Products Affected - Description

Reason for the Shortage

• Hospira had vitamin K injection on shortage due to manufacturing delays.¹
• Amphastar had vitamin K injection on shortage due to increased demand. The company has ramped up production in an effort to meet demand. Amphastar discontinued the vitamin K MINIJET syringes in April 2012.²

Available Products

Estimated Resupply Dates

Amphastar and Hospira have vitamin K injection available at this time.^1,2  

Implications for Patient Care

Vitamin K injection is labeled for use in hypoprothrombinemia due to drugs such as warfarin or derivatives, antibiotics, salicylates, and other drugs that interfere with Vitamin K metabolism.^3,4,5  Vitamin K is labeled for use in hypoprothrombinemia due to disease states or other factors that reduce absorption or prohibit synthesis of Vitamin K.  Low dose Vitamin K injection is also labeled for use in newborns with hemorrhagic disease and is used routinely after birth to prevent hemorrhagic disease.^3,4,5

Safety

Avoid intramuscular administration of vitamin K injection to prevent hematomas except in certain populations such as hemorrhagic treatment and prophylaxis in newborns.^3,4,5

Alternative Agents & Management

• Reserve supplies of vitamin K injection for use in newborn patients.
• Oral vitamin K is not affected by this shortage and should be used for adult patients whenever possible.
• The American College of Chest Physicians created guidelines for management of antithrombotic and thrombolytic therapy that were updated in 2008.⁶  Parts of the guidelines include management of hypothrombinemia due to warfarin and other Vitamin K antagonists. These guidelines include the following recommendations for warfarin reversal based on international normalized ratio (INR) and evidence of bleeding.⁶
  • If INR is <5, with no significant bleeding, no vitamin K is required. Reduce or skip warfarin dose and monitor INR frequently.
  • If INR is >5 or <9, with no significant bleeding, low doses of vitamin K of 1 to 2.5 mg given orally may be needed. For more rapid reversal give vitamin K up to 5 mg orally. Repeat a low dose of vitamin K if INR is still high the next day. Reduce or skip warfarin dose and monitor INR frequently. The INR is expected to decrease to desired level within 24 hours.
  • If INR is >9, with no significant bleeding, give higher doses of vitamin of 2.5 to 5 mg. The INR is expected to decrease within 24-48 hours.
  • Patients with serious bleeds, regardless of extent of INR elevation, should receive vitamin K 10 mg intravenously supplemented by fresh frozen plasma (FFP), prothrombin complex concentrate (PCC), or recombinant factor VIIa. Repeat as necessary.
  • Patients with life-threatening bleeds regardless of extent of INR elevation should receive fresh frozen plasma (FFP), prothrombin complex concentrate (PCC), or recombinant factor VIIa supplemented by vitamin K 10 mg intravenous. Repeat as necessary.
• Reserve any remaining supply of vitamin K10 mg ampules for severe or life threatening bleeds. Reserve supplies of the 1 mg injection for use in newborn patients.

1. Hospira, Customer Service (personal communication). October 20 and 24, November 7, 17, and 22, December 13 and 27, 2011; January 3 and 18, February 20, March 5 and 28, April 11 and 17, May 7 and 22, June 27, July 16, September 10 and 27, December 14, 2012; February 21, April 24, and June 11, 2013.
2. Amphastar, Customer Service (personal communication). October 20, November 9, 17, and 23, December 13 and 27, 2011; February 21, March 5 and 29, April 11, May 9 and 22, June 27, July 16, September 10 and 27, December 14, 2012; February 22, April 22, and June 10, 2013.
3. Vitamin K Injection (MIN-I-JET) product information. South El Monte, CA: Amphastar; 2005 April.
4. Vitamin K Injection (SAF-T-JET) product information. South El Monte, CA: Amphastar; 2005 February.
5. Vitamin K Injection product information. Lake Forest, IL: Hospira; 2004 August.
6. Ansell J, Hirsh J, Hylek K, et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. Jun 2008;133(6 Suppl):546S-592S.

Updated

Updated June 11, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. October 26, 2011, by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.