The information in this section is intended for visitors outside the United States.
Gilead seeks to develop products that represent advancements by offering enhanced modes of delivery, more convenient treatment regimens, improved resistance profiles, reduced side effects and greater efficacy. Through our own research and partnerships with universities, medical research institutions and global pharmaceutical leaders, Gilead is rapidly and efficiently making scientific and clinical advancements that raise the standard for new therapeutics that treat life-threatening diseases.
efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Download Full U.S. Prescribing Information, including BOXED WARNING
Download Patient Information
Visit www.Atripla.com
BOXED WARNING: POST TREATMENT EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients coinfected with HBV and HIV-1 who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ATRIPLA. Closely monitor hepatic function 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 or to request specific product information or report an adverse event, please click here.
MARKETING PARTNERS
Infection with HIV-1, or human immunodeficiency virus, is one of the world’s greatest health challenges, currently affecting more than 35 million people worldwide. HIV progressively damages the immune system, weakening the body’s ability to fight life-threatening infections, which can lead to AIDS, or acquired immune deficiency syndrome.
For more information, including information about HIV:
bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
Visit www.Biktarvy.com
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.
emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
Visit www.Complera.com
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 products containing emtricitabine and/or tenofovir disoproxil fumarate, 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.
MARKETING PARTNER
emtricitabine 200 mg/ tenofovir alafenamide 25 mg
Visit www.descovy.com
Limitations of Use: DESCOVY is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
DESCOVY is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of DESCOVY have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY.
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 DESCOVY. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
emtricitabine 200 mg
Additional important information regarding the use of Emtriva for the treatment of HIV-1 Infection:
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 are coinfected with HBV and HIV-1 and 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.
elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg
Visit www.Genvoya.com
Visit www.genvoya.com
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of GENVOYA. 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 GENVOYA. If appropriate, anti-hepatitis B therapy may be warranted.
emtricitabine 200 mg/rilpivirine 25 mg/ tenofovir alafenamide 25 mg
Visit www.Odefsey.com
Visit www.odefsey.com
ODEFSEY is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of ODEFSEY 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 products containing emtricitabine and/or tenofovir disoproxil fumarate, and may occur with discontinuation of ODEFSEY. 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 ODEFSEY. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Visit www.Stribild.com
Visit www.stribild.com
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate, which are components of STRIBILD. 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 STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
Download Medication Guide
Visit www.TruvadaPrEPREMS.com
Visit www.Truvada.com
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION
cobicistat 150 mg
Download Full U.S. Prescribing Information
tenofovir disoproxil fumarate 300 mg
Visit www.Viread.com
Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including VIREAD. 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, including VIREAD. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
The following points should be considered when initiating therapy with Viread for the treatment of HIV-1 infection:
The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:
sofosbuvir 400 mg/velpatasvir 100 mg
Visit www.Epclusa.com
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS:
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA . HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
ledipasvir 90 mg/sofosbuvir 400 mg
Visit www.Harvoni.com
CONTRAINDICATIONS:
If HARVONI is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.
ADVERSE REACTIONS: Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with HARVONI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
adefovir dipivoxil 10 mg
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: 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.
Chronic hepatitis B is a liver disease caused by infection with the hepatitis B virus (HBV). While some people naturally clear HBV infection, many go on to develop chronic (long-term) infection. Chronic HBV may not show symptoms for many years but over time can lead to life-threatening liver damage, including liver cirrhosis (scarring) and liver cancer.
For more information:
sofosbuvir 400 mg
Visit www.Sovaldi.com
CONTRAINDICATIONS: Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
ADVERSE REACTIONS: Most common (≥20%, all grades) adverse reactions for:
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with SOVALDI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
tenofovir alafenamide 25 mg
Visit www.Vemlidy.com
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. 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, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Visit www.viread.com
sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg tablets
Visit www.Vosevi.com
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with VOSEVI. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
axicabtagene ciloleucel
Visit www.YescartaREMS.com
Visit www.Yescarta.com
LIMITATION OF USE: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
FOR MORE INFORMATION Click here for full Prescribing Information (PDF), including details about indication and usage and important safety information.To request specific product information, report an adverse event or product complaint, contact Kite Medical Information: (844) 454-KITE
idelalisib 150 mg
Visit www.ZydeligREMS.com
Visit www.Zydelig.com
LIMITATION OF USE Zydelig is not indicated and is not recommended for first-line treatment of any patient.
Accelerated approval was granted for FL and SLL based on overall response rate. Improvement in patient survival or disease related symptoms has not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
BOXED WARNING FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, AND INTESTINAL PERFORATION
FOR MORE INFORMATION Click here for full Prescribing Information (PDF), including details about indication and usage and important safety information. For Prescribing Information or to request specific product information or report an adverse event, please click here.
ambrisentan 5 mg and 10 mg
Visit www.LetairisREMS.com
Visit www.Letairis.com
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Letairis to a pregnant female because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals.
Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment.
Because of the risk of embryo-fetal toxicity birth defects, females can only receive Letairis through a restricted program called the Letairis REMS program.
FOR MORE INFORMATION:
Click here for full Prescribing Information (PDF), including details about indication and usage and important safety information. For Prescribing Information or to request specific product information or report an adverse event, please click here.
Pulmonary arterial hypertension (PAH) is a serious cardiovascular disease that can lead to breathing difficulties and ultimately heart failure. PAH refers to a narrowing of the vessels that carry blood between the lungs and heart; this narrowing increases blood pressure in the lungs and makes the heart work harder. In many cases the underlying cause of PAH is unknown.
regadenoson injection 0.4 mg
Visit www.Lexiscan.com
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.
Radionuclide myocardial perfusion imaging (RMPI) is a medical technique for diagnosing coronary artery disease, the narrowing or blockage of blood vessels by the build-up of cholesterol or other fatty substances. Coronary artery disease is a leading cause of death in the United States and globally.
RMPI involves injecting a small amount of radioactive liquid, or tracer, into the bloodstream. As the tracer moves through blood vessels and the heart, a camera captures information about blood flow. This helps doctors assess the extent of any blockage and determine appropriate treatment options.
ranolazine 500 mg and 1000 mg
Visit www.Ranexa.com
Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
CONTRAINDICATIONS: Ranexa is contraindicated in patients taking strong inhibitors of CYP3A, taking inducers of CYP3A and with liver cirrhosis.
Coronary artery disease – the narrowing or blockage of blood vessels by the build-up of cholesterol or other fatty substances – is a leading cause of death in the United States and globally. The most common symptom of the disease is chronic angina, recurring chest pain or discomfort due to restricted blood flow to muscles that power the heart. The severe discomfort of angina can prevent people from engaging in everyday activities such as walking and running.
aztreonam for inhalation solution 75 mg/vial
Visit www.Cayston.com
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.
Cystic fibrosis (CF) is an inherited genetic disorder that causes the accumulation of mucus in the lungs. The mucus traps bacteria and increases susceptibility to serious respiratory infections (in addition to its effect on the lungs, CF also affects other bodily systems, e.g., causes high levels of mucus in the digestive tract, leading to digestion problems). Many people with CF are diagnosed as children and may experience life-threatening complications as they reach adulthood. The goal of CF treatment, which may include medication, is to reduce CF symptoms, infection and slow lung damage.
oseltamivir phosphate 75 mg
Visit www.Tamiflu.com
Visit www.tamiflu.com
The following points should be considered before initiating treatment or prophylaxis with Tamiflu:
CONTRAINDICATIONS: Tamiflu is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme.
WARNINGS AND PRECAUTIONS: Cases of anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme have been reported in postmarketing experience with Tamiflu. Tamiflu should be stopped and appropriate treatment instituted if an allergic-like reaction occurs or is suspected.
Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established. Closely monitor patients with influenza for signs of abnormal behavior. If neuropsychiatric symptoms occur, evaluate the risks and benefits of continuing treatment for each patient.
Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. Tamiflu has not been shown to prevent such complications.
Efficacy of Tamiflu in the treatment of influenza in patients with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalization.
Efficacy of Tamiflu for treatment or prophylaxis of influenza has not been established in immunocompromised patients.
Please visit www.Tamiflu.com for Full Prescribing Information.
Influenza, or the flu, is a common respiratory disease caused by infection with one of multiple influenza viruses. Influenza takes different forms: So-called seasonal, or annual, influenza occurs regionally during cold months and pandemic influenza occurs less frequently but can affect the entire globe.
Many people with influenza recover after a period of a few days. However, influenza can be significantly more serious, as well as life threatening, in some people or when caused by particular viral strains. In certain cases, antiviral medication is an appropriate option for treating influenza or for preventing those exposed to an influenza virus from becoming sick. Vaccination is also available to prevent many forms of influenza.
amphotericin b liposome for injection 50 mg/vial
Visit www.AmBisome.com
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.
MARKETING PARTNERS:
pegaptanib sodium injection 0.3 mg
Visit www.Macugen.com
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.
Neovascular (or “wet”) age-related macular degeneration (AMD) is an eye disease that makes reading and seeing details difficult. It results from abnormal blood vessels that grow underneath a part of the retina (the tissue lining the eye) that are fragile and leak. AMD is most common in people over age 60, and the cause is not understood.