Gilead has quite the product lineup, that once you look
at it, it is impressive imho:
Antiviral
Visit www.GileadHIV.com
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.
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.
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.
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.
Marketing Partner
Japan Tobacco Inc. -- Japan
Viread® (tenofovir disoproxil fumarate) is a once-daily nucleotide reverse transcriptase inhibitor. Viread was cleared for marketing in the United States in October 2001 and in Europe in February 2002.
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Viread should not be used in combination with Truvada® or Atripla™.
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. Viread is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Viread have not been established in patients coinfected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV and have discontinued Viread. 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 Viread. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Marketing Partner
Japan Tobacco Inc. -- Japan
Cardiovascular
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.
Marketing Partner
GlaxoSmithKline Inc. -- Outside U.S.
Letairis® (ambrisentan) is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO Class II or III symptoms to improve exercise capacity and delay clinical worsening.
Letairis can cause elevation of liver aminotransferases (ALT and AST) to at least 3 times the upper limit of normal (ULN). Letairs treatment was associated with aminotransferase elevations >3 x ULN in 0.8% of patients in 12-week trials and 2.8% of patients including long-term open-label trials out to one year. One case of aminotransferase elevations >3 x ULN has been accompanied by bilirubin elevations >2 x ULN. Because these changes are a marker for potentially serious liver injury, serum aminotransferase levels (and bilirubin if aminotransferase levels are elevated) must be measured prior to initiation of treatment and then monthly.
In the post-marketing period with another endothelin receptor antagonist (ERA), bosentan, rare cases of unexplained hepatic cirrhosis were reported after prolonged (>12 months) therapy. In at least one case with bosentan, a late presentation (after >20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by non-specific symptoms, all of which resolved slowly over time after discontinuation of the suspect drug. This case reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment.
Elevations in aminotransferases require close attention. Letairis should generally be avoided in patients with elevated aminotransferases (>3 x ULN) at baseline because monitoring liver injury may be more difficult. If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin >2 x ULN, treatment should be stopped. There is no experience with the re-introduction of Letairis in these circumstances.
CONTRAINDICATION: PREGNANCY
Letairis is very likely to produce serious birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals [see Contraindications (4.1) contained in the full prescribing information]. Pregnancy must therefore be excluded before the initiation of treatment with Letairis and prevented thereafter by the use of at least two reliable methods of contraception unless the patient has had a tubal sterilization or Copper T 380A IUD or LNg 20 IUD inserted, in which case no other contraception is needed. Obtain monthly pregnancy tests.
Because of the risks of liver injury and birth defects, Letairis is available only through a special restricted distribution program called the Letairis Education and Access Program (LEAP), by calling 1-866-664-LEAP (5327). Only prescribers and pharmacies registered with LEAP may prescribe and distribute Letairis. In addition, Letairis may be dispensed only to patients who are enrolled in and meet all conditions of LEAP [see WARNINGS, Prescribing and Distribution Program for Letairis contained in the full prescribing information].
Marketing Partner
GlaxoSmithKline Inc. – Outside U.S.
Respiratory
Visit www.Tamiflu.com
Tamiflu® (oseltamivir phosphate) is the first neuraminidase inhibitor in pill form for the treatment and prevention of influenza A and B. Tamiflu was cleared by the U.S. FDA for the treatment of influenza in October 1999, for the prevention of influenza in November 2000, and for the treatment of children one year and older in December 2000. Tamiflu was approved in Europe in June 2002.
The most common side effects that occurred in patients taking Tamiflu were nausea and vomiting. Taking Tamiflu with food may reduce the potential of these side effects.
Marketing Partner
F. Hoffmann-La Roche Ltd -- Worldwide
Other
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.
Marketing Partners
Astellas Pharma Inc. -- U.S. and Canada
Dainippon Sumitomo Pharma Co., Ltd. -- Japan
Visit www.MACUGEN.com More
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.
Marketing Partner
OSI Pharmaceuticals, Inc. -- U.S.
Pfizer Inc. -- Outside U.S.
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