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U.S. Department of Health and Human Services

Safety

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Jentadueto (linagliptin and metformin hydrochloride) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

May 2014

Summary View

4 CONTRAINDICATIONS

  • TRADJENTA is contraindicated in patients with a history of a hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.3 Hypersensitivity Reactions
  • There have been postmarketing reports of serious hypersensitivity reactions in patients treated with linagliptin (one of the components of JENTADUETO). These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with linagliptin, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue JENTADUETO, assess for other potential causes for the event, and institute alternative treatment for diabetes.

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions [see Warnings and Precautions (5.3)]

17 PATIENT COUNSELING INFORMATION

  • Inform patients that serious allergic reactions, such as anaphylaxis, angioedema, and exfoliative skin conditions, have been reported during postmarketing use of linagliptin (one of the components of JENTADUETO). If symptoms of allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JENTADUETO and seek medical advice promptly.

 

September 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.2 Pancreatitis
  • There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, of pancreatitis are at increased risk for the development of pancreatitis while using JENTADUETO.
5.5 Use with Medications Known to Cause Hypoglycemia

Linagliptin

  • Insulin secretagogues and insulin are known to cause hypoglycemia. The use of linagliptin in combination with an insulin secretagogue (e.g., sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial [see Adverse Reactions (6.1)]. The use of linagliptin in combination with insulin in subjects with severe renal
  • Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with JENTADUETO [see Dosage and Administration (2.2)].

Note: labeling changes align the Jentadueto label with the updated information in the current Tradjenta label

 

 

June 2013

Summary View

WARNINGS AND PRECAUTIONS

Pancreatitis
  • There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue 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 Jentadueto.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Acute pancreatitis, including fatal pancreatitis.
 

PATIENT COUNSELING INFORMATION

  • Inform patients that acute pancreatitis has been reported during postmarketing use of linagliptin. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Jentadueto promptly and contact their physician if persistent severe abdominal pain occurs.