Alcohol Prep Pads for Enfuvirtide and Peginterferon Alfa-2a Recalled
“Genentech, Inc., a member of the Roche Group, has learned of a voluntary product recall in the United States involving all lots of alcohol prep pads, alcohol swabs and alcohol swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group alcohol prep pads are co-packaged with the following Genentech products: Fuzeon®; Boniva® Injection; Pegasys®; TNKase®; Nutropin AQ® Pen 10 Kit; and Nutropin AQ® Pen 20 Kit. The Genentech medicines have not been affected in any way. In the interest of patient safety, Genentech wants to ensure that you and your [patients] are aware of this recall of only the alcohol prep products by the Triad Group.
“This recall by the Triad Group has been initiated due to concerns about potential bacterial contamination of the alcohol prep products with Bacillus cereus. This recall involves alcohol prep products marked as sterile, as well as non-sterile products. …
“Genentech recommends that you immediately discontinue use of the alcohol prep pads packaged with these medicines. …
“If you or your patients have any further questions or require additional information, please contact the Genentech Resource Center at 1-877-GENENTECH.
“You are encouraged to report side effects associated with the use of these products to Genentech and the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, which can be found at www.fda.gov/medwatch or call 1-800-FDA-1088.”
More information is available:
AIDSinfo Updates Health Topics Page!
AIDSinfo is pleased to announce the release of our updated Health Topics page on the AIDSinfo Web site and on AIDSinfo mobile! The Health Topics page is a comprehensive collection of links to government resources about HIV/AIDS-related topics, including information on treatment and prevention guidelines and resources, clinical research, and coinfections. The new page features an updated design, as well as improved navigation and additional functionality, including links to new pages and enhanced search methods.
The Health Topics page includes the following new features:
- More than 100 new links to reliable, government-approved Web pages
- Search function that allows users to search for content within all Health Topics sections
- A–Z index that allows users to view an alphabetized list of topics included on the Health Topics page
- Icons to designate easy-to-read, patient-friendly materials
- Links to relevant resources from the National Library of Medicine HIV/AIDS Portal, which provides access to reliable government and nongovernment Web sites
The Health Topics page is designed to provide federally approved HIV/AIDS treatment and research information to a range of audiences, including health care providers, researchers, and people living with HIV/AIDS and their families.
Please visit our redesigned Health Topics page today to explore our new content and added features!
Questions or comments? E-mail us at ContactUs@aidsinfo.nih.gov.
Atazanavir Label Updated with Perinatal and Postpartum Dosing Recommendations
“On February 4, 2011, FDA approved new labeling for Reyataz (atazanavir) to include dosing recommendations for treatment of HIV-1 infection during pregnancy and postpartum period. …
“Dosing During Pregnancy and the Postpartum Period:
- “Reyataz should not be administered without ritonavir
- “Reyataz should only be administered to pregnant women with HIV-1 strains susceptible to atazanavir
- “For pregnant patients, no dose adjustment is required for Reyataz with the following exceptions:
- “For treatment-experienced pregnant women during the second or third trimester, when Reyataz is coadministered with either an H2-receptor antagonist or tenofovir, Reyataz 400 mg with ritonavir 100 mg once daily is recommended. There are insufficient data to recommend a Reyataz dose for use with both an H2-receptor antagonist and tenofovir in treatment-experienced pregnant women.
- “No dose adjustment is required for postpartum patients. However, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery.”
More information is available: