Products Affected - Description

• • Paclitaxel intravenous solution for injection, Sagent, 300 mg/50 mL (6 mg/mL) multiple dose vial, NDC 25021-0255-50
  • Paclitaxel intravenous solution for injection, Teva, 100 mg/16.7 mL (6 mg/mL) multiple dose vial, NDC 00703-3216-01
  • Paclitaxel intravenous solution for injection, Teva, 30 mg/5 mL (6 mg/mL) multiple dose vial, NDC 00703-3213-01
  • Paclitaxel intravenous solution for injection, Teva, 300 mg/50 mL (6 mg/mL) multiple dose vial, NDC 00703-3218-01

Reason for the Shortage

• • Almaject has discontinued paclitaxel injection.
  • Fresenius Kabi has paclitaxel injection available.
  • Pfizer has paclitaxel injection available.
  • Sagent did not provide a reason for the shortage.
  • Teva did not provide a reason for the shortage.

Available Products

• • Paclitaxel intravenous solution for injection, Fresenius Kabi, 100 mg/16.7 mL (6 mg/mL) multiple dose vial, NDC 63323-0763-16
  • Paclitaxel intravenous solution for injection, Fresenius Kabi, 300 mg/50 mL (6 mg/mL) multiple dose vial, NDC 63323-0763-50
  • Paclitaxel intravenous solution for injection, Pfizer, 100 mg/16.7 mL (6 mg/mL) multiple dose vial, NDC 61703-0342-22
  • Paclitaxel intravenous solution for injection, Pfizer, 30 mg/5 mL (6 mg/mL) multiple dose vial, NDC 61703-0342-09
  • Paclitaxel intravenous solution for injection, Pfizer, 300 mg/50 mL (6 mg/mL) multiple dose vial, NDC 61703-0342-50
  • Paclitaxel intravenous solution for injection, Sagent, 100 mg/16.7 mL (6 mg/mL) multiple dose vial, NDC 25021-0255-17
  • Paclitaxel intravenous solution for injection, Sagent, 30 mg/5 mL (6 mg/mL) multiple dose vial, NDC 25021-0255-05
  • Paclitaxel intravenous solution for injection, Teva, 150 mg/25 mL (6 mg/mL) multiple dose vial, NDC 00703-3217-01

• • Sagent has paclitaxel 300 mg/50 mL vials on back order and the company estimates a release date of November 2024.
  • Teva has paclitaxel 30 mg/5 mL vials on back order and the company estimates a release date of late-January 2025. The 100 mg/16.7 mL vials and 300 mg/50 mL vials are on allocation.

• • Consider evaluating the health-care system's total supply of paclitaxel before beginning patients on combination chemotherapy regimens containing paclitaxel. 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 paclitaxel.
  • 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.