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Dalteparin

    DEA Class; Rx

    Common Brand Names; Fragmin

    • Anticoagulants, Cardiovascular; 
    • Anticoagulants, Hematologic

    Low molecular weight heparin
    Used for DVT prophylaxis, treatment of VTE, and prophylaxis of ischemic complications in unstable angina and non-Q-wave MI
    Consists of heparin molecules ranging in size from 2,000 to 9,000 daltons (14% to 26% are more than 8,000 daltons)

    Indicated for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy

    Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip replacement, in patients undergoing abdominal surgery who are at risk for thromboembolic complications, and in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness

    Indicated for extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce recurrence of VTE in adult patients with cancer

    Symptomatic venous thromboembolism (DVT/PE) treatment to reduce recurrence in patients with cancer

    Off-label: Treatment of thromboembolism during pregnancy, DVT prophylaxis during knee replacement surgery, neurosurgery, trauma, burns, pediatric

    Hypersensitivity to dalteparin, heparin or pork products

    Active major bleeding, thrombocytopenia associated with antiplatelet antibodies

    History of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis

    Patients undergoing epidural/neuraxial anesthesia, as a treatment for unstable angina and non-Q-wave MI or for prolonged VTE prophylaxis

    Injection site hematoma (7-35%)

    Thrombocytopenia (10.9-13.6%, patients with cancer )

    Injection site pain (4.5-12%)

    Major hemorrhage (up to 4.6%)

    Increased liver function test (up to 4.3%)

    Wound hematoma

    Hematuria

    Epidural hematoma

    Spinal hematoma

    Hemorrhagic cerebral infarction

    Intracranial hemorrhage

    Intrauterine subdural hemorrhage

    Thrombocytopenia (<1%, non-cancer indications)

    Anaphylactoid reaction (rare)

    Osteoporosis

    Skin necrosis

    Alopecia

    Risk of epidural/spinal hematoma if used in patients getting epidural/spinal anesthesia which may result in paralysis

    Periodic routine complete blood cell counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during treatment

    Use caution in patients with history of heparin-induced thrombocytopenia; heparin-induced thrombocytopenia can occur with administration of this drug; the incidence of this complication is unknown at present; in clinical practice, cases of thrombocytopenia with thrombosis, amputation and death have been observed; closely monitor thrombocytopenia of any degree

    Do not give IM

    Can’t be used interchangeably with other LMW heparins

    Multidose vials contain benzyl alcohol as preservative (associated with potentially fatal “Gasping Syndrome” in preemies); when prescribing dalteparin multiple-dose vials in neonates and low-birth-weight infants, consider combined daily metabolic load of benzyl alcohol from all sources including multiple-dose vials (dalteparin contains 14 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol; minimum amount of benzyl alcohol at which serious adverse reactions may occur not known

    If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae

    Although specific recommendation for timing of a subsequent dose after catheter removal is unknown, consider delaying this next dose for at least four hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors

    Available data have not reported a clear association with dalteparin and adverse developmental outcomes

    There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when used in pregnancy

    Limited published data indicate that the drug is present in human milk in small amounts; no adverse effects on breastfed infant reported; there are no data on effects of drug on milk production; oral absorption of dalteparin is expected to be low, but clinical implications, if any, of this small amount of anticoagulant activity on a breastfed infant are unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from the drug or from underlying maternal condition

    Dalteparin has a narrow therapeutic index, specific for the patient population and indication. The maximum dosage is individualized based on anti-Xa concentrations and assessment of efficacy and safety parameters.

    Dalteparin sodium

    injectable solution, single-dose prefilled syringe

    • 2,500 IU/0.2 mL
    • 5,000 IU/0.2 mL
    • 7,500 IU/0.3 mL
    • 12,500 IU/0.5 mL
    • 15,000 IU/0.6 mL
    • 18,000 IU/0.72 mL

    injection, single-dose graduated syringe

    • 10,000 IU/mL

    injection, multiple-dose vials

    • 95,000 IU/3.8 mL (25,000 IU/mL)