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LOVENOX dosing in acutely ill medical patients

1 shot
a day

LOVENOX
40 mg subcutaneous once daily1


DVT prophylaxis dosing information
In Acutely Ill
Medical Patients

LOVENOX has once-daily dosing for medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, including fixed dosing across durations of therapy.

LOVENOX has proven outcomes in once-daily dosing of medically ill patients, offering:

  • Once-daily dosing for DVT prophylaxis in medically ill patients
  • Fixed dosing of 40 mg for up to 14 days
  • No monitoring of aPTT
    • Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with LOVENOX
  • No dose adjustments for concomitant medication
    • If coadministration is essential, conduct close clinical and laboratory monitoring
Prophylaxis in medical patients
Medical patients during acute illness
Dosing 40 mg subcutaneous once daily
Duration
of
therapy
  • Median: 7 days
  • Usual: 6 to 11 days
  • Maximum: 14 days

Many hospitalized acutely ill medical patients and surgical patients may develop deep vein thrombosis/pulmonary embolism (DVT/PE) as outpatients.

Appropriate length of DVT prophylaxis begins in the hospital and may continue with outpatient therapy.

Average hospital length of stay (LOS) vs recommended duration of prophylaxis1,2
Acute medical illness
Average hospital LOS 5 days
Usual duration of
administration with LOVENOX
6 to 11 days
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In Surgical Patients

See the dosing and duration of therapy information for patient types across prophylaxis of DVT patients.

Prophylaxis of DVT in hip or knee replacement surgery patients1
Hip replacement surgery, during and following hospitalization
Dosing 30 mg subcutaneously every 12 hours (initiated 12 to 24 hours postoperatively) provided hemostasis has been established at the wound site or
40 mg subcutaneously once daily may be considered
(initiated 12 ± 3 hours preoperatively)
Duration
of
therapy
  • Usual: 7 to 10 days
  • Administered up to 14 days in clinical trials
Continued prophylaxis in hip replacement surgery
Dosing 40 mg subcutaneously once daily (following initial phase of thromboprophylaxis) 40 mg SC once daily may be considered
Duration
of
therapy
  • 3 weeks recommended
Knee replacement surgery
Dosing 30 mg subcutaneously every 12 hours
(initiated 12 to 24 hours
postoperatively) provided
hemostasis has been established
at the wound site
Duration
of
therapy
  • Usual: 7 to 10 days
  • Administered up to 14 days in clinical trials
Severe renal impairment
(CrCl <30mL/min)
Dosing 30 mg subcutaneously once daily
Duration
of
therapy
  • Usual: 7 to 10 days
  • Administered up to 14 days in clinical trials

CrCI=creatinine clearance

Prophylaxis of DVT in abdominal surgery patients1
Abdominal surgery
Dosing 40 mg subcutaneously once daily
(initiated 2 hours prior to surgery)
Duration
of
therapy
  • Usual: 7 to 10 days
  • Administered up to 12 days in clinical trials
Severe renal impairment
(CrCl <30>)
Dosing 30mg subcutaneously once daily
Duration
of
therapy
  • Usual: 7 to 10 days
  • Administered up to 12 days in clinical trials

LOVENOX requires no dose adjustments with moderate (CrCl=30 to 50 mL/min) and mild (CrCl=30 to 50 mL/min) renal impairment; all such patients should be observed carefully for signs and symptoms of bleeding.

LOVENOX may be largely neutralized (up to 60%) by slow intravenous injection of protamine sulphate (1% solution).

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Acute DVT Patients
Inpatient and
Outpatient

See the dosing and duration therapy information in the inpatient or outpatient settings for treatment of acute DVT.

Inpatient and outpatient treatment of acute DVT3
Inpatients with acute DVT, with or without PE
Dosing 1.5 mg/kg subcutaneously once daily
(at the same time every day)
or
1 mg/kg subcutaneously every 12 hours
(both in conjunction with warfarin
sodium therapy)
Duration
of
therapy
7 days; minimum of
5 days, until INR=2.0-3.0;
administered up to 17 days in
controlled clinical trials
Outpatients with acute DVT, without PE
Dosing 1 mg/kg subcutaneously every 12 hours
(in conjunction with
warfarin sodium therapy)
Duration
of
therapy
7 days; minimum of
5 days, until INR=2.0-3.0;
administered up to 17 days in
controlled clinical trials
Inpatients (with acute DVT, with or without PE) or outpatients (with acute DVT, without PE) with severe renal impairment (CrCl <30mL/min)
Dosing 1 mg/kg subcutaneously once daily
(in conjunction with warfarin sodium therapy)
Duration
of
therapy
7 days; minimum of
5 days, until INR=2.0-3.0;
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ACS dosing information
In UA/NSTEMI Patients

See the dosing and duration of therapy information for prophylaxis of ischemic complications in UA/NSTEMI patients.

Prophylaxis of ischemic complications of UA/NSTEMI patients1
UA/NSTEMI
(non-Q-wave MI)
Dosing 1 mg/kg subcutaneously every 12 hours
(in conjunction with oral aspirin therapy 100 mg to 325 mg once daily)
Duration of therapy
  • Minimum: 2 days and continued until clinical stabilization
  • Usual: 2 to 8 days
  • Administered up to 12.5 days clinical trials
Severe renal impairment
(CrCI <30mL/min)
Dosing 1 mg/kg subcutaneously once daily
(in conjunction with oral aspirin therapy 100 mg to 325 mg once daily)
Duration of therapy
  • Minimum: 2 days and continued until clinical stabilization
  • Usual: 2 to 8 days

UA/NSTEMI=unstable angina/non-ST-segment elevation MI.

LOVENOX requires no dose adjustments with moderate (CrCI=30 to 50 mL/min) and mild (CrCI=50 to 80 mL/min) renal impairment; all such patients should be observed carefully for signs and symptoms of bleeding.

LOVENOX may be largely neutralized (up to 60%) by slow intravenous injection of protamine sulphate (1% solution).

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Treatment after MI in
STEMI patients

See the dosing and duration of therapy information for the treatment of acute STEMI patients.

Treatment of acute STEMI patients1,3
<75 years of age
Dosing 30 mg single intravenous bolus plus 1 mg/kg subcutaneously followed by 1 mg/kg subcutaneously every 12 hours (maximum 100 mg for each of these 2 subcutaneous doses only, followed by 1 mg/kg dosing for the remaining doses). In pivotal trial, first subcutaneous dose given within 15 minutes of intravenous bolus1
Duration of therapy LOVENOX treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days
<75 years of age
renal impairment (CrCl <30>ml/min)
Dosing 30 mg single intravenous bolus plus 1 mg/kg subcutaneously followed by 1 mg/kg subcutaneously once daily
Duration of therapy LOVENOX treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first
≥75 years of age
Dosing No initial intravenous bolus; 0.75 mg/kg subcutaneously every 12 hours (maximum 75 mg for each of the first 2 subcutaneous doses only, followed by 0.75 mg/kg dosing for the remaining doses)
Duration of therapy LOVENOX treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days
≥75 years of age with severe
renal impairment (CrCl <30>)
Dosing No initial intravenous bolus; 1 mg/kg subcutaneously once daily
Duration of therapy LOVENOX treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first

CrCI=creatinine clearance

Patients transitioned to PCI1
If the last LOVENOX subcutaneous administration was given:
<8 hours before balloon inflation
>8 hours before balloon inflation




No additional dosing needed
Administer LOVENOX 0.3 mg/kg intravenous bolus

All patients should receive ASA as soon as they are identified as having STEMI, and maintained with 75 mg to 325 mg once daily, unless contraindicated.

The only adverse reaction that occurred at a rate of at least 0.5% in the Lovenox group was thrombocytopenia (1.5%).

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Use in special populations
Dose modifications

See information about the use of LOVENOX across different special population types.

Patient characteristics1
Pregnancy
  • Cases of epidural or spinal hemorrhage and subsequent hematomas have been reported with the use of LOVENOX and epidural or spinal anesthesia/ analgesia or spinal puncture procedures, resulting in long-term or permanent paralysis. The risk of these events is higher with the use of postoperative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning, Adverse Reactions (6.2) and Drug Interactions (7)]
  • Women with mechanical prosthetic heart valves may be at higher risk for thromboembolism during pregnancy, and, when pregnant, have a higher rate of fetal loss from stillbirth, spontaneous abortion and premature delivery. Therefore, frequent monitoring of peak and trough anti-Factor Xa levels, and adjusting of dosage may be needed [see Use in Specific Populations (8.6)]
  • Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high-risk pregnancy conditions (see Warnings and Precautions in full Prescribing Information)
  • Pregnant women receiving anticoagulants such as LOVENOX are at risk for bleeding and should be carefully monitored for evidence of bleeding or excessive anticoagulation (see Boxed Warning in full Prescribing Information)
Nursing mothers
  • It is not known whether this drug is excreted in human milk
  • Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from LOVENOX, a decision should be made whether to discontinue nursing or discontinue LOVENOX, taking into account the importance of LOVENOX to the mother and the known benefits of nursing.
Pediatric use
  • LOVENOX 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. LOVENOX 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 in full Prescribing Information)
Geriatric use—DVT in hip or knee replacement and abdominal surgery; treatment of DVT; prevention of ischemic complications of UA and non-Q-wave MI
  • More than 2,800 patients, 65 years and older, have received LOVENOX in pivotal clinical trials. The efficacy of LOVENOX in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years). The incidence of bleeding complications was similar between geriatric patients as compared to younger patients when LOVENOX was administered at doses of 1.5 mg/kg once daily or 1 mg/kg q12h. The risk of LOVENOX-associated bleeding increased with age. Serious adverse events increased with age for patients receiving LOVENOX. Other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of LOVENOX between geriatric and younger patients. Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. LOVENOX 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 decrease renal function should be considered (see Warnings and Precautions in full Prescribing Information)
Geriatric use—treatment of acute STEMI
  • In the clinical study for treatment of acute STEMI, there was no evidence of difference in efficacy between patients ≥75 years of age (n=1,241) and patients <75 years of age (n=9,015). Patients ≥75 years of age did not receive a 30 mg intravenous bolus prior to the normal regimen and had their subcutaneous dose adjusted to 0.75 mg/kg every 12 hours (see Dosage and Administration in full Prescribing Information)
  • The incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years of age)
Patients with mechanical prosthetic heart valves
  • Use of LOVENOX in patients with mechanical prosthetic heart valves has not been adequately studied. Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received LOVENOX for thromboprophylaxis. Some of these cases were pregnant women in whom thrombosis led to maternal and fetal deaths. Insufficient data, the underlying disease, and the possibility of inadequate anticoagulation complicate the evaluation of these cases
  • Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism (see Warnings and Precautions in full Prescribing Information)
Renal Impairment
  • In patients with renal impairment, there is an increase in exposure of enoxaparin sodium. All such patients should be observed carefully for signs and symptoms of bleeding. Because exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 mL/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. No dosage adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]
  • In patients with renal failure, treatment with enoxaparin has been associated with the development of hyperkalemia (see Adverse Reactions in full Prescribing Information)
Hepatic impairment
  • The impact of hepatic impairment on LOVENOX exposure and antithrombotic effect has not been investigated. Caution should be exercised when administering LOVENOX to patients with hepatic impairment
Low-weight patients
  • An increase in exposure of LOVENOX with prophylactic dosages (non–weight–adjusted) has been observed in low-weight women (<45 kg) and low weight men (<57 kg). All such patients should be observed carefully for signs and symptoms of bleeding (see Clinical Pharmacology in full Prescribing Information)
Obese patients
  • Obese patients are at higher risk for thromboembolism. The safety and efficacy of prophylactic doses of LOVENOX in obese patients (BMI >30 kg/m2) has not been fully determined and there is no consensus for dose adjustment. These patients should be observed carefully for signs and symptoms of thromboembolism

DVT=deep vein thrombosis; Ml=myocardial infarction; STEMI=ST-segment elevation myocardial infraction; UA=unstable angina.

LOVENOX may be largely neutralized (up to 60%) by slow intravenous injection of protarnine sulfate (1% solution).

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Dosage and administration1
Summary of dosing

See the dosage specifications for specific indications and patient types.

Indication
Dose
DVT prophylaxis in abdominal surgery
40 mg subcutaneously once daily
DVT prophylaxis in knee replacement surgery
30 mg subcutaneously every 12 hours
DVT prophylaxis in hip replacement surgery
30 mg subcutaneously every 12 hours or 40 mg subcutaneously once daily
DVT prophylaxis in medical patients
40 mg subcutaneously once daily
Inpatient treatment of acute DVT with or without pulmonary embolism
1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg subcutaneously once daily*
Outpatient treatment of acute DVT without pulmonary embolism
1 mg/kg subcutaneously every 12 hours*
Unstable angina and non-Q-wave MI
30 mg/kg subcutaneously every 12 hours (with aspirin)
Acute STEMI in patients <75 years of age [for dosing in subsequent PCI, see dosage and administration in full Prescribing Information]
30 mg single intravenous bolus plus 1 mg/kg subcutaneously every 12 hours (with aspirin)
Acute STEMI in patients ≥75 years age
0.75 mg/kg subcutaneously every 12 hours (no bolus) (with aspirin)

*See recommendations regarding transitioning to warfarin therapy in the full Prescribing Information.

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Learn about treatments with LOVENOX
in medically ill patients.

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See efficacy information about
treatment with LOVENOX in patients
with acute coronary syndrome.

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Important Safety Information
for LOVENOX®

Warning: spinal/epidural hematoma Epidural or spinal hematomas may occur in
patients who are anticoagulated with low