sodium injection)
for subcutaneous use
(enoxaparin sodium injection)
for subcutaneous use
Single-dose prefilled syringe
This Instructions for Use contains information on how to prepare and inject Lovenox prefilled syringe.
Read this Instructions for Use before using the Lovenox prefilled syringe and each time you get a new prescription. There may be new information.
Important information:
Storing Lovenox prefilled syringes:
- Store Lovenox prefilled syringes at 77°F (25°C).
- Store Lovenox prefilled syringes in the original carton or packaging until ready to use.
- Keep Lovenox and all medicines out of the reach of children.
Parts of Lovenox prefilled syringe:
Preparing to inject Lovenox:
- 1 Lovenox prefilled syringe
- 1 alcohol wipe
- 1 cotton ball or gauze
- a small adhesive bandage, if needed
- a sharps disposal container
Figure A
Step 2: Wash your hands well with soap and water.
Step 3: Preparing a dose of Lovenox
Take the prefilled syringe out of the package.
Open the packaging by peeling the lid at the arrow as directed.
Take the prefilled syringe out of the plastic container by holding the middle of the syringe body (see
- Do not remove the prefilled syringe by pulling on the plunger rod or the needle cap as this may damage the syringe.
- Do not pull off the needle cap until you are ready to inject.
- Do not use the Lovenox prefilled syringe if it has been dropped on a hard surface or damaged.
Figure B
Step 4: Check the Lovenox prefilled syringe
- When you receive your Lovenox syringes, always check to see that:
- Do not use the Lovenox prefilled syringe if the expiration date has passed.
Figure C
Step 5: Check the medicine
- Look at the medicine inside the Lovenox prefilled syringe:
- Do not use the Lovenox prefilled syringe if the liquid is discolored or cloudy, or if it contains visible flakes or particles.
Figure D
Step 6: Choose your injection site
- You can inject into either the right or left side of your stomach area (abdomen), at least 2 inches away from your belly button and out towards your side (see
- You should alternate between the left or right side of your stomach each time you give yourself an injection.
- Do not inject into skin that has bruises or scars.
- Do not inject through clothes.
Figure E
Step 7: Clean the injection site
Clean the injection site with an alcohol wipe (see
Let your skin dry before injecting.
Figure F
Step 8: Remove the needle cap
Hold the prefilled syringe in the middle of the body with the needle pointing away from you. Remove the needle cap by pulling it straight off the syringe (see
- Do not twist the needle cap to avoid bending the needle.
- Do not put the needle cap back on.
- Do not touch the needle.
Figure G
Step 9: Injecting a dose that is less than the full amount in the prefilled syringe. If your prescribed dose is the same as the amount in the prefilled syringe, go to Step 10.
If your dose is based on your bodyweight, your healthcare provider may prescribe less than the full amount in the syringe. You will have to get rid of (discard) some of the medicine from the prefilled syringe before you inject Lovenox.
To measure your prescribed dose, hold the prefilled syringe with the needle pointing down. Carefully watch the numbers on the syringe as you push the plunger down until the amount left in the syringe is the same as your prescribed dose. The tip of the plunger should line up with the number for your prescribed dose (see
Figure H
Step 10: Injecting Lovenox
Hold the prefilled syringe like a pencil in your hand with the needle pointing down. With your other hand, pinch the cleaned stomach (abdomen) area between your forefinger and thumb to make a fold in the skin (see
Figure I
Insert the full length of the needle straight into the skin fold at about a 90° angle (see
Figure J
Push the plunger rod down slowly and steadily with your thumb until the Lovenox prefilled syringe is empty (see
Figure K
Step 11: Remove the needle
Remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger rod (see
- Do not put the needle cap back on.
- Do not rub your skin after the injection.
Figure L
Step 12: Activate the safety system
Point the needle away from yourself and other people, and firmly push the plunger rod again to activate the safety system. The protective sleeve will automatically come down and cover the needle. You will hear a "click" when the protective sleeve is released (see
- You will feel some resistance. This is normal. Keep pushing until you hear the "click."
- The safety system can only be activated after the syringe has been emptied.
- Only activate the safety system after you have removed the needle from your skin.
- Activation of the safety system may cause a small amount of liquid to leak out of the syringe.
Activate the system while facing the syringe away from yourself and other people.
Figure M
Step 13: Dispose of used Lovenox prefilled syringes and needle caps
Put the used Lovenox prefilled syringe and needle cap in an FDA-cleared sharps disposal container right away after use (see
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at http://www.fda.gov/safesharpsdisposal.
Figure N
sanofi-aventis U.S. LLC
Distributed By:
Cardinal Health
Dublin, OH 43017
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©2021 sanofi-aventis U.S. LLC
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
10Package/Label Display Panel
NDC 55154-4028-5
LOVENOX® 40 mg/0.4 mL
Enoxaparin Sodium Injection
5 x 0.4mL SYRINGES
