Products Affected - Description

• • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 1 mL vial, NDC 16729-0267-63
  • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 4 mL vial, NDC 16729-0267-64
  • Docetaxel intravenous solution for injection, Accord, 20 mg/mL, 8 mL vial, NDC 16729-0267-65
  • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 1 mL vial, NDC 72485-0214-01
  • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 4 mL vial, NDC 72485-0215-04
  • Docetaxel intravenous solution for injection, Armas Pharmaceuticals, 20 mg/mL, 8 mL vial, NDC 72485-0216-08
  • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 2 mL vial, NDC 43066-0001-01
  • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 8 mL vial, NDC 43066-0006-01
  • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 16 mL vial, NDC 55150-0380-01
  • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 2 mL vial, NDC 55150-0378-01
  • Docetaxel intravenous solution for injection, Eugia US, 10 mg/mL, 8 mL vial, NDC 55150-0379-01
  • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 16 mL vial, NDC 50742-0463-16
  • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 2 mL vial, NDC 50742-0428-02
  • Docetaxel intravenous solution for injection, Ingenus Pharmaceuticals, 10 mg/mL, 8 mL vial, NDC 50742-0431-08
  • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 2 mL vial, NDC 67457-0531-02
  • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 16 mL vial, NDC 00409-0201-20
  • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 2 mL vial, NDC 00409-0201-02
  • Docetaxel intravenous solution for injection, Pfizer, 10 mg/mL, 8 mL vial, NDC 00409-0201-10
  • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 1 mL vial, NDC 00409-0366-01
  • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 4 mL vial, NDC 00409-0367-01
  • Docetaxel intravenous solution for injection, Pfizer, 20 mg/mL, 8 mL vial, NDC 00409-0368-01
  • Docetaxel intravenous solution for injection, Sagent, 20 mg/mL, 1 mL vial, NDC 25021-0245-01
  • Docetaxel intravenous solution for injection, Sagent, 20 mg/mL, 4 mL vial, NDC 25021-0245-04
  • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 1 mL vial, NDC 47335-0323-40 - discontinued
  • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 4 mL vial, NDC 47335-0895-40 - discontinued
  • Docetaxel intravenous solution for injection, Sun Pharma, 20 mg/mL, 8 mL vial, NDC 47335-0939-40 - discontinued
  • Docetaxel intravenous solution for injection, Teva, 20 mg/mL, 1 mL vial, NDC 45963-0734-54
  • Docetaxel intravenous solution for injection, Teva, 20 mg/mL, 4 mL vial, NDC 45963-0765-52
  • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 1 mL vial, NDC 00955-1020-01
  • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 4 mL vial, NDC 00955-1021-04
  • Docetaxel intravenous solution for injection, Winthrop, 20 mg/mL, 8 mL vial, NDC 00955-1022-08
  • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 16 mL vial, NDC 70700-0176-22
  • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 2 mL vial, NDC 70700-0174-22
  • Docetaxel intravenous solution for injection, Xiromed, 10 mg/mL, 8 mL vial, NDC 70700-0175-22

Reason for the Shortage

• • Accord has docetaxel on manufacturing back order.
  • Armas did not provide a reason for the shortage.
  • Baxter has docetaxel injection on shortage due to increased demand.
  • Curae Pharma360 estimates a launch date in early third-quarter 2023.
  • Eugia did not provide a reason for the shortage.
  • Hikma did not provide a reason for the shortage.
  • Ingenus did not provide a reason for the shortage.
  • Meitheal has docetaxel injection available.
  • Pfizer has docetaxel injection on shortage due to increased demand.
  • Sagent did not provide a reason for the shortage.
  • Sandoz did not provide a reason for the shortage.
  • Sun Pharm has discontinued docetaxel injection.
  • Teva did not provide a reason for the shortage.
  • Viatris did not provide a reason for the shortage.
  • Winthrop did not provide a reason for the shortage.
  • Xiromed did not provide a reason for the shortage.

Available Products

• • Docetaxel intravenous solution for injection, Baxter, 10 mg/mL, 16 mL vial, NDC 43066-0010-01
  • Docetaxel intravenous solution for injection, Hikma, 20 mg/mL, 1 mL vial, NDC 00143-9204-01
  • Docetaxel intravenous solution for injection, Hikma, 20 mg/mL, 4 mL vial, NDC 00143-9205-01
  • Docetaxel intravenous solution for injection, Meitheal Pharmaceuticals, 10 mg/mL, 16 mL vial, NDC 71288-0144-16
  • Docetaxel intravenous solution for injection, Meitheal Pharmaceuticals, 10 mg/mL, 8 mL vial, NDC 71288-0144-08
  • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 16 mL vial, NDC 67457-0533-16
  • Docetaxel intravenous solution for injection, Mylan (Viatris), 10 mg/mL, 8 mL vial, NDC 67457-0532-08
  • Docetaxel intravenous solution for injection, Mylan (Viatris), 20 mg/mL, 8 mL vial, NDC 67457-0781-08
  • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 16 mL vial, NDC 66758-0050-03
  • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 2 mL vial, NDC 66758-0050-01
  • Docetaxel intravenous solution for injection, Sandoz, 10 mg/mL, 8 mL vial, NDC 66758-0050-02

• • Accord has docetaxel injection on back order and the company cannot estimate a release date.
  • Armas has docetaxel injection on back order and the company cannot estimate a release date.
  • Baxter has docetaxel 10 mg/mL 2 mL and 8 mL vials on back order and the company estimates a release date of October 2023.
  • Eugia has docetaxel 10 mg/mL 2 mL vials on long-term back order and the company cannot estimate a release date. The 10 mg/mL 8 mL and 16 mL vials are on intermittent back order and the company is releasing supplies as they become available.
  • Ingenus has docetaxel injection on back order and the company cannot estimate a release date.
  • Pfizer has docetaxel 10 mg/mL 16 mL vials available in limited supply. The 10 mg/mL 2 mL and 8 mL vials are on back order and the company estimates a release date of December 2023 for the 2 mL vials and November 2023 for the 8 mL vials. The 20 mg/mL 4 mL and 8 mL vials are available in limited supply. The 20 mg/mL 1 mL vials are on back order and the company estimates a release date of October 2023.
  • Sagent has docetaxel 20 mg/mL 1 mL vials on back order and the company estimates a release date of September 2023. The 20 mg/mL 4 mL vials are on allocation.
  • Viatris has docetaxel 10 mg/mL 2 mL vials on back order and the company estimates a release date of September 2023.
  • Teva has short-dated docetaxel 20 mg/mL 1 mL vials available with an expiration date of April 2024. The 20 mg/mL 4 mL vials are on allocation.
  • Winthrop has docetaxel injection on back order and the company cannot estimate a release date.
  • Xiromed has docetaxel injection on long-term back order and the company cannot estimate a release date.

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