Advertisement

Fosphenytoin Injection

[02 April 2015]

Products Affected - Description

Fosphenytoin, Fresenius Kabi
75 mg/mL (50 mg PE/mL), 2 mL vial, 25 count (NDC 63323-0403-02)
75 mg/mL (50 mg PE/mL), 10 mL vial, 10 count (NDC 63323-0403-10)

Fosphenytoin, Hospira
75 mg/mL (50 mg PE/mL), 2 mL vial, 25 count (NDC 00409-4857-02)
75 mg/mL (50 mg PE/mL), 10 mL vial, 10 count (NDC 00409-4857-10)
 
Fosphenytoin, West-Ward
75 mg/mL (50 mg PE/mL), 2 mL vial, 25 count (NDC 00641-6136-25)
75 mg/mL (50 mg PE/mL), 10 mL vial, 10 count (NDC 00641-6137-10)

Reason for the Shortage

  • Fresenius Kabi recalled numerous lots of fosphenytoin due to particulate matter potentially from glass delamination and consistent with glass particulates observed in samples. Fresenius Kabi has a letter discussing the lot numbers and what to do with affected product.2
  • Hospira states the shortage is due manufacturing delays.2
  • Pfizer has Cerebyx vials available.3
  • West-Ward cannot provide a reason for the shortage.4

Available Products

Cerebyx, Pfizer
75 mg/mL (50 mg PE/mL), 2 mL vial, 25 count (NDC 00069-6001-25)
75 mg/mL (50 mg PE/mL), 10 mL vial, 10 count (NDC 00069-6001-21)

Estimated Resupply Dates

  • Pfizer has Cerebyx readily available.3
  • Hospira has all fosphenytoin 75 mg/mL presentations on back order and the company cannot estimate a release date.6
  • Fresenius Kabi has fosphenytoin 75 mg/mL 2 mL and 10 mL vials on back order and the company cannot estimate a release date.2
  • West-Ward has fosphenytoin 75 mg/mL 2 mL and 10 mL vials on back order and the company cannot estimate a release date.4

Implications for Patient Care

Fosphenytoin is labeled for the treatment or prevention of seizures occurring during neurosurgery, treatment of status epilepticus, and as a short term substitution for oral phenytoin if oral phenytoin is not able to be administered.5

Safety

  • Fosphenytoin and phenytoin are not equivalent in terms of dosing. However, fosphenytoin concentrations and dosing recommendations are expressed as phenytoin equivalents (PE) and orders for fosphenytoin should be written and dispensed as phenytoin equivalents. Fosphenytoin 75 mg/mL, also expressed as fosphenytoin 50 mg PE/mL, is equivalent to IV phenytoin 50 mg/mL.5
  • Maximum administration rates differ for fosphenytoin and phenytoin. Fosphenytoin has a maximum administration rate of 150 mg PE/minute. The maximum recommended phenytoin administration rate is 50 mg/minute in adults and 1-3 mg/kg/minute in neonates and pediatric patients.5,6
  • Phenytoin injection is a vesicant and should be administered via a central line when possible.6 Rapid infusion can lead to cardiac or respiratory arrest. Use of a 20-gauge or larger IV catheter, infusion through a well-placed line in a vein no smaller than the antecubital fossa vein, and a reduced administration rate may decrease the risk of injuries.7 The dilution of phenytoin is controversial and is not recommended due to increased risk of phenytoin precipitation.6

Alternative Agents & Management

  • The choice of an alternative agent must be patient-specific and based on the clinical situation, venous access, renal and hepatic function, and other comorbid conditions.
  • Use oral phenytoin whenever possible. If IV phenytoin is necessary, the same total daily dose can be given IV. Carefully monitor plasma phenytoin concentrations due to increased bioavailability with IV preparation.14,15
  • Table 1 provides some alternative treatment options for selected clinical situations.
  • Table 2 provides some alternative treatment options for the treatment of status epilepticus or acute repetitive seizures in neonates, infants, and children.

Related Shortages

References

  1. Fresenius Kabi, Customer Service (personal communication and website). March 4, 12, and 24, April 6, 13, and 27, May 19 and 28, June 15, July 16, 22, and 23, August 27, October 14 and 20, November 16, December 20, 2010; January 27, March 2, April 20, May 25, July 14, August 8, October 3, November 30, 2011; January 4, February 22, March 22, April 10, 19, and 23, June 12, July 16, August 7 and 13, October 24, November 9, December 21, 2012; January 14, February 5, March 6 and 27, April 29, May 9 and 28, June 17, July 16, August 12, September 10, October 29, 2013; January 27, February 28, April 11, May 6, June 3 and 23, July 11, August 19, October 6, November 12, 2014; January 20, and March 31, 2015.
  2. Hospira, Customer Service (website and personal communication). August 8, March 4, 12, and 24, April 6, 13, and 27, and May 18 and 27, June 14, July 20, October 12, 2010; January 20, February 25, April 18, May 25, June 3, July 12, August 8, October 3, November 30, 2011; January 3, February 20, March 21, April 10 and 23, June 11, July 16, August 6, October 24, November 9, December 26, 2012; January 16, February 5, March 6 and 25, April 29, May 13 and 28, June 18, July 18, August 12, September 9, October 30, 2013; January 27, March 3, April 14, May 6, June 6 and 23, July 14, August 21, October 6, November 17, 2014; January 23, and April 2, 2015.
  3. Pfizer, Customer Service (personal communication). March 12, 2010; October 29, 2013; January 24, February 28, April 11, May 6, June 6 and 23, July 11, August 15, October 6 and 17, November 14, 2014; January 23, and March 27, 2015.
  4. West-Ward, Customer Service (personal communication). November 18, December 20, 2010; January 27, March 3, April 18, May 25, August 10, October 4, 2011; January 6, February 23, March 21, April 6 and 24, June 14 and 29, August 6, October 24, November 9, December 17, 2012; January 11, February 5 March 6 and 25, April 22, May 10 and 28, June 10, July 12, August 9, September 6, October 25, 2013; January 24, February 27, April 11, May 6, June 4 and 23, July 11, August 14, October 1, November 13 and 18, 2014; January 21, and March 25, 2015.
  5. Cerebyx Injection product information. New York, NY: Pfizer; 2015 January.
  6. Phenytoin Injection product information. Eatontown, NJ: West-Ward Pharmaceuticals; 2014 January
  7. Meek PD et al. Guidelines for nonemergency use of parenteral phenytoin products: proceedings of an expert panel consensus. Arch Intern Med. 1999;159:2639-2644.

Updated

Updated April 2, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 28, 2010, by Megan Dryer, PharmD, Drug Information Specialist and M. Christina Beckwith, PharmD, Drug Information Specialist. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

« Back to Drug Shortage Product Bulletins

Advocacy Activity
Get the latest updates on ASHP's advocacy activity on drug shortages.
Advertisement