IONSYS (fentanyl iontophoretic transdermal system)
ALZA Corp (Mountain View, Calif) recently received FDA approval for IONSYS, the first needle-free patient-activated analgesic system. IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. It is the first and only product to incorporate the proprietary ETRANS iontophoretic transdermal drug delivery system developed by ALZA. The drug delivery system uses iontophoresis? a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. IONSYS securely adheres to the upper outer arm or chest and provides patients with an on-demand dose of fentanyl. When pain medication is needed, the patient double-clicks the dosing button, which delivers a preprogrammed, 40- mcg dose of fentanyl through the skin. Each dose is delivered over a 10-minute period. Patients should be titrated to comfort before initiating IONSYS. For more information, visit www.alza.com.
MitoXANTRONE Injection USP (Concentrate)
American Pharmaceutical Partners Inc (Schaumburg, Ill) recently received FDA approval for its Abbreviated New Drug Application for MitoXANTRONE Injection USP. The product is the generic equivalent of Serono Labs' Novantrone. MitoXANTRONE, in combination with corticosteroids, is indicated as initial chemotherapy for the treatment of patients with pain related to advanced hormone- refractory prostate cancer. It is also indicated in the initial therapy of acute nonlymphocytic leukemia in adults in conjunction with other approved medications. MitoXANTRONE is AP-rated, and each vial will include latex-free vial stoppers, bar codes, and "tall-man" lettering. The product is available in 20-, 25-, and 30-mg multidose vials. For more information, visit www.appdrugs.com.
Remodulin (treprostinil sodium) Injection
United Therapeutics Corp (Research Triangle Park, NC) recently received FDA approval for its supplemental New Drug Application for Remodulin Injection to diminish the rate of clinical deterioration in patients requiring transition from Flolan (GlaxoSmithKline); the risks and benefits of each drug should be carefully considered prior to transition. Remodulin is also approved as a continuous subcutaneous infusion (directly into the skin) or continuous intravenous (IV) infusion (directly into the bloodstream), if subcutaneous infusions are not tolerated, for the treatment of pulmonary arterial hypertension in patients with NYHA Class II, III, or IV symptoms to diminish symptoms associated with exercise. Remodulin is supplied in 20-mL vials in concentrations of 1 mg/mL, 2.5 mg/mL, 5 mg/mL, and 10 mg/mL. The product can be administered for subcutaneous infusion as supplied or diluted for IV infusion with Sterile Water for Injection or 0.9% Sodium Chloride Injection prior to administration. For more information, visit www.remodulin.com.
ShrinkSafe ID Bands
EPS Inc (Ivyland, Pa) has introduced new ShrinkSafe ID Bands to help reduce medication errors involving paralytic agents, high-alert, and look-alike medicines. The product was designed to easily wrap around various sized vials containing medication requiring special handling. The bright orange band is specifically designed for 10-mL bottles containing high-alert paralytic agents. The sharp green band is for concentrated high-alert medications, for drugs requiring further dilution prior to administration, or for highlighting electrolytes dispensed in specialized care settings. The clear band is available in 2 sizes, with a variety of dispensing applications for virtually all types of intravenous bottles and vials. The orange and green bands' distinctive color immediately calls attention and alerts practitioners that these peculiarly wrapped medications require special handling. The clear bands allow for use with a broader selection of high-alert medications while providing the same level of protection. A quick exposure to heat shrinks the ShrinkSafe ID Bands to the vial's shape and still permits easy viewing of the manufacturer's label. Dispensing is also easy with these bands. Health care professionals just need to peel the band's pull tab, and the medication is ready for use. For more information, visit www.medidose.com, or call 800-323-8966.