Handling the Leucovorin Shortage

AHSP and ASCO clarify implications for practitioners
On July 20, the US Food and Drug Administration (FDA) announced shortages of leucovorin for injection. One manufacturer, Bedford, has not supplied a reason for the shortage or a date when supplies will be available. The other manufacturer, Teva, has cited manufacturing delays and provided an estimated release date in the fourth quarter of 2010.
 
Levoleucovorin, a related project, is still available. However, the American Society of Health-System Pharmacists (AHSP) cautions that the two agents are not interchangeable, noting the potential dosing errors. The dose for levoleucovorin is 50% of the usual dose of leucovorin. In addition, levoleucovorin is not FDA-approved for oncology indications and may carry a higher price tag.
 
For some malignancies, substitution of capecitabine for the combination of 5-fluorouracil (5-FU)/leucovorin is supported based on high-quality randomized clinical trials, according to an American Society of Clinical Oncology (ASCO) press release. However, the release noted that such data are not available for all 5-FU/leucovorin-containing regimens. Also of consideration, the side effect profile of capecitabine differs from that of 5-FU/leucovorin (eg, more hand-foot syndrome) as does gastrointestinal absorption.
  • Capecitabine has been found to be noninferior to intravenous (IV) FU/leucovorin as single agents for both metastatic colorectal cancer and adjuvant therapy for stage III colon cancer.
  • The combination of capecitabine and oxaliplatin was found to be noninferior to IV 5-FU/leucovorin and oxaliplatin (FOLFOX).
  • Capecitabine and irinotecan (CAPIRI) was less efficacious and more toxic compared with IV 5-FU/leucovorin and irinotecan (FOLFIRI) at the doses of CAPIRI used in the BICC-C Study.
  • No efficacy data are available from two trials testing capecitabine with oxaliplatin in the adjuvant therapy setting for colon cancer to date.
 
Products affected
Leucovorin calcium lyophilized powder for injection:
·         200 mg vial, 1 count (Bedford)
·         200 mg Novaplus vial, 1 count (Bedford)
·         100 mg vial, 1 count (Teva)
·         350 mg vial, 1 count (Teva)
 
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