Category Archives: Product News

Science of Novel Drug Delivery in Respiratory Medicine

AstraZeneca’s latest approval BEVESPI AEROSPHERE™ (glycopyrrolate and formoterol fumarate) inhalation aerosol, is the first long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA) delivered in a pressurized metered dose inhaler (pMDI). It is the first approved product to use the novel Co-Suspension™ Technology. BEVESPI AEROSPHERE was recently approved by the U.S. Food and Drug Administration for long-term maintenance treatment of people with chronic obstructive pulmonary disease (COPD). BEVESPI AEROSPHERE is not for the relief of acute symptoms of COPD or for the treatment of asthma. More information about the approval can be found in our press release.

3226104-NONBRANDED PDUFA Infographics-CC-The Latest Science of Novel Drug Delivery in Resp Medicine Infographic

This progress demonstrates AstraZeneca’s continued commitment to deliver new treatment options for the millions of people affected by chronic respiratory conditions. But, what exactly is Co-Suspension Technology? Below are facts about Co-Suspension Technology to answer this question.

  1. Utilizes a specially formulated phospholipid particle designed for distribution throughout the lungs: Co-Suspension Technology uses a novel, specially engineered particle to assist with drug crystal delivery. The particles are designed to release drug crystals at their site of deposition, and dissolve in the lung fluid
  1. Designed to prevent separation and sedimentation of drug crystals over time: Co-Suspension Technology uses low-density particles that are intended to prevent settling (sedimentation) and remain in a stable homogeneous suspension 
  1. Designed for dose consistency: AstraZeneca’s Co-Suspension Technology allows for consistent dosing of one or more different drugs from a single pMDI, the most commonly used inhaler in the US.

We remain focused on developing innovative technology for respiratory patients, and look forward to Co-Suspension Technology as the platform for future combination products within AstraZeneca’s robust respiratory pipeline. Click here for more information about Co-Suspension Technology.

INDICATION

BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Important Safety Information about BEVESPI AEROSPHERE, including Boxed WARNING

WARNING: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate. The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.

All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. BEVESPI is contraindicated in patients with a hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product.

BEVESPI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.

BEVESPI should not be used for the relief of acute symptoms, i.e., as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result.

If paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy.

If immediate hypersensitivity reactions, including angioedema, urticaria, or skin rash, occur, discontinue BEVESPI at once and consider alternative treatment.

BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued.

Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

Be alert to hypokalemia and hyperglycemia.

Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur.

The most common adverse reactions with BEVESPI (≥2% and more common than placebo) were: cough, 4.0% (2.7%), and urinary tract infection, 2.6% (2.3%).

Use caution if administering adrenergic drugs because the sympathetic effects of formoterol may be potentiated.

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol.

Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta2-agonists.

The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval.  Therefore BEVESPI should be used with extreme caution in patients being treated with these agents.

Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.

Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

Please see full Prescribing Information including Boxed WARNING, and Medication Guide.

First-in-Class Treatment Brings Hope to Patients with Advanced Non-Small-Cell Lung Cancer

Norman Pease was diagnosed in 2012 with non-small cell lung cancer (NSCLC) and progressed beyond treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), and was found to have the T790M mutation. He knew that he was going to be facing one of the biggest challenges of his life. Resolute, he and his wife committed to doing all they could to help him live the life he wanted.

Norman is not alone in his experience, approximately 85 percent of all lung cancers in the US are NSCLC, and about 15% of these are EGFR mutation-positive. Nearly two-thirds of patients with this mutation who are treated with a first-generation EGFR-TKI will form further resistance due to a secondary mutation, T790M.

LogoNorman was treated with what was then an investigational drug known as AZD9291, and is now TAGRISSO(osimertinib), which was recently approved by the US Food and Drug Administration (FDA) and is the first targeted therapy for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after TKI therapy.

The unmet need amongst these patients was so great that TAGRISSO was granted Breakthrough Therapy designation, Accelerated Approval, Orphan Drug and Fast Track status by the FDA, making it one of the fastest prescription drugs approved within the oncology therapeutic area from first in human to US FDA approval.

“The accelerated regulatory track that led to the approval of TAGRISSO demonstrates the urgent need for patients living with this disease,” said David Fredrickson, Vice President, Specialty Care, AstraZeneca US. “The approval of TAGRISSO is another step forward in ensuring that NSCLC patients receive targeted care for the treatment of their disease.”

With this breakthrough therapy for patients, AstraZeneca continues to make significant progress in delivering a robust pipeline of targeted, innovative oncology treatments. We see a future in which lung cancer becomes a chronic disease that patients can effectively manage.

“I feel like Norman has been very fortunate to receive this kind of targeted care. My hats off to these researchers,” said Sydney Pease, Norman’s wife. “It is just a remarkable thing that they do. We as a couple are grateful.”

Pictured above, Norman Pease with his wife, Sydney Pease.

To learn more about TAGRISSO and hear from other patients like Norman, visit our multimedia news release on this announcement.

Important Safety Information about TAGRISSO

TAGRISSO is a prescription medicine used to treat non-small cell lung cancer (NSCLC). TAGRISSO may be used when your NSCLC has spread to other parts of the body and:

  • has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, and
  • you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working

Your doctor will perform a test to make sure that TAGRISSO is right for you.

TAGRISSO may cause serious side effects, including:

  • lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problem symptoms, including trouble breathing, shortness of breath, cough, or fever.
  • heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking TAGRISSO and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.

Before taking TAGRISSO, tell your doctor if you:

  • have lung or breathing problems
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • are pregnant or plan to become pregnant. TAGRISSO can harm an unborn baby. Tell your doctor right away if you become pregnant during TAGRISSO treatment or think you may be pregnant.
  • Females who are able to become pregnant should use an effective birth control during TAGRISSO treatment and for 6 weeks after the final TAGRISSO dose.
  • Males who have female partners that are able to become pregnant should use effective birth control during TAGRISSO treatment and for 4 months after the final TAGRISSO dose.
  • are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during TAGRISSO treatment and for 2 weeks after your final TAGRISSO dose. Talk to your doctor about the best way to feed your baby during this time.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine.

The most common side effects of TAGRISSO are:

  • diarrhea
  • rash
  • dry skin
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails

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

These are not all the possible side effects of TAGRISSO. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see accompanying complete Prescribing Information including Patient Information.

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

3160618 Last updated: 11/15

 

US FDA Approves Expanded Indication for AZ Medicine

On September 3, 2015, the US Food and Drug Administration (FDA) approved BRILINTA® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.

The approval is based on the PEGASUS TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients. PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the long-term prevention of cardiovascular death, heart attack and stroke in patients ≥ 50 years old who had experienced a heart attack one to three years prior to study enrollment and had at least one risk factor for thrombotic cardiovascular events. The PEGASUS-TIMI 54 trial demonstrated that the addition of BRILINTA to low-dose aspirin in patients with a prior heart attack significantly reduced the risk of dying from cardiovascular causes, having another heart attack, or having a stroke.  In PEGASUS, TIMI Major and TIMI Major/Minor bleeding1 were higher for BRILINTA than for aspirin alone.

Paul Hudson, President, AstraZeneca US and Executive Vice President, North America, explains what this approval means for BRILINTA, healthcare practitioners and patients:

BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.

BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS 

WARNING:  (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

A. BLEEDING RISK

  • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
  • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
  • Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery
  • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided

CONTRAINDICATIONS

  • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product

WARNINGS AND PRECAUTIONS

  • Dyspnea was reported in about 14% of patients treated with BRILINTA, more frequently than in patients treated with control agents. Dyspnea resulting from BRILINTA is often self-limiting
  • Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible
  • Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients

ADVERSE REACTIONS

  • The most common adverse reactions associated with the use of BRILINTA included bleeding and dyspnea: In PLATO, for BRILINTA vs clopidogrel, non-CABG PLATO-defined major bleeding (3.9% vs 3.3%) and dyspnea (14% vs 8%); in PEGASUS, BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs 0.8%) and dyspnea (14% vs 6%)

DRUG INTERACTIONS

  • Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor
  • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events
  • Monitor digoxin levels with initiation of, or change in, BRILINTA therapy

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Between PLATO and now PEGASUS, nearly 40,000 patients have been studied in clinical trials with BRILINTA. BRILINTA has been approved in over 100 countries for patients with ACS and is included in 12 major ACS treatment guidelines globally. In the American Heart Association (AHA)/American College of Cardiology (ACC) 2014 NSTE-ACS Guideline, BRILINTA is preferred over clopidogrel for the maintenance treatment in NSTE-ACS patients (Class IIa; Level of Evidence B) and is recommended as a treatment option in the management of NSTE-ACS patients (Class I; Level of Evidence B).2-4

The new BRILINTA 60mg tablet is expected to be available in pharmacies by the end of September 2015.

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

Patients can find out more information about BRILINTA at www.BRILINTAtouchpoints.com or by calling 1-888-412-7454.

AstraZeneca offers the AZ&MeTM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).

BRILINTA is a registered trademark of AstraZeneca group of companies.

1TIMI Major Bleeding Classification

  • Any intracranial bleeding, or
  • Clinically overt signs of hemorrhage associated with a drop in hemoglobin (Hgb) of ≥5 g/dL (or, when hemoglobin is not available, a fall in hematocrit of ≥15%), or
  • Fatal bleeding (a bleeding event that directly led to death within 7 days).

2Class IIa states that it is reasonable to perform procedure/administer treatment

3Class I recommends that the procedure/treatment should be performed/administered

4Level B is based on data derived from a single randomized clinical trial or nonrandomized studies

© AstraZeneca 2015

 

3150803 Last Updated 9/15

 

Celebrating 10 Years of Exenatide: The First GLP-1 RA Treatment Option

When BYETTA® (exenatide) injection was approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes by the U.S. Food and Drug Administration (FDA) in 2005, headlines over the following few days highlighted its unique origin:

“FDA OKs Lizard-Derived Shot for Diabetes” – Associated Press

“Lizard Is Source of Newest Diabetes Drug” – Los Angeles Times

“Lizard-Derived Diabetes Drug Is Approved by the F.D.A.” – The New York Times

“FDA OKs Lizard Spit Drug for Diabetes” – WebMD

Though the Gila monster may have led the news, the real story was that with the approval of BYETTA, adult patients with type 2 diabetes (T2D) and prescribers had a new class of diabetes treatment – called glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. The GLP-1 RA class was a new therapeutic option that worked differently from other diabetes medications available at that time.

“As the first GLP-1 receptor agonist approved to treat type 2 diabetes, BYETTA offered a new treatment approach for adult patients who were struggling to meet their A1C goals,” said Dr. Ralph DeFronzo, Deputy Director of the Texas Diabetes Institute and an early clinical researcher of exenatide. “BYETTA helped kick off an era of development that changed the diabetes treatment landscape dramatically over the past decade.”

Dr. Ralph DeFronzo was an early investigator and adopter of exenatide.

Dr. Ralph DeFronzo was an early investigator and adopter of exenatide.

“At the time of its launch, BYETTA was considered the most innovative new type 2 diabetes products since the early 1990s,” said Curtis Carter, Director of Advocacy, AstraZeneca, who was Manager of Professional Education during the BYETTA approval. “The response from the physician and advocacy community was tremendous. Everyone was excited about the approval, because they knew BYETTA offered another critical treatment option that could help a large number of adults with type 2 diabetes manage the condition.”

Exenatide is the synthetic version of a protein called exendin-4, which comes from the saliva of the Gila monster. Since the launch of BYETTA, AstraZeneca has developed a new formulation and delivery methods for exenatide. In 2012, the FDA approved BYDUREON® (exenatide extended-release) for injectable suspension, the first once-weekly treatment, indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. Originally packaged as a single-dose tray, in 2014 AstraZeneca additionally launched the BYDUREON Pen, a pre-filled, single-use pen. The extensive exenatide clinic trial program has helped to inform changes in medical guidelines for treating adults with type 2 diabetes, such as the American Diabetes Association’s recommendations for managing diabetes.

Exenatide-based products are now marketed in more than 80 countries worldwide, and it is estimated that more than 2 million people have used exenatide products since the launch of BYETTA. Over the past 10 years, the GLP-1 receptor agonist class has grown to include five marketed products in the U.S.

Diabetes is projected to affect more than 592 million people by 2035. To help address the treatment needs of people with diabetes, AstraZeneca will continue to push the boundaries of science in an effort to create life-changing medicines. Additionally, AstraZeneca offers market-leading resources such as SteadySTART, a robust program that connects adults with type 2 diabetes with a live clinical educator, as well as Fit2Me™, a comprehensive, online, personalized diet and lifestyle support program.

WHAT IS BYETTA?

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise. BYETTA is not insulin and should not be taken instead of insulin. BYETTA can be used with Lantus® (insulin glargine), which is a long-acting insulin, but should not be taken with short- and/or rapid-acting insulin.

BYETTA should not be used in people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYETTA is not recommended for use in children. BYETTA has not been studied in people who have pancreatitis. BYETTA should not be used in people who have severe kidney problems.

IMPORTANT SAFETY INFORMATION for BYETTA

  • Do not take BYETTA if you have had an allergic reaction to exenatide or any of the other ingredients in BYETTA. Severe allergic reactions can happen with BYETTA. Symptoms of a severe allergic reaction include severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop taking BYETTA and get medical help right away.
  • Do not share your BYETTA Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before taking BYETTA, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop taking BYETTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away, occurs with or without vomiting or is felt going from your abdomen through to your back. These may be symptoms of pancreatitis.
  • Your risk for getting low blood sugar (hypoglycemia) is higher if you take BYETTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin medicine may need to be lowered while you use BYETTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
  • Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYETTA may cause new or worse problems with the way your kidneys work. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away, or if you cannot take liquids by mouth.
  • Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
  • The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation, and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.
  • Before using BYETTA, tell your doctor about all the medicines you take, as taking them with BYETTA may affect how each medicine works. Tell your healthcare provider if you take other diabetes medicines, especially insulin or a sulfonylurea, or birth control pills, an antibiotic, warfarin sodium (Coumadin® or Jantoven®), a blood pressure medicine, water pill, pain medicine, or lovastatin (Altoprev®, Mevacor®, or Advicor®). Take your birth control pills or antibiotics at least one hour before injecting BYETTA.
  • Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYETTA will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

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 click here for Medication Guide and click here for US Full Prescribing Information for BYETTA (exenatide) injection.

BYDUREON® (exenatide extended-release) for injectable suspension was approved by the U.S. Food and Drug Administration (FDA) in 2012 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BYDUREON should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. BYDUREON is not a substitute for insulin. The concurrent use of BYDUREON with insulin has not been studied and is not recommended.

IMPORTANT SAFETY INFORMATION for BYDUREON® (exenatide extended-release) for injectable suspension

  • POSSIBLE THYROID TUMORS, INCLUDING CANCER: Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In animal studies, BYDUREON and medicines that work like it caused thyroid tumors, including thyroid cancer. It is not known if BYDUREON will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
  • Do not use BYDUREON if you or any of your family members have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON.

BYDUREON may cause serious side effects, including:             

  • Inflammation of the pancreas (pancreatitis).Stop using BYDUREON and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
  • Low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or lightheadedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery
  • Kidney problems (kidney failure).Tell your healthcare provider if you have or had kidney problems. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse
  • Stomach problems.Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems digesting food. Other medicines like BYDUREON may cause severe stomach problems. It is not known if BYDUREON causes or worsens stomach problems
  • Serious allergic reactions.Stop using BYDUREON and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing
  • Injection-site reactions.Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgery. Call your healthcare provider if you have any symptoms of injection-site reactions, including severe pain, swelling, blisters, an open wound, or a dark scab

The most common side effects with BYDUREON may include nausea, diarrhea, headache, vomiting, constipation, itching at the injection site, a small bump (nodule) at the injection site, and indigestion. Nausea is most common when you first start using BYDUREON, but decreases over time in most people as their body gets used to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as taking them with BYDUREON may affect how each medicine works.

Before using BYDUREON, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other diabetes medicines, including insulin or sulfonylureas.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.

APPROVED USES for BYDUREON

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.

BYDUREON is not recommended as the first choice of medicine for treating diabetes.

BYDUREON is not a substitute for insulin and is not for people with type 1 diabetes or people with diabetic ketoacidosis.

BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used at the same time.

It is not known if BYDUREON can be used in people with a history of pancreatitis or if BYDUREON is safe and effective for use in children.

Please click here for Medication Guide, and click here for Full Prescribing Information for BYDUREON 2 mg, including Boxed WARNING about possible thyroid tumors including thyroid cancer.

3156200 Last Updated 8/15

The Journey of Having a Child with GERD

By Kristie Johnson, AstraZeneca Employee

My husband Ben and I have worked at AstraZeneca for 11 years and have a personal story that makes us grateful to work for the maker of the Purple Pill. Our son Cash spent his first months crying with what was initially diagnosed as colic. It’s not what we expected as new parents, to say the least.

On September 7, 2012, our beautiful baby boy, Cash, was born. At the time, there were no other children in our extended family so Cash was our parents’ first grandchild, our pride and joy. The first night we brought him home, we could not have been more excited. Our feelings turned to fear during the first week when Cash was constantly screaming, arching his back and wiggling, especially after feeding. His face was red and sweaty, and his fists were always balled up in discomfort. We felt helpless as we constantly rocked him and drove him around, doing anything and everything we could think of to soothe him. We sought answers by making an appointment with his pediatrician. The pediatrician diagnosed Cash with colic and told us it would last about six months.

The best way to describe the next year of our lives would be as house arrest; getting a full night of sleep and leaving the house with Cash were both out of the question. Our parents were too nervous to watch Cash because they felt helpless trying to calm him. Due to Ben’s family history of gastrointestinal problems and because of our work in the pharmaceutical industry, we refused to believe that Cash’s behavior and condition was normal. About two months into this journey, we decided to switch pediatricians. Our new pediatrician suggested a medication, but after it did not resolve the issues, he referred us to a pediatric gastroenterologist (GI).

Photo 1We were able to secure an appointment with a GI when Cash was one year old. During our visit, Cash was diagnosed with gastroesophageal reflux disease (GERD), more commonly known as acid reflux. The GI prescribed NEXIUM® (esomeprazole magnesium) Packets for Delayed-Release Oral Suspension, which is FDA-approved for use in children as young as one month old with complications of GERD. Within two days of Cash taking NEXIUM Packets, we saw dramatic changes. Cash stopped screaming and arching his back. He finally seemed comfortable. Thankfully for Cash, Ben and me, sleep came easily at last. Now nearing his third birthday, Cash is a happy, healthy young boy who no longer shows symptoms of GERD.

We are proud AstraZeneca employees and thankful parents. We feel strongly that all parents and caregivers should be aware of the signs and symptoms of GERD so that they’ll know when it might be time to consult their pediatrician or a specialist. We’re glad we were able to get the help our son needed with an accurate diagnosis and treatment for his symptoms.

 

About GERD

It is important to recognize that GERD is different than colic, or a “happy spitter.” While infants with colic may suffer from frequent bouts of crying, GERD is not a common cause of unexplained crying, irritability or distressed behavior. “Happy spitters” are also healthy-appearing with normal growth, but have painless regurgitation and do not show other infant-specific GERD warning signs. “Happy spitters” tend to grow out of recurrent regurgitation after 12 to 18 months. If you suspect symptoms of GERD in your child, make an appointment with your pediatrician for a diagnosis and to learn more about what treatment options are available.

Important Safety Information About NEXIUM® (esomeprazole magnesium) Packets

  • Symptom relief does not rule out the presence of other serious stomach conditions your child may have
  • NEXIUM may increase your child’s risk of getting severe diarrhea. Call your doctor right away if your child has watery stool, stomach pain and fever that does not go away
  • Talk to your doctor about your child’s risk for:
    • Bone fractures if your child takes multiple daily doses of NEXIUM for a long period of time
    • Low vitamin B12 if your child has been on NEXIUM for a long time (more than 3 years)
    • Low magnesium levels if your child takes NEXIUM for a long period of time
  • Tell your doctor about all the medicines your child takes, prescription and nonprescription drugs, including clopidogrel, vitamins and herbal supplements. NEXIUM may affect how other medicines work and other medicines may affect how NEXIUM works
  • In children 1 to 17 years of age, side effects with NEXIUM include headache, diarrhea, abdominal pain, nausea, and sleepiness
  • In infants aged 1 month to less than 1 year old, side effects with NEXIUM include abdominal pain, regurgitation, rapid breathing and abnormal liver blood tests

Approved Uses

NEXIUM is prescribed to treat the symptoms of acid reflux disease, which typically include persistent heartburn on 2 or more days per week, despite treatment and change of diet in patients 1 year of age and older.

For patients as young as 1 month of age, NEXIUM is also prescribed to heal damage to the esophagus called erosive esophagitis. This damage may be caused over time from stomach acid wearing away the lining of the esophagus. Only a doctor can diagnose this condition. With NEXIUM, most erosions heal in 4 to 8 weeks. Results with NEXIUM may vary.

Please see Prescribing Information.

Please see Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA by visiting www.FDA.gov/medwatch or calling 1-800-FDA-1088.

This product information is intended for US consumers only.

3129512    Last Updated 7/15

Help Your Child Cope with Asthma This Winter

While the winter brings plenty of fun activities—snowball fights, sledding, and snowmen—for children with asthma, the winter months can be difficult to deal with.

Asthma is a chronic disease that affects the airways in the lungs. When your child has an asthma attack, the airways become irritated and inflamed, making it more difficult for your child to breathe. Over 7 million children—or 1 out of 11 kids—suffer from asthma and it can be a serious health concern that can impact daily life.

The bitter cold temperatures and dry air of the winter months can worsen symptoms for children. Due to the change in temperature and air quality, children may experience increased asthma symptoms.

What To Look For

Symptoms of asthma include shortness of breath, tightness in the chest, wheezing, and chronic cough. When environmental factors impact your child, these symptoms may happen more frequently or more severely.

How You Can Help

Luckily, there are steps you can take to help while still allowing your child to enjoy winter activities.

  • Inside the home, replace the filters of your heating system to minimize dust and air pollutants
  • Place a humidifier in your child’s bedroom to moisten the dry winter air
  • When your child is playing outside, wrap a scarf around his mouth or have him wear a mask. This small covering will help filter and moisten the cold, dry air
  • Make sure your child takes regular breaks when playing to prevent overexertion and trouble breathing

If Your Child’s Symptoms Persist

If your child’s symptoms continue or worsen, consult with a doctor. Complete the asthma action plan guide; it will enable you and your doctor to develop an effective plan for your child, controlling symptoms effectively. This guide will help your doctor make an appropriate diagnosis and proper treatment recommendations.

One example of potential treatment is PULMICORT RESPULES® (budesonide inhalation suspension). PULMICORT RESPULES is an FDA-approved asthma maintenance medication created just for kids ages 12 months to 8 years to control and prevent asthma symptoms. PULMICORT RESPULES helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms. By breathing through a jet nebulizer connected to an air compressor with an adequate air flow, your child receives the medicine in his or her lungs. PULMICORT RESPULES is available in a once or twice-daily dosing option. It is available in 3 strengths: 0.25 mg/2 mL, 0.5 mg/2 mL, or 1 mg/2 mL.

Important Safety Information

PULMICORT RESPULES is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to PULMICORT RESPULES from an oral corticosteroid, follow the doctor’s instructions to avoid serious health risks when your child stops using oral corticosteroids.

Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.

Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.

Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.

Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.

Be sure to tell the healthcare provider about all your child’s health conditions and all medicines he or she may be taking.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.

The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.

For more information about PULMICORT RESPULES, visit http://www.pulmicortrespules.com or call 1-800-236-9933 (Monday – Friday 8 AM – 6 PM ET, excluding holidays) to speak directly with a nurse, who will answer any questions that you may have.

Maintain the Action Plan

Make sure your child consistently takes medication as prescribed. By minimizing asthma triggers and maintaining appropriate treatment recommendations, your child can enjoy the winter months and remain active. Talk to your doctor about what steps are right for your child.

Approved Use

PULMICORT RESPULES® (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

Please click here for full Prescribing Information for PULMICORT RESPULES.

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.

This product information is intended for US consumers only.

PULMICORT RESPULES is a registered trademark of the AstraZeneca group of companies.

©2015 AstraZeneca. All rights reserved.

3086203 Last Updated 1/15

Setting Your New Year Resolutions: Taking Care of Yourself

As the New Year quickly approaches, now is when we start thinking about improvements we want to make in various facets of our lives. Though losing weight and getting more exercise is often on many New Year’s resolution lists, we at AstraZeneca suggest adding one more important goal: check and control your blood pressure to help maintain your health.

High blood pressure, also known as hypertension, affects nearly 1 in 3 Americans. Many people don’t realize they have high blood pressure until it escalates and they have a heart attack or stroke.

What is blood pressure?

Blood pressure is the measure of the force of blood pressing against the walls of your arteries.

Your blood pressure is measured with a blood pressure cuff in millimeters of mercury (mm Hg) and is recorded as two numbers: the top number (the higher of the two) measures the pressure in the arteries when the heart beats. The bottom number measures the pressure in the arteries between heartbeats.

What is normal blood pressure?

For healthy adults, normal blood pressure is anything below 120/80 mm Hg. High blood pressure occurs when the blood traveling through your blood vessels push too hard against the artery walls. Depending on your overall health, blood pressure over 120/80 mm Hg may be considered high.

Talk to your own health care provider about normal blood pressure and the right range for you.

What causes high blood pressure?

The exact cause of high blood pressure isn’t known, but several factors are believed to play a role in its development, such as smoking, being overweight, lack of exercise, stress, genetics, and family history of high blood pressure.

Why should I be concerned about lowering my blood pressure?

If you have high blood pressure, you may feel just fine, but it’s still important to lower your levels. Lowering high blood pressure reduces the risk of heart-related problems like stroke or heart attack. That’s why it’s important to get your blood pressure checked regularly.

What can I do to improve my blood pressure?

If you’ve been diagnosed with high blood pressure, your doctor may recommend lifestyle changes to reduce your blood pressure, such as:

  • Losing weight
  • Exercising regularly
  • Eating a healthier diet, rich in fruits and vegetables
  • Reducing your sodium intake
  • Limiting alcohol consumption

Your doctor may also prescribe a medication like TOPROL-XL (metoprolol succinate) to treat your blood pressure.

Ring in the new year by keeping your health in mind! Celebrate 2015 by checking your levels and talking with your doctor about an appropriate treatment plan.

Important Safety Information About TOPROL-XL® (metoprolol succinate) Extended-Release Tablets

Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking TOPROL-XL suddenly. If your doctor decides you should stop taking TOPROL-XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.

TOPROL-XL may not be right for everyone, especially people who have the following health conditions:

  • Extreme slowing of the heart rate
  • Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally
  • Uncontrolled heart failure
  • Slowdown of the heart’s electrical signal causing a slower heart rate
  • Damage to the heart’s natural pacemaker that affects the heart’s rhythm unless one has a pacemaker device
  • Any allergies to TOPROL-XL or its ingredients

It is important to take your medications every day as directed by your doctor.

Patients who have asthma or asthma-like lung disease should, in general, not take TOPROL-XL.

Your doctor may not want you to take TOPROL-XL if you are currently taking certain types of high blood pressure medicine, or have adrenal gland tumors, diabetes, low blood sugar, liver damage, overactive thyroid disease, or hardening of the arteries in the arms or legs.

Your doctor may not want you to start taking TOPROL-XL if you are about to have any type of surgery.

If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking TOPROL-XL.

Until you know how you will react to TOPROL-XL, avoid activities that require alertness.

Contact your doctor if you have any difficulty in breathing.

In patients with high blood pressure, the most common side effects were tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, and slow heart rate. If you experience any of these or other side effects, contact your doctor.

Approved Use for TOPROL-XL

TOPROL-XL is approved for the treatment of high blood pressure. It may be used alone or in combination with other medications to treat high blood pressure. It’s good for you to know more about your medical condition and the medicine you are taking for it, so talk to your doctor about high blood pressure and TOPROL-XL.

Click here for full Prescribing Information, including Boxed WARNING about suddenly stopping therapy with TOPROL-XL.

For more information about TOPROL-XL, or to receive TOPROL-XL delivered right to your door, visit TOPROL-XL.com.

©2014 AstraZeneca. All rights reserved.

TOPROL-XL is a registered trademark of the AstraZeneca group of companies

3079402 Last Updated 12/14

US FDA Approves a New Force in the Fight Against Ovarian Cancer

One of the leading causes of ovarian cancer is an inherited genetic mutation in one of two genes known as BRCA1 and BRCA2. Of the 1.4 percent of all women who will develop ovarian cancer by 70 years of age, 39 percent will have a BRCA1 mutation and 11 to 17 percent a BRCA2 mutation.

Currently there is no test for early detection of ovarian cancer and many cases are discovered only after the cancer has progressed to an advanced stage, as many symptoms, such as bloating, abdominal or pelvic pain and trouble eating, are similar to those of everyday ailments. While the first defense against ovarian cancer is being aware of the symptoms, AstraZeneca has a new option to aid women with BRCA mutated (as detected by an FDA- approved test) advanced ovarian cancer who have had three or more rounds of chemotherapy fight against this disease.

Lynparza_Logo_Bigger_GenericThe U.S. Food and Drug Administration (FDA) has approved LYNPARZA™ (olaparib) capsules as a new treatment option. It is intended for use as monotherapy, meaning it can be used without any other concurrent treatment, in women living with advanced ovarian cancer described as deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) ovarian cancer, who have been treated with three or more prior lines (3L+) of chemotherapy. The indication is approved under accelerated approval based on objective response rates and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The most common side effects are  anemia, nausea or vomiting, tiredness or weakness, diarrhea, indigestion or heartburn, headache, loss of appetite, changes in how food tastes, changes in kidney function blood tests, sore throat or runny nose, upper respiratory infection, cough, pain in the joints, muscles, and back, rash, and pain or discomfort in the stomach area. See below for Important Safety Information.

LYNPARZA is the first approved PARP inhibitor for patients with gBRCA-mutated advanced ovarian cancer.

BRCA testing is required to determine eligibility for treatment with LYNPARZA, and major guidelines recommend that all patients with ovarian cancer be considered for BRCA testing. The Society of Gynecologic Oncology recommends that all women with ovarian cancer get tested for a BRCA mutation, because the results may impact future treatment decisions.

The approval of LYNPARZA strengthens AstraZeneca’s existing and growing oncology portfolio and reflects our ongoing commitment to fulfilling unmet needs in the gynecologic cancer community. Talk to your doctor about your own risks, and the possible benefits of genetic testing for you and your family.

Important Safety Information  

There are no contraindications for LYNPARZA.

LYNPARZA may cause serious side effects that can lead to death including bone marrow problems and lung problems. Some people who have ovarian cancer or who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed bone marrow problems called Myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML) during treatment with LYNPARZA. Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML.

You will undergo blood tests before, and every month during, treatment with LYNPARZA to monitor your blood cell counts. Symptoms to discuss with your healthcare provider include weakness, weight loss, fever, frequent infections, blood in your urine/stool, shortness of breath, feeling very tired, and bruising or bleeding more easily.

Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing.

Avoid pregnancy when taking LYNPARZA and tell your healthcare provider right away if you are, or think you have become, pregnant.

Avoid grapefruit, grapefruit juice and Seville oranges during treatment as they may increase the levels of LYNPARZA in your blood.

Click [here] for full Prescribing Information, including Patient Information (Medication Guide). 

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

3064817 Last Updated 12/14

The Importance of Access to Blood Pressure Medications

By Rick R. Suarez, Head of Mature Brands, AstraZeneca 

The health care industry is rapidly evolving including how patients access their medications. I am proud to share that one constant patients can count on in the ever-changing health care marketplace is AstraZeneca’s commitment to high quality manufacturing standards and ensuring access to important medications.

Did you know? •Beta blockers like Toprol-XL are mainstay medications for treating high blood pressure •Our patented microencapsulation technology allows for 24-hour extended release of the active ingredients to maintain consistent plasma levels in a once-daily dose.

Did you know?
• Beta blockers like Toprol-XL are mainstay medications for treating high blood pressure
• Our patented microencapsulation technology allows for 24-hour extended release of the active ingredients to maintain consistent plasma levels in a once-daily dose.

Ongoing access to medicines is extremely important when treating chronic conditions like cardiovascular diseases. Over the years, AstraZeneca has consistently demonstrated a commitment to this disease area. We know that millions of Americans suffer from cardiovascular diseases, and that one in three Americans live with hypertension or high blood pressure. Left untreated or under-treated, this disease can cause fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions.

Backed by our promise to patients, we are proud to continue to sell branded  TOPROL-XL® (metoprolol succinate)  and to manufacture the authorized generic version of metoprolol succinate for Par Pharmaceuticals.  With more than 22 years of proven safety and efficacy, TOPROL-XL has been at the forefront and remains an important treatment option for people with hypertension.

We also provide patients with access to resources like access to co-pay cards and patient assistance programs including our signature prescription savings program, AZ & Me, to make medicine more accessible and affordable.

As patients also seek convenient ways to get their medications, we recently announced that TOPROL-XL is available through AstraZeneca Direct,  a direct-to-patient program that will ship TOPROL-XL directly to patients’ homes at a discounted price. People who sign up for TOPROL-XL Direct can get it for as low as $10 a month for a 3-month supply (90 pills).

Pharmacist Packing Toprol XL 2At AstraZeneca, we have a history of delivering medicines that meet the needs of patients with cardiovascular diseases. And during a  time where there may be questions about the quality and availability of once-a-day extended-release hypertension medications,  we are committed to continued  safety and accessibility of these important medicines in multiple channels.

Click here for more information about TOPROL-XL Direct.

Important Safety Information About Toprol-XL® (metoprolol succinate) Extended-Release Tablets

Because of the possibility of serious side effects, such as chest pain or a heart attack, you should not stop taking TOPROL-XL suddenly. If your doctor decides you should stop taking TOPROL-XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.

TOPROL-XL may not be right for everyone, especially people who have the following health conditions:

  • Extreme slowing of the heart rate
  • Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally
  • Uncontrolled heart failure
  • Slowdown of the heart’s electrical signal causing a slower heart rate
  • Damage to the heart’s natural pacemaker that affects the heart’s rhythm unless one has a pacemaker device
  • Any allergies to TOPROL-XL or its ingredients

It is important to take your medications every day as directed by your doctor.

Patients who have asthma or asthma-like lung disease should, in general, not take TOPROL-XL.

Your doctor may not want you to take TOPROL-XL if you are currently taking certain types of high blood pressure medicine, or have adrenal gland tumors, diabetes, low blood sugar, liver damage, overactive thyroid disease, or hardening of the arteries in the arms or legs.

Your doctor may not want you to start taking TOPROL-XL if you are about to have any type of surgery.

If you have a history of serious allergic reactions, the usual dose of epinephrine (adrenaline) may not work as well if you are taking TOPROL-XL.

Until you know how you will react to TOPROL-XL, avoid activities that require alertness.

Contact your doctor if you have any difficulty in breathing.

In patients with high blood pressure, the most common side effects were tiredness, dizziness, depression, diarrhea, itching or rash, shortness of breath, and slow heart rate. If you experience any of these or other side effects, contact your doctor.

Approved Use for TOPROL-XL

TOPROL-XL is approved for the treatment of high blood pressure. It may be used alone or in combination with other medications to treat high blood pressure. It’s good for you to know more about your medical condition and the medicine you are taking for it, so talk to your doctor about high blood pressure and TOPROL-XL.

Click here for full Prescribing Information, including Boxed WARNING about suddenly stopping therapy with TOPROL-XL.

3018903 Last Updated 9/14

US FDA Approves MOVANTIK™ (naloxegol) Tablets C-II

On September 16, the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Movantik_US_CII_TM_5COpioids play an important role in chronic pain relief by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract. That is why patients taking opioids for chronic pain can develop OIC.

For patients who take opioids for chronic pain, constipation is one of the most common side effects, which can continue throughout their pain management therapy.  

MOVANTIK is expected to be available by prescription in pharmacies nationwide in the first half of 2015.

MOVANTIK strengthens AstraZeneca’s existing portfolio of medicines and aligns with our strategic focus on scientific leadership. AstraZeneca is dedicated to filling an unmet need for adult patients taking prescription opioids for chronic non-cancer pain who are experiencing OIC not adequately relieved by laxatives. It reflects our ongoing commitment to developing treatment options and supporting health care providers, patients and caregivers.

Important Safety Information for MOVANTIK

  • MOVANTIK is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation
    • Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
    • Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
  • Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
  • Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients.
  • The most common adverse reactions with MOVANTIK in clinical trials were: abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)

Please see full US Prescribing Information

http://www.azpicentral.com/movantik/movantik.pdf

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

3026008 Last Updated 9/14

 

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