danaparoid sodium

General

Canada-Approved Medicine

This monograph describes a medication approved for use in Canada by the Therapeutic Products Directorate, a division of Health Canada’s Health Products and Food Branch. The medication is not approved by the United States Food and Drug Administration; however, a similar formulation carrying a different generic or brand name might be available in the US.

Pronunciation:
da-nap-a-roid

Trade Name(s)

  • Orgaran Canadian Tradename

Ther. Class.

anticoagulants

Pharm. Class.

low molecular weight heparins

Indications

  • Prevention of thromboembolic phenomena including deep vein thrombosis and pulmonary emboli after surgical procedures known to increase the risk of such complications (knee/hip replacement, abdominal surgery).
  • Management of non-hemorrhagic stroke.
  • Treatment/prevention of thromboembolic phenomena in patients with a history of heparin-induced thrombocytopenia (HIT)

Action

  • Potentiates the inhibitory effect of antithrombin on factor Xa and thrombin.
  • Danaparoid sodium is a heparinoid.

Therapeutic Effect(s):

Prevention of thrombus formation.

Pharmacokinetics

Absorption: 100% absorbed after subcut administration; IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Excreted mostly by the kidneys.

Half-life: 24 hr.

TIME/ACTION PROFILE (anticoagulant effect)

ROUTEONSETPEAKDURATION
Subcutunknown2–5 hr12 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to danaparoid sodium, pork products, or sulfites;
  • Uncontrolled bleeding;
  • Imminent/threatened abortion;
  •  Lactation: Avoid breast feeding.

Use Cautiously in:

  • Severe hepatic or renal impairment (dosage ↓ may be necessary in severe renal impairment);
  • Retinopathy (hypertensive or diabetic);
  • Untreated hypertension;
  • Recent history of ulcer disease;
  • Spinal/epidural anesthesia;
  • History of congenital or acquired bleeding disorder;
  • Malignancy;
  • History of thrombocytopenia related to heparin (HIT), has been used successfully;
  • OB:  Safe use in pregnancy has not been established;
  • Geri:  Dosage ↓ may be necessary in severe renal impairment;
  • Pedi:  Safety not established.

Exercise Extreme Caution in:

  • Severe uncontrolled hypertension;
  • Bacterial endocarditis, bleeding disorders;
  • GI bleeding/ulceration/pathology;
  • Hemorrhagic stroke;
  • Recent CNS or ophthalmologic surgery;
  • Active GI bleeding/ulceration.

Adverse Reactions/Side Effects

CNS: dizziness, headache, insomnia

CV: edema

GI: constipation, nausea, reversible increase in liver enzymes, vomiting

GU: urinary retention

Derm: ecchymoses, pruritus, rash, urticaria

Hemat: BLEEDING, anemia, thrombocytopenia

Local: erythema at injection site, hematoma, irritation, pain

Misc: fever

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Risk of bleeding may be ↑ by concurrent use of other  anticoagulants  including  warfarin  or  drugs that affect platelet function, including  aspirin,  NSAIDs,  dipyridamole, some  penicillins,  clopidogrel,  ticlopidine, and  dextran.

Route/Dosage

Prophylaxis of DVT (non HIT patients)

Subcut (Adults): 750 anti-factor Xa IU every 12 hr starting 1–4 hr preop and at least 2 hr postop for 7–10 days or until ambulatory (up to 14 days).  Prophylaxis of DVT following Orthopedic, Major Abdominal Surgery and Thoracic Surgery– 750 anti-factor Xa units, twice daily up to 14 days, initiate 1–4 hr preop.

IV Subcut (Adults): Prophylaxis of Deep Vein Thrombosis in Non-hemorrhagic Stroke Patients– up to 1000 anti-Xa units IV, followed by 750 anti-Xa units subcutaneously, twice daily for 7–14 days.

HIT

IV Subcut (Adults): DVT prophylaxis, current HIT, ≤90 kg– 750 anti-Xa units SC two or three times daily for 7–10 days (initial bolus of 1250 anti-Xa units IV may be used);  DVT prophylaxis, current HIT, >90 kg– 1250 anti-Xa units SC two or three times daily for 7–10 days (initial bolus of 1250 anti-Xa units IV may be used);  DVT prophylaxis, past (>3 mo) HIT, ≤90 kg– 750 anti-Xa units SC two or three times daily for 7–10 days;  DVT prophylaxis, past (>3 mo) HIT, >90 kg– 750 anti-Xa units SC three times daily or 1250 anti-Xa units SC twice daily for 7–10 days;  Established pulmonary embolism or DVT, thrombus <5 days, >90 kg– 3750 anti-Xa units IV bolus, then 400 anti-Xa units/hr for 4 hr, then 300 anti-Xa units/hr for 4 hr, then 150–200 anti-Xa units/hr for 5–7 days or 1750 anti-Xa units SC twice daily for 4–7 days;  Established pulmonary embolism or DVT, thrombus <5 days, 55–90 kg– 2250–2500 anti-Xa units IV bolus, then 400 anti-Xa units/hr for 4 hr, then 300 anti-Xa units/hr for 4 hr, then 150–200 anti-Xa units/hr for 5–7 days or 2000 anti-Xa units SC twice daily for 4–7 days;  Established pulmonary embolism or DVT, thrombus <5 days, <55 kg– 1250–1500 anti-Xa units IV bolus, then 400 anti-Xa units/hr for 4 hr, then 300 anti-Xa units/hr for 4 hr, then 150–200 anti-Xa units/hr for 5–7 days or 1500 anti-Xa units SC twice daily for 4–7 days;  Established pulmonary embolism or DVT, thrombus ≥5 days, >90 kg– 1250 anti-Xa units IV bolus, then 750 anti-Xa units SC three times daily or 1250 anti-Xa units twice daily;  Established pulmonary embolism or DVT, thrombus ≥5 days, ≤90 kg– 1250 anti-Xa units IV bolus, then 750 anti-Xa units SC 2–3 times daily;  Surgical prophylaxis, nonvascular surgery, >90 kg– 750 anti-Xa units SC, repeat ≥6 hr after procedure, then 1250 anti-Xa units SC twice daily for 7–10 days;  Surgical prophylaxis, nonvascular surgery, ≤90 kg– 750 anti-Xa units SC, repeat ≥6 hr after procedure, then 750 anti-Xa units SC twice daily for 7–10 days;  Surgical prophylaxis, embolectomy, >90 kg– 2250–2500 anti-Xa units IV bolus before procedure, then 150–200 anti-Xa units/hr IV starting ≥6 hr after procedure for 5–7 days or 750 anti-Xa units 2–3 times daily or change to oral anticoagulants after several days;  Surgical prophylaxis, embolectomy, 55–90 kg– 2250–2500 anti-Xa units IV bolus before procedure, then 1250 anti-Xa units SC twice daily starting ≥6 hr after procedure, then 750 anti-Xa units 2–3 times daily or change to oral anticoagulants after several days;  Cardiac catheterization >90 kg– 3750 anti-Xa units IV bolus prior to procedure;  Cardiac catheterization <90 kg– 2500 anti-Xa units IV bolus prior to procedure;  Percutaneous transluminal coronary angioplasty– 2500 anti-Xa units IV prior to procedure, then 150–200 anti-Xa units/hr IV for 1–2 days after procedure, may be followed by 750 anti-Xa units SC for several several days;  Intra-aortic balloon pump catherization, >90 kg– 3750 anti-Xa units IV bolus before procedure, then 150–200 anti-Xa units/hr IV or a 2nd bolus of 1250 anti-Xa units IV or 750 anti-Xa units SC two or three times daily or 1250 anti-Xa units SC twice daily;  Intra-aortic balloon pump catherization, <90 kg– 2500 anti-Xa units IV bolus before procedure, then 150–200 anti-Xa units/hr IV or a 2nd bolus of 1250 anti-Xa units IV or 750 anti-Xa units SC two or three times daily or 1250 anti-Xa units SC twice daily;  Peripheral vascular bypass– 2250–2500 anti-Xa units IV bolus before procedure, then 150–200 anti-Xa units/hr IV started ≥6 hr after procedure for 5–7 days or 750 anti-Xa units SC two or three times daily or change to oral anticoagulants.

Availability

Solution for injection (contains sulfites): 750 anti-factor Xa units/0.6 mL ampule

Assessment

  • Assess for signs of bleeding and hemorrhage (bleeding gums; nosebleed; unusual bruising; black, tarry stools; hematuria; fall in hematocrit or BP; guaiac-positive stools); bleeding from surgical site. Notify health care professional if these occur.

    • Assess for evidence of additional or increased thrombosis. Symptoms will depend on area of involvement. Monitor neurological status frequently for signs of neurological impairment. May require urgent treatment.
    • Monitor patient for hypersensitivity reactions (chills, fever, urticaria).
    • Monitor patients with epidural catheters frequently for signs and symptoms of neurologic impairment.
  • Subcut Observe injection sites for hematomas, ecchymosis, or inflammation.

Lab Test Considerations:

Monitor CBC, and stools for occult blood periodically during therapy. Monitor platelet count every other day for first wk, twice weekly for next 2 wk, and weekly thereafter. If thrombocytopenia occurs, monitor closely. If hematocrit decreases unexpectedly, assess patient for potential bleeding sites.

  • Special monitoring of clotting times (aPTT) is not necessary.
  • May cause ↑ in AST, ALT, and alkaline phosphatase levels.

Toxicity and Overdose:

Danaparoid sodium is not reversed with protamine sulfate. If overdose occurs, discontinue danaparoid sodium. Transfusion with fresh frozen plasma and plasmapheresis has been used if bleeding is uncontrollable.

Potential Diagnoses

Implementation

  • Cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
  • Conversion to oral anticogulant therapy (unless it is contraindicated) should not be started until adequate antithrombotic control with parenteral danaparoid sodium has been achieved; conversion may take up to 5 days.
  • Subcut Administer deep into subcut tissue. Alternate injection sites daily between the left and right anterolateral and left and right posterolateral abdominal wall. Inject entire length of needle at a 45° or 90° angle into a skin fold held between thumb and forefinger; hold skin fold throughout injection. Do not aspirate or massage. Rotate sites frequently. Do not administer IM because of danger of hematoma formation. Solution should be clear; do not inject solution containing particulate matter.
    • If excessive bruising occurs, ice cube massage of site before injection may lessen bruising.

IV Administration

  • IV Push:  Subcut is preferred route. Dilution:  If administered IV, give as a bolus. May dilute with 0.9% NaCl, D5/0.9% NaCl, Ringer's, LR, and mannitol. Stable for up to 48 hr at room temperature.
  • Y-Site Incompatibility: Administer separately; do not mix with other drugs.

Patient/Family Teaching

  • Instruct patient in correct technique for self-injection, care and disposal of equipment.
  • Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care professional immediately.
  • Instruct patient not to take aspirin, naproxen, or ibuprofen without consulting health care professional while on danaparoid sodium therapy.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

Prevention of deep vein thrombosis and pulmonary emboli.

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