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desirudin (Iprivask)

 

Classes: Anticoagulants, Hematologic; Thrombin Inhibitors

Dosing and uses of Iprivask (desirudin)

 

Adult dosage forms and strengths

lyophilized powder for injection

  • 15mg

 

Deep Vein Thrombosis Prevention

Indicated for prophylaxis of DVT in patients undergoing elective hip replacement surgery

15 mg SC q12hr; initiate 5-15 min before surgery (but after induction of regional block anesthesia) and continue for 9-12 days

 

Administration

Administer by deep SC injection into anterolateral or posterolateral thigh or abdominal walL

Rotate injection sites

Do not mix with other injection, solvents, infusion

 

Renal Impairment

CrCl 31-60 mL/min/1.73 m²: Initiate with 5 mg SC q12hr

CrCl <31 mL/min/1.73 m²: Initiate with 1.7 mg SC q12hr

Severe renal impairment may prolong half-life (up to 12 hr)

Adjust dose in relation to degree of renal impairment or aPTT abnormality

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Iprivask (desirudin) adverse (side) effects

1-10%

Hemorrhage (1-3%)

Injection site mass (4%)

Wound secretion (4%)

Serious hemorrhage (3%)

Anemia (3%)

Deep thrombophlebitis (2%)

Nausea (2%)

Allergic reaction (2%)

 

<1%

Major hemorrhage

Hypotension

Leg edema

Fever

Decreased hemoglobin

Hematuria

Dizziness

Epistaxis

Vomiting

Impaired healing

Cerebrovascular disorder

Leg pain

Hematemesis

Hematuria

Leg edema

 

Warnings

Black box warnings

Epidural or spinal hematomas may occur if receiving neuraxial anesthesia (ie, epidural/spinal anesthesia) or with spinal puncture

These hematomas may result in long-term or permanent paralysis

When scheduling patient for spinal procedures, thoroughly evaluate risk and consider other forms of anesthesia

Risk Factors

  • Indwelling epidural catheters
  • Coadministration with drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
  • History of traumatic or repeated epidural or spinal punctures
  • History of spinal deformity or spinal surgery

Monitor for signs and symptoms of neurological impairment; urgent treatment required if neurologic compromise observed

 

Contraindications

Hypersensitivity

Active bleeding or irreversible coagulation disorders

 

Cautions

Renal impairment (decrease dose)

Increased hemorrhage risk (eg, recent surgery, biopsy, major vessel venipuncture, hemorrhagic stroke, retinopathy, GI bleed)

Spinal or epidural anesthesia

Advanced age (>75 years)

May develop antibodies with reexposure

Prolongs thrombin-dependent coagulation assays (eg, aPTT, thrombin time [TT])

Any agent which may enhance the risk of hemorrhage should be discontinued prior to initiation of desirudin therapy (eg, Dextran 40, systemic glucocorticoids, thrombolytics, and anticoagulants)

Caution when coadministered with drugs that affect platelet function (eg, salicylates, NSAIDS, acetylsalicylic acid, ticlopidine, dipyridamole, sulfinpyrazone, clopidogrel, and glycoprotein IIb/IIIa antagonists [eg, abciximab])

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk, caution advised

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Iprivask (desirudin)

 

Mechanism of action

Recombinant hirudin product; selective inhibitor of free circulating and clot-bound human thrombin, with protein structures similar to naturally occurring hirudin (an anticoagulant present in medicinal leeches)

Inhibits activation of thrombin-induced platelet aggregation, coagulation factors V, VII, and XIII, which in turn results in prolongation of the activated partial thromboplastin time

 

Pharmacokinetics

Half-Life: 2-4 hr

Vd: 25 L/kg

Peak Plasma Time: 1-3 hr  

Clearance: 1.5-2.7 mL/min/kg

Excretion: Unchanged in urine (40-50%)