B. Braun Medical Inc's (Bethlehem, PA) ONGUARD Contained Medication System is a drug admixture and delivery system that provides a new level of hazard protection and passive needle-stick prevention for pharmacists and nurses at the front line of chemotherapy preparation and administration. The American Society of Health-System Pharmacists, the National Institute for Occupational Safety and Health, and the United States Pharmacopeia <797> have each recommended the use of protective devices for the preparation of hazardous medications. The system with TEVADAPTOR components provides protection from hazardous vapors, particles, and aerosols, by means of a hydrophobic 0.2-µm sterilizing grade membrane and the TOXIGUARD activated charcoal drug-binding matrix. Independent laboratory studies using chemotherapy medications demonstrate this system effectively prevents hazardous vapors from escaping by binding them within the activated charcoal matrix while also preventing nonsterile air from entering the medication vial. The ONGUARD Contained Medication System further protects workers and the patient care environment from admixture to delivery by preventing liquid droplets from exiting the dispensing units during use. For more information, visit www.bbraunusa.com, or call 800-854-6851.
Genzyme Corp (Cambridge, MA) recently received FDA approval for a supplemental indication for Thyrogen to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. The product was initially approved in the United States in 1998 for use as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. A 2-injection regimen is recommended. The 2-injection regimen is Thyrogen 0.9 mg intramuscularly (IM), followed by a second 0.9-mg IM injection 24 hours later. After reconstitution with 1.2 mL sterile water for injection, a 1.0-mL solution (0.9 mg thyrotropin alfa) is administered by IM injection to the buttock. For radioiodine imaging or remnant ablation, radioiodine should be administered 24 hours following the final Thyrogen injection. The product is supplied as a sterile, nonpyrogenic, lypophilized product. It is available in a 2- or 4-vial kit. The 2-vial kit contains two 1.1-mg vials of Thyrogen. The 4-vial kit contains two 1.1-mg vials of Thyrogen as well as two 10-mL vials of sterile water for injection USP. For more information, visit www.thyrogen.com, or call 88-THYROGEN (888-497-6436).
Parenta Pharmaceuticals (West Columbia, SC), the US subsidiary of Austrian-based Ebewe Pharma, recently launched Paclitaxel Injection USP. The product is the generic equivalent of Bristol-Myers Squibb Co's Taxol Injection. Paclitaxel Injection USP is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, the product is indicated in combination with cisplatin. Paclitaxel Injection USP also is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. The product is AP-rated, bar-coded, and supplied in latex-free vials in the following presentations: 30-mg/5-mL, 100-mg/ 16.7-mL, and 300-mg/50-mL multidose vials. For more information, visit www.parentarx.com, or call 800-898-9948.
Elan Pharmaceuticals Inc (South San Francisco, CA) and Biogen Idec Inc (Cambridge, MA) recently received FDA approval for a supplemental biologics license application for Tysabri. The product is now approved for inducing and maintaining clinical response and remission in adult patients with moderate-to-severe active Crohn's disease (CD), with evidence of inflammation, who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of tumor necrosis factor-alpha. Tysabri will be available for the treatment of CD upon the completion of key implementation activities related to the approved risk management plan. Tysabri is prescribed only by physicians enrolled in the Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing Program, infused at an infusion center that is enrolled in the program, and given to patients who are enrolled in the program. The TOUCH Prescribing Program has been implemented for patients receiving Tysabri therapy for multiple sclerosis. For more information, visit www.tysabri.com, or call 800-456-2255.