Indications

FRAGMIN^® is a low molecular weight heparin (LMWH) indicated for:

• Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction

• Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness

• Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN^® therapy begins with the initial VTE treatment and continues for six months.

Limitations of Use

• FRAGMIN^® is not indicated for the acute treatment of VTE.

Important Safety Information

• FRAGMIN^® is contraindicated in patients with active major bleeding, history of heparin induced thrombocytopenia, hypersensitivity to dalteparin sodium, heparin, or pork products.

• FRAGMIN^® is contraindicated in patients undergoing epidural/neuraxial anesthesia as a treatment for unstable angina and non-Q-wave MI and for prolonged VTE prophylaxis due to an increased risk of bleeding associated with the dosage of FRAGMIN^® recommended for these indications.

• 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 caution in patients with bleeding diathesis, thrombocytopenia or platelet defects, severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding.

• FRAGMIN^® should be used with extreme caution in patients with history of heparin-induced thrombocytopenia.
  • In FRAGMIN^® clinical trials supporting non-cancer indications, platelet count of <50,000/mm3 occurred in <1% of patients.
  • In FRAGMIN^® clinical trials supporting the extended treatment of symptomatic VTE in patients with cancer, 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.

• Each multiple-dose vial of FRAGMIN^® contains benzyl alcohol as a preservative. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Because benzyl alcohol may cross the placenta, use caution when administering FRAGMIN^® preserved with benzyl alcohol to pregnant women. If anticoagulation with FRAGMIN^® is needed during pregnancy, use preservative-free formulations, where possible.

• Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with FRAGMIN^®.

• The most commonly reported side effect is hematoma at the injection site.

• Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred. A few cases of anaphylactoid reactions have been reported.

• Use FRAGMIN^® with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding.

• FRAGMIN^® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low molecular weight heparins.

• FRAGMIN^® Injection is not intended for intramuscular administration.

For more information about FRAGMIN, please see Full Product Information.