| FRAGMIN® is contraindicated in patients with active
major bleeding or with known hypersensitivity to the drug, heparin, or pork products, or
with thrombocytopenia associated with a positive antiplatelet antibody test |
|
| Patients undergoing regional anesthesia should not receive FRAGMIN® for unstable angina or non–Q-wave myocardial
infarction, and patients with cancer undergoing regional anesthesia should not receive FRAGMIN® for extended treatment
of symptomatic VTE, due to an increased risk of bleeding associated with the dosage of FRAGMIN® recommended for these indications |
|
| FRAGMIN® Injection is not intended for intramuscular administration |
|
| FRAGMIN® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low–molecular-weight heparins |
|
| FRAGMIN®, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage;
bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site |
|
| FRAGMIN® should be used with extreme caution in patients with history of heparin-induced thrombocytopenia |
|
| In FRAGMIN® clinical trials supporting non-cancer indications, platelet counts of <100,000/mm3 and <50,000/mm3
occurred in <1% and <1%, respectively |
|
| In a clinical trial of patients with cancer and acute symptomatic VTE treated for up to 6 months in the FRAGMIN® treatment arm,
platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm3.
In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN® arm and
8.1% of patients in the oral anticoagulant arm. FRAGMIN® dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3 |
|
| Thrombocytopenia of any degree should be monitored closely. Heparin-induced thrombocytopenia
can occur with administration of FRAGMIN®. The incidence of this complication is unknown at present.
In clinical practice, rare cases of thrombocytopenia with thrombosis have also been observed |
|
| FRAGMIN® should be used with caution in patients with bleeding diathesis, thrombocytopenia, or platelet defects;
severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding |
|
| Each multiple-dose vial of FRAGMIN® contains benzyl alcohol as a preservative [which] has been reported to be
associated with a fatal “Gasping Syndrome” in premature infants. Because benzyl alcohol may cross the placenta,
FRAGMIN® preserved with benzyl alcohol should be used with caution in pregnant women and only if
clearly needed. If anticoagulation with FRAGMIN® is needed during pregnancy, preservative-free
formulations should be used, where possible |
|
| FRAGMIN® should be used with care in patients receiving oral anticoagulants, platelet inhibitors,
and thrombolytic agents because of increased risk of bleeding (see PRECAUTIONS, Laboratory Tests). Aspirin, unless contraindicated,
is recommended in patients treated for unstable angina or non–Q-wave myocardial infarction (see DOSAGE AND ADMINISTRATION) |
|
| Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred rarely. A few
cases of anaphylactoid reactions have been reported |
|
| The most commonly reported side effect is hematoma at the injection site |
