Welcome to Fragmin: Power to Prevent

Resources are available for you to help educate your patients and their caregivers about FRAGMIN®. These include a:


	Patient Kit

	The patient kit contains the following helpful items:

		A guide about how to self-inject FRAGMIN®

		A DVD and videotape on self-injecting FRAGMIN®

		A SHARPS container for syringe disposal

		Alcohol swabs

		Important Safety Information


	Patient Video

	The patient video shows the proper injection techniques. Click on the Play Now button to begin viewing.


	FAQ Sheet

	Download a PDF file with the most frequently asked questions and answers about FRAGMIN®

		Click here to download the PDF.




The content on this Web site is dynamic and will be updated on a regular basis. You will find a robust collection of information, such as:

	Review of FRAGMIN^® across its indications

	Dosing Information

	Details about the use of FRAGMIN^®



	For information on:
		Patient Kits
		Benefits Verification
		Patient Assistance Program
		Contacting a Sales Rep

Call the FRAGMIN^® HOTLINE 1-866-272-8804 Mon thru Fri 9am to 6pm (EST)

	Indications
	FRAGMIN^® injection is indicated for the prophylaxis of DVT, which may lead to PE, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness, in patients undergoing hip-replacement surgery, and in patients undergoing abdominal surgery who are at risk for thromboembolic complications. FRAGMIN^® is indicated for the extended treatment of symptomatic VTE (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer. FRAGMIN^® is also indicated for the prophylaxis of ischemic complications in UA^‡ and NQWMI, when concurrently administered with aspirin therapy. ‡ With EKG changes.

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

Legal Notices | Privacy Policy | Prescribing Information

This Web site contains information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to substitute the advice of a physician or other health care professional.

The laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The information provided in this Web site is intended for residents/physicians of the United States only. The products discussed herein may have different product labeling in different countries.