Products Affected - Description

• • Xeloda oral tablet, H2 Pharma, 500 mg, bottle, 120 count, NDC 61269-0475-12
  • Capecitabine oral tablet, Teva, 150 mg, bottle, 60 count, NDC 00093-7473-06

Reason for the Shortage

• • Accord has capecitabine tablets available.
  • Armas has temporarily discontinued capecitabine.
  • Armas has temporarily discontinued capecitabine.
  • Aurobindo has capecitabine tablets available.
  • Dr. Reddy's has capecitabine tablets available.
  • Camber has capecitabine tablets available.
  • H2-Pharma did not provide a reason for the shortage. Genentech is no longer marketing Xeloda.
  • Hikma is not marketing capecitabine.
  • Lifestar Pharma has capecitabine tablets available
  • 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
  • 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, Aurobindo, 150 mg, bottle, 60 count, NDC 59651-0204-60
  • Capecitabine oral tablet, Aurobindo, 500 mg, bottle, 120 count, NDC 59651-0205-08
  • Capecitabine oral tablet, Camber, 150 mg, bottle, 60 count, NDC 31722-0774-60
  • Capecitabine oral tablet, Camber, 500 mg, bottle, 60 count, NDC 31722-0775-60
  • Capecitabine oral tablet, Camber, 500 mg, bottle, 120 count, NDC 31722-0775-12
  • 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, Lifestar Pharma, LLC, 150 mg, bottle, 60 count, NDC 70756-0815-60
  • Capecitabine oral tablet, Lifestar Pharma, LLC, 500 mg, bottle, 120 count, NDC 70756-0815-22
  • 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
  • Capecitabine oral tablet, Teva, 500 mg, bottle, 120 count, NDC 00093-7474-89

• • H2 Pharma has Xeloda 500 mg tablets in 120 count bottles on back order and the company cannot estimate a release date.
  • Teva has capecitabine 150 mg tablets in 60 count bottles on intermittent back order and the company is releasing product as it becomes available.

• • 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.