Recent News

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

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

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

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.

Lexiscan^® (regadenoson) injection is the first A_2A adenosine receptor agonist approved by the FDA (in April 2008) for use as a pharmacologic stress agent in radionuclide MPI studies. The product has been designed to target the A_2A adenosine receptor, which is the adenosine receptor subtype responsible for coronary vasodilation.

Important Safety Information

Do not administer Lexiscan to patients with second- or third-degree AV block or sinus node dysfunction unless these patients have a functioning artificial pacemaker.

Fatal cardiac arrest, life-threatening ventricular arrhythmias, and myocardial infarction may result from the ischemia induced by pharmacologic stress agents. Cardiac resuscitation equipment and trained staff should be available before administering Lexiscan.

Adenosine receptor agonists, including Lexiscan, can depress the SA and AV nodes and may cause first-, second-, or third-degree AV block, or sinus bradycardia. In postmarketing experience, heart block (including third degree), and asystole within minutes of Lexiscan administration have occurred.

Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with cardiac or cerebrovascular insufficiency. Decreased systolic blood pressure (>35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (>25 mm Hg) was observed in 4% of patients within 45 minutes of Lexiscan administration.

Adenosine receptor agonists, including Lexiscan, may cause bronchoconstriction and respiratory compromise. For patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD), or asthma, appropriate bronchodilator therapy and resuscitative measures should be available prior to Lexiscan administration.

The most common adverse reactions (≥5%) to Lexiscan are dyspnea, headache, flushing, chest discomfort, angina pectoris or ST-segment depression, dizziness, chest pain, nausea, abdominal discomfort, dysgeusia, and feeling hot. Most adverse reactions began soon after dosing, and generally resolved within approximately 15 minutes, except for headache, which resolved in most patients within 30 minutes. Lexiscan overdosage may result in serious reactions. Aminophylline was used as a reversal agent in 3% of patients.

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

Marketing Partner

• Astellas Pharma Inc. -- U.S.

Cayston® (aztreonam for inhalation solution) is a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV₁) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cayston and other antibacterial drugs, Cayston should only be used to treat patients with CF known to have P. aeruginosa in the lungs.

Important Safety Information

Cayston is contraindicated in patients with a known allergy to aztreonam.

Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling and throat tightness was reported with Cayston in clinical trials. If allergic reaction to Cayston does occur, stop administration of Cayston and initiate treatment as appropriate.

Caution is advised when administering Cayston to patients if they have a history of beta-lactam allergy, although patients with known beta-lactam allergy have received Cayston in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics such as penicillins, cephalosporins, and/or carbapenems may be a risk factor, since cross-reactivity may occur.

Bronchospasm is a complication associated with nebulized therapy, including Cayston. Reduction of 15 percent or more of FEV₁ immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3 percent of patients treated with Cayston.

In clinical trials, patients with increases in FEV₁ during a 28-day course of Cayston were sometimes treated for pulmonary exacerbations when FEV₁ declined after the treatment period. Healthcare providers should consider a patient’s baseline FEV₁ measured prior to Cayston therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV₁ are caused by a pulmonary exacerbation.

Prescribing Cayston in the absence of known P. aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

Adverse reactions occurring in more than 5 percent of patients treated with Cayston compared to placebo in Phase III studies were cough (54 percent versus 51 percent), nasal congestion (16 percent versus 12 percent), wheezing (16 percent versus 10 percent), pharyngolaryngeal pain (12 percent versus 11 percent), pyrexia (13 percent versus 6 percent), chest discomfort (8 percent versus 6 percent), abdominal pain (7 percent versus 5 percent) and vomiting (6 percent versus 4 percent).

Cayston is administered by inhalation and is delivered via the Altera® Nebulizer System, a portable, drug-specific delivery device using the eFlow® Technology Platform, developed by PARI Pharma GmbH. Cayston should only be administered with the Altera Nebulizer System. Cayston should not be mixed with any other drugs in the Altera Nebulizer Handset.

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

• Eyetech Inc. -- U.S.
• Pfizer Inc. -- Outside U.S.