
February 10, 2005
From: Abbott Pharmaceuticals
Introducing new Norvir (ritonavir) 100-mg capsule 30-count bottle
Abbott is pleased to announce a new 100-mg capsule 30-count bottle of Norvir. After discussions with the HIV/AIDS community, pharmacists and physicians early last year, Abbott committed to providing Norvir in a 30-count bottle in the United States. This new packaging provides yet another prescription option to pharmacists, physicians, and most importantly, persons living with HIV/AIDS. The Norvir 100-mg capsule 120-count bottle will also continue to be available.
Available now
The new Norvir 100-mg capsule 30-count bottle is now available. More than 120 Abbott sales representatives, Advocacy Relations Managers, and Clinical Scientists will call on pharmacists, physicians, AIDS Service organizations, and managed care organizations nationwide to introduce the new bottle.
Ordering information
The indication, efficacy and safety of Norvir will remain unchanged from the 120-count bottle, as will the drug's price. The NDC numbers for the new 30-count bottle are as follows:
Norvir 100-mg capsules NDC 0074-6633-30
Please order the new Norvir packaging in your usual manner or contact Abbott Customer Service at 1-800-255-5162.
If you have any questions or need additional information about the new Norvir 100-mg capsule 30-count bottle, please contact your Abbott Laboratories Sales Representative. The 30-count bottle is only available in the United States.
Please see accompanying full prescribing information
Norvir Indication and Safety Information
NORVIR (ritonavir) is indicated in combination with other antiretroviral agents for the treatment of HIV infection. This indication is based on the results from a study in patients with advanced HIV disease that showed a reduction in both mortality and AIDS-defining clinical events for patients who received NORVIR either alone or in combination with nucleoside analogues. Median duration of follow-up in this study was 13.5 months.
Safety Information
Co-administration of NORVIR with certain nonsedating antihistamines, sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life threatening adverse events due to possible effects of NORVIR on the hepatic metabolism of certain drugs.
NORVIR is contraindicated with amiodarone, astemizole, bepridil, cisaprode, dihydroergotamine, ergonovine, ergotamine, flecainide, methylergonovine, midazolam, pimozide, propafenone, quinidine, terfenadine, and triazolam. NORVIR should not be administered with lovastatin, simvastatin or St. John's wort (Hypericum perforatum).
NORVIR should not be given to patients with known hypersensitivity to ritonavir or any of its ingredients. Allergic reactions ranging from mild to severe have been reported.
Co-administration of NORVIR with sildenafil associated adverse events, including hypotension, syncope, visual changes and prolonged erection.
Caution should be exercised when administering NORVIR to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Increased AST/ALT monitoring should be considered in these patients, especially during the first three months of NORVIR treatment. There have been postmarketing reports of hepatic dysfunction, including some fatalities. These have generally occurred in patients taking multiple concomitant medication and/or advanced AIDS.
Pancreatitis, including some fatalities, has been observed in patients receiving NORVIR therapy.
In patients receiving protease inhibitors, increased bleeding (in patients with hemophilia), new onset or exacerbation of diabetes mellitus and hyperglycemia have been reported.
Varying degrees of cross-resistance among protease inhibitors have been observed.
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. A causal relationship has not been established.
Treatment with NORVIR has resulted in substantial increases in the concentration of total triglycerides and cholesterol, which should be monitored before and during therapy.
In NORVIR clinical trials, the most frequently reported adverse events included diarrhea, nausea, vomiting, asthenia, taste perversion, abdominal pain, anorexia, peripheral paresthesia and cirumoral paresthesia.
Abbott remains committed to the HIV/AIDS community and to ensuring that every patients who needs Norvir has access to it.
Regards,
Jeffrey Devlin
Vice President and General Manager, Virology
PPD Specialty Operations
Abbott Laboratories
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