Baxa Corp (Englewood, Colo) recently launched the PadLock Set Saver. The product is the first and only aseptic intravenous (IV) administration set storage solution that can be swabbed and reused. PadLock Set Saver provides a secure seal for the end of the administration set, preventing contamination when the set is not being used for infusion. Effective for multiple uses, the product attaches to an IV administration set and replaces the need for sterile, single-use caps. The PadLock Set Saver device is designed to promote best practice for aseptic IV administration set disconnections, preventing touch contamination and securing the IV line in between drug administrations. The product also eliminates the use of IV administration set caps, which are a known choking hazard. The PadLock Set Saver provides temporary aseptic storage of the IV administration line when disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. For more information, call 800-567-BAXA (800-567-2292) or visit www.baxa.com.
B. Braun Medical Inc (Bethlehem, Pa) recently received FDA approval for Cefotetan for Injection and Dextrose for Injection in the DUPLEX Drug Delivery System. With a unique design that helps ensure accurate dosage delivery and allows for room-temperature storage, the system is now the only ready-to-use intravenous (IV) drug delivery system available for Cefotetan therapy in the United States. The DUPLEX Drug Delivery System, a dual chamber IV container, stores the drug and diluent in separate compartments until the seal is broken just prior to administration. The system is also equipped with a unique bar-code system that references the final admixture and can be used to reduce medication errors, automate patient charting, track inventory, and facilitate reimbursement tracking. The DUPLEX Drug Delivery System is a closed system that ensures sterility and dose accuracy. It consists of a prefilled, latex- and PVC/DEHP-free IV bag containing accurate doses of drug and diluent in different compartments, separated by a quick release seal. There are no vials to attach or activate, and there is no possibility of delivering the diluent without the drug. Prior to activation, it can be stored at room temperature for up to 12 months and does not require a thawing process. For more information, call 800-854-6851, or visit www.bbraunusa.com.
sanofi-aventis (Bridgewater, NJ) recently received FDA approval for Taxotere Injection Concentrate in combination with cisplatin and 5- fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck (SCCHN) before patients undergo chemoradiotherapy and surgery. The product is also indicated as a single agent for locally advanced or metastatic breast cancer (BC) after chemotherapy failure, and with doxorubicin and cyclophosphamide as adjuvant treatment for operable node-positive BC; as a single agent for locally advanced or metastatic non?small cell lung cancer (NSCLC) after platinum therapy failure, and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC; with prednisone in androgenindependent (hormone-refractory) metastatic prostate cancer; and with cisplatin and fluorouracil for untreated advanced gastric adenocarcinoma, including the gastroesophageal junction. The 2 recommended doses for Taxotere Injection Concentrate for SCCHN are 75 mg/m2 followed by cisplatin 75 mg/m2 intravenous (IV) (day 1), followed by fluorouracil 750 mg/m2 per day as a 24-hour IV (days 1-5), starting at the end of cisplatin infusion; for 4 cycles, or 75 mg/m2 followed by cisplatin 100 mg/m2 IV (day 1), followed by fluorouracil 1000 mg/m2 per day as a 24-hour IV (days 1-4); for 3 cycles. For additional information, visit www.taxotere.com, or call 800-981-2491.
MGI Pharma Inc (Bloomington, Minn) and its partner Helsinn Healthcare SA (Lugano, Switzerland) recently received FDA approval for a supplemental New Drug Application (sNDA) for Aloxi Injection. This sNDA includes the removal of a dosing recommendation, which limited Aloxi Injection to once per 7-day interval, from the product's label. Aloxi Injection is a serotonin subtype 3 (5-HT3) receptor antagonist indicated for moderately emetogenic cancer chemotherapy for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses, and highly emetogenic cancer chemotherapy for the prevention of acute nausea and vomiting associated with initial and repeat courses. The recommended adult dose is a single 0.25-mg intravenous dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy. Aloxi Injection is supplied as a single-use sterile, clear, colorless solution in glass vials that provides 0.25 mg (free-base) per 5 mL. For additional information, visit www.aloxi.com, or call 800-562-4531.