ENOXAPARIN SODIUM injection

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)
Available from:
Cardinal Health
INN (International Name):
ENOXAPARIN SODIUM
Composition:
ENOXAPARIN SODIUM 100 mg in 1 mL
Administration route:
SUBCUTANEOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Enoxaparin sodium injection, USP is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): Enoxaparin sodium injection, USP is indicated for: Enoxaparin sodium injection, USP is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin. Enoxaparin sodium injection, USP, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI). Enoxaparin sodium injection is contraindicated in patients with: Risk Summary Placental transfer of enoxaparin was observed in the animal studies. Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of maj
Product summary:
Enoxaparin sodium injection, USP is available in two concentrations (see Tables 26 and 27 ): Prefilled Syringes ‡ 30 mg / 0.3 mL 3000 IU 10 syringes Medium Blue 0781-3133-63 40 mg / 0.4 mL 4000 IU 10 syringes Yellow 0781-3224-64 Graduated Prefilled Syringes ‡ 60 mg / 0.6 mL 6000 IU 10 syringes Orange 0781-3356-66 80 mg / 0.8 mL 8000 IU 10 syringes Brown 0781-3428-68 100 mg / mL 10,000 IU 10 syringes Black 0781-3500-69 Multiple-Dose Vial § 300 mg/3 mL 30,000 IU 1 vial Red 0781-3122-93 Graduated Prefilled Syringes ‡   120 mg / 0.8 mL 12,000 IU 10 syringes Purple 0781-3612-68   150 mg / mL 15,000 IU 10 syringes Navy Blue 0781-3655-69 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use.
Authorization status:
Abbreviated New Drug Application
Authorization number:
55154-5441-5

ENOXAPARIN SODIUM- enoxaparin sodium injection

Cardinal Health

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ENOXAPARIN SODIUM safely and

effectively. See full prescribing information for ENOXAPARIN SODIUM.

ENOXAPARIN SODIUM injection, USP for subcutaneous and intravenous use

Initial U.S. Approval: 1993

WARNING: SPINAL/EPIDURAL HEMATOMAS

See full prescribing information for complete boxed warning.

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:

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological

compromise is noted, urgent treatment is necessary. (5.1),(7)

INDICATIONS AND USAGE

Enoxaparin sodium injection, USP is a low molecular weight heparin [LMWH] indicated for:

DOSAGE AND ADMINISTRATION

See full prescribing information for dosing and administration information. (2)

DOSAGE FORMS AND STRENGTHS

100 mg/mL concentration (3):

150 mg/mL concentration (3):

CONTRAINDICATIONS

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.

Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement

surgery, or medical patients with severely restricted mobility during acute illness (1.1)

Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)

Outpatient treatment of acute DVT without pulmonary embolism. (1.2)

Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (1.3)

Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent

percutaneous coronary intervention [PCI] (1.4)

Prefilled syringes: 30 mg/0.3 mL, 40 mg/0.4 mL

Graduated prefilled syringes: 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL

Multiple-dose vial: 300 mg/3 mL

Graduated prefilled syringes: 120 mg/0.8 mL, 150 mg/mL

Active major bleeding (4)

History of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating

antibodies (4)

Hypersensitivity to enoxaparin sodium (4)

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

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

DRUG INTERACTIONS

Discontinue agents which may enhance hemorrhage risk prior to initiation of enoxaparin sodium injection or conduct close

clinical and laboratory monitoring (2.6, 7).

USE IN SPECIFIC POPULATIONS

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SPINAL/EPIDURAL HEMATOMAS

1 INDICATIONS AND USAGE

1.1 Prophylaxis of Deep Vein Thrombosis

1.2 Treatment of Acute Deep Vein Thrombosis

1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial

Infarction

1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Evaluation

2.2 Adult Dosage

2.3 Dose Reduction for Patients with Severe Renal Impairment

2.4 Recommended Dosage for Geriatric Patients with Acute ST-Segment Elevation Myocardial

Infarction

2.5 Administration

2.6 Monitoring for Safety

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Increased Risk of Hemorrhage

5.2 Increased Risk of Bleeding following Percutaneous Coronary Revascularization Procedures

5.3 Increased Risk of Bleeding in Patients with Concomitant Medical Conditions

5.4 Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis

5.5 Thrombocytopenia

Hypersensitivity to heparin or pork products (4)

Hypersensitivity to benzyl alcohol [for multiple-dose formulation only] (4)

Increased Risk of Hemorrhage: Monitor for signs of bleeding. (5.1) , 5.2, 5.3)

Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis. (5.4)

Thrombocytopenia: Monitor platelet count closely (5.5)

Interchangeability with other heparins: Do not exchange with heparin or other LMWHs (5.6)

Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves: Women and their

fetuses may be at increased risk. Monitor more frequently and adjust dosage as needed. (5.7)

Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min (2.3, 8.7)

Geriatric Patients: Monitor for increased risk of bleeding. (8.5)

Low-Weight Patients: Observe for signs of bleeding. (8.8)

5.6 Interchangeability with Other Heparins

5.7 Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves

5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Patients with Mechanical Prosthetic Heart Valves

8.7 Renal Impairment

8.8 Low-Weight Patients

8.9 Obese Patients

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

13.3 Reproductive and Developmental Toxicology

14 CLINICAL STUDIES

14.1 Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery in Patients at Risk for

Thromboembolic Complications

14.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

14.3 Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility

During Acute Illness

14.4 Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism

14.5 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial

Infarction

14.6 Treatment of Acute ST-Segment Elevation Myocardial Infarction

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

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 [see Warnings and Precautions (5.1) and Drug

Interactions (7)].

1 INDICATIONS AND USAGE

1.1 Prophylaxis of Deep Vein Thrombosis

Enoxaparin sodium injection, USP is indicated for the prophylaxis of deep vein thrombosis (DVT),

which may lead to pulmonary embolism (PE):

1.2 Treatment of Acute Deep Vein Thrombosis

Enoxaparin sodium injection, USP is indicated for:

1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial

Infarction

Enoxaparin sodium injection, USP is indicated for the prophylaxis of ischemic complications of

unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see

Clinical Studies (14.1)].

in patients undergoing hip replacement surgery, during and following hospitalization.

in patients undergoing knee replacement surgery.

in medical patients who are at risk for thromboembolic complications due to severely restricted

mobility during acute illness.

the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism,

when administered in conjunction with warfarin sodium.

the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when

administered in conjunction with warfarin sodium.

1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction

Enoxaparin sodium injection, USP, when administered concurrently with aspirin, has been shown to

reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with

acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed

medically or with percutaneous coronary intervention (PCI).

2 DOSAGE AND ADMINISTRATION

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 <30mL/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

1 mg/kg administered subcutaneously once daily

(no initial bolus)

administered in conjunction with aspirin

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

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.

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

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:

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.

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.

3 DOSAGE FORMS AND STRENGTHS

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.

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