danaparoid

Therapeutic Classification: anticoagulants

Pharmacologic Classification: low molecular weight heparins

REMS

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

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

Therapeutic effects:

Prevention of thrombus formation.

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

Distribution: Unknown.

Metabolism/Excretion: Excreted mostly by the kidneys.

Half-Life: 25 hr.

(anticoagulant effect)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	4—5 hr	12 hr

Contraindicated in:

Hypersensitivity to danaparoid sodium, pork products, or sulfites;
Uncontrolled bleeding;
Lactation: Lactation.

Use Cautiously in:

Severe renal impairment (↓ dose);
Severe hepatic impairment;
Retinopathy (hypertensive or diabetic);
Untreated hypertension;
Recent history of ulcer disease;
Spinal/epidural anesthesia;
History of congenital or acquired bleeding disorder;
Malignancy;
OB: Safety and effectiveness not established in pregnancy;
Pedi: Safety and effectiveness not established in children;
Geri: Dose ↓ may be necessary in older adults with severe renal impairment.

Exercise Extreme Caution in:

Severe uncontrolled hypertension;
Bacterial endocarditis;
Recent CNS or ophthalmologic surgery.

CV: edema

Derm: ecchymoses, pruritus, rash, urticaria

GI: ↑liver enzymes, constipation, nausea, vomiting

GU: urinary retention

Hemat: anemia, bleeding, thrombocytopenia

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

Neuro: dizziness, headache, insomnia

Misc: fever

Prophylaxis of DVT/PE (non-HIT patients)

SUBQ (Adults ): 750 anti-Xa units every 12 hr starting 1—4 hr preoperatively and ≥2 hr postoperatively for 7—10 days or until ambulatory (up to 14 days). Following orthopedic, major abdominal surgery, and thoracic surgery: 750 anti-Xa units, twice daily up to 14 days; initiate 1—4 hr preoperatively.
IV SUBQ (Adults ): Nonhemorrhagic stroke: Up to 1000 anti-Xa units IV, followed by 750 anti-Xa units SUBQ twice daily for 7—14 days.

HIT

IV SUBQ (Adults ): DVT/PE prophylaxis, current HIT, >90 kg: 1250 anti-Xa units SUBQ 2—3 times daily for 7—10 days (initial bolus of 1250 anti-Xa units IV may be used); DVT/PE prophylaxis, current HIT, ≤90 kg: 750 anti-Xa units SUBQ 2—3 times daily for 7—10 days (initial bolus of 1250 anti-Xa units IV may be used); DVT/PE prophylaxis, past (>3 mo) HIT, >90 kg: 750 anti-Xa units SUBQ 3 times daily OR 1250 anti-Xa units SUBQ twice daily for 7—10 days; DVT/PE prophylaxis, past (>3 mo) HIT, ≤90 kg: 750 anti-Xa units SUBQ 2—3 times daily for 7—10 days; DVT/PE treatment, 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 SUBQ twice daily for 4—7 days; DVT/PE treatment, 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 SUBQ twice daily for 4—7 days; DVT/PE treatment, 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 SUBQ twice daily for 4—7 days; DVT/PE treatment, thrombus ≥5 days, >90 kg: 1250 anti-Xa units IV bolus, then 750 anti-Xa units SUBQ 3 times daily OR 1250 anti-Xa units SUBQ 2—3 times daily; DVT/PE treatment, thrombus ≥5 days, ≤90 kg: 1250 anti-Xa units IV bolus, then 750 anti-Xa units SUBQ 2—3 times daily; Surgical prophylaxis, nonvascular surgery, >90 kg: 750 anti-Xa units SUBQ 1—4 hr before procedure; repeat ≥6 hr after procedure; then 1250 anti-Xa units SUBQ twice daily OR 750 anti-Xa units SUBQ 3 times daily for 7—10 days; Surgical prophylaxis, nonvascular surgery, ≤90 kg: 750 anti-Xa units SUBQ 1—4 hr before procedure; repeat ≥6 hr after procedure; then 750 anti-Xa units SUBQ 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 starting ≥6 hr after procedure for 5—7 days OR 750 anti-Xa units SUBQ 2—3 times daily or change to oral anticoagulant after several days; Surgical prophylaxis, embolectomy, 55—90 kg: 2250—2500 anti-Xa units IV bolus before procedure, then 1250 anti-Xa units SUBQ twice daily starting ≥6 hr after procedure, then 750 anti-Xa units SUBQ 2—3 times daily or change to oral anticoagulant after several days; Cardiac catheterization, >90 kg: 3750 anti-Xa units IV bolus before procedure; Cardiac catheterization, <90 kg: 2500 anti-Xa units IV bolus before procedure; Percutaneous transluminal coronary angioplasty: 2500 anti-Xa units IV bolus before procedure, then 150—200 anti-Xa units/hr for 1—2 days after procedure; may receive 750 anti-Xa units SUBQ 2—3 times daily or oral anticoagulant after several days of IV therapy; Intra-aortic balloon pump catheterization, >90 kg: 3750 anti-Xa units IV bolus before procedure, then 150—200 anti-Xa units/hr or a 2nd bolus of 1250 anti-Xa units IV OR 750 anti-Xa units SUBQ 2—3 times daily OR 1250 anti-Xa units SUBQ twice daily; Intra-aortic balloon pump catheterization, <90 kg: 2500 anti-Xa units IV bolus before procedure, then 150—200 anti-Xa units/hr or a 2nd bolus of 1250 anti-Xa units IV OR 750 anti-Xa units SUBQ 2—3 times daily OR 1250 anti-Xa units SUBQ twice daily; Peripheral vascular bypass: 2250—2500 anti-Xa units IV bolus before procedure, then 150—200 anti-Xa units/hr started ≥6 hr after procedure for 5—7 days OR 750 anti-Xa units SUBQ 2—3 times daily or change to oral anticoagulant; Cardiopulmonary bypass:125 anti-Xa units/kg IV bolus after thoracotomy, then 3 anti-Xa units/mL as priming fluid, then 7 anti-Xa units/kg/hr (started at bypass hookup and stopped 45 min before expected end of bypass), then 1250 anti-Xa units SUBQ twice daily or 750 anti-Xa units 3 times daily or 150—200 anti-Xa units/hr IV started 6 hr after procedure. Hemodialysis, every other day or less frequently: 3750 anti-Xa units IV bolus before 1st 2 hemodialysis, then 3000 anti-Xa units IV bolus (if plasma antifactor Xa level <300 units/L) or 2500 anti-Xa units IV (if plasma antifactory Xa levels 300—350) or 2000 anti-Xa units IV (if plasma antifactor Xa levels 350—400); Hemodialysis, every other day or less frequently, <55 kg: 2500 anti-Xa units IV bolus before 1st 2 hemodialysis, then 2000 anti-Xa units IV bolus (if plasma antifactory Xa level <300 units/L), or 1500 anti-Xa units IV (if plasma antifactory Xa levels 300—400); Hemodialysis, daily: 3750 anti-Xa units IV before 1st dialysis, then 2500 before 2nd dialysis; Hemodialysis, daily, <55 kg: 2500 anti-Xa units IV before 1st dialysis, then 2000 before 2nd dialysis; Hemofiltration, 55—90 kg: 2500 anti-Xa units IV bolus, then 600 anti-Xa units/hr for 4 hr, then 400 anti-Xa units/hr for 4 hr, then 200—600 anti-Xa units/hr to maintain plasma anti-Xa concentrations of 500—1000 units/L; Hemofiltration, <55 kg: 2000 anti-Xa units IV bolus, then 400 anti-Xa units/hr for 4 hr, then 150—400 anti-Xa units/hr to maintain anti-Xa concentrations of 500—1000 units/L.

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

Assess for signs/symptoms of bleeding (bleeding gums; nosebleed; unusual bruising; black, tarry stools; hematuria; ↓ in hematocrit or BP; guaiac-positive stools; bleeding from surgical site). Notify health care provider if these occur.
- Assess for evidence of additional or ↑ thrombosis. Symptoms will depend on area of involvement. Monitor neurological status frequently for signs of neurological impairment. May require urgent treatment.
- Assess for hypersensitivity reactions (chills, fever, urticaria).
- Monitor patients with epidural catheters frequently for signs/symptoms of neurologic impairment.
SUBQ: 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 1st wk, twice weekly for next 2 wk, and weekly thereafter. If thrombocytopenia occurs, monitor closely. If hematocrit ↓ unexpectedly, assess patient for potential bleeding sites.
- Special monitoring of clotting times (aPTT) is not necessary.
- May ↑ AST, ALT, and alkaline phosphatase.

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.

Cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.
Conversion to oral anticoagulant 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.
SUBQ: Administer deep into SUBQ 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: SUBQ is preferred route. Diluent: If administered IV, give as a bolus. May dilute with 0.9% NaCl, D5/0.9% NaCl, Ringer’s, LR, or mannitol. Stable for up to 48 hr at room temperature. Rate: Push rapidly.
Y-Site Incompatibility: Do not administer other drugs through same IV line.

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Advise patient in correct technique for self-injection and care and disposal of equipment.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient to report any symptoms of unusual bleeding or bruising, dizziness, itching, rash, fever, swelling, or difficulty breathing to health care provider immediately.
Advise patient not to take aspirin, naproxen, or ibuprofen without consulting health care provider while on danaparoid sodium therapy.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Prevention of thrombus formation.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

Canadian Brand Names ⬆