FDA Announces Leucovorin Drug Shortage
On April 9, 2020, the U.S. Food and Drug Administration (FDA) announced that (https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm) supplies of leucovorin calcium lyophilized powder for injection manufactured by Sagent Pharmaceuticals are currently in shortage. On April 21, the agency expanded the shortage to include supplies manufactured by Fresenius Kabi USA and Teva Pharmaceuticals.
The following leucovorin preparations are affected.
Fresenius Kabi USA
- 200 mg SDV (NDC 63323-710-50) is available but demand has increased. Check wholesaler inventory.
- 500 mg SDV (NDC 63323-711-00) is backordered and expected to release May 2020. Check Wholesaler Inventory. The company attributed it to a manufacturing delay.
Sagent Pharmaceuticals
All of the following are backordered with expected availability in December 2020. The company attributed the shortage to a manufacturing delay.
- 50 mg vial (NDC 25021-813-10)
- 100 mg vial (NDC 25021-814-30)
- 200 mg vial (NDC 25021-815-30)
- 350 mg vial (NDC 25021-816-30)
- 500 mg vial (NDC 25021-828-50)
Teva Pharmaceuticals
The company is reporting an increased demand for the drug in the following preparations but still has quantities available.
- 100 mg vial, 20 ml (NDC 0703-5140-01)
- 350 mg vial, 30 ml (NDC 0703-5145-01)
FDA advises, “Please note levoleucovorin is available in ample quantities. There is potential for dosing errors when interchanging leucovorin and levoleucovorin. The dose of levoleucovorin is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin 7.5 mg = racemic leucovorin 15 mg).” For more information on dosing and drug substitutions, refer to FDA guidelines and recommendations.
Oncology nurses can help their institutions and workplaces plan ahead for drug shortages to ensure that patient care and communication are consistent. Read what strategies Rowena Schwartz, PharmD, BCOP, professor of pharmacy practice and ONS’s pharmacist liaison, recommends for oncology nurses to address challenges (https://voice.ons.org/news-and-views/plan-ahead-to-ensure-consistency-in-patient-care-and-communication-during-drug) associated with critical drug shortages.