[07 January 2014]
Products Affected - Description
Aminocaproic acid injection, American Regent
250 mg/mL, 20 mL vial (NDC 00517-9120-25)
Reason for the Shortage
American Regent has aminocaproic acid on shortage due to manufacturing delays.1
Aminocaproic acid injection, Hospira2
250 mg/mL, 20 mL vial (NDC 00409-4346-73)
Estimated Resupply Dates
- American Regent has aminocaproic acid 250 mg/mL 20 mL vials on back order and the company cannot estimate a release date.1
- Aminocaproic acid oral products are not affected by this shortage.3
Implications for Patient Care
- Aminocaproic acid inhibits fibrinolysis, primarily by inhibiting plasminogen activators. It is labeled for the treatment of excessive bleeding, specifically to increase hemostasis in patients with fibrinolytic bleeding of various causes, including surgical complications, hematologic diseases, placental abruption, hepatic cirrhosis, or neoplasms.4,5
- Common off-label uses include treating traumatic hyphema; controlling bleeding of thrombocytopenia; controlling oral bleeding in patients with coagulation disorders (acquired, congenital, drug-induced); and preventing periprocedural bleeding in patients undergoing cardiac surgery, extracorporeal membrane oxygenation, orthopedic surgery, or spinal surgery.6-8
- Aminocaproic acid is rapidly and completely absorbed after oral administration. Peak plasma concentrations occur within 1.2+0.45 hours after an orally administered dose. The dose and pharmacodynamic profile of aminocaproic acid are similar whether administered by the oral or IV routes.4,5
- For the labeled use of acute bleeding, the dose of aminocaproic acid is the same for the injection or the oral tablets: 4 – 5 g IV / PO during the first hour, then 1 gram/hour IV / PO for 8 hours or until bleeding is controlled. If the oral solution is used, the dose is 4 – 5 g during the first hour, then 1.25 gram/hour PO for 8 hours or until bleeding is controlled. Do not exceed a maximum daily dose of 30 g.4,5,7
There is potential for dosing errors when interchanging between aminocaproic acid and tranexamic acid, especially if different administration routes are used. Double-check doses and administration routes.
Alternative Agents & Management
- Use oral aminocaproic acid whenever possible. However, aminocaproic acid injection may be necessary when oral therapy is not an option for a specific patient (eg, swallowing difficulty, unconscious, gastrointestinal absorption problems).
- Tranexamic acid is another fibrinolysis inhibitor that is similar to aminocaproic acid.6-8 Tranexamic acid may be an alternative to aminocaproic acid injection in some clinical settings.
- The table compares dosage regimens of injectable fibrinolysis inhibitors for selected clinical uses.
Table. Alternatives to Aminocaproic Acid Injection for Selected Clinical Uses7-14
Prevent perioperative bleeding in patients undergoing cardiac surgery7,9,11
75 – 150 mg/kg IV (usual range 5 – 10 g) initially, then 10 – 15 mg/kg/hr IV (usual dose 1 g/hr). May add to bypass priming solution at concentration of 2 – 2.5 g/L.7
10 g IV initially, then 2 g/hr intraoperatively. Not added to bypass priming solution.7,9
30 mg/kg IV over 30 minutes initially prior to incision, then 16 mg/kg/hr IV until closure. Add an additional 2 mg/kg to bypass priming solution.7,9
10 – 15 mg/kg IV over 10 – 15 minutes, then 1 – 2 mg/kg/hr. May add 2 – 2.5 mg/kg to bypass priming solution.7,11
Prevent perioperative bleeding in patients undergoing spinal surgery7.8,11-14
100 mg/kg IV bolus after induction, then 10 mg/kg/hr IV intraoperatively until closure.7.8,12,13
2 g IV over 20 minutes before incision, then 100 mg/hr IV intraoperatively and continued for 5 hours after surgery.7,11
10 mg/kg IV before incision, then 1 mg/kg/hr IV until closure.7,11-13
Reduce blood loss in patients undergoing total knee replacement7,8,10,11
150 mg/kg IV given before surgery, then 12.5 – 15 mg/kg/hr IV intraoperatively for 3 – 5 hours.8
5 – 10 g IV given before surgery, then 5 g IV intraoperatively for 3 – 5 hours.8
10 mg/kg IV over 30 minutes before tourniquet deflation, followed by 10 mg/kg IV given 3 hours after the first dose.7,10,11
10 mg/kg IV given 30 minutes before tourniquet release, then 1 mg/kg/hr IV beginning at the end of surgery and continuing for 6 hours afterward.7
- American Regent (personal communications and website). February 21, March 7, April 8, May 17 and 30, June 10, July 2, 11, and 31, August 21, September 19, October 17, December 2 and 11, 2013; and January 2, 2014.
- Hospira (personal communications and website). February 21, March 7, April 9, May 17 and 31, June 10, July 2 and 11, August 1 and 21, September 19, October 17, December 4 and 11, 2013; and January 7, 2014.
- Versapharm (personal communication). March 18, 2013.
- Aminocaproic acid injection solution [product information]. Lake Forest, IL: Hospira; March 2007.
- Amicar (aminocaproic acid tablet, solution) [product information]. Newport, KY: Xanodyne; September 2008.
- McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2013.
- Lacy CF, Armstrong LL, Goldman MP, Lance LL, eds. Lexi-Comp Online. 14th ed. Hudson, OH: Lexi-Comp; 2013.
- Wickersham RM, Novak KK, Horenkamp JR, et al., eds. Drug Facts and Comparisons (updated monthly). St. Louis, MO: Wolters Kluwer Health / Facts and Comparisons; 2013.
- Fergusson DA, Hebert PC, Mazer CD, et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med. 2008;358(22):2319-31.
- Camarasa MA, Ollé G, Serra-Prat M, et al. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006;96(5):576-82.
- McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012;72(5):585-617.
- Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010;18(3):132-8.
- Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008;90(11):2399-407.
- Florentino-Pineda I, Thompson GH, Poe-Kochert C, et al. The effect of Amicar on perioperative blood loss in idiopathic scoliosis. Spine. 2004;29(3):233-238.
Updated January 7, 2014 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 20, 2013, by M. Christina Beckwith, PharmD, and Erin R. Fox, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.
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