Dalteparin

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 adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months. • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks). • Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE

Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

Indication Dosing Regimen Unstable angina and non-Q-wave MI 120 units/kg subcutaneous every 12 hours (with aspirin). DVT prophylaxis in abdominal surgery 2,500 units subcutaneous once daily or 5,000 units subcutaneous once daily or 2,500 units subcutaneous followed by 2,500 units subcutaneous 12 hours later and then 5,000 units subcutaneous once daily. DVT prophylaxis in hip replacement surgery Postoperative start – 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily, or Preoperative start – day of surgery 2,500 units subcutaneous 2 hours before surgery followed by 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily. Preoperative start – Evening Before Surgery 5,000 units subcutaneous followed by 5,000 units subcutaneous 4 hours to 8 hours after surgery.

FRAGMIN is contraindicated in: • Patients with active major bleeding. • Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. • Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions). • Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN, o As a treatment for unstable angina and non-Q-wave MI. o For prolonged VTE prophylaxis. • Patients with prior hypersensitivity to heparin or pork products. • Active major bleeding. • History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. • Hypersensitivity to dalteparin sodium.

Boxed warning (spinal/epidural hematomas): Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. • Hemorrhage: Use caution in conditions with increased risk of hemorrhage. • Thrombocytopenia: Monitor thrombocytopenia of any degree closely. • Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol. • Laboratory Tests: Periodic blood counts recommended

The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information. • Risk of Hemorrhage including Spinal/Epidural Hematomas • Thrombocytopenia • Benzyl Alcohol Preservative Risk to Premature Infants Most common adverse reactions (>1%) are: bleeding (including hemorrhage), thrombocytopenia (Type I), hematoma at the injection site, pain at the injection site, transient elevation of transaminases

The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding.

Store at 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F).