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FDA Approves Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (LLY)'s Tradjenta and Jentadueto Labeling to Reflect Pancreatitis Risk


6/21/2013 8:29:41 AM

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Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Announce Updates to Prescribing Information for TRADJENTA® (linagliptin) Tablets and JENTADUETO® (linagliptin and metformin hydrochloride) Tablets

RIDGEFIELD, Conn.
and INDIANAPOLIS, June 20, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) announce the U.S. Food and Drug Administration (FDA) has approved updates to the full U.S. Prescribing Information (PI) for TRADJENTA® (linagliptin) tablets and JENTADUETO® (linagliptin and metformin hydrochloride) tablets. These updates are part of ongoing efforts to update product labels to ensure physicians, pharmacists and patients have the information they need to use our medications appropriately. Information about pancreatitis was included in the adverse reactions sections of the original labels for these products; it is now displayed in additional sections of the PIs.1,2

As part of our ongoing commitment to patient safety, Boehringer Ingelheim and Lilly will issue a separate communication to prescribers of dipeptidyl peptidase 4 (DPP-4) inhibitors and pharmacists to inform them about the label updates.

The updates are the same for both products, and include the following changes to the respective PIs:

  • The Important Limitations of Use sections within the Indications and Usage sections, stating that TRADJENTA and JENTADUETO have not been studied in patients with a history of pancreatitis and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA or JENTADUETO.1,2
  • Inclusion of pancreatitis in the Warnings and Precautions section, stating there have been post marketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. Physicians should take careful notice of potential signs and symptoms of pancreatitis and if pancreatitis is suspected promptly discontinue TRADJENTA or JENTADUETO and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using TRADJENTA or JENTADUETO. 1,2 (For additional information regarding other DPP-4 inhibitors, please refer to the Warnings and Precautions sections in their labels.)
  • The Patient Counseling Information section was also updated. In addition to instructing healthcare providers to inform their patients about the potential risks and benefits of TRADJENTA or JENTADUETO, the potential risk and symptoms of pancreatitis were added.1,2

In addition, new information on post marketing experience was added to each label and the Patient Information leaflets have been replaced with Medication Guides for patients to read before taking TRADJENTA or JENTADUETO.

"Patient safety is our top priority at Boehringer Ingelheim and Lilly," said Sabine Luik, M.D., senior vice president, medicine & regulatory affairs, U.S. regional medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "We work closely with the U.S. FDA to ensure our labels give physicians, pharmacists and people living with diabetes the information they need to make informed decisions about our treatments and how to properly use them."

Physicians, pharmacists and their patients are encouraged to report any unexpected effects or problems with products made by Boehringer Ingelheim to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

TRADJENTA® (linagliptin) tablets is a once-daily 5 mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). If patients have had pancreatitis in the past, it is not known if they have a higher chance of getting pancreatitis while taking TRADJENTA. TRADJENTA is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.

JENTADUETO® (linagliptin and metformin hydrochloride) tablets is a prescription medicine that contains two 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). It is not known if JENTADUETO is safe and effective when used with insulin. 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.

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

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

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 tell 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 U.S. FDA. Visit www.fda.gov/medwatchor call 1-800-FDA-1088.

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

TJ CONS ISI 19JUNE2013

What is JENTADUETO?
JENTADUETO is a prescription medicine that contains two 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).

It is not known if JENTADUETO is safe and effective when used with insulin.

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.

JD CON ISI 19JUNE2013

To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

Please see Important Safety Information including Boxed Warning about the Risk of Lactic Acidosis, and full Prescribing Information, including Medication Guide for additional safety information.

About Diabetes
Approximately 25.8 million Americans3 and an estimated 371 million people worldwide4 have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.3 Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.5 Diabetes was estimated to cost the U.S. $245 billion in 2012.6

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three compounds representing several of the largest diabetes treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers through medicines and information for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions-from medicines to support programs and more-to make lives better.

For more information, visit www.lillydiabetes.com.

P-LLY

TJ568117

CONTACT:

Catherine London
Associate Director, Public Relations
Boehringer Ingelheim Pharmaceuticals, Inc.
Email: usnews@boehringer-ingelheim.com
Phone: (203) 798-4638

Tammy Hull
Communications Manager
Lilly Diabetes
Email: hullta@lilly.com
Phone: (317) 651-9116

References

  1. Tradjenta(r) (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.
  2. Jentadueto(r) (linagliptin and metformin hydrochloride) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011.
  3. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and pre-diabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention, 2011.
  4. International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
  5. International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: July 27, 2012.
  6. American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36(4):1033-1046.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

(Logo: http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )

SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.



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