Aprotinin

Aprotinin Brand Name– Trasylol

What is Aprotinin

Aprotinin is a proteolytic enzyme inhibitor obtained from bovine lung that has multiple effects on the coagulation system.

Aprotinin is indicated for use during repeat CABG, when patients are likely to sustain excessive bleeding. It is useful during the initial surgery if there is an especially high risk of bleeding (e.g., impaired hemostasis, or pretreatment with aspirin or NSAIDs) or when transfusion is unacceptable or unavailable.

Use of aprotinin reduces the need for blood transfusion and its associated risks, and also allows for a clearer field of view during surgery.

Aprotinin also inhibits clotting, although therapy with aprotinin does not replace heparinization. In January 2006, Mangano et al reported that in patients undergoing CABG surgery, patients who received aprotinin versus tranexamic acid, aminocaproic acid, or no treatment had a significantly higher risk of renal failure, myocardial infarction, heart failure, stroke, and encephalopathy.

In addition, the risk of death over a 5-year period was increased in patients receiving aprotinin after CABG surgery vs. no treatment; in contrast, an increased risk of death was not demonstrated in patients receiving tranexamic acid or aminocaproic acid as compared to no treatment.

Similarly, Karkouti et al reported that the use of aprotinin versus tranexamic acid was associated with a significantly increased risk of renal dysfunction in patients undergoing CABG.

Indications

  1. bleeding prophylaxis
  2. cardiac surgery
  3. cardiopulmonary bypass
  4. surgical bleeding
  5. thrombolytic therapy reversal

For prophylactic use to reduce surgical bleeding (i.e., bleeding prophylaxis) and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) cardiac surgery who are at increased risk for blood loss and blood transfusion

NOTE: Aprotinin has been designated an orphan drug by the FDA for this indication.

NOTE: In May 2008, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of the Trasylol brand of aprotinin from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol will be limited to investigational use.

Because of the potential for increased risk of death or renal, cardiovascular, or cerebrovascular toxicity, FDA recommends limiting the use of aprotinin to those patients where reduced blood loss is essential for their medical management.

Clinicians considering to use aprotinin for this indication should be fully aware of the risks associated with its use.

NOTE: In low risk patients, there is no difference in efficacy between regimen A and regimen B. Therefore, the dosage used (A vs. B) is at the discretion of the practitioner.

NOTE: Each milliliter contains aprotinin 10,000 KIU (Kallikrein Inhibitor Units) (1.4 mg/ml).

Side Effects

  1. anaphylactic shock
  2. anaphylactoid reactions
  3. angioedema
  4. coma
  5. dyspnea
  6. encephalopathy
  7. erythema
  8. heart failure
  9. hemolysis
  10. myocardial infarction
  11. nausea
  12. phlebitis
  13. pruritus
  14. pulmonary edema
  15. renal failure (unspecified)
  16. renal tubular necrosis
  17. serious hypersensitivity reactions or anaphylaxis
  18. sinus tachycardia
  19. stroke
  20. urticaria
  21. vomiting

Monitoring Parameters

  • clotting time
  • serum creatinine/BUN

Contraindications

  • anticoagulant therapy
  • aprotinin exposure in the previous 12 months
  • aprotinin hypersensitivity
  • atopy
  • bovine protein hypersensitivity
  • breast-feeding
  • children
  • dialysis
  • obstetric delivery
  • pregnancy
  • renal failure
  • renal impairment
  • serious hypersensitivity reactions or anaphylaxis

Interactions

  • Acyclovir
  • Aminoglycosides
  • Amlodipine; Benazepril
  • Amphotericin B
  • Amphotericin B cholesteryl sulfate complex (ABCD)
  • Amphotericin B lipid complex (ABLC)
  • Amphotericin B liposomal (LAmB)
  • Angiotensin-converting enzyme inhibitors
  • Benazepril
  • Benazepril; Hydrochlorothiazide, HCTZ
  • Captopril
  • Captopril; Hydrochlorothiazide, HCTZ
  • Cidofovir
  • Cisplatin
  • Cyclosporine
  • Enalapril, Enalaprilat
  • Enalapril; Felodipine
  • Enalapril; Hydrochlorothiazide, HCTZ
  • Foscarnet
  • Fosinopril
  • Fosinopril; Hydrochlorothiazide, HCTZ
  • Ganciclovir
  • Heparin
  • Hydrochlorothiazide, HCTZ; Lisinopril
  • Hydrochlorothiazide, HCTZ; Moexipril
  • Hydrochlorothiazide, HCTZ; Quinapril
  • Iohexol
  • Iopamidol
  • Iopromide
  • Ioversol
  • Isosulfan Blue
  • Lisinopril
  • Moexipril
  • Non-Ionic Contrast Media
  • Nonsteroidal antiinflammatory drugs
  • Pamidronate
  • Perindopril
  • Perindopril; Amlodipine
  • Quinapril
  • Ramipril
  • Thrombolytic Agents
  • Trandolapril
  • Trandolapril; Verapamil
  • Tretinoin, ATRA
  • Valacyclovir
  • Valganciclovir
  • Vancomycin
  • Zoledronic Acid
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