(dalteparin sodium injection) for Subcutaneous Use Only
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.
Eisai Inc. acquired exclusive U.S. rights from Pfizer Inc in September 2005 to promote, further develop and distribute FRAGMIN.
DVT is a blood clot that forms in a deep vein, commonly in the calf or thigh and partially or completely obstructs blood flow. The clot may break off and travel to the vessels in the lungs, causing a pulmonary embolism (PE). While DVT and PE can occur at any time, the risk is increased during periods of immobility. Some of the symptoms of DVT include swelling, redness or discoloration, pain and increased warmth in the skin of the affected leg. Once a clot has traveled to the lungs, common symptoms of PE include chest pain, shortness of breath, dizziness, fainting anxiety or rapid pulse. A VTE is a medical episode involving a DVT, PE or both.
IMPORTANT SAFETY INFORMATION
WARNING: SPINAL/EPIDURAL HEMATOMA
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 and Drug Interactions].
- 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 ask your doctor or pharmacist or visit www.FRAGMIN.com. Please see Full Product Information or call Eisai Medical Information at 888-274-2378. To report suspected adverse reactions, call 888-274-2378.
For help with questions regarding access to FRAGMIN, contact the Eisai Assistance Program at 866-613-4724.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care professional, considering the unique characteristics of the patient.
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