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| |  Sporanox Available In US For Life-Threatening Fungal Infections RARITAN, N.J. -- February 4, 2000 - Sporanox (itraconazole) Injection is now available for the treatment of potentially life-threatening fungal infections, including blastomycosis, histoplasmosis and aspergillosis in patients who are intolerant of or refractory to amphotericin B, a first-line therapy. These deadly fungal infections are usually found in individuals whose immune systems are compromised by bone marrow transplantation, chemotherapy, HIV infection or AIDS, or drugs designed to prevent rejection of transplanted organs. As a result of the growing number of these immunocompromised patients, hospitals are increasingly concerned about the risk of fungal infections. "This is a critical problem because without adequate treatment, serious fungal infections of this type can rapidly lead to death," said Bruce L. Moskovitz, M.D., group director, clinical research infectious disease, dermatology and allergy, Janssen Research Foundation. The active ingredient in Sporanox Injection, itraconazole, has been proven to be effective in treating aspergillosis in patients intolerant of or refractory to amphotericin B. In fact, 58 per cent of patients treated with Sporanox (itraconazole) Capsules experienced an improvement in their condition or were cured of aspergillosis. The survey also reveals that 93 per cent of physicians prefer to prescribe a treatment with flexible dosing options, such as a combination of oral and intravenous formulations. Sporanox is the only anti-fungal medication effective for aspergillus infections that offers these flexible treatment options. Sporanox Injection demonstrated an excellent safety profile in clinical trials and a low incidence of renal side effects compared to standard first-line therapies. In clinical trials, the most common side effects experienced with Sporanox Injection included nausea (9 per cent), hypokalemia (8 per cent), bilirubinemia (6 per cent), diarrhea (6 per cent), and vomiting (6 per cent). Sporanox Injection is associated with increased SGPT/ALT (3 per cent), abnormal hepatic function (2 per cent), and jaundice (2 per cent), which may be indicative of possible liver disease. If patients develop clinical signs and symptoms consistent with liver disease, Sporanox Injection should be discontinued. Sporanox Injection should not be co-administered with astemizole (Hismanal(R)), cisapride (Propulsid(R)), pimozide or quinidine, which have been associated with potentially serious cardiovascular events-including death-when used with contraindicated drugs. In addition, Sporanox Injection should not be co-administered with triazolam (Halcion(R)), oral midazolam (Versed(R)), lovastatin (Mevacor(R)) or simvastatin (Zocor(R)). Post-marketing experience with Sporanox Capsules and Oral Solution has included reports of elevated liver enzymes and rare cases of hepatitis. If clinical signs and symptoms consistent with liver disease develop, Sporanox Injection should be discontinued. There are no studies of Sporanox Injection in pregnant women. Sporanox should be used for the treatment of systemic fungal infections in pregnancy only if the benefit outweighs the potential risk. Sporanox Injection was developed by the Janssen Research Foundation and will be marketed by Ortho Biotech Inc. Sporanox Injection was approved in 1999 by the U.S. Food and Drug Administration (FDA) and the product is also available in oral solution and capsule formulations. Janssen Research Foundation and Ortho Biotech Inc. are both part of the Johnson & Johnson family of companies. The physician survey, conducted in August 1999 by the research organization Yankelovich Partners, was supported by Ortho Biotech. The survey sample consisted of 153 oncologists, infectious disease specialists and critical care specialists who have treated aspergillosis, blastomycosis and histoplasmosis. Related links: Halcion, Hismanal, Mevacor, Propulsid, Sporanox, Versed, Zocor and Janssen Research Foundation.
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