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Desirudin (United States: Not available): Drug information

Desirudin (United States: Not available): Drug information
(For additional information see "Desirudin (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Spinal/Epidural hematoma:

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as desirudin may be at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.

The risk of these events may be increased by the use of indwelling spinal catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. Likewise with such agents, the risk appears to be increased by traumatic or repeated epidural or spinal puncture.

Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

The physician should consider the potential benefit versus risk before neuraxial intervention, in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Pharmacologic Category
  • Anticoagulant;
  • Anticoagulant, Direct Thrombin Inhibitor
Dosing: Adult

Note: Iprivask has been discontinued in the US for more than 1 year.

Note: Initial dose may be given up to 5 to 15 minutes prior to surgery (after induction of regional anesthesia, if used); has been administered for up to 12 days (average: 9 to 12 days) in clinical trials

Deep vein thrombosis prophylaxis

Deep vein thrombosis prophylaxis: SubQ: 15 mg every 12 hours; interrupt therapy if aPTT exceeds 2 times control; resume at a reduced dose (based on the degree of aPTT abnormality) when aPTT is <2 times control

Dosing: Kidney Impairment: Adult

Moderate impairment (CrCl ≥31 to 60 mL/minute/1.73 m2): Initial dose: 5 mg every 12 hours. Interrupt therapy if aPTT exceeds 2 times control; resume at a reduced dose (based on the degree of aPTT abnormality) when aPTT is <2 times control.

Severe impairment (CrCl <31 mL/minute/1.73 m2): Initial dose: 1.7 mg every 12 hours. Interrupt therapy if aPTT exceeds 2 times control; resume at a reduced dose (based on the degree of aPTT abnormality) when aPTT is <2 times control.

Hemodialysis: Dialyzable: Yes (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As with all anticoagulants, bleeding is the major adverse effect. Hemorrhage may occur at any site.

2% to 10%:

Cardiovascular: Deep vein thrombophlebitis (2%)

Dermatologic: Wound secretion (4%)

Gastrointestinal: Nausea (2%)

Hematologic & oncologic: Hematoma (6%), anemia (3%), major hemorrhage (≤3%; may include hemophthalmos, intracranial hemorrhage, intraspinal hemorrhage, prosthetic joint hemorrhage, or retroperitoneal hemorrhage)

Local: Residual mass at injection site (4%)

<2%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, cerebrovascular disease, decreased hemoglobin, dizziness, epistaxis, fever, hematemesis, hematuria, hemorrhage (fatal), hypersensitivity reaction, hypotension, leg pain, lower extremity edema, thrombosis, vomiting, wound healing impairment

Contraindications

Hypersensitivity to natural or recombinant hirudins or any component of the formulation; active bleeding and/or irreversible coagulation disorders

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Allergic and hypersensitivity reactions, including anaphylaxis and fatal anaphylactoid reactions have been reported with other hirudin derivatives. Exercise caution when re-exposing patients (anaphylaxis has been reported).

• Bleeding: Can occur at any site (eg, brain, GI tract, spleen, rectum, vagina); fatal and serious bleeding events have been reported. Certain patients are at increased risk of bleeding. Risk factors include recent major surgery; organ biopsy or puncture of a noncompressible vessel within the last month; intracranial or intraocular bleeding (including diabetic [hemorrhagic] retinopathy); recent ischemic stroke; history of gastrointestinal or pulmonary bleeding within the past 3 months; bacterial endocarditis; congenital or acquired bleeding disorders; severe uncontrolled hypertension; history of hemorrhagic stroke; thrombocytopenia or platelet defects; renal impairment; hepatic impairment; or in patients undergoing invasive procedures. Do not administer with other agents that increase the risk of hemorrhage unless coadministration cannot be avoided. Monitor patient closely for signs and/or symptoms of bleeding.

Disease-related concerns:

• Hepatic impairment: Use with caution; risk of bleeding may be increased.

• Renal impairment: Use with caution, especially in patients with moderate-to-severe renal impairment (CrCl <60 mL/minute/1.73 m2); dosage reduction is necessary; monitor aPTT and renal function daily.

Special populations:

• Older adult: Use with caution in the elderly; elimination half-life prolonged in patients >75 years of age.

Other warnings/precautions:

• Appropriate use: Do not administer intramuscularly (IM). Do not use interchangeably (unit-for-unit) with other hirudins.

• Neuraxial anesthesia: [U.S. Boxed Warning]: Patients with recent or anticipated neuraxial anesthesia (epidural or spinal anesthesia) or spinal puncture are at risk of developing an epidural or spinal hematoma resulting in long-term or permanent paralysis. Consider risk versus benefit prior to neuraxial anesthesia; risk is increased by the use of indwelling spinal catheters for administration of analgesia or concomitant agents which may alter hemostasis, as well as traumatic or repeated epidural or spinal puncture. Patient should be observed closely for bleeding and signs and symptoms of neurological impairment.

Product Availability

Iprivask has been discontinued in the US for more than 1 year.

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (Iprivask Subcutaneous)

15 mg (per each): $270.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

SubQ: Do not administer IM; for deep SubQ administration only. Administration should be alternated between the left and right anterolateral and left and right posterolateral thigh or abdominal wall. Insert whole needle length into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. Do not rub injection site.

Use: Labeled Indications

Deep vein thrombosis, prophylaxis: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip-replacement surgery

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acalabrutinib: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Alemtuzumab: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anacaulase: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anagrelide: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Anticoagulants: May enhance the anticoagulant effect of Desirudin. Management: Discontinue treatment with other anticoagulants prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Apixaban: May enhance the anticoagulant effect of Anticoagulants. Refer to separate drug interaction content and to full drug monograph content regarding use of apixaban with vitamin K antagonists (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Risk X: Avoid combination

Bromperidol: May enhance the adverse/toxic effect of Anticoagulants. Risk C: Monitor therapy

Caplacizumab: May enhance the anticoagulant effect of Anticoagulants. Management: Avoid coadministration of caplacizumab with antiplatelets if possible. If coadministration is required, monitor closely for signs and symptoms of bleeding. Interrupt use of caplacizumab if clinically significant bleeding occurs. Risk D: Consider therapy modification

Collagenase (Systemic): Anticoagulants may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Dabigatran Etexilate: May enhance the anticoagulant effect of Anticoagulants. Refer to separate drug interaction content and to full drug monograph content regarding use of dabigatran etexilate with vitamin K antagonists (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Risk X: Avoid combination

Dasatinib: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Deferasirox: Anticoagulants may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Defibrotide: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination

Deoxycholic Acid: Anticoagulants may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Risk C: Monitor therapy

Dextran: May enhance the anticoagulant effect of Desirudin. More specifically, dextran may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with dextran prior to desirudin initiation when possible. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk X: Avoid combination

Dipyridamole: May enhance the adverse/toxic effect of Desirudin. Specifically, the risk of bleeding may be increased. Risk C: Monitor therapy

Edoxaban: May enhance the anticoagulant effect of Anticoagulants. Refer to separate drug interaction content and to full drug monograph content regarding use of edoxaban with vitamin K antagonists (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Management: Some limited combined use may be indicated during periods of transition from one anticoagulant to another. See the full edoxaban drug monograph for specific recommendations on switching anticoagulant treatment. Risk X: Avoid combination

Hemin: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination

Herbal Products with Anticoagulant/Antiplatelet Effects (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Anticoagulants. Bleeding may occur. Risk C: Monitor therapy

Ibritumomab Tiuxetan: Anticoagulants may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to an increased risk of bleeding. Risk C: Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Anticoagulants. Risk C: Monitor therapy

Icosapent Ethyl: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Inotersen: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Kanamycin: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Lecanemab: May enhance the adverse/toxic effect of Anticoagulants. Specifically, the risk of hemorrhage may be increased. Risk C: Monitor therapy

Limaprost: May enhance the adverse/toxic effect of Anticoagulants. The risk for bleeding may be increased. Risk C: Monitor therapy

Lipid Emulsion (Fish Oil Based): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Mesoglycan: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

MiFEPRIStone: May enhance the adverse/toxic effect of Anticoagulants. Specifically, the risk of bleeding may be increased. Risk X: Avoid combination

Nintedanib: Anticoagulants may enhance the adverse/toxic effect of Nintedanib. Specifically, the risk for bleeding may be increased. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Obinutuzumab: Anticoagulants may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Risk C: Monitor therapy

Omacetaxine: Anticoagulants may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of anticoagulants with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Omega-3 Fatty Acids: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Oritavancin: May diminish the therapeutic effect of Anticoagulants. Specifically, oritavancin may artificially increase the results of laboratory tests commonly used to monitor anticoagulant effectiveness, which could lead to incorrect decisions to decrease anticoagulant doses. Risk C: Monitor therapy

Pentosan Polysulfate Sodium: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Pirtobrutinib: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the adverse/toxic effect of Anticoagulants. Specifically, the antiplatelet effects of these agents may lead to an increased risk of bleeding with the combination. Risk C: Monitor therapy

Protein C Concentrate (Human): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Rivaroxaban: Anticoagulants may enhance the anticoagulant effect of Rivaroxaban. Refer to separate drug interaction content and to full drug monograph content regarding use of rivaroxaban with vitamin K antagonists (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Risk X: Avoid combination

Salicylates: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Sugammadex: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Sulfinpyrazone: May enhance the adverse/toxic effect of Desirudin. Specifically, the risk of bleeding may be increased. Risk C: Monitor therapy

Sulodexide: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Telavancin: May diminish the therapeutic effect of Anticoagulants. Specifically, telavancin may artificially increase the results of laboratory tests commonly used to monitor anticoagulant effectiveness, which could lead to incorrect decisions to decrease anticoagulant doses. Risk C: Monitor therapy

Thrombolytic Agents: May enhance the anticoagulant effect of Desirudin. Management: Discontinue treatment with thrombolytic agents prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider therapy modification

Tibolone: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Tipranavir: May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Urokinase: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination

Vitamin E (Systemic): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Vorapaxar: May enhance the adverse/toxic effect of Anticoagulants. More specifically, this combination is expected to increase the risk of bleeding. Risk X: Avoid combination

Zanubrutinib: May enhance the adverse/toxic effect of Anticoagulants. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Data are insufficient to evaluate the safety of thrombin inhibitors during pregnancy (Guyatt, 2012).

Breastfeeding Considerations

It is not known if desirudin is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. However, due to the low enteral absorption of desirudin, it is unlikely to cause significant adverse events in a nursing infant, if it is present in breast milk. Therefore, some references state use of desirudin may be continued in breast-feeding women (Guyatt, 2012).

Monitoring Parameters

Signs and symptoms of bleeding; aPTT (daily in patients with increased risk of bleeding and/or renal impairment); serum creatinine (daily in patients with renal impairment).

Mechanism of Action

Desirudin is a direct, highly selective thrombin inhibitor. Reversibly binds to the active thrombin site of free and clot-associated thrombin. Inhibits fibrin formation, activation of coagulation factors V, VII, and XIII, and thrombin-induced platelet aggregation resulting in a dose-dependent prolongation of the activated partial thromboplastin time (aPTT).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Subcutaneous: Complete

Distribution: Vdss: 0.25 L/kg

Metabolism: Stepwise degradation from the C-terminus catalyzed by carboxypeptidase(s)

Half-life elimination: ~2 hours; Prolonged with renal impairment (CrCl <31 mL/minute/1.73 m2: Up to 12 hours)

Time to peak, plasma: 1 to 3 hours

Excretion: Urine (40% to 50% as unchanged drug)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Revasc;
  • (AU) Australia: Revasc;
  • (DE) Germany: Revasc;
  • (ES) Spain: Revasc;
  • (FI) Finland: Revasc;
  • (FR) France: Revasc;
  • (GB) United Kingdom: Revasc;
  • (HU) Hungary: Revasc;
  • (PR) Puerto Rico: Iprivask;
  • (SE) Sweden: Revasc
  1. Bates SM, Greer IA, Middeldorp S, et al. “VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines,” Chest, 2012, 141(2 Suppl):e691-736. [PubMed 22315276]
  2. Eriksson BI, Wille-Jorgensen P, Kalebo P, et al, “A Comparison of Recombinant Hirudin With a Low-Molecular-Weight Heparin to Prevent Thromboembolic Complications After Total Hip Replacement,” N Engl J Med, 1997, 337(19):1329-35. [PubMed 9358126]
  3. Eriksson BI, Ekman S, Kalebo P, et al, “Prevention of Deep-Vein Thrombosis After Total Hip Replacement: Direct Thrombin Inhibition With Recombinant Hirudin, CGP 39393,” Lancet, 1996, 347(9002):635-9. [PubMed 8596376]
  4. Eriksson BI, Ekman S, Lindbratt S, et al, “Prevention of Thromboembolism With Use of Recombinant Hirudin. Results of a Double-blind, Multicenter Trial Comparing the Efficacy of Desirudin (Revasc) with that of Unfractionated Heparin in patients Having a Total Hip Replacement,” J Bone Joint Surg Am, 1997, 79(3):326:33. [PubMed 9070519]
  5. Frontera JA, Lewin JJ 3rd, Rabinstein AA, et al; Guideline for reversal of antithrombotics in intracranial hemorrhage: a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care. 2016;24(1):6-46. [PubMed 26714677]
  6. Guyatt GH, Akl EA, Crowther M, et al, “Executive Summary: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines,” Chest, 2012, 141(2 Suppl):7-47. [PubMed 22315257]
  7. Iprivask (desirudin subcutaneous injection) [prescribing information]. Northbrook, IL: Marathon Pharmaceuticals; June 2015.
  8. Lefevre G, Duval M, Gauron S, et al, “Effect Renal Impairment on the Pharmacokinetics and Pharmacodynamics of Desirudin,” Clin Pharmacol Ther, 1997, 62(1):50-9. [PubMed 9246019]
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