Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) is the first once-daily single tablet regimen (STR) for HIV-1 infection intended as a stand-alone therapy or in combination with other antiretrovirals. The product combines Sustiva® (efavirenz), manufactured by Bristol-Myers Squibb Company, and Truvada® (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences. Atripla was cleared for marketing in the United States in July 2006.

Atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Atripla, Truvada, Viread and Emtriva are not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of these drugs have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread (components of Atripla and Truvada). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Atripla, Truvada, Emtriva or Viread and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partners

• Bristol-Myers Squibb Company -- U.S. and Canada
• Merck & Co, Inc. -- Developing World

Emtriva® (emtricitabine) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients over three months of age. This indication is based on the analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies of 48 weeks duration in antiretroviral-naïve and antiretroviral-experienced patients who were virologically suppressed on an HIV-treatment regimen. In treatment-experienced patients, the use of Emtriva may be considered for patients with HIV strains that are expected to be susceptible to Emtriva as assessed by genotypic or phenotypic testing.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Emtriva is not indicated for the treatment of chronic hepatitis B virus infection and the safety and efficacy of Emtriva have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva. Hepatic function should be monitored closely with both clinical and laboratory follow-up at least several months in patients who discontinue Emtriva and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partner

• Japan Tobacco Inc. -- Japan

Hepsera® (adefovir dipivoxil) is a once-daily, orally-administered nucleotide analogue reverse transcriptase inhibitor for the treatment of patients with chronic hepatitis B. Hepsera was approved in the United States in September 2002 and in Europe in March 2003.

In the United States, Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy including Hepsera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis b therapy. If appropriate, resumption of anti-hepatitis b therapy may be warranted. In patients at risk of or having underlying renal dysfunction, chronic administration of Hepsera may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment. HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated human immunodeficiency virus (HIV) infection treated with anti-hepatitisB therapies, such as therapy with Hepsera, that may have activity against HIV. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partner

• GlaxoSmithKline Inc. -- Asia, Latin America

Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a once-daily fixed-dose combination of two nucleoside reverse transcriptase inhibitors, Viread® (tenofovir disoproxil fumarate) and Emtriva® (emtricitabine). Truvada was cleared for marketing in the United States in August 2004 and in Europe in February 2005.

In the United States, Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. It is not recommended that Truvada be used as a component of a triple nucleoside regimen. Truvada should not be co-administered with Atripla™, Emtriva, Viread or lamivudine-containing products. In treatment experienced patients, the use of Truvada should be guided by laboratory tests and treatment history.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infections and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread, the components of Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partner

• Japan Tobacco Inc. -- Japan

Flolan® (epoprostenol sodium) for Injection was approved by the FDA in 1995 and is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA class III and class IV patients who do not respond adequately to conventional therapy.

Chronic use of Flolan is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction. Flolan should not be used chronically in patients who develop pulmonary edema during dose initiation.

Flolan must be reconstituted only as directed using Sterile Diluent for Flolan. Flolan must not be reconstituted or mixed with any other parenteral medications or solutions prior to or during administration. Abrupt withdrawal or reductions in delivery of Flolan, as well as overdoses, may result in hemodynamic instability, including rebound pulmonary hypertension or fatal hypertension. Flolan should be used only by clinicians experienced in the diagnosis and treatment of pulmonary hypertension.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partner

• GlaxoSmithKline Inc. -- Outside U.S.

AmBisome® (amphotericin B) liposome for injection is a treatment for life-threatening, systemic fungal infections. AmBisome was cleared for marketing in the United States in 1997, and first cleared for marketing in Europe in 1990.

In the United States, AmBisome is indicated for the following:

• Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
• Treatment of Cryptococcal Meningitis in HIV- infected patients.
• Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
• Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites.

AmBisome is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. Anaphylaxis has been reported with amphotericin B and other amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be discontinued immediately and the patient should not receive further infusions of AmBisome.

Click here for full prescribing information (PDF), including details about indication and usage and important safety information. For Prescribing Information outside the United States, please contact our medical information department at 1-800-GILEAD-5 (1-800-445-3235), Option 2, or email Medical Information Request Form.

Marketing Partners

• Astellas Pharma Inc. -- U.S. and Canada
• Dainippon Sumitomo Pharma Co., Ltd. -- Japan

Macugen® (pegaptanib sodium injection) was approved by the FDA on December 17, 2004 for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision. Macugen is a pegylated anti-VEGF aptamer, a single strand of nucleic acid that binds with specificity to a particular target. Macugen specifically binds to VEGF 165, a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular AMD. Macugen is administered in a 0.3 mg dose once every six weeks by intravitreal injection.

In the United States, Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

The most frequently reported adverse events in patients treated with Macugen 0.3mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure, ocular discomfort, punctuate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10-40% of patients.

Please visit www.Macugen.com for Full Prescribing Information.

Marketing Partner

• OSI Pharmaceuticals, Inc. -- U.S.
• Pfizer Inc. -- Outside U.S.