Recent News

Atripla® (efavirenz/ emtricitabine/ tenofovir disoproxil fumarate) 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.

BOXED WARNING:
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA, in combination with other antiretrovirals.

Atripla is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Atripla have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread, which are components of Atripla. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Atripla. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

FOR MORE INFORMATION:
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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partners

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

Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is indicated for use as a complete regimen for the treatment of HIV-1 infection in treatment-naïve adults. The following points should be considered when initiating therapy with Complera:

• More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.
• The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz.
• More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz.
• Complera is not recommended for patients less than 18 years of age.

BOXED WARNING:
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Complera have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Complera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Complera. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Emtriva® (emtricitabine) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Additional important information regarding the use of Emtriva for the treatment of HIV-1 Infection:

• Emtriva should not be coadministered with Atripla®, Truvada®, or lamivudine-containing products.
• In treatment-experienced patients, the use of Emtriva should be guided by laboratory testing and treatment history.

BOXED WARNING:
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B

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.

Emtriva is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Emtriva have not been established in patients coinfected with HBV and HIV-1. 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 for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Emtriva. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

FOR MORE INFORMATION: 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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partner

• Japan Tobacco Inc. -- Japan

Truvada® (emtricitabine/ tenofovir disoproxil fumarate), a combination of Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate), 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.

The following points should be considered when initiating therapy with Truvada for the treatment of HIV-1 infection:

• It is not recommended that Truvada be used as a component of a triple nucleoside regimen.
• Truvada should not be coadministered with Atripla®, Emtriva, Viread or lamivudine-containing products.
• In treatment experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.

BOXED WARNING:
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread, a component of Truvada, in combination with other antiretrovirals.

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

FOR MORE INFORMATION:
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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partner

• Japan Tobacco Inc. -- Japan

Hepsera® (adefovir dipivoxil) is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.

For patients 12 to <18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg chronic hepatitis B virus infection with compensated liver function.

BOXED WARNING:
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS

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-hepatitis B 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 analogues alone or in combination with other antiretrovirals.

FOR MORE INFORMATION:
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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partner

• GlaxoSmithKline Inc. -- Asia, Latin America

Letairis® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (64%) or PAH associated with connective tissue diseases (32%).

BOXED WARNING: CONTRAINDICATED IN 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. Pregnancy must therefore be excluded before the initiation of treatment with Letairis and prevented during treatment and for one month after stopping treatment by the use of two acceptable methods of contraception unless the patient has had a tubal sterilization or chooses to use a Copper T 380A IUD or LNg 20 IUS, in which case no additional contraception is needed. Obtain monthly pregnancy tests.

Because of the risk of 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.

FOR MORE INFORMATION:

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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partner

• GlaxoSmithKline Inc. – Outside U.S.

Lexiscan® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

CONTRAINDICATIONS:
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.

WARNINGS AND PRECAUTIONS:
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. If serious reactions to Lexiscan occur, consider the use of aminophylline, an adenosine antagonist, to shorten the duration of increased coronary blood flow induced by 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 requiring intervention. In clinical trials first degree AV block (PR prolongation > 220 msec) developed in 3% of patients within 2 hours of Lexiscan administration; transient second degree AV block with one dropped beat was observed in one patient receiving Lexiscan. In postmarketing experience, third degree heart block and asystole within minutes of Lexiscan administration have occurred.

Adenosine receptor agonists, including Lexiscan, induce arterial vasodilation and hypotension. In clinical trials, 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 min of Lexiscan administration. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. In postmarketing experience, syncope, transient ischemic attacks and seizures have been observed.

Administration of adenosine receptor agonists, including Lexiscan, may result in clinically significant increases in blood pressure in some patients. Among patients who experienced an increase in blood pressure in clinical trials, the increase was observed within minutes of Lexiscan administration. Most increases resolved within 10 to 15 minutes, but in some cases, increases were observed at 45 minutes following administration. In post-marketing experience, cases of potentially clinically significant hypertension have been reported, particularly with underlying hypertension and when low-level exercise was included in the MPI.

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 incidence of bronchoconstriction (FEV1 reduction > 15% from baseline) was assessed in two clinical studies. In a randomized, controlled study of 49 patients with moderate to severe COPD, the rate of bronchoconstriction was 12% and 6%, for the Lexiscan and placebo groups, respectively. In a randomized, controlled study of 48 patients with mild to moderate asthma who had previously been shown to have bronchoconstrictive reactions to adenosine monophosphate, the rate of bronchoconstriction was the same (4%) for both the Lexiscan and placebo groups. In both studies, dyspnea was reported as an adverse reaction in the Lexiscan group (61% for patients with COPD; 34% for patients with asthma) while no subjects in the placebo group experienced dyspnea.

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

Marketing Partners

• Astellas Pharma Inc. -- U.S.
• Rapidscan Pharma Solutions Inc. (RPS) -- E.U

Cayston® (aztreonam for inhalation solution) is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% 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 be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.

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

WARNINGS AND PRECAUTIONS:
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 an allergic reaction to Cayston occurs, 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 a 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 therapies, including Cayston. Reduction of 15% or more in forced expiratory volume in 1 second (FEV1) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% 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 Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

FOR MORE INFORMATION:
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. You may also request specific product information or report an adverse event or product complaint by clicking here.

AmBisome® (amphotericin B) liposome for injection 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.

CONTRAINDICATIONS:
AmBisome is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.

WARNINGS:
Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome.

PRECAUTIONS:
As with any amphotericin B-containing product the drug should be administered by medically trained personnel. During the initial dosing period, patients should be under close clinical observation. AmBisome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.

Patient management should include laboratory evaluation of renal, hepatic and hematopoietic function, and serum electrolytes (particularly magnesium and potassium).

No formal clinical studies of drug interactions have been conducted with AmBisome. However, the following drugs are known to interact with amphotericin B and may interact with AmBisome:

• Antineoplastic Agents
  Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with caution.
  
• Corticosteroids and Corticotropin (ACTH)
  Concurrent use of corticosteroids and ACTH may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly, serum electrolytes and cardiac function should be closely monitored.
  
• Digitalis Glycosides
  Concurrent use may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly, serum potassium levels should be closely monitored.
  
• Flucytosine
  Concurrent use of flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion.
  
• Azoles (e.g. ketoconazole, miconazole, clotrimazole, fluconazole, etc.)
  In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B. Combination therapy should be administered with caution, especially in immunocompromised patients.
  
• Leukocyte Transfusions
  Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions.
  
• Other Nephrotoxic Medications
  Concurrent use of amphotericin B and other nephrotoxic medications may enhance the potential for drug-induced renal toxicity. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
  
• Skeletal Muscle Relaxants
  Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine) due to hypokalemia. When administered concomitantly, serum potassium levels should be closely monitored.

No long term studies in animals have been performed to evaluate carcinogenic potential of AmBisome. AmBisome has not been tested to determine its mutagenic potential. A Segment I Reproductive Study in rats found an abnormal estrous cycle (prolonged diestrus) and decreased number of corpora lutea in the high dose groups (10 and 15 mg/kg, doses equivalent to human doses of 1.6 and 2.4 mg/kg based on body surface area considerations). AmBisome did not affect fertility or days to copulation. There were no effects on male reproductive function.

There have been no adequate and well-controlled studies of AmBisome in pregnant women. Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small.

Segment II studies in both rats and rabbits have concluded that AmBisome had no teratogenic potential in these species. In rats, the maternal non-toxic dose of AmBisome was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction. Rabbits receiving the higher doses, (equivalent to 0.5 to 2 times the recommended human dose) of AmBisome experienced a higher rate of spontaneous abortions than did the control groups. AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks involved.

Many drugs are excreted in human milk. However, it is not known whether AmBisome is excreted in human milk. Due to the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric patients, age 1 month to 16 years, with presumed fungal infection (empirical therapy), confirmed systemic fungal infections or with visceral leishmaniasis have been successfully treated with AmBisome. In studies which included 302 pediatric patients administered AmBisome, there was no evidence of any differences in efficacy or safety of AmBisome compared to adults. Since pediatric patients have received AmBisome at doses comparable to those used in adults on a per kilogram body weight basis, no dosage adjustment is required in this population. Safety and effectiveness in pediatric patients below the age of one month have not been established.

Experience with AmBisome in the elderly (65 years or older) comprised 72 patients. It has not been necessary to alter the dose of AmBisome for this population. As with most other drugs, elderly patients receiving AmBisome should be carefully monitored.

FOR MORE INFORMATION:
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. You may also request specific product information or report an adverse event or product complaint by clicking here.

Marketing Partners

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

Macugen® (pegaptanib sodium injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration.

CONTRAINDICATIONS:
Macugen is contraindicated in patients with ocular or periocular infections, and in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.

WARNINGS:
Intravitreal injections including those with Macugen have been associated with endophthalmitis. Proper aseptic injection technique should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure have been seen within 30 minutes of injection with Macugen. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately.

PRECAUTIONS:
FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure.

In the days following Macugen administration, patients are at risk for the development of endophthalmitis. If the eye becomes red, sensitive to light, painful or develops a change in vision, the patient should seek the immediate care with their ophthalmologist.

Drug interaction studies have not been conducted with Macugen. Pegaptanib is metabolized by nucleases and is generally not affected by the cytochrome P450 system.

Two early clinical studies conducted in patients who received Macugen alone and in combination with photodynamic therapy revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.

Carcinogenicity studies with pegaptanib have not been conducted.

Pegaptanib and its monomer component nucleotides (2'-MA, 2'-MG, 2'-FU, 2'-FC) were evaluated for genotoxicity in a battery of in vitro and in vivo assay systems. Pegaptanib, 2'-O-methyladenosine (2'-MA), and 2'-O-methylguanosine (2'-MG) were negative in all assay systems evaluated. 2'-fluorouridine (2'-FU) and 2'-fluorocytidine (2'-FC) were nonclastogenic and were negative in all S. typhimurium tester strains, but produced a non-dose related increase in revertant frequency in a single E. coli tester strain. Pegaptanib, 2'-FU, and 2'-FC tested negative in cell transformation assays.

No data are available to evaluate male or female mating or fertility indices.

Teratogenic Effects: Pregnancy Category B.

Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or fetal mortality in mice at intravenous doses of up to 40 mg/kg/day (about 7,000 times the recommended human monocular ophthalmic dose of 0.3 mg/eye). Pegaptanib crosses the placenta in mice.

There are no studies in pregnant women. The potential risk to humans is unknown. Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

It is not known whether pegaptanib is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Macugen is administered to a nursing woman.

Safety and effectiveness of Macugen in pediatric patients have not been studied.

Approximately 94% (834/892) of the patients treated with Macugen were ≥ 65 years of age and approximately 62% (553/892) were ≥ 75 years of age. No difference in treatment effect or systemic exposure was seen with increasing age.

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

Marketing Partner

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