Products Affected - Description

• • Xeloda oral tablet, Genentech, 150 mg, bottle, 60 count, NDC 00004-1100-20 - discontinued
  • Xeloda oral tablet, Genentech, 500 mg, bottle, 120 count, NDC 00004-1101-50 - discontinued
  • Capecitabine oral tablet, Accord, 150 mg, bottle, 60 count, NDC 16729-0072-12
  • Capecitabine oral tablet, Accord, 500 mg, bottle, 120 count, NDC 16729-0073-29
  • Capecitabine oral tablet, Areva, 500 mg, bottle, 120 count, NDC 59923-0722-12
  • Capecitabine oral tablet, Armas Pharmaceuticals, 150 mg, bottle, 60 count, NDC 72485-0204-60
  • Capecitabine oral tablet, Armas Pharmaceuticals, 500 mg, bottle, 120 count, NDC 72485-0205-12
  • Capecitabine oral tablet, Dr. Reddy's, 150 mg, bottle, 60 count, NDC 55111-0496-60
  • Capecitabine oral tablet, Dr. Reddy's, 500 mg, bottle, 120 count, NDC 55111-0497-04
  • Capecitabine oral tablet, Eugia US, 150 mg, bottle, 60 count, NDC 59651-0204-60
  • Capecitabine oral tablet, Eugia US, 500 mg, bottle, 120 count, NDC 59651-0205-08
  • Capecitabine oral tablet, Hikma, 150 mg, bottle, 60 count, NDC 00054-0271-21
  • Capecitabine oral tablet, Hikma, 500 mg, bottle, 120 count, NDC 00054-0272-23
  • Capecitabine oral tablet, Teva, 150 mg, bottle, 60 count, NDC 00093-7473-06
  • Capecitabine oral tablet, Teva, 500 mg, bottle, 120 count, NDC 00093-7474-89

Reason for the Shortage

• • Accord has cabecitabine tablets on manufacturing back order.
  • Areva did not provide a reason for the shortage.
  • Armas did not provide a reason for the shortage.
  • Dr. Reddy's has not provided availability updates at this time.
  • Eugia has capecitabine tablets on shortage due to increased demand.
  • H2-Pharma has Xeloda available. Genentech is no longer marketing Xeloda.
  • Hikma did not provide a reason for the shortage.
  • Novadoz has capecitabine tablets available.
  • Teva did not provide a reason for the shortage.

Available Products

• • Xeloda oral tablet, H2 Pharma, 150 mg, bottle, 60 count, NDC 61269-0470-60
  • Xeloda oral tablet, H2 Pharma, 500 mg, bottle, 120 count, NDC 61269-0475-12
  • Capecitabine oral tablet, Novadoz, 150 mg, bottle, 60 count, NDC 72205-0006-60
  • Capecitabine oral tablet, Novadoz, 500 mg, bottle, 120 count, NDC 72205-0007-92

• • Accord has capecitabine 150 mg tablets on intermittent back order and the company is releasing product as it becomes available. The 500 mg tablets are on back order and the company cannot estimate a release date.
  • Areva has capecitabine 150 mg and 500 mg tablets on back order and the company cannot estimate a release date.
  • Armas has capecitabine 150 mg and 500 mg tablets on back order and the company cannot estimate a release date.
  • Dr. Reddy's has capecitabine 150 mg and 500 mg tablets available to current customers only.
  • Eugia has capecitabine 150 mg and 500 mg tablets on allocation.
  • Hikma has capecitabine 150 mg and 500 mg tablets on back order and the company cannot estimate a release date.
  • Teva has capecitabine 150 mg and 500 mg tablets on back order and the company estimates a release date of November 2023 for the 150 mg tablets and September 2023 for the 500 mg tablets.

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