Enoxiluv Kit

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• See full prescribing information for dosing and administration information.
• ( 2 )
• 2.1 Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting enoxaparin sodium injection treatment, unless treatment is urgently needed.
• 2.2 Adult 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 [see Clinical Studies ( 14.1 )] .
• 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 [see Clinical Studies ( 14.2 )].
• 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.
• Administer the initial dose 12 (±3) hours prior to surgery.
• 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 [see Clinical Studies ( 14.3 )].
• 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).
• In both outpatient and inpatient (hospital) treatments, initiate warfarin sodium therapy when appropriate (usually within 72 hours of enoxaparin sodium injection).
• Continue enoxaparin sodium injection for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2 to 3).
• The average duration of administration is 7 days [see Clinical Studies ( 14.4 )] .
• 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.
• Treat with enoxaparin sodium injection for a minimum of 2 days and continue until clinical stabilization.
• The usual duration of treatment is 2 to 8 days [see Warnings and Precautions ( 5.2 ) and Clinical Studies ( 14.5 ) ].
• Treatment of Acute ST-Segment Elevation Myocardial Infarction The recommended dose of enoxaparin sodium injection is a single intravenous bolus of 30 mg plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses) in patients with acute ST-segment elevation myocardial infarction.
• Reduce the dosage in patients ≥75 years of age [see Dosage and Administration ( 2.4 ) ] .
• Unless contraindicated, administer aspirin to all patients as soon as they are identified as having STEMI and continue dosing with 75 to 325 mg once daily.
• When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), administer enoxaparin sodium injection between 15 minutes before and 30 minutes after the start of fibrinolytic therapy.
• The usual duration of enoxaparin sodium injection therapy is 8 days or until hospital discharge.
• For patients managed with percutaneous coronary intervention (PCI), if the last enoxaparin sodium injection subcutaneous administration was given less than 8 hours before balloon inflation, no additional dosing is needed.
• If the last enoxaparin sodium injection subcutaneous administration was given more than 8 hours before balloon inflation, administer an intravenous bolus of 0.3 mg/kg of enoxaparin sodium injection [see Warnings and Precautions ( 5.2 ) ] .
• 2.3 Dose Reduction for Patients with Severe Renal Impairment The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 ) ] .
• Table 1 Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance <30 mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered subcutaneously once daily Prophylaxis in hip or knee replacement surgery 30 mg administered subcutaneously once daily Prophylaxis in medical patients during acute illness 30 mg administered subcutaneously once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered subcutaneously once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered subcutaneously once daily 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) Although no dose adjustment is recommended in patients with creatinine clearance 30 to 50 mL/min and creatinine clearance 50 to 80 mL/min, observe these patients frequently for signs and symptoms of bleeding.
• 2.4 Recommended Dosage for Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age,
• do not use an initial intravenous bolus .
• Initiate dosing with 0.75 mg/kg subcutaneously every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations ( 8.5 ) and Clinical Pharmacology ( 12.3 ) ] .
• No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration ( 2.2 ) ] .
• 2.5 Administration Do not administer enoxaparin sodium injection by intramuscular injection.
• Administer enoxaparin sodium injection by intravenous or subcutaneous injection only.
• Enoxaparin sodium injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
• Use a tuberculin syringe or equivalent
• when using enoxaparin sodium injection multiple-dose vials to assure withdrawal of the appropriate volume of drug.
• Patients may self-inject by the subcutaneous route of administration only after their physicians determine that it is appropriate and with medical follow-up, as necessary.
• Provide proper training in subcutaneous injection technique before allowing self-injection (with or without the assistance of an injection device).
• Subcutaneous Injection Technique Position patients in a supine position for enoxaparin sodium administration by deep subcutaneous injection.
• Do not expel the air bubble from the prefilled syringes before the injection, to
• avoid the loss of drug.
• Alternate injection sites between the left and right anterolateral and left and right posterolateral abdominal wall.
• Introduce the whole length of the needle into a skin fold held between the thumb and forefinger; hold the skin fold throughout the injection.
• To minimize bruising, do not rub the injection site after completion of the injection.
• Enoxaparin sodium injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
• Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister.
• Do not remove by pulling on the plunger as this may damage the syringe.
• Remove the needle shield by pulling it straight off the syringe (see Figure A ).
• If less than the full syringe volume is needed to administer the prescribed dose, eject syringe contents until the prescribed dose is left in the syringe.
• Figure A Inject using standard technique, pushing the plunger to the bottom of the syringe (see Figure B ).
• Figure B Remove the syringe from the injection site keeping your finger on the plunger rod (see Figure C ).
• Figure C Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod.
• The protective sleeve will automatically cover the needle and an audible “click” will be heard to confirm shield activation (see Figure D ).
• Figure D Immediately dispose of the syringe in the nearest sharps container (see Figure E ).
• Figure E NOTE: The safety system can only be activated once the syringe has been emptied.
• Activation of the safety system must be done only after removing the needle from the patient’s skin.
• Do not replace the needle shield after injection.
• The safety system should not be sterilized.
• Activation of the safety system may cause minimal splatter of fluid.
• For optimal safety, activate the system while orienting it downwards away from yourself and others.
• Enoxaparin Figure A Enoxaparin Figure B Enoxaparin Figure C Enoxaparin Figure D Enoxaparin Figure E Intravenous (Bolus) Injection Technique Use the multiple-dose vial for intravenous injections.
• Administer enoxaparin sodium injection through an intravenous line.
• Do not mix or coadminister enoxaparin sodium injection with other medications.
• Flush the intravenous access device with a sufficient volume of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium injection, to prevent mixing of drugs.
• Enoxaparin sodium injection is compatible with normal saline solution (0.9%) or 5% dextrose in water.
• 2.6 Monitoring for Safety During therapy monitor complete blood counts including platelets and stool occult blood.
• Assess for signs and symptoms of bleeding.
• In patients with renal impairment anti-Factor Xa levels may be used to monitor the anticoagulant effects of enoxaparin sodium injection.
• If during enoxaparin sodium therapy abnormal coagulation parameters or bleeding should occur, anti-Factor Xa levels may be used to monitor the anticoagulant effects of enoxaparin sodium injection [see Clinical Pharmacology ( 12.3 )] .
• Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) are not adequate for monitoring the anticoagulant effects of enoxaparin sodium injection.
• apply to skin as needed discard after single use

Quoted from the official label, section “Dosage & Administration”.

Stop and get help if

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use 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.
• Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative.
• In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L).
• Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.
• Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.
• The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.
• Enoxaparin sodium injection multiple-dose vials contain 15 mg/mL of benzyl alcohol (at the dose of 1.5 mg/kg twice a day, benzyl alcohol exposure in patients is 0.45 mg/kg daily) [see Warnings and Precautions ( 5.8 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Prevention of Deep Vein Thrombosis in Hip, Knee and Abdominal Surgery;
• Treatment of Deep Vein Thrombosis, Prevention of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction Over 2800 patients, 65 years and older, have received enoxaparin sodium injection in clinical trials.
• The efficacy of enoxaparin sodium injection in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years).
• The incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of enoxaparin sodium injection were employed.
• The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when enoxaparin sodium injection was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours.
• The risk of enoxaparin sodium injection -associated bleeding increased with age.
• Serious adverse events increased with age for patients receiving enoxaparin sodium injection.
• Other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of enoxaparin sodium injection between geriatric and younger patients.
• Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised.
• Enoxaparin sodium injection should be used with care in geriatric patients who may show delayed elimination of enoxaparin.
• Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered [see Warnings and Precautions ( 2.6 ) and Clinical Pharmacology ( 12.3 )] .
• Treatment of Acute ST-Segment Elevation Myocardial Infarction In the clinical study for treatment of acute ST-segment elevation myocardial infarction, there was no evidence of difference in efficacy between patients ≥75 years of age (n = 1241) and patients less than 75 years of age (n = 9015).
• Patients ≥75 years of age did not receive a 30 mg intravenous bolus prior to the normal dosage regimen and had their subcutaneous dose adjusted to 0.75 mg/kg every 12 hours [see Dosage and Administration ( 2.4 )] .
• The incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years).

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are also discussed in other sections of the labeling:
• Spinal/epidural hematomas [see Boxed Warning and Warnings and Precautions ( 5.1 ) ] Increased Risk of Hemorrhage [see Warnings and Precautions ( 5.1 ) ] Thrombocytopenia [see Warnings and Precautions ( 5.5 ) ] Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical 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.
• Hemorrhage The following rates of major bleeding events have been reported during clinical trials with enoxaparin sodium injection (see Tables 2 to 7 ).
• Table 2 Major Bleeding Episodes Following Abdominal and Colorectal Surgery Bleeding complications were considered major:
• (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products.
• Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.
• Dosing Regimen Indications Enoxaparin Sodium Injection 40 mg daily subcutaneously Heparin 5000 U q8h subcutaneously Abdominal Surgery n = 555 23 (4%) n = 560 16 (3%) Colorectal Surgery n = 673 28 (4%) n = 674 21 (3%) Table 3 Major Bleeding Episodes Following Hip or Knee Replacement Surgery Bleeding complications were considered major:
• (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products.
• Retroperitoneal and intracranial hemorrhages were always considered major.
• In the knee replacement surgery trials, intraocular hemorrhages were also considered major hemorrhages.
• Dosing Regimen Indications Enoxaparin Sodium Injection 40 mg daily subcutaneously Enoxaparin Sodium Injection 30 mg q12h subcutaneously Heparin 15,000 U/24h subcutaneously Hip Replacement Surgery Without Extended Prophylaxis Enoxaparin sodium injection 30 mg every 12 hours subcutaneously initiated 12 to 24 hours after surgery and continued for up to 14 days after surgery. n = 786 31 (4%) n = 541 32 (6%) Hip Replacement Surgery With Extended Prophylaxis Peri-operative Period Enoxaparin sodium injection 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery and continued for up to 7 days after surgery. n = 288 4 (2%) Extended Prophylaxis Period Enoxaparin sodium injection 40 mg subcutaneously once a day for up to 21 days after discharge. n = 221 0 (0%) Knee Replacement Surgery Without Extended Prophylaxis n = 294 3 (1%) n = 225 3 (1%) 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.
• Table 4 Major Bleeding Episodes in Medical Patients With Severely Restricted Mobility During Acute Illness Bleeding complications were considered major:
• (1) if the hemorrhage caused a significant clinical event, (2) if the hemorrhage caused a decrease in hemoglobin of ≥2 g/dL or transfusion of 2 or more units of blood products.
• Retroperitoneal and intracranial hemorrhages were always considered major although none were reported during the trial.
• Dosing Regimen Indication Enoxaparin Sodium Injection The rates represent major bleeding on study medication up to 24 hours after last dose. 20 mg daily subcutaneously Enoxaparin Sodium Injection 40 mg daily subcutaneously Placebo Medical Patients During Acute Illness n = 351 1 (<1%) n = 360 3 (<1%) n = 362 2 (<1%) Table 5 Major Bleeding Episodes in Deep Vein Thrombosis with or without Pulmonary Embolism Treatment Bleeding complications were considered major:
• (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease ≥2 g/dL or transfusion of 2 or more units of blood products.
• Retroperitoneal, intraocular, and intracranial hemorrhages were always considered major.
• Dosing Regimen All patients also received warfarin sodium (dose-adjusted according to PT to achieve an INR of 2.0 to 3.0) commencing within 72 hours of enoxaparin sodium injection or standard heparin therapy and continuing for up to 90 days.
• Indication Enoxaparin Sodium Injection 1.5 mg/kg daily subcutaneously Enoxaparin Sodium Injection 1 mg/kg q12h subcutaneously Heparin aPTT Adjusted Intravenous Therapy Treatment of DVT and PE n = 298 5 (2%) n = 559 9 (2%) n = 554 9 (2%) Table 6 Major Bleeding Episodes in Unstable Angina and Non-Q-Wave Myocardial Infarction Dosing Regimen Indication Enoxaparin Sodium Injection The rates represent major bleeding on study medication up to 12 hours after dose. 1 mg/kg q12h subcutaneously Heparin aPTT Adjusted Intravenous Therapy Unstable Angina and Non- Q-Wave MI Aspirin therapy was administered concurrently (100 to 325 mg per day). , Bleeding complications were considered major:
• (1) if the hemorrhage caused a significant clinical event, or (2) if accompanied by a hemoglobin decrease by ≥3 g/dL or transfusion of 2 or more units of blood products.
• Intraocular, retroperitoneal, and intracranial hemorrhages were always considered major. n = 1578 17 (1%) n = 1529 18 (1%) Table 7 Major Bleeding Episodes in Acute ST-Segment Elevation Myocardial Infarction Dosing Regimen Indication Enoxaparin Sodium Injection The rates represent major bleeding (including ICH) up to 30 days Initial 30 mg intravenous bolus followed by 1 mg/kg q12h subcutaneously Heparin aPTT Adjusted Intravenous Therapy Acute ST-Segment Elevation Myocardial Infarction n = 10176 n (%) n = 10151 n (%) Major bleeding (including ICH) Bleedings were considered major if the hemorrhage caused a significant clinical event associated with a hemoglobin decrease by ≥ 5 g/dL.
• ICH were always considered major. 211 (2.1) 138 (1.4) Intracranial hemorrhages (ICH) 84 (0.8) 66 (0.7) Elevations 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.
• Local Reactions Local irritation, pain, hematoma, ecchymosis, and erythema may follow subcutaneous injection of enoxaparin sodium injection.
• Adverse 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 Tables 8 to 11 ).
• Table 8 Adverse Reactions Occurring at ≥2% Incidence in Enoxaparin Sodium Injection-Treated Patients Undergoing Abdominal or Colorectal Surgery Dosing Regimen Enoxaparin Sodium Injection 40 mg daily subcutaneously n = 1228 % Heparin 5000 U q8h subcutaneously n = 1234 % Adverse Reaction Severe Total Severe Total Hemorrhage <1 7 <1 6 Anemia <1 3 <1 3 Ecchymosis 0 3 0 3 Table 9 Adverse Reactions Occurring at ≥2% Incidence in Enoxaparin Sodium Injection-Treated Patients Undergoing Hip or Knee Replacement Surgery Dosing Regimen Enoxaparin Sodium Injection 40 mg daily subcutaneously Enoxaparin Sodium Injection 30 mg q12h subcutaneously Heparin 15,000 U/24h subcutaneously Placebo q12h subcutaneously Peri-Operative Period n = 288 Data represent enoxaparin sodium injection 40 mg subcutaneously once a day initiated up to 12 hours prior to surgery in 288 hip replacement surgery patients who received enoxaparin sodium injection peri-operatively in an unblinded fashion in one clinical trial. % Extended Prophylaxis Period n = 131 Data represent enoxaparin sodium injection 40 mg subcutaneously once a day given in a blinded fashion as extended prophylaxis at the end of the peri-operative period in 131 of the original 288 hip replacement surgery patients for up to 21 days in one clinical trial. % n = 1080 % n = 766 % n = 115 % Adverse Reaction Severe Total Severe Total Severe Total Severe Total Severe Total Fever 0 8 0 0 <1 5 <1 4 0 3 Hemorrhage <1 13 0 5 <1 4 1 4 0 3 Nausea <1 3 <1 2 0 2 Anemia 0 16 0 <2 <1 2 2 5 <1 7 Edema <1 2 <1 2 0 2 Peripheral edema 0 6 0 0 <1 3 <1 4 0 3 Table 10 Adverse Reactions Occurring at ≥2% Incidence in Enoxaparin Sodium Injection-Treated Medical Patients with Severely Restricted Mobility During Acute Illness Dosing Regimen Adverse Reaction Enoxaparin Sodium Injection 40 mg daily subcutaneously n = 360 % Placebo daily subcutaneously n = 362 % Dyspnea 3.3
• 5.2 Thrombocytopenia 2.8
• 2.8 Confusion 2.2
• 1.1 Diarrhea 2.2
• 1.7 Nausea 2.5
• 1.7 Table 11 Adverse Reactions Occurring at ≥2% Incidence in Enoxaparin Sodium Injection-Treated Patients Undergoing Treatment of Deep Vein Thrombosis With or Without Pulmonary Embolism Dosing Regimen Enoxaparin Sodium Injection 1.5 mg/kg daily subcutaneously n = 298 % Enoxaparin Sodium Injection 1 mg/kg q12h subcutaneously n = 559 % Heparin aPTT Adjusted Intravenous Therapy n = 544 % Adverse Reaction Severe Total Severe Total Severe Total Injection Site Hemorrhage 0 5 0 3 <1 <1 Injection Site Pain 0 2 0 2 0 0 Hematuria 0 2 0 <1 <1 2 Adverse 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 Table 12 ).
• Table 12 Serious Adverse Events Occurring at ≥0.5% Incidence in Enoxaparin Sodium Injection-Treated Patients With Unstable Angina or Non-Q-Wave Myocardial Infarction Dosing Regimen Adverse Event Enoxaparin Sodium Injection 1 mg/kg q12h subcutaneously n = 1578 n (%) Heparin aPTT Adjusted Intravenous Therapy n = 1529 n (%) Atrial fibrillation 11 (0.70) 3 (0.20) Heart failure 15 (0.95) 11 (0.72) Lung edema 11 (0.70) 11 (0.72) Pneumonia 13 (0.82) 9 (0.59) Adverse 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%.
• 6.2 Postmarketing 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 ( e.g. nodules, inflammation, oozing), systemic allergic reactions ( e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions including shock), vesiculobullous rash, cases of hypersensitivity cutaneous vasculitis, purpura, skin necrosis (occurring at either the injection site or distant from the injection site), thrombocytosis, and thrombocytopenia with thrombosis [ see Warnings and Precautions (5.5) ] have been reported.
• 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.

Quoted from the official label, section “Adverse Reactions”.

Keep away from children

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

What to discuss with your doctor

• 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 [ see Warnings and Precautions ( 5.1 , 5.5 ) ]. 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 [ see Warnings and Precautions ( 5.1 , 5.3 ) ]. to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [ see Drug Interactions ( 7 ) ].
• Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd.
• Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Enoxaparin sodium injection is available as follows:
• 100 mg/mL Concentration -Prefilled Syringes 40 mg / 0.4 mL 100 mg/mL concentration ( 3 ):
• Prefilled syringes:
• 40 mg/0.4 mL

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Enoxaparin sodium injection, USP is available as follows (see Tables 26 ):
• Table 26 100 mg/mL Concentration Dosage Unit/Strength Strength represents the number of milligrams of enoxaparin sodium in Water for Injection.
• Enoxaparin sodium injection, USP 40 mg prefilled syringes, each contain 10 mg enoxaparin sodium per 0.1 mL Water for Injection.
• Anti-Xa Activity Approximate anti-Factor Xa activity based on reference to the W.H.O.
• First International Low Molecular Weight Heparin Reference Standard.
• Package Size (per carton) Label Color NDC # Prefilled Syringes Each enoxaparin sodium injection, USP prefilled syringe is for single, one-time use only and is affixed with a 27 gauge × 1/2 inch needle. 40 mg/0.4 mL 4000 IU 10 syringes Yellow 0781-3246-64
• 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 .

Quoted from the official label, section “How Supplied”.

How to store it

Protect from freezing and avoid excessive heat

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Antiseptic

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

Water

Quoted from the official label, section “Inactive Ingredients”.

What is in it

• 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:
• <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% 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. [see Dosage and Administration ( 2 ) and How Supplied/Storage and Handling ( 16 ) ] .
• Enoxaparin Sodium Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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