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Important Safety Information
LOVENOX® (enoxaparin sodium injection) cannot
be used interchangeably with other low-molecular-weight
heparins or unfractionated heparin, as they differ
in their manufacturing process, molecular weight
distribution, anti-Xa and anti-IIa activities,
units, and dosage. When epidural/spinal anesthesia
or spinal puncture is employed, patients anticoagulated
or scheduled to be anticoagulated with low-molecular-weight
heparins or heparinoids are at risk of developing
an epidural or spinal hematoma, which can result
in long-term or permanent paralysis. The risk
of these events is increased by the use of postoperative
indwelling epidural catheters or by the concomitant
use of drugs affecting hemostasis. Patients should
be frequently monitored for signs and symptoms
of neurological impairment. (See boxed WARNING.)
As with other anticoagulants, use with extreme
caution in patients with conditions that increase
the risk of hemorrhage. Dosage adjustment is
recommended in patients with severe renal impairment.
Unless otherwise indicated, agents that may affect
hemostasis should be discontinued prior to LOVENOX
therapy. Bleeding can occur at any site during
LOVENOX therapy. An unexplained fall in hematocrit
or blood pressure should lead to a search for
a bleeding site. (See WARNINGS and PRECAUTIONS.)
Thrombocytopenia can occur with LOVENOX®.
In patients with a history of heparin-induced
thrombocytopenia, LOVENOX® should be used
with extreme caution. Thrombocytopenia of any
degree should be monitored closely. If the platelet
count falls below 100,000/mm³, LOVENOX® should
be discontinued. Cases of heparin-induced thrombocytopenia
have been observed in clinical practice. (See
WARNINGS.) The use of LOVENOX® has not been
adequately studied for thromboprophylaxis in
pregnant women with mechanical prosthetic heart
values. (See WARNINGS.) LOVENOX® is contraindicated
in patients with hypersensitivity to enoxaparin
sodium, heparin, or pork products, and in patients
with active major bleeding. Please see full prescribing
information, including boxed WARNING.
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