Innovation in Treatments

IMPORTANT SAFTEY INFORMATION

AGGRENOX is a prescription medication used to lower the risk of stroke in people who have had a "mini-stroke" (transient ischemia attack or TIA) or stroke due to a blood clot.

AGGRENOX should be avoided in patients allergic to any ingredient in AGGRENOX, allergic to non-steroidal anti-inflammatory drugs (NSAIDS), or who have the combination of asthma, runny nose and nasal polyps. AGGRENOX should not be given to a child or teenager due to the risk of Reye’s syndrome.

AGGRENOX may cause an increased bleeding risk, including into the brain, stomach or intestines and any bleeding may take longer to stop. AGGRENOX should be avoided in patients with a history of stomach ulcers or those who drink three or more alcoholic drinks a day due to the risk of bleeding. Patients should inform their doctor of all medications they are currently taking including NSAIDS or blood thinners.

AGGRENOX should be avoided during pregnancy, especially in the third trimester, or in patients with severe liver or kidney problems. The most common side effects of AGGRENOX are headache, upset stomach and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Important Safety Information for APTIVUS

Patients taking APTIVUS, together with NORVIR, may develop severe liver disease that can cause death. If you develop any of the following symptoms of liver problems, you should stop taking APTIVUS and NORVIR and call your healthcare professional right away: tiredness, general ill feeling or “flu-like” symptoms, loss of appetite, nausea (feeling sick to your stomach), yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale stools (bowel movements), or pain, ache, or sensitivity on your right side below your ribs. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems.

Patients taking APTIVUS together with NORVIR may develop bleeding in the brain that can cause death. You should report any unusual or unexplained bleeding to your healthcare professional if you are taking APTIVUS together with NORVIR.

Contraindications:

Do not take ATIVUS or NORVIR if you are allergic to the active ingredients tipranavir or ritonavir or any other ingredients in this medicine.

Do not take APTIVUS if you have moderate to severe liver problems.

Tell your healthcare professional about all the medicines you take including St. John’s Wort or Rifampin. Taking APTIVUS with certain drugs can reduce the effectiveness of your treatment and can result in serious side effects.

APTIVUS may also cause serious side effects, including:

• liver problems, including liver failure and death
• bleeding in the brain
• rash including flat or raised rashes or sensitivity to the sun with the following symptoms: joint pain or stiffness, throat tightness, generalized itching, muscle aches, fever, redness, blisters, or peeling of the skin
• increased bleeding in patients with hemophilia
• new or worsening diabetes and high blood sugar (hyperglycemia)
• increased blood fat (lipid) levels. Your healthcare professional should do blood tests to monitor your blood fat (triglycerides and cholesterol) during treatment with APTIVUS
• changes in body fat

Most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen more frequently in children.

Tell your healthcare professional about all of your medical conditions, including if you:

• have hemophilia or another medical condition that increases your chance of bleeding, or are taking medicines which increase your chance of bleeding
• have liver problems or are infected with hepatitis B or hepatitis C
• are allergic to sulfa medicines
• have diabetes since APTIVUS may worsen diabetes or high blood sugar levels
• are pregnant or planning to become pregnant. It is not known if APTIVUS can harm your unborn baby
• are breast-feeding. Do not breastfeed since it is not known if APTIVUS can be passed in your breast milk and cause harm to your baby. HIV-1 can be passed to your baby in breast milk
• are using estrogens for birth control or hormone replacement. Women using estrogens for birth control or hormone replacement have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs call your healthcare professional.
• If you are taking APTIVUS oral solution, which contains vitamin E, you should not take additional vitamin E other than that contained in a standard multivitamin
  

Tell your healthcare professional about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. APTIVUS and many other medicines can interact and may cause serious side effects. Women taking birth control pills need to use another birth control method since APTIVUS makes birth control pills work less well and may cause a skin rash.

APTIVUS should not be used in children under 2 years of age.

Please see the full Prescribing Information as well as the Patient Package Insert (PPI) including boxed WARNINGS for APTIVUS® (tipranavir).

IMPORTANT SAFTEY INFORMATION
Do not use COMBIVENT Inhalation Aerosol if you:

• Are allergic to soya lecithin or related food products such as soybeans and peanuts
• Are allergic to any of the ingredients in COMBIVENT Inhalation Aerosol or to atropine or other similar drugs

COMBIVENT Inhalation Aerosol can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.

COMBIVENT Inhalation Aerosol can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms.

COMBIVENT Inhalation Aerosol may increase eye pressure which may cause or worsen some types of glaucoma.

Do not get the spray into your eyes.

COMBIVENT Inhalation Aerosol may cause difficulty with urination.

If you have vision changes or eye pain or if you have difficulty with urination, stop taking COMBIVENT Inhalation Aerosol and call your doctor right away.

Dizziness and blurred vision may occur with COMBIVENT Inhalation Aerosol. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.

Do not use COMBIVENT Inhalation Aerosol more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much.

Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.

Tell your doctor about all your medical conditions especially if you:

• Have narrow-angle glaucoma
• Have prostate or urinary problems
• Have a history of heart conditions (such as irregular heartbeat and high blood pressure) 
• Have seizures
• Have a thyroid disorder
• Have diabetes
• Have low potassium levels
• Have kidney disease
• Have liver disease

Also tell your doctor if you are pregnant or nursing.

Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression.

The most common side effects reported with use of COMBIVENT Inhalation Aerosol were bronchitis, infection of the ears, nose, and throat, headache, shortness of breath, cough, pain, sore throat with difficulty breathing or swallowing, sinus problems or sinus pain, and nausea.

Read the step by step Patient's Instructions for Use before using this medicine.
Remember to vigorously shake your COMBIVENT Inhalation Aerosol for 10 seconds before each use or inhalation.

IMPORTANT SAFETY INFORMATION
Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs.

COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms.

COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma.

Do not get the spray into your eyes.

COMBIVENT RESPIMAT may cause difficulty with urination.

If you have vision changes or eye pain or if you have difficulty with urination, stop taking COMBIVENT RESPIMAT and call your doctor right away.

Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.

Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much.

Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), seizures, thyroid disorder, diabetes, low potassium levels, or kidney or liver disease. Also tell your doctor if you are pregnant or nursing.

Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression.

The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath.

IMPORTANT SAFTEY INFORMATION
Only your doctor can tell if you have BPH, not a more serious condition like prostate cancer. When taking FLOMAX, avoid driving or hazardous tasks until you know how FLOMAX will affect you, especially after your first dose or change in dose, as a sudden drop in blood pressure may occur, rarely resulting in fainting. Tell your doctor about all medications you take. If considering cataract surgery, tell your eye surgeon if you've taken FLOMAX. Common side effects are runny nose, dizziness, and decrease in semen.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

WARNING: RISK OF LACTIC ACIDOSIS

Serious side effects can happen in people taking JENTADUETO. Metformin, one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking JENTADUETO and call your doctor right away if you feel very weak or tired, have unusual muscle pain, have trouble breathing, are very sleepy, have sudden nausea and vomiting or diarrhea, feel cold, especially in your arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis.

You have a higher chance of getting lactic acidosis with JENTADUETO if you have kidney problems, liver problems, congestive heart failure that requires medicines, drink alcohol very often, or drink a lot of alcohol in short-term "binge drinking", get dehydrated (lose a large amount of body fluids), have certain x-ray tests with dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke, and are 80 years of age or older and have not had your kidneys tested.

IMPORTANT SAFTEY INFORMATION
MICARDIS can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking MICARDIS, tell your doctor right away.

If you are breast-feeding or plan to breast-feed talk to your doctor about ways to reduce your blood pressure.

Do not take MICARDIS if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any other ingredient in this medicine.

Serious allergic reactions may occur. Tell your doctor right away if you have signs of allergic reaction such as swelling of the face, tongue, or throat; difficulty breathing; or skin rash.

Before taking MICARDIS, tell your doctor about any medical conditions you have, including any liver, kidney, or heart problems and if you are pregnant or breast-feeding. Tell your doctor about all other medications and supplements you are taking.

MICARDIS can cause serious side effects including harm to and death of your unborn child, low blood pressure, kidney problems, and high potassium in your blood. Other side effects include sinus pain, back pain, and diarrhea. Other rare but serious side effects may occur.

Please see full Prescribing Information, including Boxed WARNING, for MICARDIS.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION
MIRAPEX (pramipexole dihydrochloride) tablets may cause you to fall asleep without warning during daily activities, including talking, eating, and driving, which may result in accidents. Tell your doctor if you feel new or increased sleepiness while taking MIRAPEX. Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX affects you.

Before taking MIRAPEX, talk to your doctor about all of your medical conditions, including if you feel sleepy during the day. Tell your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX will make you feel sleepy or fall asleep when you should be awake.

When taking MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

Some patients taking certain medicines, including MIRAPEX, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.

In clinical trials for RLS, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea, headache, and tiredness.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION
MIRAPEX ER or MIRAPEX may cause you to fall asleep without warning during daily activities, including talking, eating, and driving, which may result in accidents. Tell your doctor if you feel new or increased sleepiness while taking MIRAPEX ER or MIRAPEX. Do not drive a car, operate a machine, or do anything that needs you to be alert until you know how MIRAPEX ER or MIRAPEX affects you.

Before taking MIRAPEX ER or MIRAPEX, talk to your doctor about all of your medical conditions, including if you feel sleepy during the day. Tell your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake.

When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems, such as gambling, compulsive eating, compulsive buying, and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

The most common side effects in people taking MIRAPEX ER for early PD are sleepiness, nausea and vomiting, constipation, dizziness, tiredness, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).

The most common side effects in people taking MIRAPEX ER who have later-stage PD are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.

The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFTEY INFORMATION
Do not use Spiriva® HandiHaler® (tiotropium bromide inhalation powder) if you are allergic to tiotropium or ipratropium (e.g., Atrovent®) or any of the ingredients in SPIRIVA. If your breathing suddenly worsens, your face, throat, lips, or tongue swells, you get hives, itching or rash, stop taking SPIRIVA and seek immediate medical help.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device.

If you have vision changes or eye pain or if you have difficulty passing urine or painful urination, stop taking SPIRIVA and call your doctor right away.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not let the powder from the SPIRIVA capsule get into your eyes.

Dizziness and blurred vision may occur with SPIRIVA. Should you experience these symptoms, you should use caution when engaging in activities such as driving a car or operating appliances or other machines.

Read the Patient Information and the step-by-step Instructions for Use for SPIRIVA before you use your inhaler.

INDICATION 
SPIRIVA HandiHaler is a prescription medicine used once each day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations).

The information provided on this site is for general information and educational purposes only. You should always consult a doctor for diagnosing and treating a health or fitness problem, and before using any drug product discussed on this site.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information and Instructions for Use.

What are TRADJENTA tablets?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

IMPORTANT SAFETY INFORMATION

Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.  

Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing.  If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.

What should I tell my doctor before taking TRADJENTA?TelI your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.

TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA. 

Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin  (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements..

What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more safety information, please see Patient Information and full Prescribing Information.

IMPORTANT SAFETY INFORMATION
TWYNSTA IS NOT FOR PREGNANT WOMEN. Taking TWYNSTA during pregnancy can cause injury and even death to your unborn baby. If you get pregnant, stop taking TWYNSTA and call your doctor right away. If you plan to become pregnant or breastfeed, talk to your doctor about other ways to lower your blood pressure. The most serious side effect with TWYNSTA include low blood pressure, kidney problems, heart problems or heart attack. Other rare but serious side effects may occur.

TWYNSTA is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. Base the choice of TWYNSTA tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of TWYNSTA tablets. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use TWYNSTA tablets as initial therapy.

Volume depletion and/or salt depletion should be corrected in patients before initiation of therapy or start treatment under close medical supervision with a reduced dose, otherwise symptomatic hypotension may occur. Observe patients with severe aortic stenosis closely for acute hypotension when administering amlodipine.

In patients with impaired hepatic function, initiate telmisartan at low doses and titrate slowly, or initiate amlodipine at 2.5 mg. The lowest dose of TWYNSTA is 40/5 mg; therefore, initial therapy with TWYNSTA is not recommended in hepatically impaired patients.

Monitor carefully in patients with impaired renal function, especially in patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction); treatment of these patients with ACE inhibitors and ARBs has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur.

When adding an ACE inhibitor to an ARB, monitor renal function closely. Use of telmisartan with ramipril is not recommended.

Uncommonly, increased frequency, duration, and/or severity of angina or acute myocardial infarction have developed in patients treated with calcium channel blockers, particularly patients with severe obstructive coronary artery disease. Closely monitor patients with heart failure.

In clinical trials, the most commonly reported adverse events with TWYNSTA that were more frequent than with placebo were peripheral edema (4.8% vs. 0%), dizziness (3.0% vs. 2.2%), clinically meaningful orthostatic hypotension (6.3% vs. 4.3%), and back pain (2.2% vs. 0).

In clinical studies, the magnitude of blood pressure lowering with TWYNSTA in black patients approached that observed in non-black patients, but the number of black patients was limited. TWYNSTA is not recommended as initial therapy in patients who are 75 years or older, or who are hepatically impaired. In nursing mothers, nursing or TWYNSTA should be discontinued.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.

VIRAMUNE does not cure HIV or AIDS, and has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

VIRAMUNE can cause severe liver disease and skin reactions that can cause death. These reactions occur most often during the first 18 weeks of treatment, but can occur later. Ask your healthcare provider about how to recognize symptoms of skin and liver problems.

Stop taking VIRAMUNE if you have any of these reactions. Do not restart VIRAMUNE if you experience any of these reactions. Call your healthcare provider immediately if you have any of these reactions.

VIRAMUNE is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take VIRAMUNE.

Any patient can experience liver problems with VIRAMUNE, but women and patients who have higher CD4 counts when they begin VIRAMUNE treatment have a greater risk. If you are a woman with CD4+ >250 cells/mm3, or a man with CD4+ >400 cells/mm3, you should not begin taking VIRAMUNE unless you and your doctor have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk.

Do not take VIRAMUNE if you have severe liver problems.

The dose of VIRAMUNE for adults is one 200-mg tablet daily for the first 14 days, followed by one 200-mg tablet twice daily. VIRAMUNE is always taken with other anti-HIV medications. The 14-day lead-in period is important because it can help reduce your chances of getting a potentially serious skin rash. If you have a skin rash during the first 14 days, immediately contact your doctor and do not increase your VIRAMUNE dose to twice a day. The total duration of the once daily lead-in dosing period should not exceed 28 days, at which point an alternative regimen may need to be started.

Other side effects that patients have experienced include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Changes in body fat may occur in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including boxed WARNING, and Medication Guide for VIRAMUNE.

IMPORTANT SAFETY INFORMATION
VIRAMUNE and VIRAMUNE XR can cause severe and life-threatening liver and skin reactions that can, in some cases, cause death. These problems can happen at any time but occur most often during the first 18 weeks of treatment, but can occur later. People who have abnormal liver test results before starting VIRAMUNE treatment and people with hepatitis B or C also have a greater chance of getting liver problems. Your healthcare provider (HCP) will closely monitor you and test the function of your liver during the first 18 weeks of therapy. Ask your healthcare provider how to recognize symptoms of liver and skin problems. Do not take VIRAMUNE unless you have been diagnosed with HIV.

You must stop taking VIRAMUNE or VIRAMUNE XR and call your HCP immediately if you have signs or symptoms of liver or skin problems. If you stop treatment with VIRAMUNE because you had any serious liver or skin reactions, you must never take VIRAMUNE again. For some patients, damage to the liver can continue to occur after VIRAMUNE is stopped.

Any patient can experience liver problems with VIRAMUNE or VIRAMUNE XR, but women and patients who have higher CD4+ counts when they begin nevirapine treatment have a greater risk. If you are a woman with CD4+ greater than 250 cells/mm3, or a man with CD4+ greater than 400 cells/mm3, you should not begin taking VIRAMUNE unless you and your doctor have decided that the benefit of doing so outweighs the risk. Women, including pregnant women, with CD4+ cell counts greater than 250 cells/mm3 are at the greatest risk of severe liver problems.

Do not take VIRAMUNE or VIRAMUNE XR unless you have been diagnosed with HIV. Do not take VIRAMUNE or VIRAMUNE XR if your HCP has told you that you have moderate to severe liver disease.

VIRAMUNE and VIRAMUNE XR can cause serious side effects, including changes to your immune system (Immune Reconstitution Syndrome) and changes in body fat. The most common side effect of VIRAMUNE is rash. These are not all the possible side effects of VIRAMUNE. For more information, ask your HCP.

You should not take St. John's wort or efavirenz if you take VIRAMUNE or VIRAMUNE XR. Talk to your HCP about the additional drug to drug interactions associated with VIRAMUNE and VIRAMUNE XR.

VIRAMUNE and VIRAMUNE XR do not cure HIV or AIDS, and have not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

Patients new to nevirapine must start treatment with a lead-in dose of one 200 mg tablet of immediate-release VIRAMUNE once daily for the first 14 days of treatment. The 14-day lead-in period is important because it has been shown to reduce your chances of getting a potentially serious skin rash. If you experience a rash during the first 14 days, immediately contact your HCP and do not increase your dose to VIRAMUNE 200 mg twice daily or start VIRAMUNE XR 400 mg once daily until the rash has resolved. If your rash persists longer than 28 days, stop taking VIRAMUNE and call your HCP for an alternative regimen. If you stop taking VIRAMUNE or VIRAMUNE XR for longer than seven days, talk to your HCP because you will need to restart the 14-day lead-in dose.

Adult patients already on a regimen of VIRAMUNE 200 mg twice daily can be switched to VIRAMUNE XR 400 mg once daily without the 14-day lead-in period of VIRAMUNE.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including boxed WARNING, and Medication Guide for VIRAMUNE.