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Pronunciation:

(da NAP a roid)

U.S. Brand Names:

Orgaran® [DSC]

Synonyms:

Danaparoid Sodium

Generic Available:

Canadian Brand Names:

Orgaran®

Use:

Prevention of postoperative deep vein thrombosis following elective hip replacement surgery

Use - Unlabeled/Investigational:

Systemic anticoagulation for patients with heparin-induced thrombocytopenia: factor Xa inhibition is used to monitor degree of anticoagulation if necessary

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/compatible

Contraindications:

Hypersensitivity to danaparoid or thrombocytopenia associated with a positive in vitro test for antiplatelet antibodies in the presence of danaparoid; hypersensitivity to pork products or to sulfites (contains metabisulfite); patients with active major bleeding; severe hemorrhagic diathesis (hemophilia, idiopathic thrombocytopenic purpura); not for I.M. or I.V. use

Warnings/Precautions:

Patients with recent or anticipated neuraxial anesthesia (epidural or spinal anesthesia) are at risk of spinal or epidural hematoma and subsequent paralysis. Consider risk versus benefit prior to neuraxial anesthesia; risk is increased by concomitant agents which may alter hemostasis, as well as traumatic or repeated epidural or spinal puncture. Patient should be observed closely for bleeding if danaparoid is administered during or immediately following diagnostic lumbar puncture, epidural anesthesia, or spinal anesthesia.

Not to be used interchangeably (unit for unit) with heparin or any other low molecular weight heparins. Use with caution in patients with known hypersensitivity to methylparaben or propylparaben. Use with caution in patients with history of heparin-induced thrombocytopenia. Monitor patient closely for signs or symptoms of bleeding. Certain patients are at increased risk of bleeding. Risk factors include bacterial endocarditis; congenital or acquired bleeding disorders; active ulcerative or angiodysplastic GI diseases; severe uncontrolled hypertension; hemorrhagic stroke; use shortly after brain, spinal, or ophthalmology surgery; patient treated concomitantly with platelet inhibitors; recent GI bleeding; thrombocytopenia or platelet defects; severe liver disease; hypertensive or diabetic retinopathy; or patients undergoing invasive procedures. Use with caution in patients with severe renal failure (has not been studied). Safety and efficacy in pediatric patients have not been established. Heparin can cause hyperkalemia by affecting aldosterone. A similar reaction could occur with danaparoid. Monitor for hyperkalemia.

Adverse Reactions:

As with all anticoagulants, bleeding is the major adverse effect of danaparoid. Hemorrhage may occur at virtually any site. Risk is dependent on multiple variables.

>10%:

Central nervous system: Fever (22%)

Gastrointestinal: Nausea (4% to 14%), constipation (4% to 11%)

1% to 10%:

Cardiovascular: Peripheral edema (3%), edema (3%)

Central nervous system: Insomnia (3%), headache (3%), asthenia (2%), dizziness (2%), pain (9%)

Dermatologic: Rash (2% to 5%), pruritus (4%)

Gastrointestinal: Vomiting (3%)

Genitourinary: Urinary tract infection (3% to 4%), urinary retention (2%)

Hematologic: Anemia (2%)

Local: Injection site pain (8% to 14%), injection site hematoma (5%)

Neuromuscular & skeletal: Joint disorder (3%)

Miscellaneous: Infection (2%)

<1% (Limited to important or life-threatening): Spinal or epidural hematomas can occur following neuraxial anesthesia or spinal puncture, resulting in paralysis. Risk is increased in patients with indwelling epidural catheters or concomitant use of other drugs affecting hemostasis, thrombocytopenia, hyperkalemia, wound infection, skin rash, allergic reaction.

Overdosage/Toxicology:

Symptoms of overdose include hemorrhage. Protamine zinc has been used to reverse effects, but the effects of danaparoid are not effectively antagonized.

Drug Interactions:

Drugs which affect platelet function (eg, aspirin, NSAIDs, dipyridamole, ticlopidine, clopidogrel) may potentiate the risk of hemorrhage.

Thrombolytic agents increase the risk of hemorrhage.

Warfarin (and other oral anticoagulants) may increase the risk of bleeding with danaparoid.

Ethanol/Nutrition/Herb Interactions:

Herb/Nutraceutical: Avoid cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, and ginseng (all have additional antiplatelet activity).

Stability:

Store intact vials or ampuls under refrigeration

Mechanism of Action:

Prevents fibrin formation in coagulation pathway via thrombin generation inhibition by anti-Xa and anti-IIa effects.

Pharmacodynamics/Kinetics:

Onset of action: Peak effect: SubQ: Maximum antifactor Xa and antithrombin (antifactor IIa) activities occur in 2-5 hours

Half-life elimination, plasma: Mean: Terminal: ~24 hours

Excretion: Primarily urine

Dosage:

SubQ:

Children: Safety and effectiveness have not been established.

Adults:

Prevention of DVT following hip replacement: SubQ: 750 anti-Xa units twice daily; beginning 1-4 hours before surgery and then not sooner than 2 hours after surgery and every 12 hours until the risk of DVT has diminished. The average duration of therapy is 7-10 days.

Adults: Treatment (unlabeled uses): Based on diagnosis/indication: See table.

Deep Vein Thrombosis
OR Acute
Pulmonary
Embolism:

Adult Danaparoid Treatment Dosing Regimens (not FDA approved)

	Body Weight (kg)	I.V. Bolus aFXaU	Long-Term Infusion aFXaU	Level of aFXaU/mL	Monitoring
Deep Vein Thrombosis OR Acute Pulmonary Embolism	<55 55-90 >90	1250 2500 3750	400 units/h over 4 h, then 300 units/h over 4 h, then 150-200 units/h maintenance dose	0.5-0.8	Days 1-3 daily, then every alternate day
Deep Vein Thrombosis OR Pulmonary Embolism >5 d old	<90 >90	1250 1250	SubQ: 3 x 750/d SubQ: 3 x 1250/d	<0.5	Not necessary
Embolectomy	<90 >90 and high risk	2500 preoperatively 2500 preoperatively	SubQ: 2 x 1250/d postoperatively 150-200 units/h I.V.; perioperative arterial irrigation, if necessary: 750 units/20 mL NaCl	<0.4 0.5-0.8	Not necessary Days 1-3 daily, then every alternate day
Peripheral Arterial Bypass		2500 preoperatively	150-200 units/h	0.5-0.8	Days 1-3 daily, then every alternate day
Cardiac Catheter	<90 >90	2500 preoperatively 3750 preoperatively
Surgery (excluding vascular)			SubQ: 750, 1-4 h preoperatively SubQ: 750, 2-5 h postoperatively, then 2 x 750/d	<0.35	Not necessary

Dosing adjustment in elderly and severe renal impairment: Adjustment may be necessary. Patients with serum creatinine levels 2.0 mg/dL should be carefully monitored.

Hemodialysis: See table.

Dialysis on alternate days::

Hemodialysis With Danaparoid Sodium

Dialysis on alternate days:	Dosage prior to dialysis in aFXaU (dosage for body wt <55 kg):
First dialysis	3750 (<55 kg 2500)
Second dialysis	3750 (<55 kg 2000)
Further dialysis:
aFXa level before dialysis (eg, day 5)	Bolus before next dialysis, aFXaU (eg, day 7)	aFXa level during dialysis
<0.3	3000 (<55 kg 2000)	0.5-0.8
0.3-0.35	2500 (<55 kg 2000)
0.35-0.4	2000 (<55 kg 1500)
>0.4	No bolus; if fibrin strands occur, 1500 aFXaU I.V.
Monitoring: 30 minutes before dialysis and after 4 hours of dialysis
Daily Dialysis
First dialysis	3750 (<55 kg 2500)
Second dialysis	2500 (<55 kg 2000)
Further dialyses	See above
As with "dialysis on alternate days", always take the aFXa activity preceding the previous dialysis as a basis for the current dosage.

Monitoring Parameters:

Platelets, occult blood, and anti-Xa activity, if available; the monitoring of PT and/or PTT is not necessary

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. This drug can only be administered by injection. You may have a tendency to bleed easily while taking this drug (brush teeth with soft brush, floss with waxed floss, use electric razor, avoid scissors or sharp knives and potentially harmful activities). Report unusual fever; unusual bleeding or bruising (bleeding gums, nosebleed, blood in urine, dark stool); pain in joints or back; severe head pain; skin rash; or redness, swelling, or pain at injection site.

Additional Information:

A 750 anti-Xa unit dose of danaparoid is approximately equivalent to 55 mg of danaparoid.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: As with all anticoagulants, bleeding is the major adverse effect of danaparoid. Hemorrhage may occur at virtually any site; risk is dependent on multiple variables.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause insomnia

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Injection, solution, as sodium 750 anti-Xa units/0.6 mL (0.6 mL) [prefilled syringe or ampul; contains sodium sulfite]

International Brand Names:

Orgaran® (AT, AU, BE, CA, CH, DE, FR, GB, LU, NL, NZ, SE)

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