[07 September 2011]
Products Affected - Description
Xeloda 500 mg tablets, Genentech
Reason for the Shortage
- Genentech voluntarily recalled 13 lots of Xeloda 500 mg tablets because of possible contamination with low levels of naphthalene and 1,4-dichlorobenzene. Low levels of these contaminants are unlikely to produce a significant health risk to patients. This recall does not affect Xeloda 150 mg tablets.1,2
- FDA was allowing Genentech to temporarily import Xeloda 500 mg tablets in 120 count blister packs from the United Kingdom. The blister packs contain Xeloda tablets identical to the FDA-approved product. Xeloda blister packs are not child resistant, and include the UK approved package leaflet rather than the US prescribing information.1,2
Estimated Resupply Dates
Genentech has available Xeloda 500 mg in 120 count bottles (NDC 00004-1101-50) and Xeloda 150 mg in 60 count bottles (NDC 0004-1100-20). Genentech is no longer distributing the Xeloda 500 mg blister packs; however, there may still be some in the supply chain during this time.1
Implications for Patient Care
- Capecitabine is a fluorouracil prodrug. It is labeled for treating metastatic colorectal cancer, as an adjuvant to surgery in Dukes’ C colon cancer, and for treatment resistant metastatic breast cancer alone or in combination with docetaxel.3,4,5
- Capecitabine is used off-label for treatment-resistant, advanced or metastatic breast cancer in combination with lapatinib or ixabepilone. Capecitabine is also being studied for treating gastric cancer.3,4,5
- Chemotherapy agents, such as capecitabine, pose additional safety risks both for patients and for healthcare workers handling these agents.3,4
- Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).3,4
Alternative Agents & Management
- There are no alternative manufacturers of capecitabine tablets.
- 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.3,4
- 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.
- 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.
- Genentech (personal communications). March 29 and 31, June 10, August 4, and September 7, 2011.
- Genentech. Dear Healthcare Professional Letter. Accessed March 31, 2011.
- Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2011.
- Antineoplastic agents. In: McEvoy GK, ed. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2011: 905-1276.
- Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. March 2011.
Updated September 7, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Created March 31, 2011 by David M. Peterson, PharmD, Drug Information Specialist. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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