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Desirudin

Pronunciation

(des i ROO din)

Index Terms

  • CGP - 39393
  • Desulfato - Hirudin
  • Desulfatohirudin
  • Desulphatohirudin
  • r - Hirudin
  • Recombinant Desulfatohirudin
  • Recombinant Hirudin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Subcutaneous:

Iprivask: 15 mg (1 ea)

Brand Names: U.S.

  • Iprivask

Pharmacologic Category

  • Anticoagulant
  • Anticoagulant, Direct Thrombin Inhibitor

Pharmacology

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)

Excretion

Urine (40% to 50% as unchanged drug)

Time to Peak

Plasma: 1 to 3 hours

Half-Life Elimination

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

Use: Labeled Indications

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

Contraindications

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

Dosing: Adult

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

DVT 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: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

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.

Dosing: Hepatic Impairment

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

Reconstitution

Attach enclosed vial adapter to vial containing desirudin. Attach provided syringe containing diluent to adapter on vial. Slowly push plunger down to transfer entire contents of syringe into vial. Do not remove syringe from vial adapter. Gently swirl solution; powder will dissolve within 10 seconds. Resultant solution concentration is 31.5 mg/mL (15.75 mg/0.5 mL provides a 15 mg dose). Turn vial upside down; withdraw appropriate dose amount back into syringe. Remove syringe from vial. Attach enclosed Eclipse™ needle; pull pink lever down and uncap needle; ready for injection. After injection, flip up pink lever to cover needle until it snaps into place; dispose of syringe appropriately.

Administration

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.

Compatibility

Do not mix or administer with other injections, solvents, or infusions.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Following reconstitution, solution may be stored at room temperature for up to 24 hours; protect from light. Discard unused solution after 24 hours.

Drug Interactions

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

Anticoagulants: May enhance the anticoagulant effect of other Anticoagulants. Monitor therapy

Apixaban: May enhance the anticoagulant effect of Anticoagulants. Avoid combination

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. Monitor therapy

Dabigatran Etexilate: May enhance the anticoagulant effect of Anticoagulants. Avoid combination

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

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. Monitor therapy

Edoxaban: May enhance the anticoagulant effect of Anticoagulants. 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. Avoid combination

Estrogen Derivatives: May diminish the anticoagulant effect of Anticoagulants. More specifically, the potential prothrombotic effects of some estrogens and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of estrogens against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Exceptions: Tibolone. Consider therapy modification

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

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Anticoagulants. Bleeding may occur. Consider therapy modification

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

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

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

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

Nonsteroidal Anti-Inflammatory Agents: May enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Obinutuzumab: Anticoagulants may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. 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. Avoid combination

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

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

Progestins: May diminish the therapeutic effect of Anticoagulants. More specifically, the potential prothrombotic effects of some progestins and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of progestins against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Consider therapy modification

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. Monitor therapy

Rivaroxaban: Anticoagulants may enhance the anticoagulant effect of Rivaroxaban. Avoid combination

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

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

Thrombolytic Agents: May enhance the anticoagulant effect of Anticoagulants. Management: See full drug monograph for guidelines for the use of alteplase for acute ischemic stroke during treatment with oral anticoagulants. Monitor therapy

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

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

Tositumomab and Iodine I 131 Tositumomab: Anticoagulants may enhance the adverse/toxic effect of Tositumomab and Iodine I 131 Tositumomab. Specifically, the risk of bleeding-related adverse effects may be increased. Monitor therapy

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

Vitamin E: May enhance the anticoagulant effect of Anticoagulants. Vitamin E may also increase the overall risk for bleeding. Monitor therapy

Vitamin E (Oral): May enhance the anticoagulant effect of Anticoagulants. Monitor therapy

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

Adverse Reactions

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% (Limited to important or life-threatening): 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

ALERT: U.S. 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.

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:

• Elderly: 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.

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).

Pregnancy Risk Factor

C

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).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds, coughing up blood, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, bruises without a reason or that get bigger, or any bleeding that is very bad or that you cannot stop), severe dizziness, syncope, a fall hitting head, signs of stroke (strength differences from one side to another, difficulty speaking or thinking, change in balance, or blurred vision), back pain, signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), or injection site redness or edema (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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