Value through InnovationApril 17 2014

Innovation in Treatments

Boehringer Ingelheim is a research-driven group of companies dedicated to the discovery, development, manufacture and marketing of innovative health care products. We are committed to offering the highest quality products to treat diseases, enhance health, and improve the quality of life for patients and their families.

  • Aggrenox® (aspirin/ extended-release dipyridamole) 25mg / 200mg capsules

    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 works by reducing the risk of stroke-causing blood clots from forming.

    AGGRENOX combines 2 effective medications—low-dose aspirin and extended-release dipyridamole. These medicines are known as antiplatelets. They work to make platelets in the blood less sticky, so they are less likely to clump together and form blood clots. In a clinical trial, the combination of both medications was better than either medication alone at reducing the risk for a subsequent stroke.

    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.

  • Aptivus® (tipranavir) capsules / oral solution
    Aptivus

    APTIVUS (tipranavir) is a medicine called a “protease inhibitor” that is used to treat adults with Human Immunodeficiency Virus (HIV). APTIVUS blocks HIV protease, an enzyme which is needed for HIV to make more virus. When used with other anti-HIV medicines, APTIVUS may reduce the amount of HIV in your blood and increase the number of CD4+ cells. Reducing the amount of HIV in the blood may keep your immune system healthy, so it can help fight infections.

    APTIVUS is always taken with NORVIR® (ritonavir) and at the same time as NORVIR. When you take APTIVUS with NORVIR, you must always use at least 2 other anti-HIV medicines.

    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).
  • Combivent® Respimat® (ipratropium bromide and albuterol) inhalation spray

    COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator (inhaler) who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator.

    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.

  • Flomax® (tamsulosin HCl) capsules
    Flomax

    FLOMAX capsules are approved to treat male urinary symptoms due to BPH (Benign Prostatic Hyperplasia), also called an enlarged prostate.

    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.

  • Gilotrif™ (afatinib) tablets for oral use

    What is GILOTRIF?
    GILOTRIF is a prescription medication used to treat people with non-small cell lung cancer (NSCLC) that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and who have not had previous treatment for cancer that has spread to other parts of the body.

    It is not known if GILOTRIF is safe and effective in children. 

    IMPORTANT SAFTEY INFORMATION

    GILOTRIF may cause serious side effects. While receiving GILOTRIF tell your doctor right away if you have any of the symptoms listed below.

    • Diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.

    • Skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin.

      Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin while you are taking GILOTRIF if you have to be in sunlight.

    • Lung or breathing problems. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms:
      • trouble breathing or shortness of breath
      • cough
      • fever
    • Liver problems. symptoms may include:
      • yellowing of your skin or the white part of your eyes (jaundice)
      • dark or brown (tea colored) urine
      • pain on the upper right side of your stomach area (abdomen)
      • bleeding or bruising more easily than normal
      • feeling very tired

    Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.

    • Eye problems. Symptoms may include:
      • eye pain, swelling, redness, or tearing
      • blurred vision
      • sensitivity to light
      • other changes in your vision
    • Heart problems. symptoms may include:
      • new or worsening shortness of breath while at rest or with activity
      • cough
      • tiredness
      • swelling of your ankles, feet, or legs
      • feeling that your heart is pounding or racing (palpitations)
      • sudden weight gain

    The most common side effects of GILOTRIF include diarrhea, rash, mouth sores, nail infection, dry skin, acne, decreased appetite, itching

    Before you take GILOTRIF, tell your doctor if you:

    • have kidney or liver problems
    • have lung or breathing problems other than lung cancer
    • have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
    • have heart problems
    • have any other medical conditions
    • are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby.  You should not become pregnant while taking GILOTRIF.
      • Women who are able to become pregnant should use effective birth control during treatment with GILOTRIF and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
      • Tell your doctor right away if you become pregnant while taking GILOTRIF.
    • are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk. You and your doctor should decide if you will take GILOTRIF or breastfeed. You should not do both.

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines may affect the way GILOTRIF works.


    Tell your doctor if you have any side effect that bothers you or that does not go away.

    These are not all of the possible side effects of GILOTRIF. For more information, ask your doctor or pharmacist.

    Call your doctor for medical advice about side effects. 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.

    GF PROF ISI SEPT 20 13

  • Jentadueto® (linagliptin and metformin hydrochloride) tablets

    What is JENTADUETO?

    JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.

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

    If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JENTADUETO.

    IMPORTANT SAFETY INFORMATION

    What is the most important information I should know about JENTADUETO?

    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.

    Inflammation of the pancreas (pancreatitis) is another serious side effect that can happen to people taking JENTADUETO. Pancreatitis may be severe and lead to death. Before you start taking JENTADUETO tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

    Stop taking JENTADUETO and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

    Who should not take JENTADUETO?

    Do not take JENTADUETO if you:

    • have kidney problems.
    • have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine).
    • are allergic to linagliptin, metformin or any of the ingredients in JENTADUETO. Symptoms of any allergic reaction may include rash, itching, flaking or peeling; raised red patches on your skin (hives); and swelling of your face, lips, tongue and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO and call your doctor or go to the emergency room right away.

    What should I tell my doctor before using JENTADUETO?

    Before you take JENTADUETO, tell your doctor if you:

    • have kidney problems.
    • are going to get an injection of dye or contrast agents for an x-ray procedure. JENTADUETO will need to be stopped for a short time. Talk to your doctor about when you should stop JENTADUETO and when you should start JENTADUETO again.
    • have liver problems.
    • have heart problems, including congestive heart failure.
    • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.
    • have any other medical conditions.
    • are pregnant or planning to become pregnant. It is not known if JENTADUETO will harm your unborn baby.
    • are breast-feeding or plan to breast-feed. It is not known if JENTADUETO passes into your breast milk.
    • are older than 80 years; you should not take JENTADUETO unless your kidneys have been checked and they are normal.

    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO may affect the way other medicines work, and other medicines may affect how JENTADUETO works.

    Especially tell your doctor if you take:

    • other medicines that can lower your blood sugar. JENTADUETO may cause serious side effects, including low blood sugar (hypoglycemia). If you take JENTADUETO 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 JENTADUETO.

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

    • rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

      Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.

    Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

    What are the possible side effects of JENTADUETO tablets?

    The most common side effects of JENTADUETO include stuffy or runny nose, sore throat, 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.

    For more safety information, please see full Prescribing Information, including Boxed Warning regarding risk of lactic acidosis, and Medication Guide.

              JD CON ISI 12SEPT2013

  • Micardis® (telmisartan) tablets

    MICARDIS® (telmisartan) is a prescription medicine used to treat high blood pressure (hypertension).

    Additionally, MICARDIS 80 mg is used in certain high-risk people aged 55 years and older who are unable to take a medicine called an angiotensin converting enzyme inhibitor (ACE-I) to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death.


    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.

  • Mirapex® (pramipexole dihydrochloride) tablets
    Mirapex

    MIRAPEX (pramipexole dihydrochloride) tablets are a prescription medicine to treat the signs and symptoms of Parkinson's disease (PD). 

    MIRAPEX (pramipexole dihydrochloride) tablets are a prescription medicine for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

    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.

  • Mirapex ER™ (pramipexole dihydrocloride)

    Once daily MIRAPEX ER is a prescription medicine to treat the signs and symptoms of Parkinson's disease. MIRAPEX ER is proven effective in relieving symptoms of early and later stage Parkinson's disease. Because MIRAPEX ER is taken just once a day, many people may find more convenient than medicines taken multiple times a day. Your doctor will work with you to make sure you are taking the right dose to help control your symptoms. MIRAPEX ER contains the same medicine as Mirapex® (pramipexole dihydrochloride) tablets. MIRAPEX has been a trusted treatment for Parkinson's disease for more than 12 years

    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.

  • Pradaxa® (dabigatran etexilate mesylate) capsules

    What is PRADAXA?

    Pradaxa® (dabigatran etexilate mesylate) capsules is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. Pradaxa is not for use in people with artificial (prosthetic) heart valves.

    IMPORTANT SAFETY INFORMATION ABOUT PRADAXA

    Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke.  PRADAXA may need to be stopped prior to surgery or a medical or dental procedure. Your doctor will tell you when you should stop taking PRADAXA and when you may start taking it again. If you have to stop taking PRADAXA, your doctor may prescribe another medicine to help prevent a blood clot from forming.

    PRADAXA can cause bleeding which can be serious and sometimes lead to death.  Don’t take PRADAXA if you:

    • currently have abnormal bleeding;
    • have ever had an allergic reaction to it;
    • have had or plan to have a valve in your heart replaced

    Your risk of bleeding with PRADAXA may be higher if you:

    • are 75 years old or older
    • have kidney problems
    • have stomach or intestine bleeding that is recent or keeps coming back or you have a stomach ulcer
    • take other medicines that increase your risk of bleeding, like aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs) and blood thinners
    • have kidney problems and take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®)

    Call your doctor or seek immediate medical care if you have any of the following signs or symptoms of bleeding:

    • any unexpected, severe, or uncontrollable bleeding; or bleeding that lasts a long time
    • unusual or unexpected bruising
    • coughing up or vomiting blood; or vomit that looks like coffee grounds
    • pink or brown urine; red or black stools (looks like tar)
    • unexpected pain, swelling, or joint pain
    • headaches and feeling dizzy or weak

    Take PRADAXA exactly as prescribed. It is important to tell your doctors about all medicines, vitamins and supplements you take.  Some medicines may affect the way PRADAXA works. 

    PRADAXA can cause indigestion, stomach upset or burning, and stomach pain.  

    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


      PXCONSISIAPRIL292013

  • Spiriva® HandiHaler® (tiotropium bromide inhalation powder)

    SPIRIVA Handihaler is a prescription medicine used once every 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). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

    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.


    NOVEMBER2013

  • Tradjenta® (linagliptin) tablets
    tradjenta

    TRADJENTA® (linagliptin) tablets is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA. TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It is FDA approved at one dosage strength (5 mg, once daily) and can be taken with or without food. With TRADJENTA, no dose adjustment is recommended for patients with kidney or liver impairment. TRADJENTA lowers blood sugar in a glucose dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

    What are TRADJENTA® (linagliptin) 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).

    If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.

    Important Safety Information

    What is the most important information I should know about TRADJENTA?

    Serious side effects can happen to people taking TRADJENTA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.

    Stop taking TRADJENTA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

    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 may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue 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 using TRADJENTA?

    Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

    Especially 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.
    • rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

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

    What are the possible side effects of TRADJENTA?

    The most common side effects of TRADJENTA include stuffy or runny nose, sore throat, cough 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.

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

                                                                                         TJ CONS ISI 19JUNE2013

  • Twynsta® (telmisartan/amlodipine) tablets

    TWYNSTA is a once-daily, fixed-dose combination of the angiotensin II receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine. TWYNSTA is indicated for the treatment of hypertension, alone or in combination with other antihypertensive agents, or as an initial therapy for patients who are likely to need multiple medications to achieve their blood pressure goals.

    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.

  • Viramune® (nevirapine) tablets / oral suspension

    VIRAMUNE is a medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

    VIRAMUNE is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood ("viral load"). You must take VIRAMUNE with other anti-HIV medicines. When taken with other anti-HIV medicines, VIRAMUNE can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. VIRAMUNE may not have these effects in every patient.

    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.

  • Viramune® XR™ (nevirapine) extended-release tablets

    VIRAMUNE is a prescription medication indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV infection.

    VIRAMUNE XR is a prescription medication indicated for use in combination with other ARVs for the treatment of HIV infection in adults.

    VIRAMUNE XR (400 mg), also called nevirapine, is a medicine that treats HIV in adult patients.

    Specifically, it is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). VIRAMUNE XR is used in combination with other antiretrovirals. It can reduce the amount of HIV in the blood (viral load) and increase the number of CD4+ cells. VIRAMUNE XR may not have these effects in every patient.VIRAMUNE XR must be given in combination with other drugs, like NRTIs or PIs.

    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.

  • Dulcolax®

    For more than 50 years, Dulcolax® has provided predictable, gentle relief from constipation to millions of people throughout America and around the world. Dulcolax is trusted by doctors and pharmacists to safely and effectively help treat constipation. It is available in laxative tablets, laxative suppositories, and stool softener products, as well as Dulcolax Balance®, a new powder formulation that mixes with water.

    • Dulcolax Balance®
    • Ducolax® Laxative Tablets
    • Dulcolax® Laxative Suppositories
    • Dulcolax® Stool Softener
  • Zantac®

    Zantac® is a nonprescription acid reducer available for the relief and prevention of heartburn associated with acid indigestion and sour stomach. Its ingredient, rantidine, has been prescribed by doctors for years to treat millions of patients safely and effectively.

    ZANTAC comes in two strengths and one innovative flavor:

    • Zantac 75®
    • Maximum Strength Zantac 150®
    • Maximum Strength Zantac 150® Cool Mint Tablets

     

    More Information

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