The FDA ( Food and Drug Administration ) has approved updates to the full U.S. Prescribing Information ( PI ) for Tradjenta ( Linagliptin ) tablets and Jentadueto ( Linagliptin and Metformin hydrochloride ) tablets.
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.
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.
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.
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.
Tradjenta 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 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. It is not known if Jentadueto is safe and effective when used with Insulin. ( Xagena )
Source: Lilly, 2013