Dalteparin Sodium

Class and Category

Pharmacologic Class: Low-molecular-weight heparin
Therapeutic ClassAnticoagulant

Indications and Dosages

To prevent ischemic complications in patients who receive aspirin as part of treatment for unstable angina and non-Q-wave MI
SUBCUTANEOUS INJECTION
Adults: 
120 international units/kg every 12 hr with aspirin (75 to 165 mg daily) until patient is stable, usually 5 to 8 days. Maximum: 10,000 international units/dose.

To prevent deep vein thrombosis in patients undergoing hip replacement surgery
SUBCUTANEOUS INJECTION
Adults: 
Initial: 2,500 international units 4 to 8 hr after surgery (or later if hemostasis has not been achieved) and then 5,000 international units once daily for 5 to 10 days postoperatively or 2,500 international units 1 to 2 hr before surgery, repeated in 4 to 8 hr after surgery and then 5,000 international units once daily for 5 to 10 days postoperatively. Alternatively, 5,000 international units the evening before surgery followed by 5,000 international units 4 to 8 hr after surgery and then 5,000 international units once daily for 5 to 10 days postoperatively.

To prevent deep vein thrombosis in patients undergoing abdominal surgery who are at risk for thromboembolic complications
SUBCUTANEOUS INJECTION
Adults: 
2,500 international units daily, starting 1 to 2 hr before surgery and repeated once-daily postoperatively for 5 to 10 days.
Dosage Adjustment: 
For patients at high risk (i.e., those with cancer), 5,000 international units the evening before surgery, repeated once-daily postoperatively for 5 to 10 days; or alternatively for patients with cancer, 2,500 international units 1 to 2 hr before surgery followed by 2,500 international units 12hr later and then 5,000 international units once daily postoperatively for 5 to 10 days.

To prevent deep vein thrombosis in patients with severe mobility restrictions during acute illness
SUBCUTANEOUS INJECTION
Adults: 
5,000 international units once daily for 12 to 14 days.

To provide extended treatment of symptomatic venous thromboembolism in patients with cancer
SUBCUTANEOUS INJECTION
Adults: 
200 international units/kg once daily for 30 days. Then 150 international units/kg once daily for 5 more months.
Maximum: 18,000 international units daily.


To treat symptomatic venous thromboembolism in pediatric patients
SUBCUTANEOUS INJECTION
Children age 8 to 17 years:
100 IU/kg twice daily.
Children 2 years to less than 8 years:
125 IU/kg twice daily.
Infants 4 weeks to children less than 2 years:
150 IU/kg twice daily.
Dosage Adjustment:
For an adult patient with thrombocytopenia and cancer who experiences a platelet count between 50,000 and 100,000/mm3, dosage reduced by 2,500 international units until platelet count recovers to or above 100,000 mm3. For adult patient with thrombocytopenia and cancer who experiences a platelet count less than 50,000 mm3, dalteparin withheld until platelet count is above 50,000 mm3. For children 4 weeks and older, who experiences a platelet count between 50,000 and 100,000/mm3, dosage reduced by 50%. For children 4 weeks and older, who experiences a platelet count less than 50,000 mm3, dalteparin withheld until platelet count is above 50,000 mm3. For adult patient needing extended treatment of acute symptomatic venous thrombosis and having severely impaired renal function (creatinine clearance below 30 ml/min), anti-Xa levels monitored to determine appropriate dose. Target anti-Xa range is 0.5 to 1.5 international units/ml.

Mechanism of Action
Binds to and accelerates the activity of antithrombin III, thus inhibiting thrombin and blocking the formation of fibrin clots.

Incompatibilities
Don’t mix dalteparin with other drugs.

Contraindications
Active major bleeding; history of heparin-induced thrombocytopenia or heparininduced thrombocytopenia with thrombosis; hypersensitivity to dalteparin, heparin, or pork products; treatment for unstable angina and non-Q-wave MI or for prolonged venous thromboembolism prophylaxis while undergoing epidural/neuraxial anesthesia

Interactions
DRUGS
NSAIDs, oral anticoagulants, platelet aggregation inhibitors, thrombolytic: Possibly increased risk of hemorrhage and spinal or epidural hematoma


Adverse Reactions
EENT: Epistaxis
GI: Elevated liver enzymes
HEME: Hemorrhage, thrombocytopenia
MS: Osteoporosis
SKIN: Alopecia, bullous eruption, necrosis, pruritus, rash
Other: Anaphylaxis; injection-site bruising, hematoma and pain

Childbearing Considerations
PREGNANCY
  • It is not known if drug causes fetal harm although it has the potential for adverse effects on preterm infants when used in pregnancy if the 3.8 ml multiple dose vial of the drug is because it contains benzyl alcohol.
  • Use with caution only if benefit to mother outweighs potential risk to fetus.
    LACTATION
    • Drug is present in breast milk.
    • The patient should check with prescriber before breastfeeding.

    Nursing Considerations
    • Use dalteparin with extreme caution in patients with a history of heparin-induced thrombocytopenia; those at increased risk for hemorrhage (such as those who use a platelet inhibitor or have active ulcerative GI disorder, bacterial endocarditis, bleeding disorders, hemorrhagic stroke, or uncontrolled hypertension); and those with recent brain, eye, or spinal surgery.
    • Use drug cautiously in patients with bleeding diathesis, diabetic retinopathy, platelet defects, recent GI bleeding, severe hepatic or renal insufficiency, or thrombocytopenia.
    • Inform Jewish or Islamic patients that drug comes from porcine intestine before giving first dose.
    WARNING: Question patient regarding use of aspirin and other NSAIDs, platelet inhibitors or other anticoagulants prior to dalteparin therapy that may increase risk of bleeding.
    • Be aware that risk factors for thromboembolic events include age over 40, cancer, history of deep vein thrombosis or pulmonary embolism, obesity, and planned use of anesthesia for more than 30 minutes.
    • Don’t give drugs by I.M. or I.V. injection.
    • Administer drug deep into subcutaneous tissue in a U-shaped area around the navel, upper outer thigh, or upper outer quadrant of buttocks with the patient seated. If using the area around navel or on thigh, lift skin fold with the thumb and forefinger while giving injection. Insert entire length of needle at a 45- to 90- degree angle. Rotate sites daily.
    • Know that routine coagulation tests and dosage adjustments usually aren’t required. Instead, anti-Xa levels are measured, prior to the fourth dose and as needed. Samples should be drawn 4 hours after drug administration. Dosages are then adjusted in increments of 25 IU/kg to achieve a target anti-Xa level between 0.5 and 1 IU/ml. Thereafter anti-Xa levels are measured periodically for children and in adults with severe renal impairment or if abnormal coagulation parameters or bleeding occurs during drug therapy.
    WARNING: Monitor patients receiving dalteparin and epidural or spinal anesthesia or spinal puncture because spinal hematomas can occur, causing long-term or permanent paralysis. Watch for evidence of neurologic impairment, such as changes in motor or sensory. If present, notify the prescriber immediately; the patient needs urgent care to minimize the effect of hematoma. Use of indwelling epidural catheters; concurrent use of other drugs that affect hemostasis such as nonsteroidal anti-inflammatory drugs, platelet inhibitors, and other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; or a history of spinal deformity or spinal surgery increase the risk of spinal or epidural hematoma in patients receiving dalteparin.

    PATIENT INFORMATION
    • Teach patient or caregiver administering drug at home how to select injection sites, give subcutaneous injections, and rotate sites daily. Tell patient to discard drug if it’s discolored or contains particles. Review safe handling and disposal of syringes and needles.
    • Teach patient to store drug at room temperature, away from moisture and heat.
    • Urge patient to report adverse reactions, especially bleeding, and to seek help immediately if signs of blood clots develop, such as severe difficulty breathing or changes in mental status or motor or sensory abnormalities.
    • Instruct patient to inform all dentists and prescribers of dalteparin therapy. Tell patient who is receiving spinal anesthesia or a spinal puncture to alert medical staff immediately if he experiences muscular weakness, numbness (especially in his legs), or tingling following the procedure.
    • Emphasize the importance of follow-up visits.

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