Welcome to Fragmin: Power to Prevent

FRAGMIN^® is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer.

Cancer and Its Therapies Increase the Risk of Thrombosis

Cancer types, chemotherapy, and surgery compound the risk of thrombosis.


		Cancer types commonly associated with VTE include ovarian, pancreatic, colorectal, stomach, lung, lymphatic, prostate, and breast ^10,27

Thrombosis is one of the most common complications in patients with cancer ⁹

	FRAGMIN®, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery.

	As with other anticoagulants, bleeding can occur at any site during therapy with FRAGMIN®.

	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.

	If a thromboembolic event should occur despite dalteparin prophylaxis, FRAGMIN® should be discontinued and appropriate therapy initiated.

	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).

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

		Anti-Factor Xa may be used to monitor the anticoagulant effect of FRAGMIN^®, such as in patients with severe renal impairment or if abnormal coagulation parameters or bleeding should occur during FRAGMIN^® therapy

Reconsidering the Standard of Care

Warfarin—Clinical Limitations in Cancer Patients

		Although warfarin is still commonly used as part of a long-term treatment regimen for VTE in patients with cancer...³⁰

		—	Patients with cancer have a high risk of recurrent VTE and bleeding complications^28,29

		—	Warfarin therapy is associated with clinical drawbacks in patients with cancer³⁰

		—	Anticoagulant therapy is often interrupted by invasive procedures and chemotherapy, and poor venous access can complicate laboratory monitoring³⁰



	*	INR=International Normalized Ratio.




		Cancer and its therapies increase the risk of thrombosis^10,22-27



		Thrombosis is one of the most common complications in patients with cancer⁹

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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