Products Affected - Description

• • Topotecan lyophilized powder for injection, Accord, 4 mg, vial, 1 count, NDC 16729-0151-31
  • Topotecan solution for injection, Accord, 1 mg/mL, 4 mL vial, 1 count, NDC 16729-0243-31
  • Topotecan lyophilized powder for injection, Fresenius Kabi, 4 mg, vial, 1 count, NDC 63323-0762-10
  • Topotecan solution for injection, Pfizer, 1 mg/mL, 4 mL vial, 1 count, NDC 00409-0302-01
  • Topotecan lyophilized powder for injection, Teva, 4 mg, vial, 1 count, NDC 45963-0615-56

Reason for the Shortage

• • Accord has topotecan injection on shortage due to manufacturing delays.
  • Fresenius Kabi did not provide a reason for the shortage.
  • Pfizer has topotecan injection on shortage due to manufacturing delays.
  • Teva did not provide a reason for the shortage.

Available Products

• • There is insufficient supply for usual ordering

• • Accord has topotecan 1 mg/mL 4 mL vials and 4 mg powder for injection vials on back order and the company cannot estimate a release date.
  • Fresenius Kabi has topotecan 4 mg powder for injection vials on back order and the company estimates a release date of late-April 2024.
  • Pfizer has topotecan 1 mg/mL 4 mL vials available in limited supply.
  • Teva has topotecan 4 mg powder for injection vials on allocation.

• • Consider evaluating the health-care system's total supply of topotecan before beginning patients on combination chemotherapy regimens containing topotecan. If adequate supplies are not available, select an alternative regimen.
  • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for topotecan.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
  • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.pdf
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.