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.
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: 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
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).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.
Refer to adult dosing.
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
Hypersensitivity to natural or recombinant hirudins or any component of the formulation; active bleeding and/or irreversible coagulation disorders
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.
Iprivask has been discontinued in the US for more than 1 year.
Yes
Solution (reconstituted) (Iprivask Subcutaneous)
15 mg (per each): $270.00
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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.
Deep vein thrombosis, prophylaxis: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip-replacement surgery
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (direct thrombin inhibitor) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
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 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
Alteplase: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination
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
Streptokinase: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination
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
Tenecteplase: May enhance the anticoagulant effect of Anticoagulants. Risk X: Avoid combination
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. Management: Consider avoiding this combination due to an increased risk of hemorrhage. If anticoagulants are coadministered with urokinase, monitor patients closely for signs and symptoms of bleeding. Risk D: Consider therapy modification
Vitamin E (Systemic): May enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Volanesorsen: 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
Adverse events have been observed in animal reproduction studies. Data are insufficient to evaluate the safety of thrombin inhibitors during pregnancy (Guyatt, 2012).
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).
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).
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).
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)
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