Welcome to Fragmin: Power to Prevent

Medical Thromboprophylaxis Clinical Trials

FRAGMIN^® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

Acutely ill medical patients with restricted mobility are at increased risk for the development of DVT and PE. Studies have shown that hospitalized medical patients who have at least one major risk factor for VTE have approximately a 10-15% risk for developing DVT if they do not receive prophylaxis therapy. Anticoagulant prophylaxis has been shown to reduce symptomatic DVTs in hospitalized medical patients by 53%. ¹⁷

The Joint Commission's National Patient Safety Goals (JCAHO) have recognized the importance of anticoagulation therapy in their latest update for hospital patients. They have implemented policies that require baseline and ongoing testing for patients receiving heparin and low molecular weight heparin therapies. ¹⁸

Acute deep venous thrombosis (DVT) on helical CT venography: pelvic DVT. Arrow is pointing to the dark spot in the right external iliac vein, consistent with DVT.

Reprinted with permission of Anderson Publishing, Ltd., from Gotway MB, Yee J. Helical CT pulmonary angiography for acute pulmonary embolism. Appl Radiol. 2002;31(4):21-30. Copyright 2002. Anderson Publishing, Ltd.


		Thromboprophylaxis is significantly underutilized (over half not treated promptly)¹⁹

		Limited mobility		Smoking

		Increasing age		Myeloproliferative disorders

		History of DVT/PE		Cancer and cancer therapy

		Varicose veins		Heart or respiratory failure

		Obesity		Inflammatory bowel disease




		Each year DVT strikes approximately 2 million Americans⁶



		Up to 20% of hospitalized medical patients develop DVT⁸

		More than 600,000 patients develop PE each year in the United States⁷

		"...it is estimated that as many as 10 million patients hospitalized annually for medical conditions merit screening for and prophylaxis against venous thromboembolic disease." —Bosker et al (Consensus Panel Statements for Outcome- Effective and Evidence-Based Patient Management)⁷

Important Safety Information

SPINAL/EPIDURAL HEMATOMAS
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications 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 indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug Interactions).

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

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