Generic Name and Formulations:
Dalteparin sodium 2500 IU/0.2mL syringe, 5000 IU/0.2mL syringe, 7500 IU/0.3mL syringe, 10000 IU/0.4mL syringe, 10000 IU/1mL graduated syringe, 12500 IU/0.5mL syringe, 15000 IU/0.6mL syringe, 18000 IU/0.72mL syringe for SC inj (preservative-free); 10000 IU/1mL, 25000 IU/1mL multidose vial, for SC inj (contains benzyl alcohol).

Company:
Eisai Pharmaceuticals
Indications for FRAGMIN:
Prevention of ischemic complications in unstable angina and non-Q-wave MI with aspirin. Prevention of DVT in patients undergoing hip replacement or abdominal surgery or those with severely restricted mobility during acute illness at risk for thromboembolic complications. Extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or pulmonary embolism), to reduce the recurrence of VTE in cancer patients.

Adult:
Give deep SC; rotate inj sites. Angina, MI: 120 IU/kg (max 10000 IU) every 12hrs until stabilized (usually 5–8 days), with aspirin 75–165mg once daily. Hip replacement, post-op start: 2500 IU 4–8hrs after surgery, then 5000 IU once daily (at least 6 hrs after 1st dose); hip replacement, pre-op start day of surgery: 2500 IU within 2hrs before surgery, then 2500 IU 4–8hrs after surgery, then 5000 IU once daily (at least 6hrs after previous dose); hip replacement pre-op evening before surgery: 5000 IU 10–14hrs before surgery, then 5000 IU 4–8hrs after surgery, then 5000 IU once daily (allow 24hrs between doses); for all hip replacement regimens: usually treat for 5–10 days; max up to 14 days post-op. Abdominal surgery: 2500 IU once daily (usually for 5–10 days) starting 1–2hrs pre-op; for high risk of thromboembolism (eg, malignancy): see literature. Severely restricted mobility: 5000 IU once daily (usually for 12–14 days). Extended treatment of symptomatic VTE in patients with cancer: 200 IU/kg once daily for the first 30 days, then 150 IU/kg once daily for months 2–6; max daily dose 18000 IU; dose reductions for thrombocytopenia or renal insufficiency: see literature.

Children:
Not recommended.

Contraindications:
Active major bleeding. Not for use in unstable angina, non-Q-wave MI, or cancer patients undergoing regional anesthesia. Thrombocytopenia associated with (+) in vitro tests for anti-platelet antibody in presence of dalteparin. Heparin or pork allergy.

Warnings/Precautions:
Not interchangeable (unit-for-unit) with heparin or other low molecular weight heparin products. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Uncontrolled hypertension. Bleeding disorders. Acute ulcerative or angiodysplastic GI disease. Hemorrhagic stroke. Bacterial endocarditis. Recent brain, spinal, or eye surgery. Thrombocytopenia (esp. heparin-induced). Platelet dysfunction or defects. Obtain CBCs, platelets, blood chemistry, and stool occult blood tests during therapy. Severe renal or hepatic insufficiency. Diabetic retinopathy. Recent GI bleeding. Pregnancy (Cat.B; do not use multidose vial). Nursing mothers.

Interactions:
Caution with oral anticoagulants, platelet inhibitors, thrombolytics.

Pharmacological Class:
Low molecular weight heparin.

Adverse Reactions:
Inj site pain, hematoma, hemorrhage; rare: anaphylaxis, rash, fever, thrombocytopenia.

How Supplied:
Prefilled syringes (w. needle)—10; 10000 IU/mL (9.5mL multidose vial)—1 (95000 IU/vial); 25000 IU/mL (3.8mL multidose vial)—1 (95000 IU/vial)