Generic Name
Enoxaparin
Brand Names
Enoxiluv, Lovenox
FDA approval date: March 29, 1993
Classification: Low Molecular Weight Heparin
Form: Injection, Kit
What is Enoxiluv (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
Enoxiluv Kit (Enoxaparin Sodium, Isopropyl Alcohol)
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 enoxaparin sodium injection 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
Enoxaparin sodium injection is available as follows:
100 mg/mL Concentration
-Prefilled Syringes 40 mg / 0.4 mL
2CONTRAINDICATIONS
Enoxaparin sodium injection 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 (
- Known hypersensitivity to heparin or pork products.
- Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of enoxaparin sodium injection)
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 enoxaparin sodium. 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. Enoxaparin sodium 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 enoxaparin sodium doses were a 30 mg intravenous bolus followed by 1 mg/kg every 12 hours subcutaneously.
3.1.1Hemorrhage
The following rates of major bleeding events have been reported during clinical trials with enoxaparin sodium injection (see
NOTE: At no time point were the 40 mg once a day pre-operative and the 30 mg every 12 hours postoperative hip replacement surgery prophylactic regimens compared in clinical trials.
Injection site hematomas during the extended prophylaxis period after hip replacement surgery occurred in 9% of the enoxaparin sodium injection patients versus 1.8% of the placebo patients.
3.1.2Elevations of Serum Aminotransferases
Asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than three times the upper limit of normal of the laboratory reference range have been reported in up to 6.1% and 5.9% of patients, respectively, during treatment with enoxaparin sodium injection. Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like enoxaparin sodium injection should be interpreted with caution.
3.1.3Local Reactions
Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of enoxaparin sodium injection.
3.1.4Adverse Reactions in Patients Receiving Enoxaparin Sodium Injection for Prophylaxis or Treatment of DVT, PE:
Other adverse reactions that were thought to be possibly or probably related to treatment with enoxaparin sodium injection, heparin, or placebo in clinical trials with patients undergoing hip or knee replacement surgery, abdominal or colorectal surgery, or treatment for DVT and that occurred at a rate of at least 2% in the enoxaparin sodium injection group, are provided below (see
3.1.5Adverse Events in Enoxaparin Sodium Injection-Treated Patients with Unstable Angina or Non-Q-Wave Myocardial Infarction:
Non-hemorrhagic clinical events reported to be related to enoxaparin sodium injection therapy occurred at an incidence of ≤1%.
Non-major hemorrhagic events, primarily injection site ecchymosis and hematomas, were more frequently reported in patients treated with subcutaneous enoxaparin sodium injection than in patients treated with intravenous heparin.
Serious adverse events with enoxaparin sodium injection or heparin in a clinical trial in patients with unstable angina or non-Q-wave myocardial infarction that occurred at a rate of at least 0.5% in the enoxaparin sodium injection group are provided below (see
3.1.6Adverse Reactions in Enoxaparin Sodium Injection-Treated Patients with Acute ST-Segment Elevation Myocardial Infarction
In a clinical trial in patients with acute ST-segment elevation myocardial infarction, thrombocytopenia occurred at a rate of 1.5%.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of enoxaparin sodium injection. 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 enoxaparin sodium injection 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 (
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 enoxaparin sodium injection 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 enoxaparin sodium injection may lead to hemorrhagic complications. Injected enoxaparin sodium 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 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, 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 enoxaparin sodium injection 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 enoxaparin sodium 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
Enoxaparin sodium injection, USP 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
Enoxaparin Sodium Injection, USP 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.
The enoxaparin sodium injection, USP prefilled syringes are preservative-free and intended for use only as a single-dose injection.
7HOW SUPPLIED/STORAGE AND HANDLING
Enoxaparin sodium injection, USP is available as follows (see
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
8PATIENT COUNSELING INFORMATION
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 enoxaparin sodium injection if they continue enoxaparin sodium injection 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 enoxaparin sodium injection.
- 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 enoxaparin sodium injection multi-dose vials, in neonates, infants, and pregnant women.
- to tell their physicians and dentists they are taking enoxaparin sodium injection 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 [
Manufactured by
Shenzhen Techdow Pharmaceutical Co., Ltd.
Shenzhen City, Guangdong Province 518057, China for
Sandoz Inc., Princeton, NJ 08540
9Active ingredient
Isopropyl Alcohol 70% v/v
10Purpose
Antiseptic
11Uses
For first aid to decrease germs in
- minor cuts
- scrapes
- burns
For preparation of the skin prior to injection
12Warnings
For external use only
Flammable - keep away from fire or flame
12.1Do not use
with electrocautery procedures
12.2When using this product do not
- get into eyes
- apply over large areas of the body
- in case of deep or puncture wounds, animal bites or serious burns consult a doctor
12.3Stop use and ask a doctor if
- condition persists or gets worse or lasts for more than 72 hours
- do not use longer than 1 week unless directed by a doctor
12.4Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
13Directions
- apply to skin as needed
- discard after single use
14Other information
Protect from freezing and avoid excessive heat
15Inactive ingredient
Water