• In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ. Healthcare providers may do blood tests before and during treatment with XELJANZ.

As biological medicinal products, vaccines present risks to the patient that must be managed:
a. Some vaccines are not “pure” or well defined / characterized products, but contain complex mixtures of proteins, lipids, and other inherent biological materials. As such, the identification and complete removal of “impurities” can be difficult if not impossible;
b. Some vaccines are produced from highly pathogenic and transmissible microorganisms. These microorganisms are present in high concentrations in the production environment, and cross-contamination of products with viable production microorganisms represent a major GMP risk and risk to the vaccinee; 
c. The formulation of some vaccines may be optimized for the survival of microorganisms, making it likely that viable contaminants derived from the production environment (starting materials, operators, and those endemic to the facility) will survive in product substance and be administered to vaccinees; 
d. A number of parenterally administered live viral and live bacterial vaccines cannot be sterilized by filtration. Moreover, some viruses and mycoplasma found in the manufacturing environment may potentially pass through sterilizing filters, making the effectiveness of filtration as a method of reducing environmentallyderived microorganisms not completely reliable. 

“The government alleged that McKesson failed to comply with the shipping and handling requirements of its vaccine distribution contract with the CDC. Under the contract, McKesson provided distribution services, receiving vaccines purchased by the government from manufacturers and then distributing the vaccines to health care providers. The government alleged that the contract required McKesson to ensure that during shipping, the vaccines were maintained at proper temperatures by, among other things, including electronic temperature monitors set to detect when the air temperature in the box reached two degrees Celsius and below or eight degrees Celsius and above. The government alleged that, from approximately April 2007 to November 2007, McKesson failed to set the monitors to the appropriate range, and as a result, knowingly submitted false claims to the CDC for shipping and handling services that did not satisfy its contractual obligations.”